(90 days)
Not Found
Not Found
No
The 510(k) summary describes a physical medical device (condom) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is described as a contraceptive and prophylactic, which are preventative measures, not therapeutic treatments for a disease, injury, or medical condition.
No
The device is described as a contraceptive and prophylactic, not for diagnosing any condition. The "Summary of Performance Studies" section discusses material strength testing, not diagnostic accuracy.
No
The device description clearly identifies the device as a physical product (a latex condom) and the performance studies focus on physical properties. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device is a condom, which is a physical barrier used for contraception and prophylaxis. It does not involve testing samples from the body.
- Intended Use: The intended use clearly states it's for contraception and prophylaxis, not for diagnosing any condition.
- Device Description: The description confirms it's a physical product (a condom).
- Lack of IVD Indicators: The document lacks any mention of laboratory tests on biological samples, image processing, AI/ML for analysis of biological data, or any other characteristics typically associated with IVDs. The "laboratory tests" mentioned are physical property tests of the condom itself, not tests on human samples.
N/A
Intended Use / Indications for Use
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic. Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is good for prevention of pregnancy, but its breakage rate during sex has not been tested."
Product codes
85 HIS
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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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
Not Found
Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 884.5300 Condom.
(a)
Identification. A condom is a sheath which completely covers the penis with a closely fitting membrane. The condom is used for contraceptive and for prophylactic purposes (preventing transmission of sexually transmitted infections). The device may also be used to collect semen to aid in the diagnosis of infertility.(b)
Classification. (1) Class II (special controls) for condoms made of materials other than natural rubber latex, including natural membrane (skin) or synthetic.(2) Class II (special controls) for natural rubber latex condoms. The guidance document entitled “Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21 CFR 884.5300” will serve as the special control. See § 884.1(e) for the availability of this guidance document.
0
Image /page/0/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and three lines extending from the eagle's body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 2 1997
Ms. Lillie C. Thomas, M.S. Executive Director of Ouality Assurance . . . . . . Custom Services International, Inc. ----------3111 West Post Road Las Vegas, Nevada 89118
Re: K970792
ExtraWear™, Gentlemen's Choice™, Extra Strength ... ... Non-Lubricated Latex Condom -----Dated: February 28, 1997 Received: March 4, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS
Dear Ms. Thomas:
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 devices marketed in interstate commerce prior to May 28, 1976, the ensement 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 Foderal 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 GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Badger. Please note: this response to your premarket notification submission dees 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) 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) 594-4616. 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 regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/dsmamain.html".
Sincerely yours,
William Yi, Ph.D.
Lilian 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
Page 1 of 1
1 . CE
510(k) Number: K970792
Condom (rubber) Contraceptive 85-HIS Device Name:
Indications for Use:
Extra strength nonlubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is Additional Statellient. " Eaod alor " tools of processage rate during sex has not been tested."
Date Submitted:
February 28, 1997
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dater R Nathing
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K970092 |
|---|---|
| --------------- | --------- |
| Prescription Use | OR | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801 109 | (Optional Format 1-2-96) |