GEMINI E

K993623 · Allen Medical Instruments Corp. · DQD · Jun 23, 2000 · Cardiovascular

Device Facts

• Record ID: K993623
• Device Name: GEMINI E
• Applicant: Allen Medical Instruments Corp.
• Product Code: DQD · Cardiovascular
• Decision Date: Jun 23, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1875
• Device Class: Class 2

Intended Use

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 Story

GEMINI E Electronic Stethoscope is an electronic auscultation device. It utilizes conventional stethoscope components integrated with a 3-volt electronic circuit to amplify sounds. The device features a single-button interface for power and four-level amplitude adjustment. An output jack supports headphone connectivity for the user and additional listeners. Used by healthcare professionals in clinical settings to facilitate cardiovascular, pulmonary, and gastro-intestinal examinations. The amplification capability assists clinicians with hearing impairments and supports educational environments by allowing multiple listeners to hear the same auscultated sounds simultaneously.

Clinical Evidence

No clinical data. Substantial equivalence determined via bench testing, including emissions testing and safety testing conducted by third-party laboratories.

Technological Characteristics

Electronic stethoscope; 3-volt electronic circuit for sound amplification; four-level amplitude adjustment; single-button control; output jack for headphones; conventional stethoscope chest piece components.

Indications for Use

Indicated for healthcare professionals, including those using hearing aids, to perform auscultation of cardiovascular, pulmonary, or gastro-intestinal systems, and to facilitate group listening for up to four additional individuals (e.g., students).

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

• Simulscope Bedside Auscultation System

Submission Summary (Full Text)

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| 93623 |

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### ALLEN MEDICAL INSTRUMENTS CORP.

505 Superior Avenue Newport Beach, CA 92663 949 (平中市) 646-3215 FAX [phone]

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

- 2. Name of the Device:
GEMINI E Electronic Stethoscope

- 3. Predicate Device Information:
Simulscope Bedside Auscultation System

- 4. 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.
- 6. 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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.
- 2) Normal auscultation as above by a health care professional who wears hearing aids.
- 3) 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

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