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1 HID Medical Services Original Premarket 5 10(k) Notification HD Medical Services (India) Private Ltd 1 ~~~~~~~~~~~~#48, Industrial Estate IT Highway, Perungudi Chennai, , India Tel: Fax: ww.hcdmedicalgrou~p~ccr FDA CDRII DMIC 'JULL2'1?Ollo Received SUBMITTER INFORMATION Company Name: HD Medical Services (India) Pvt. LTD. Company Address: No. 48, Perungudi Industrial Estate IT Highway Perungudi, Chennai ZIP Company Phone: Company Fax: Contact Persons: S. Subramanlam Manager- Quality Management Date Summary Prepared: January 26, 2010 Page 5-I 5-4
2 C-to93l ) HD Medical Services Original Prernarket 510(k) Notification DEVICE IDENTIFICATION Common or Usual Name: Electronic Stethoscope, Cardiogram Trade/Proprietary Name: ViScope Classification: Class 11, 21 CFR , Product Code: DQD, DQC Performance Standard :None PREDICATE DEVICES: * CADI Tech AG CADIscope electronic ECU Stethoscope, K Dated 09/21/199 * 3M Healthcare Littman Electronic Stethoscope, Model 3200 with Zargis Sethassist Stware, K Dated 07/15/09 and K Dated 08/07/2009 DEVICE DESCRIPTION The (ViScope) is an audio-visual auscultation tool for quick and effective auscultation a patient to aid healthcare pressional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Cram (VPCG) with visual display on which heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dialwide) for hearing heart, lung, blood vessel, enteral and or body sounds with different frequency ranges. In addition, ViScope has an incorporated 'memory' feature that provides user with ability to review saved 4 waveforms. The user also has option to delete each waveform individually. The ViScope comes in two models, ViScope I1005 and ViScope l OOP. The models are same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that ViScope l OOP has ability to download data to a PC or printer, ViScope IJOOS does not fer this download feature. The ViScope l oop is supported by stware that can be installed in a PC. The user can see real-time waveforms on PC monitor (as live data) and record in 10 second intervals. The stware allows user with an option selecting entire 10 second signal or select Page
3 HD Medical Services Original Premarket 510(k) Notification any 3.5 seconds within 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The stware tools such as zoom, calipers, and player functions can be used on saved signals for furr analysis. The saved signals can be printed from PC or directly from ViScope l OOP. INDICATIONS FOR USE The ViScope is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part a physical assessment a patient by health care pressionals or or individuals trained to administer emergency first aid or orwise care for a patient. It can be used for amplification heart, lung, blood vessel, enteral and or body sounds. SUBSTANTIAL EQUIVALENCE The ViScope is substantially equivalent to following predicate devices: Predicate Manufacturer 510(k) No. Date SE Component Device Cleared CADlscope CADI Tech K /21/1999 -Indications for Use Electronic EGG AG -Visual Display Stethoscope -General Operation 3M Littman * 3M Healthcare K /15/09 -Indication for Use Model 3200 K /07/09 -Download Electronic capabilities Stethoscope with -General Operation Zargis Sethassist Stware* *The two devices are sold as a package. Page
4 )&tloo24 ~ I HD Medical Services Original Prentarket 510(k) Notification TECHNOLOGICAL CHARACTERISTICS A comparison technological characteristics ViScope and predicate devices has been performed. The results this comparison demonstrate that ViScope is substantially equivalent to marketed predicate devices in technological characteristics and performance requirements. PERFORMANCE DATA and CONCLUSION: The performance data indicate that Viscope meets specified requirements, and is substantially equivalent to predicate devices. Page
5 DEPARTMENT OF HEALTH & HUMAN SERVICES Public Hieali Ser vice Food arid Drug Administration Newv I ampshire Avenue ldocurment Control Roomn -W066-G609 Silver Spr ing. MD HD Medical Services PVT., LTD. c/o Mr. William H. Murphy Murphy & Associates Twinleaf Way San Diego, CA JUL Re: K Trade/Device Name: (models l OOP and I OOS) Regulation Number: 21 CFR Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD, DQC Dated: July 13, 2010 Received: July 14, 2010 Dear Mr. Murphy: We have reviewed your Section 510(k) premarket referenced notification above and intent have to market determined device device is substantially for use stated equivalent in enclosure) (for indications to legally marketed commerce Predicate prior devices to May marketed 28, 1976, in interstate enactment I devices date that have Medical been Device reclassified Amendnments, in accordance or to with and Cosmetic provisions Act (Act) that Federal do Food, not require Drug, approval You may, refore, a premarket market approval device, application subject (PMA). to general general controls controls provisions provisions Act include Act. The requirements devices, for good annual manufacturing registration, practice, listing labeling, and prohibitions adulteration. against misbranding and If your device is classified (see above) into eir class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in Code Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish furr announcements concerning your device in Federal Register.
6 Page 2 - Mr. William H. Murphy Please be advised that FDA's issuance a substantial equivalence determination does not mean that FDA has made a determination that your device complies with or requirements Act or any Federal statutes and regulations administered by or Federal agencies. You must comply with all Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in quality systems (QS) regulation (21 CFR Part 820); and if applicable, electronic product radiation control provisions (Sections Act); 21 CFR If you desire specific advice for your device on our labeling regulation (21 CER Part 801), please go tohtp/ ~ fagvao td/itesfie/c /D~~fie/cl5809.hitm for Center for Devices and Radiological Health's (CDRH's) Office Compliance. Also, please note regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part ). For questions regarding reporting adverse events under MDR regulation (21 CFR Part 803), please go to lit:/w~d~o/eia~vcssft/eo-arbe/eal~t for CDRH-'s Office Surveillance and Biometrics/Division Postmarket Surveillance. You may obtain or general information on your responsibilities under Act from Division Small Manufacturers, International and Consumer Assistance at its toll-free number (800) or (301) or at its Internet address httio:/hww.fda.gov/medicaldevices/resourcesforyou/industr-y/default1htm. Sincere yours, -k~bam DZuckerman, M.D Director Division Cardiovascular Devices Office Device Evaluation Center for Devices and Radiological Health Enclosure
7 HD Medical Services Original Prenmarket 510(k) Notification Indications for use IJ ~HD Medical Services (India) Private Ltd Lj -' ~~~~~~~~~~~~~~48, Industrial Estate ITHihwnai, 60005ungdia ITHihwnay6006,PeInudia Tel: Fax: ~~~~~~~~~~~~~ 510(k) Number: K Device Name: JUL Indications for Use Statement: The is a patented electronic stethoscope with an integrated graphics display to show amplified heart sounds as phonocardiograms. It is intended for use as a diagnostic aid as part a physical assessment a patient by health care pressionals or or individuals trained to administer emergency first aid or orwise care for a patient. It can be used for amplification heart, lung, blood vessel, enteral and or body sounds. Prescription Use Yes AN Over-The-Counter Use No (Part 21 CFR 8017 Subpart D) AD(21 CER 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence CDRH Office Device Evaluation (ODE) (Division Sign-Off) Division Cardiovascular Devices 510(k) Number..Ce ZX.\ Page 4-1
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