For listening and amplification of sounds associated with the heart, arteries, veins and other internal organs, using the principles of electronic amplification to intensify the acoustical sounds of the device.

American Diagnostic Corporation's number 656 Electronic Stethoscope indications for use as an electronic stethoscope which will electronically amplfy sounds associated with the heart, arteries, veins and other internal organs. American Diagnostic intends to provide this device for use by healthcare providers and not for use by the general public.

Device Description

ADC #656BK Electronic Scope

Basic design is identical in both operation and functionality to the Graham-Field Healthcare Products, Labtron Electronmax (510(k) K961857). The main amplifying chestpiece is identical to the Graham-Field Healthcare Products stethoscope in design, function and performance. The headset assembly is identical to one used on numerous other ADC stethoscopes (510(k) 935544).

AI/ML Overview

The provided documentation for the ADC 656 Electronic Stethoscope does not include specific acceptance criteria or a study proving that the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Graham-Field Healthcare Products Electronic Stethoscope Model: Labtron Electromax, 510(k) number: K961857).

Here's an breakdown based on the information available:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria or reported device performance metrics are provided in these documents. The submission relies on demonstrating that the ADC 656 Electronic Stethoscope is functionally and operationally identical to its predicate device.

2. Sample sized used for the test set and the data provenance

No test set or associated sample size is mentioned for a performance study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable, as no performance study with a test set and ground truth establishment is described.

4. Adjudication method for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electronic stethoscope, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, and its function involves human operation. There is no mention of an "algorithm only" performance.

7. The type of ground truth used

Not applicable, as no performance study is detailed.

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device that would require a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Device's Approval Process (based on the provided text):

The ADC 656 Electronic Stethoscope gained clearance through the 510(k) pathway by demonstrating substantial equivalence to a predicate device.

Rationale for Substantial Equivalence: The submission states that the basic design, operation, functionality, and the main amplifying chestpiece are identical to the predicate device (Graham-Field Healthcare Products, Labtron Electromax, K961857). The headset assembly is also noted as being identical to one used on numerous other ADC stethoscopes (510(k) 935544).
Non-Clinical Testing: The submission mentions that testing information substantiating safety and effectiveness was conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submission" and DCRND outlining electrical, mechanical, and environmental performance standards. However, the specific results or details of these tests are not included in the provided excerpt.
Clinical Testing: The document explicitly states "Non-Applicable" for clinical tests performed. This is common for devices seeking 510(k) clearance where substantial equivalence can be demonstrated through non-clinical data and comparison to a legally marketed predicate device.

In essence, the "study" that proves the device meets requirements is the demonstration of its likeness to a previously cleared device, backed by non-clinical engineering and performance tests (though details of these specific tests are not given beyond their adherence to FDA guidelines). The FDA's clearance letter (K012304) confirms that based on the provided information, the device was found to be substantially equivalent to the predicate.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for American Diagnostic Corporation. The logo is made up of the letters ADC in a stylized font. The letters are made up of horizontal lines. The words "AMERICAN DIAGNOSTIC CORPORATION" are printed below the logo in a smaller font.

NOV 0 1 2001

Exhibit #1 Page 1 of 3

510 (k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

1. Submitter's Identification:

Mr. Marc Blitstein President American Diagnostic Corporation 55 Commerce Drive Hauppauge, NY 11788

Date Summary Prepared: April 16, 2001

Name of the Device:

ADC 656 Electronic Stethoscope.......

SK27

55 Commerce Dri Hauppauge, NY 11788 Customer Service: 1-800-ADC-2 Voice: 1-516-273-Fax: 1-516-27 Email: adcprod@aol.com http://www.mastermall.com/adc NEW YORK · LONDON · TAIPEI · TOKYO

173607 HUGO /

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Image /page/1/Picture/0 description: The image shows the logo for American Diagnostic Corporation. The logo is made up of a stylized "ADC" in a bold, black font. The letters are formed by horizontal lines, giving the logo a modern and geometric look. Below the logo, the full name of the company, "AMERICAN DIAGNOSTIC CORPORATION," is printed in a smaller, sans-serif font.

Exhibit #1 Page 2 of 3

Predicate Device Information: 3.

Graham-Field Healthcare Products Electronic Stethoscope Model: Labtron Electromax 510(k) number: K961857

Device Description: 4.

ADC #656BK Electronic Scope

5. Intended Use:

Comparison of Predicate Devices: 6.

