Premarket Notification 510(k) Summary As required by section Datex Ohmeda S/5 Network and Central (icentral) '03 with L-NET03 Software

Transcription

1 NOV Pge 1 of5 KWJ 28/ Premrket Notifiction 510(k) Summry As required by section Dtex Ohmed S/5 Network nd Centrl (icentrl) '03 with L-NET03 Softwre GENERAL COMPANY INFORMATION s reuired bv ()(l) COMPANY NAME/ADDRESS/PHONE/FAX: Dtex-Ohmed 86 Pilgrim Rod Needhm, MA USA Tel: Fx: NAME OF CONTACT: Mr. Joel Kent DATE: October 10, 2003 DEVICE NAME s rewired bv ()(2) TRADE NAME: Dtex Ohmed S/5 Network nd Centrl (Centrl) '03 with L-NET03 Sohre COMMON NAME: Remote monitoring device CLASSIFICATION NAME: The following Clss I1 clssifiction ppers pplicble: MSX System, network nd communiction, physiologicl monitors NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE s required bv ()(3) The Dtex-Ohmed SI5 Network nd Centrl '03 is substntilly equivlent in sfety nd effectiveness to the Dtex-Ohmed S/5 Network nd Centrl '02 (5 10(k) number: K022507).

2 Pge 2 of 5 DEVICE DESCRIPTION s rewired by (#4) The Dtex-Ohmed S/5 Network (lso referred s D-0 Network in the relted documenttion) is system, which consists of networked devices (which hve seprte 510(k) clernce) nd the ctul networking hrdwre. The networked devices re Dtex-Ohmed products contining network dpter for physicl ccess to the D-0 Network s well s softwre modules supporting network ccess. Exmples of currently vilble networked devices re: 1. Dtex-Ohmed S/5 Anesthesi Monitor Dtex-Ohmed SI5 Compct Anesthesi Monitor Dtex-Ohmed SI5 Criticl Cre Monitor Dtex-Ohmed S/5 Compct Criticl Cre Monitor Dtex-Ohmed SI5 Light Monitor 6. Dtex-Ohmed S/5 Crdiocp 5 Monitor 7. Dtex-Ohmed SI5 Webviewer 8. Dtex-Ohmed SI5 Network nd Centrl, included in this 510(k) The DeioRecorder for Anesthesi (formerly nmed s Dtex-Ohmed AS/3 Record Keeper) is lso relted to the D-0 Network s n ppliction using the services provided by the D-0 Network. No chnges must be mde to the Dtex-Ohmed S/5 Network nd Centrl itself due to new type of networked device. As consequence, dding new types of Dtex-Ohmed devices to Dtex-Ohmed Network does not in ny wy ffect the sfety nd effectiveness of Dtex-Ohmed Network or Centrl, if the devices re using the sme protocol nd the sme design principles re followed s in the currently networked Dtex-Ohmed devices. The Dtex-Ohmed,515 Centrl (lso referred to s D-0 icentrl in the relted documenttion) is the primry mintiner of communiction between other networked devices nd is, thus, n essentil prt of the network. The structure nd functionlity of the revised network corresponds to the structure nd functionlity of the substntilly equivlent predicte device Dtex- Ohmed Network nd Centrl '02 (510(k) number: K022507). The Dtex-Ohmed Network will be used for rel-time communiction between devices, for record keeping nd for dt mngement in hospitl. Prcticl exmples of currently vilble fetures re: Trnsmission nd disply of mesured vlues nd lrms in the Dtex-Ohmed S/5 icentrl screen (centrl monitoring) nd on the screen of nother networked monitor (monitor-to-monitor communiction). Anesthesi record keeping. Storing nd trnsferring of trend nd record keeping dt in the network. When the ptient is moved from one monitor to nother, the dt cn be trnsferred with the ptient. This feture includes lso trnsferring dt frodto n externl system (HIS, lbortory, etc.) to/from Dtex-Ohmed S/5 Network. Printing of nesthesi records, ICU reports, trend printouts, spirometry loop printouts, wveform snpshot printouts, etc. The ctul networking hrdwre consists of cbling, ptch pnels, rcks, connectors, repeters, ccess points with ntenns etc. The networking hrdwre is similr to the networking hrdwre of the substntilly equivlent predicte device Dtex-Ohmed Network nd Centrl '02 (5 10(k) number: K022507).

3 Pge 3 of 5 k033;28/ INTENDED USE s rewired bv (X5) Intended use: The Dtex-Ohmed S/5 Network nd Centrl is intended to be used with Dtex-Ohmed devices for displying, storing, printing nd otherwise processing informtion received from other networked devices. Indiction for use: The Dtex-Ohmed S/STM Network nd Centrl trnsfers informtion between networked Dtex- Ohmed devices in the Dtex-Ohmed monitor network. It lso llows informtion trnsfer between severl icentrls. Within one Dtex-Ohmed monitor network it llows networked device to disply, store, print nd otherwise process informtion received from other networked devices. The Dtex-Ohmed S/STM icentr1 mintins the network connections between the Dtex- Ohmed bedside monitors nd other networked devices in Dtex-Ohmed monitor network. Network connections consist of hrdwired network cbles nd/or Wireless LAN (WLAN) connections. Furthermore, it coordintes the trnsfer of informtion between devices in the Dtex- Ohmed S/STM Network s well s between the Dtex-Ohmed Network nd Hospitl Informtion Systems (HIS). The Dtex-Ohmed S/STM Centrl cn be used for remote monitor mngement, storing, printing, viewing, reviewing or otherwise processing of informtion from severl bedside monitors or other networked devices. The Dtex-Ohmed S/STM Network will be used for ptients in the hospitl nd it is ment for continuous use. The device is for use by qulified personnel only.

