(38 days)
Not Found
Not Found
No
The summary describes a simple physical device (ear plugs) with no mention of software, data processing, or AI/ML terms.
No
The device, Silicone Putty Ear Plugs, is intended to block water from entering the ear canal, which is a preventative rather than a therapeutic action. It does not treat or cure a disease or condition.
No
The intended use of Silicone Putty Ear Plugs is to block water from entering the ear canal, which is a protective function, not a diagnostic one. They do not analyze or identify medical conditions.
No
The device description clearly states "Silicone Putty Ear Plugs," which are a physical, hardware product, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "block water from entering the ear canal." This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: "Silicone Putty Ear Plugs" describes a physical object, not a reagent, instrument, or system used for in vitro examination of specimens.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening
IVDs are used to perform tests outside of the body on samples taken from the body to provide information about a person's health. Silicone putty ear plugs do not fit this description.
N/A
Intended Use / Indications for Use
Silicone Putty Ear Plugs are used to block water from entering the ear canal.
Product codes
77 EWD
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Ear canal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
Image /page/0/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features a stylized drawing of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Briant Benson President and CEO Bentec Medical 4234 North Fwy. Blvd. Sacramento, CA 95834
Re: K971517 Silicone Putty Ear Plugs Dated: April 24, 1997 Received: April 25, 1997 Regulatory class: Unclassified Procode: 77 EWD
JUN - 2 1997
Dear Mr. Benson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have desemined the device is substantially equivalent (for the indications for use sated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical; Device Amendances, or to devices that have been reclassified in socordance with the provisions of the Federal Food, Drug, ind Cosmotic 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 probibitions sgainst misbranding and adulteration.
If your device is classified (see above) into either class II (Prematker Approval), it may be subject to such additional controls. Existing major regulations affecting your device in be found in the Code of Februal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the OMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please astas response to your premarket notification does not affect any obligation 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:
This letter will allow you to begin marketing your device as described in your 510(k) prematice notification. The FDA finding of substantial equivalence of your device to a legally marketed predication 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 80) and additionally 809.10 for in vice diagnostic devices), please contact the Office of Compliance at (301) 594-4591 for Radiology devices, or 594-4613 for Ear, Nose and Throat devices. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation cations by reference to premarket notification' (21 CFR 807.97). Other general information on your responsibilities wase 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/cdrtvdsmamain.html".
Sincerely yours.
Olliaul,
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
| 510(k) Number (if known): | K071517 |
|---|---|
| --------------------------- | --------- |
Device Name: Silicone Putty Ear Plugs
Indications For Use:
Silicone Putty Ear Plugs are used to block water from entering the ear canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vaind A. Seymon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)
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