(91 days)
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic. Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Not Found
Here's an analysis of the provided text regarding the acceptance criteria and study for the ExtraWear™, Gentlemen's Choice™, Extra Strength… Lubricated Latex Condom:
The provided document is a 510(k) clearance letter from the FDA, not a detailed study report. As such, it does not contain the specific acceptance criteria or the study data that proves the device meets those criteria in the format requested.
The letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, meaning it has similar indications for use, technological characteristics, and performs as safely and effectively. The letter also mentions general controls and relevant regulations for medical devices.
However, based on the limited information, we can extract some points about the indications for use and a very high-level statement about testing:
Indications for Use:
"Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic."
Statement about testing (from the "Indications for Use" section):
"Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
Addressing your specific questions based on the available text (and noting where information is absent):
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A table of acceptance criteria and the reported device performance
This information is not present in the provided document. The document is an FDA clearance letter, not a detailed technical report of the device's performance against specific criteria. It only states that laboratory tests show the ExtraWear condom is "stronger than the InnerWear condom." No numerical values for strength or specific acceptance criteria are given.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not present in the provided document. The document refers generally to "Laboratory tests of physical properties" but provides no details on sample size, data provenance, or study design (retrospective/prospective).
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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)
This information is not present in the provided document. The concept of "ground truth" established by experts, as typically applied in AI/diagnostic device studies, is not applicable or discussed in this 510(k) clearance letter for a condom. The testing mentioned appears to be physical property tests, which would be measured objectively rather than through expert consensus.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided document. Adjudication methods are typically relevant for subjective assessments or when discrepancies arise in expert reviews, which is not indicated for the type of testing broadly mentioned here.
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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
This information is not present in the provided document. An MRMC study or AI-assisted improvement for human readers is entirely irrelevant to a physical device like a latex condom.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not present in the provided document. This concept applies to AI algorithms, not a physical device like a condom.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Based on the statement "Laboratory tests of physical properties," the "ground truth" would likely be objective physical measurements rather than expert consensus, pathology, or outcomes data. However, the exact methods are not detailed.
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The sample size for the training set
This information is not present in the provided document. The concept of a "training set" applies to machine learning models, which is not applicable to this device.
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How the ground truth for the training set was established
This information is not present in the provided document. As above, "training set" and its "ground truth" establishment are not relevant to this device.
Summary of what can be gleaned about the study:
The only study mentioned is "Laboratory tests of physical properties" which determined "the ExtraWear condom is stronger than the InnerWear condom." No further details on the methodology, sample sizes, or specific results are provided in this regulatory letter. A critical limitation is explicitly stated: "However, the breakage rate during sex has not been tested." This implies that while laboratory strength tests were conducted, real-world performance data regarding breakage was not part of this submission for substantial equivalence.
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Image /page/0/Picture/0 description: The image is a seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an image of an eagle with its wings spread.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Lillie C. Thomas, M.S. Executive Director of Quality Assurance ... ........................................................................................................................... Custom Services International, Inc. . . . . . . 3111 West Post Road Las Vegas. Nevada 89118
Re: K970767
ExtraWear™, Gentlemen's Choice™, Extra Strength ... ... ... . Lubricated Latex Condom Dated: February 28, 1997 Received: March 3, 1997 Regulatory class: II 21 CFR §884.5300/Product code: 85 HIS JUN - 2 1997
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 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drag 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 obligation you might have under sections 53 I 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,
hilliai Yi
Lillian Yin, Ph.D.
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
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MAY-29-1997 12:23
Page 1 of 1
K970167 510(k) Number:
Condom (rubber) Contraceptive 85-HIS Device Name:
Indications for Use:
Extra Strength lubricated rubber male condom for use as a contraceptive and prophylactic.
Additional Statement: "Laboratory tests of physical properties show the ExtraWear condom is stronger than the InnerWear condom. However, the breakage rate during sex has not been tested."
| Date Submitted: | l tFebruary 28, 1997 |
|---|---|
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | Robert R. Melling |
|---|---|
| (Division Sign-Off) | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K970767 |
| Prescription Use (Per 21 CFR 801.109 | OR | Over-The-Counter Use ✓ (Optional Format 1-2-96) |
|---|---|---|
| -------------------------------------- | ---- | -------------------------------------------------------------------------------------------------- |
§ 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.