ADC 656 ELECTRONIC STETHOSCOPE

K012304 · American Diagnostic Corp. · DQD · Nov 1, 2001 · Cardiovascular

Device Facts

• Record ID: K012304
• Device Name: ADC 656 ELECTRONIC STETHOSCOPE
• Applicant: American Diagnostic Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: Nov 1, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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.

Device Story

Electronic stethoscope; amplifies acoustic sounds from heart, arteries, veins, and internal organs. Device consists of an electronic amplifying chestpiece and a headset assembly. Used by healthcare providers in clinical settings to assist in auscultation. Operates via electronic amplification principles to intensify sounds for the clinician. Benefits include improved sound clarity for diagnostic assessment.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Electronic stethoscope; amplifying chestpiece; headset assembly. Operates via electronic amplification. Designed for clinical use by healthcare providers. No specific materials or software architecture details provided.

Indications for Use

Indicated for healthcare providers to electronically amplify sounds associated with the heart, arteries, veins, and other internal organs. Not for use by the general public.

Regulatory Classification

Identification

Manual stethoscope: A mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs. Electronic stethoscope: An electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.

Special Controls

*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.

Predicate Devices

• Labtron Electromax (K961857)

Reference Devices

• ADC stethoscopes (K935544)

Submission Summary (Full Text)

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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

2. 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: [e-mail] 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:

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.

#### Comparison of Predicate Devices: 6.

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).

> 55 Commerce Drive Hauppauge, NY 11788 Customer Service: 1-800-ADC-2670 Voice: 1-516-273-9600 Fax: [phone] Email: [e-mail] 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: [phone] Email: [e-mail] http://www.mastermall.com/adc ΝΕΨ YORK • LONDON • ΤΑΙΡΕΙ • ΤΟΚΥΟ

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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 [phone]. First of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

I

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

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.

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: [phone] Email: [e-mail] http://www.mastermall.com/adc NEW YORK · LONDON · TAIPEI · TOKYO