Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional.
Normal auscultation as above by a health care professional who wears hearing aids.
To allow four other listeners (e.g. students) to listen together with a health care professional.

Device Description

An electronic stethoscope utilizing conventional stethoscope components but amplifying auscultated sounds by means of a 3 volt electronic circuit. An output jack is provided for headphone use. The stethoscope is controlled by a single button which turns the unit on and adjusts the amplitude through four levels.

AI/ML Overview

The provided document states that no clinical tests were performed for the GEMINI E Electronic Stethoscope.

Therefore, the following information cannot be extracted from the document:

A table of acceptance criteria and the reported device performance: Not applicable as no clinical tests were performed to establish performance metrics against acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is an electronic stethoscope, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The document indicates that the determination of substantial equivalence was based on non-clinical tests, specifically:

Emissions testing conducted by Acme Laboratories in Acme, Washington.
Safety testing in accordance with government requirements conducted by Intertek Testing Services in Laguna Niquel, California.

The conclusion states that the GEMINI E stethoscope is substantially equivalent to the Simulscope Bedside Auscultation System in its applications and that safety has been established through these non-clinical tests.

Summary

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K9
93623

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ALLEN MEDICAL INSTRUMENTS CORP.

505 Superior Avenue Newport Beach, CA 92663 949 (平中市) 646-3215 FAX (74) 646-5908

JUN 2 3 2000

510(K) SUMMARY

DATE SUMMARY PREPARED: 10/22/99

Submitter's Identification: 1.
Mrs. Judith Allen Vice President Allen Medical Instruments Corp. 505 Superior Avenue Newport Beach, CA 92663
1. Name of the Device:
  GEMINI E Electronic Stethoscope
1. Predicate Device Information:
  Simulscope Bedside Auscultation System
1. Device Description:
  An electronic stethoscope utilizing conventional stethoscope components but amplifying auscultated sounds by means of a 3 volt electronic circuit. An output jack is provided for headphone use. The stethoscope is controlled by a single button which turns the unit on and adjusts the amplitude through four levels.
ર. Indications for use:
- Normal auscultation of the cardiovascular system, pulmonary system or a) gastro-intestinal system by a healthcare professional.
- b) Normal auscultation as above by a healthcare professional who wears hearing aids.
- b) To allow four other listeners [e.g. students] to listen together with a healthcare professional.
1. Discussion of non-clinical tests performed for determination of substantial equivalence.

Emissions testing was conducted by Acme Laboratories in Acme, Washington. Safety testing in accordance with government requirements was conducted by Intertek Testing Services in Laguna Niquel, California.

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7. Discussion of clinical tests performed:

Non-applicable.

8. Conclusions:

Based on the above, the GEMINI E stethoscope is substantially equivalent to the Simulscope Bedside Auscultation System in it's applications. Safety has been established.

Tab 3 - Page 2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2000

Ms. Judith Allen, Vice President Allen Medical Instruments Corp. 505 Superior Ave. Newport Beach, CA 92663

K993623 Re: · Trade Name: GEMINI E Electronic Stethoscope Regulatory Class: II (Two) Product Code: 74 DQD May 18, 2000 Dated: May 22, 2000 Received:

Dear Ms. Allen:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 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, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2-Judith Allen

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 yours

sincerely yours,

Mark N Mulkerson

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

Enclosure

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INDICATIONS FOR USE

1. Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional.
1. Normal auscultation as above by a health care professional who wears hearing aids.
1. To allow four other listeners (e.g. students) to listen together with a health care professional.

for Mark N. Millhiser

(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devio 510(k) Number

Page 1 Tab 2 -

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.