The ViScope Electronic Stethoscope 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 of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.

Device Description

The ViScope Electronic Stethoscope (ViScope) is an audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional as necessary during patient care and/or for triage purposes. The ViScope is a Visual Phono Cardio Gram (VPCG) with visual display on which the heart sounds are represented as waveforms, which medical practitioners recognize and understand. The ViScope, similar to most electronic stethoscopes, has switchable modes (Bell/Dia/wide) for hearing heart, lung, blood vessel, enteral and other body sounds with different frequency ranges. In addition, the ViScope has an incorporated 'memory' feature that provides the user with the ability to review the saved 4 waveforms. The user also has the option to delete each waveform individually.

The ViScope comes in two models. the ViScope 100S and the ViScope 100P. The models are the same device (design, technology, operation, manufacture, use, labeling, etc). The only difference is that the ViScope 100P has the ability to download data to a PC or printer, the ViScope 100S does not offer this download feature. The ViScope 100P is supported by software that can be installed in a PC. The user can see the real-time waveforms on the PC monitor (as live data) and record in 10 second intervals. The software allows the user with an option of selecting the entire 10 second signal or select any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.

AI/ML Overview

The ViScope Electronic Stethoscope's acceptance criteria and the study proving it meets these criteria are described below. The device is intended to be a diagnostic aid as part of a physical assessment, using an integrated graphics display to show amplified heart sounds as phonocardiograms. It can amplify heart, lung, blood vessel, enteral, and other body sounds.

The device's performance was evaluated against predicate devices, specifically the CADI Tech AG CADIscope electronic ECG Stethoscope (K990809) and the 3M Healthcare Littman Electronic Stethoscope, Model 3200 with Zargis Sethassist Software (K083903 and K090493). The primary metric for acceptance was substantial equivalence to these predicate devices in terms of technological characteristics and performance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated or Implied)	Reported Device Performance
Substantial equivalence in technological characteristics to predicate devices	The ViScope meets specified requirements and is substantially equivalent to the predicate devices in technological characteristics.
Substantial equivalence in performance requirements to predicate devices	The ViScope meets specified requirements and is substantially equivalent to the predicate devices in performance requirements.
Functionality as an audio-visual auscultation tool	The ViScope is an audio-visual auscultation tool.
Ability to represent heart sounds as waveforms (phonocardiograms)	The ViScope displays heart sounds as waveforms.
Switchable modes (Bell/Dia/wide) for different frequency ranges	The ViScope has switchable modes for hearing various body sounds.
Memory feature to review saved waveforms	The ViScope incorporates a 'memory' feature for reviewing saved 4 waveforms.
Ability to download data to PC/printer (for 100P model)	The ViScope 100P has the ability to download data to a PC or printer.
Software for real-time waveform display and recording on PC (for 100P model)	The ViScope 100P is supported by software for real-time waveform display and recording.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify a numerical sample size for a test set in the context of clinical or performance data collection. Instead, it states that "PERFORMANCE DATA and CONCLUSION: The performance data indicate that the Viscope meets specified requirements, and is substantially equivalent to the predicate devices." This suggests that the evaluation was likely based on engineering testing, functional verification, and a comparative analysis of specifications against the predicate devices, rather than a clinical study involving a specific patient cohort for performance assessment.

Therefore, information on data provenance (country of origin, retrospective/prospective) is not applicable or provided within this document.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The substantial equivalence argument relies on a comparison of technological characteristics and performance requirements to existing legally marketed devices, rather than a clinical study requiring expert-established ground truth on patient cases.

4. Adjudication Method for the Test Set

Since a specific clinical test set and ground truth establishment by experts are not described, an adjudication method is not applicable or provided in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no indication that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission focuses on substantial equivalence based on technological and performance specifications rather than a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The ViScope is described as an "audio-visual auscultation tool for quick and effective auscultation of a patient to aid the healthcare professional," implying it is always used with a human in the loop. The device displays waveforms for medical practitioners to recognize and understand, and the software allows for further analysis by the user.

7. Type of Ground Truth Used

The concept of "ground truth" as typically understood in AI/medical imaging studies (e.g., pathology, outcomes data) is not directly applicable or specified in this 510(k) summary. The submission argues for substantial equivalence primarily based on design specifications, technological characteristics, and demonstrated performance (e.g., sound amplification, waveform display, memory function) that match or are comparable to predicate devices. The "ground truth" implicitly used for comparison would be the established performance and characteristics of the legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not applicable or provided. The ViScope is an electronic stethoscope that visualizes heart sounds; it is not presented as an AI/machine learning device that requires a training set in the conventional sense for algorithmic development.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable or provided for the same reason as above (not an AI/ML device requiring a training set).

Summary

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KIDOS31

HD Medical Services ViScope Electronic Stethoscope Original Premarket 510(k) Notification Summary of Safety and Effectiveness

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HD Medical Services (India) Private Ltd

48, Industrial Estate IT Highway, Perungudi Chennai, 600096, India Tel: +91 44 4215 4771 Fax: +91 44 4215 4772 www.hdmedicalgroup.com

FDA CDRH DMC

1/4

ນັ້ນ 2 2 201910 Received

Summary of Safety and Effectiveness ViScope Electronic Stethoscope

SUBMITTER INFORMATION

Company Name:

HD Medical Services (India) Pvt. LTD.

