(104 days)
935544
No
The description focuses on electronic amplification and comparison to predicate devices based on basic design, operation, and functionality, with no mention of AI or ML.
No
The device is used for listening and amplification of sounds, which is a diagnostic function, not a therapeutic one.
No
The device is an electronic stethoscope intended for listening and amplification of sounds, which is a tool for examination but does not provide a diagnosis.
No
The device description explicitly states it is an "Electronic Scope" with a "main amplifying chestpiece" and "headset assembly," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "listening and amplification of sounds associated with the heart, arteries, veins and other internal organs". This describes a device that interacts with the body externally to amplify sounds, not a device that analyzes samples taken from the body (like blood, urine, or tissue).
- Device Description: The description focuses on the physical design and functionality as an electronic stethoscope, comparing it to other stethoscopes.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any process that would involve testing in vitro (outside the living body).
The device is clearly described as an electronic stethoscope, which is a diagnostic tool used for auscultation (listening to internal body sounds), but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for 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.
American Diagnostic Corporation's number 656 Electronic Stethoscope indications for use as an electronic stethoscope which will electronically amplify sounds associated with the heart, arteries, veins and other internal organs.
Product codes (comma separated list FDA assigned to the subject device)
DQD
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, arteries, veins and other internal organs
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare providers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test: 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.
Clinical Test Performed: Non- Applicable
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
935544
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 /
1
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: 1-516-273-9659 Email: adcprod@aol.com http://www.mastermall.com/adc NEW YORK . LONDON . TAIPEI . TOKYO
2
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.
4
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.
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
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: 1-516-273-9659 Email: adcprod@aol.com http://www.mastermall.com/adc NEW YORK · LONDON · TAIPEI · TOKYO