4 Pge 4 of 5 KO3328 / SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE s required by (M6) The Dtex-Ohmed SI5 Network nd Centrl 03 is substntilly equivlent in sfety nd effectiveness to the Dtex-Ohmed SI5 Network nd Centrl 02 (5 10(k) number: K022507) currently in distribution Similrities: The indictions for use re the sme s in the predicte except tht reviewing hs been expressed in the sttement nd the SI5 Viewsttion hs been removed. The structure nd functionlity of the Dtex-Ohmed S/5 Network nd Centrl 03 closely corresponds to the structure nd hnctionlity of the Dtex-Ohmed Network nd Centrl 02 (predicte). The bsic rchitecture of Dtex- Ohmed S/5 Network nd Centrl 03 is the sme s tht of Dtex-Ohmed Network nd Centrl 02 (predicte), The user interfce, lthough n entirely new one, uses the sme bsic functionlity s with the predicte: multiple ptient views with the possibility to select single ptient for more detiled exmintion. Most lrm functionlities in the new SI5 Centrl nd the predicte re identicl. Differences: The user interfce hs been redone nd it s now written using Microsoft Windows UI services. Severl enhncements hve been implemented to the UI e.g. multiple orgn-specific single ptient views re now offered. Also new prmeters such s 12-led ECG with ST vlues, EEG, NMT, Entropy, V02kg nd V02/m2 hve been mde vilble on the Centrl. Full Disclosure nd Event History for ll ptients hs been dded with the respective UI prts. Also the trend disply hs been improved lthough it still uses the methods proven in the predicte device. Alrm mngement hs been improved by introducing monitor groups so tht multiple sets of monitors with seprte lrm settings cn now be defined. Also, if monitor disconnects bnormlly from the network yellow lrm is produced in SI5 icentrl insted of the disconnection notifiction used in the predicte. New printouts with the possibility to store the printout s PDF file hs been dded. These new printouts re Admission informtion, 12-led ECG, grphicl nd numericl trends nd full disclosure. The licensing hs been ltered to be softwre bsed insted of the predicte hrdwre bsed scenrio. This hs lso enbled D-0 to strt licensing softwre fetures nd not only the mount of monitors tht re llowed to connect to centrl sttion. The offered licenses tht cn be purchced to ctivte fetures in the softwre re Trends nd Alrm Mngement, Event History s well s Full Disclosure for either 28 or 72hrs. Browser ctivtion hs been mde vilble to llow users to ccess e.g. hospitl Intrnet right from the centrl sttion. Also viewing the generted PDF printouts is implemented utilizing the browser. Summry: In summry, the new Dtex-Ohmed SI5 Network nd Centrl, described in this submission is substntilly equivlent to the predicte device (K022507).

5 Pge 5 of 5 ~ ~ 3i 3 SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE nd CONCLUSIONS s required by (bM 1M3) Dtex Ohmed S/5 Network nd Centrl (Centrl) '03 with L-NET03 Softwre complies with the sfety stndrds below nd is therefore sfe nd effective for the intended use. The device hs been thoroughly tested through vlidtion nd verifiction of specifictions. Verifiction of complince with the following mndtory nd voluntry stndrds hs been mde: EN60950: 2000 (IEC rd edition) - Product Sfety EN 55022: 1998 (IEC-CISPR 22) -Rdio Frequency Interfce EN 55024: IT Equipment -Immunity chrcteristics EMC Directive 89/336/EEC (including mendments) Low Voltge Directive 73/23/EEC(mended by 93/68/EEC) EN 1441, Medicl devices - Risk nlysis EN 475, Medicl devices - Electriclly-generted lrm signls IS , IS , Anesthesi nd respirtory cre lrm signls IEC Medicl electricl equipment. Prt 1: Generl requirements for sfety 4. Collterl Stndrd: Sfety requirements for progrmmble medicl systems. CANKSA-C22.2 No 950: Informtion Technology Equipment Including Electricl Business Equipment UL 1950: Informtion Technology Equipment Including Electricl Business Equipment FDNODE Guidnce for the Content of Premrket Submission for Sohre Contined in Medicl Devices, My 29,1998 FDA/ODE Guidnce for the Off-The-Shelf Softwre Use in Medicl Devices, September 9, 1999 ISOAEC (ANSIAEEE 802.3),EIA/TIA-568, EIA/TIA-TSB40,interntionl network cbling stndrds ETS ( ) - Rdio Widebnd Systems CONCLUSION: The summry bove shows tht there re no new questions of sfety nd effectiveness for the Dtex Ohmed S/5 Network nd Centrl (Centrl) '03 with L-NET03 Softwre s compred to the predicte device.