Company Address:

No. 48, Perungudi Industrial Estate IT Highway Perungudi, Chennai ZIP - 600096

Company Phone:

+91 44 4215 4771

Company Fax:

+91 44 4215 4772

Contact Persons:

S. Subramaniam Manager- Quality Management

January 26, 2010 Date Summary Prepared:

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જેવા

Original Premarket 510(k) Notification Summary of Safety and Effectiveness

DEVICE IDENTIFICATION

Common or Usual Name:	Electronic Stethoscope, Cardiogram
Trade/Proprietary Name:	ViScope
Classification:	Class II, 21 CFR 870.1875, 870.2390
Product Code:	DQD, DQC
Performance Standard :	None

PREDICATE DEVICES:

CADI Tech AG CADIscope electronic ECG Stethoscope, K990809 Dated 09/21/199 .
3M Healthcare Littman Electronic Stethoscope, Model 3200 with Zargis Sethassist . Software, K083903 Dated 07/15/09 and K090493 Dated 08/07/2009

DEVICE DESCRIPTION

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any 3.5 seconds within the 10 second signal for a more detailed view. These selected signals can be saved with patient name, auscultation region, along with age & sex. The software tools such as zoom, calipers, and player functions can be used on the saved signals for further analysis. The saved signals can be printed from the PC or directly from the ViScope 100P.

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 of a physical assessment of a patient by health care professionals or other individuals trained to administer emergency first aid or otherwise care for a patient. It can be used for the amplification of heart, lung, blood vessel, enteral and other body sounds.

SUBSTANTIAL EQUIVALENCE

The ViScope is substantially equivalent to the following predicate devices:

Predicate	Manufacturer	510(k) No.	DateCleared	SE Component
Device
CADIscopeElectronic ECGStethoscope	CADI TechAG	K990809	9/21/1999	-Indications for Use-Visual Display-General Operation
3M Littman Model 3200ElectronicStethoscope withZargis SethassistSoftware	3M Healthcare	K083903 K090493	07/15/0908/07/09	-Indication for Use-Downloadcapabilities-General Operation

The two devices are sold as a package.

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KL00531

પ્રીપ્

HD Medical Services ViScope Electronic Stethoscope Original Premarket 510(k) Notification Summary of Safety and Effectiveness

TECHNOLOGICAL CHARACTERISTICS

A comparison of the technological characteristics of the ViScope and the predicate devices has been performed. The results of this comparison demonstrate that the ViScope is substantially equivalent to the marketed predicate devices in technological characteristics and performance requirements.

PERFORMANCE DATA and CONCLUSION: The performance data indicate that the Viscope meets specified requirements, and is substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

HD Medical Services PVT., LTD. c/o Mr. William H. Murphy Murphy & Associates 11143 Twinleaf Way San Diego, CA 92131

JUL 2 1 2010

Re: K100531

Trade/Device Name: ViScope Electronic Stethoscope (models 100P and 100S)
Regulation Number: 21 CFR 870 1875 Regulation Number: 21 CFR 870.1875 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 notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications)
for use stated in the enclosure) to legally market aredicated a for use and in the enclosure) to legally marketed predicate devices marketed in indical commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food.
devices that have been reclassified in accordance with the provisions of the Federa and Cosmetic Act (Act (Act that do not require approval of the Federal Food, Joug,
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM You may, therefore, market the device, subject to the general controls provisions (PMA),
You may, therefore, market the device, subject to the general controls provisions of general controls provisions of the Act include requirements for annual registration, if the Act.
devices, good manufacturing practice, lebeling, ond mail registration, listin devices, good manufacturing practice, labeling, and prohibitions against misbranding and

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to addition (soc above) filio entrols) or class III (PMA)
may be subject to additional controls. Existing major regulations affective your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements, Thie 21, Parts 800 to 898. In addition
publish further announcements concerning your device in the Federal Register,

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Page 2 - Mr. William H. Murphy

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Original Premarket 510(k) Notification Indications for use

Image /page/6/Picture/3 description: The image shows a 3D rendering of an abstract shape. The shape is composed of rectangular and curved segments, creating an interlocking design. The color scheme appears to be grayscale, with variations in shading to emphasize the three-dimensional aspect of the structure. The overall impression is that of a modern, geometric sculpture.

HD Medical Services (India) Private Ltd

48, Industrial Estate IT Highway, Perungudi Chennai, 600096, India Tel: +91 44 4215 4771 Fax: +91 44 4215 4772 www.hdmedicalgroup.com

510(k) Number : K100531

Device Name: ViScope Electronic Stethoscope

JUL 21 2010

Indications for Use Statement:

Prescription Use Yes AND (Part 21 CFR 801 Subpart D)

Over-The-Counter
(21 CFR 801

Over-The-Counter Use No (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Cardiovascular Devices

510(k) Number	K100531
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Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.