(241 days)
Not Found
Not Found
No
The description focuses on electronic amplification and basic controls, with no mention of AI/ML terms or functionalities.
No.
The device is used for diagnostic purposes (auscultation) and sound amplification, not for treating any condition or disease.
No
Explanation: The device is described as an electronic stethoscope intended for normal auscultation, which is the act of listening to sounds from the body, typically for medical diagnosis. While auscultation is a diagnostic technique, the device itself, as described by its intended use and function (amplifying sounds), does not perform a diagnosis. It is a tool that aids a healthcare professional in performing auscultation, but it does not analyze the sounds or output a diagnostic conclusion.
No
The device description explicitly states it utilizes "conventional stethoscope components" and a "3 volt electronic circuit," indicating it is a hardware device with electronic amplification, 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 "Normal auscultation of the cardiovascular system, pulmonary system or gastro-intestinal system by a health care professional." This involves listening to sounds within the body, which is a physical examination technique, not a test performed on samples taken from the body.
- Device Description: The device is an electronic stethoscope that amplifies sounds. It does not involve the analysis of biological samples (like blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
IVDs are devices used to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. This electronic stethoscope does not fit that definition.
N/A
Intended Use / 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.
Product codes
74 DQD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiovascular system, pulmonary system, gastro-intestinal system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professional
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
Non-applicable.
Key Metrics
Not Found
Predicate Device(s)
Simulscope Bedside Auscultation System
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
| K9 |
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| 93623 |
Image /page/0/Picture/22 description: The image is a black and white graphic. The graphic is a triangular shape in the lower right corner of the image. There are two white lines that run parallel to the edge of the triangle.
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 -
- Name of the Device:
GEMINI E Electronic Stethoscope
- Name of the Device:
-
- Predicate Device Information:
Simulscope Bedside Auscultation System
- Predicate Device Information:
-
- 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.
- Device Description:
-
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.
-
- 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.
1
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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2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a symbol. The symbol consists of a stylized caduceus-like design with three human profiles facing right, representing health and human services. The profiles are connected by a flowing ribbon-like element, creating a sense of unity and movement.
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.
3
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
4
INDICATIONS FOR 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.
for Mark N. Millhiser
(Division Sign-Off) Division of Cardiovascular, Re and Neurological Devio 510(k) Number
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