6 DEPARTMENT OF HEALTH &HUMAN SERVICES Public Helth Service NOV Food nd Drug Administrtion 9200 Corporte Boulevrd Rockville MD Dtex Ohmed c/o Mr. Joel C. Kent Mnger, Qulity & Regultory Affirs 86 Pilgrim Rod Needhm, MA Re: KO33281 Trde Nme: Dtex-Ohmed S/5 Network nd icentrl '03 Regultion Number: 21 CFR Regultion Nme: System, Network & Communiction, Physiologicl Monitors Regultory Clss: Clss I1 (two) Product Code: MSX Dted: October 10, 2003 Received: October 14,2003 Der Mr. Kent: We hve reviewed your Section 5 1 O(k) premrket notifiction of intent to mrket the device referenced bove nd hve determined the device is :ubstntilly equivlent (for the indictions for use stted in the enclosure) to leglly mrketed predicte devices mrketed in interstte commerce prior to My 28, 1976, the enctment dte of the Medicl Device Amendments, or to devices tht hve been reclssified in ccordnce with the provisions of the Federl Food, Drug, nd Cosmetic Act (Act) tht do not require pprovl of premrket pprovl ppliction (PMA). You my, therefore, mrket the device, subject to the generl controls provisions of the Act. The generl controls provisions of the Act include requirements for nnul registrtion, listing of devices, good mnufcturing prctice, lbeling, nd prohibitions ginst misbrnding nd dultertion. If your device is clssified (see bove) into either clss I1 (Specil Controls) or clss I11 (PMA), it my be subject to such dditionl controls. Existing mjor regultions ffecting your device cn be found in the Code of Federl Regultions, Title 2 1, Prts 800 to 898. In ddition, FDA my publish further nnouncements concerning your device in the Federl Register.

7 Pge 2 - Mr. Joel C. Kent Plese be dvised tht FDA s issunce of substntil equivlence determintion does not men tht FDA hs mde determintion tht your device complies with other requirements of the Act or ny Federl sttutes nd regultions dministered by other Federl gencies. You must comply with ll the Act s requirements, including, but not limited to: registrtion nd listing (21 CFR Prt 807); lbeling (21 CFR Prt Sol); good mnufcturing prctice requirements s set forth in the qulity systems (QS) regultion (21 CFR Prt 820); nd if pplicble, the electronic product rdition control provisions (Sections of the Act); 2 1 CFR This letter will llow you to begin mrketing your device s described in your Section 5 1 O(k) premrket notifiction. The FDA finding of substntil equivlence of your device to leglly mrketed predicte device results in clssifiction for your device nd thus, permits your device to proceed to the mrket. If you desire specific dvice for your device on our lbeling regultion (2 1 CFR Prt 80 l), plese contct the Office of Complince t (301) Also, plese note the regultion entitled, Misbrnding by reference to premrket notifiction (21 CFR Prt ). You my obtin other generl informtion on your responsibilities under the Act from the Division of Smll Mnufcturers, Interntionl nd Consumer Assistnce t its toll-free number (800) or (301) or t its Internet ddress Sincerely yours, Director Division of Crdiovsculr Devices Office,of Device Evlution Center for Devices nd Rdiologicl Helth Enclosure

8 510(k) Number (if known): Device Nme: Dtex-Ohmed S/5 Network nd icentrl O3 Indictions For Use: The Dtex-Ohmed S /F Network nd Centrl trnsfers informtion between networked Dtex-Ohmed devices in the Dtex-Ohmed monitor network. It lso llows informtion trnsfer between severl icentrls. Within one Dtex-Ohmed monitor network it llows networked device to disply, store, print nd otherwise process informtion received from other networked devices. The Dtex-Ohmed S/STM Centrl mintins the network connections between the Dtex-Ohmed bedside monitors nd other networked devices in Dtex-Ohmed monitor network. Network connections consist of hrdwired network cbles nd/or Wireless LAN (WLAN) connections. Furthermore, it coordintes the trnsfer of informtion between devices in the Dtex-Ohmed S/STM Network s well s between the Dtex-Ohmed Network nd Hospitl Informtion Systems (HIS). The Dtex-Ohmed S/STM Centrl cn be used for remote monitor mngement, storing, printing, viewing, reviewing or otherwise processing of informtion from severl bedside monitors or other networked devices. The Dtex-Ohmed S /P Network will be used for ptients in the hospitl nd it is ment for continuous use. The device is for use by qulified personnel only. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of De*ice Evlution (ODE) Prescription Use x (Per 21 CFR ) OR Over-The-Counter Use (Optionl Formt ) 51 O(k) Number k 0 3%-t( Revised :45 EET OST MI REG-DECL, D-0 S15 Network nd Centrl 03: Indictions for Use, 0-0, For S15 icentrl 1st relese (mde ) Reproduced from the electronic miler in MAlRlX