55 Commerce Drive Hauppauge, NY 11788 Customer Service: 1-800-ADC-2670 Voice: 1-516-273-9600 Fax: 1-516-273-9659 Email: adcprod@aol.com http://www.mastermall.com/adc NEW YORK . LONDON . TAIPEI . TOKYO

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Image /page/2/Picture/0 description: The image shows the logo for American Diagnostic Corporation. The logo is made up of the letters ADC in a stylized font. The letters are made up of horizontal lines, and the word "AMERICAN DIAGNOSTIC CORPORATION" is written below the letters in a smaller font. The logo is black and white.

Exhibit #1 Page 3 of 3

Discussion of Non-Clinical Test Performed for Determination of Substantial 7. Equivalence are as follows :

Testing information substantiating safety and effectiveness of the ADC 656BK Electronic Scope in the intended environment of use is supported by testing conducted in accordance with FDA's guidelines "Reviewer Guidance for PMN Submission". DCRND outlining electrical, mechanical and environmental Performance standards.

Discussion of Clinical Test Performed: 8.

Non- Applicable

9. Conclusion:

Based upon the previous information, the ADC 656BK Electronic Scope is substantially equivalent to the Graham-Field Healthcare Products Labtron Electromax Electronic Stethoscope. Both safety and effectiveness have been established.

55 Commerce Drive Hauppauge, NY 11788 Customer Service: 1-800-ADC-2670 Voice: 1-516-273-9600 Fax: 1-516-273-9659 Email: adcprod@aol.com http://www.mastermall.com/adc ΝΕΨ YORK • LONDON • ΤΑΙΡΕΙ • ΤΟΚΥΟ

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 1 2001

Mr. Marc Blitstein President/CEO American Diagnostic Corporation 55 Commerce Drive Hauppauge, NY 11788

Re: K012304

Trade Name: ADC 656 Electronic Stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Electronic Stethoscope Regulatory Class: Class II (two) Product Code: DQD Dated: August 13, 2001 Received: August 21, 2001

Dear Mr. Blitstein:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Security (10). "I substantially equivalent (for the indications
referenced above and have determined the device is substantials in interstate referenced above and nave decimined the arrests as a cases of the marketed in interstate for use stated in the encrosule, to regally mancess promotion Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1976, the characters and stars of the Federal Food. Drug, devices that have been reciassince in accerdance what a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the Act . and Cosment Act (Act) that to hot require approvial controls provisions of the Act. The You may, therefore, market the device, because to the genirements for annual registration, listing of
eneral controls provisions of the Act include requirements for annual re general controls provisions of the rict merator requirement misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (secrative major regulations affecting your device can
may be subject to such additional controls. Existing major regulation EDA may may be subject to such additional controller Entralians of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts 800 to 898 may be found in the Code of Poderal Regarities in the Federal Register.

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Page 2 - Mr. Marc Blitstein

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least be advised that I Drivedants or our device complies with other requirements of the Act that I DA has made a ceculations administered by other Federal agencies. You must or any I catal statutes and regulations .including, but not limited to: registration and listing (21 comply with an the 11ct 810 care manses (01); good manufacturing practice requirements as set CTN Fat 807), ademig (21 CFR Part 820), and if applicable, the electronic forth in the quality by stone (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter with anow you to ogen maing of substantial equivalence of your device to a legally promated predicated device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and 11 you desire specific acrise for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Further 646. Additionally, for questions on the promotion and advertising of Compliance at (301) 591-1010. First of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general miormation on your and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

n James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/5/Picture/0 description: The image shows the logo for the American Diagnostic Corporation. The logo is made up of the letters ADC in a stylized font. The letters are made up of horizontal lines, and the words "AMERICAN DIAGNOSTIC CORPORATION" are printed below the logo in a smaller font. The logo is black and white.

NOV 0 1 2001

K012304

August 13, 2001

Indications for Use

Device Name: ADC 656 Electronic Stethoscope 510k: K012304

Sincerely AMERICAN DIGNOSTIC CORP.

Marc Blitzstein

Marc Blitstein President/CEO

Division of Cardiovascular & Respiratory Devices
510(k) Number R012304

Prescription Use
(Per 21 CFR 801.109)

55 Commerce Drive Hauppauge, NY 11788 Customer Service: 1-800-ADC-2670 Voice: 1-516-273-9600 Fax: 1-516-273-9659 Email: adcprod@aol.com http://www.mastermall.com/adc NEW YORK · LONDON · TAIPEI · TOKYO

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.