(125 days)
The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
Not Found
The provided text is a 510(k) clearance letter from the FDA for a Non-Spermicidal Lubricated Male Latex Condom. This document is a regulatory approval, not a scientific study report. It does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving device performance as it refers to these elements implicitly through the substantial equivalence determination rather than explicitly detailing them.
Therefore, I cannot provide a complete answer to your request based solely on the provided text. The document refers to compliance with existing regulations and suggests that supporting test data for expiration dating must be maintained, but the specifics of that test data are not included in this letter.
However, I can extract the information that is present and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of specific acceptance criteria or detailed reported device performance. The clearance is based on substantial equivalence to a predicate device, meaning it meets the regulatory requirements for condoms as defined in 21 CFR 884.5300. These regulations would implicitly define performance standards (e.g., burst strength, freedom from holes, dimensions, etc.), but the actual data from the study demonstrating compliance is not in this letter.
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified in the provided document.
- Data Provenance: Not specified in the provided document. The manufacturer is Secure Scientific SDN. BHD. from Malaysia, suggesting the device and potentially test data originate from there. The letter mentions "test data developed under the conditions specified in §801.435(d)" for expiration dating, but doesn't detail this data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable and not provided. The "ground truth" for a medical device like a condom is typically established through direct physical testing against performance standards (e.g., burst tests, visual inspection for holes), not through expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable and not provided. Adjudication methods are typically relevant for interpretive tasks where human judgment of complex data (like medical images) is involved. Condom testing involves direct physical measurement and objective pass/fail criteria.
5. 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:
Not applicable and not provided. This type of study is relevant for medical imaging or diagnostic AI systems, not for a physical medical device like a condom.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable and not provided. A condom is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for a medical device like a condom would involve adherence to specified physical and material properties, assessed through objective testing methods and comparison against codified standards (e.g., ISO standards for condoms). The document does not detail these specific test methods or standards but references the regulation 21 CFR §801.435 for expiration dating.
8. The sample size for the training set:
Not applicable and not provided. Training sets are relevant for machine learning algorithms, which are not involved in the regulatory approval of this physical device.
9. How the ground truth for the training set was established:
Not applicable and not provided.
Summary of what the document does provide:
- Device: Non-Spermicidal Lubricated Male Latex Condom
- Regulatory Class: II
- Regulation Number: 21 CFR 884.5300
- Indications for Use: Contraception and prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
- Approval Basis: Substantial equivalence to a legally marketed predicate device.
- Key Requirement Highlighted: Labeling must comply with "Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435," requiring an expiration date supported by test data. The manufacturer must maintain this data for inspection.
To answer your questions fully, the actual 510(k) submission document from Secure Scientific SDN. BHD. for K023128, along with the test reports referenced within that submission, would be required. This letter only confirms the FDA's decision based on its review of that submission.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 22 2003
Mr. Chong Ngit-Heng Managing Director Secure Scientific SDN. BHD. Lot 122, Kampung Titi Tok Aris, Sungai Seluang, 09600 Lunas, Kedah MALAYSIA
Re: K023128
Trade Name/Device: Non-Spermicidal Lubricated Male Latex Condom Regulation Number: 21 CFR 884.5300 Regulation Name: Condom Regulatory Class: II Product Code: 85 HIS Dated: November 30, 2002 Received: December 4, 2002
Dear Mr. Ngit-Heng:
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 Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS 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 Federal Register.
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Page 2 - Mr. Ngit-Heng
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.
Please be advised that, as of March 25, 1998, labeling for latex condoms (21 CFR §884.5300 and $884.5310) must comply with Use Labeling for Latex Condoms: Expiration Dating, 21 CFR 801.435. Therefore, an expiration date, supported by test data developed under the conditions specified in §801.435(d), must be displayed prominently and legibly on condom labeling. For condoms with spermicidal lubricant, the effective shelf life of the spermicide must be compared with the shelf life of the condom and labeled with the earlier of the two expiration dates. Although supporting data is not to be provided in your 510(k) submission, §801.435(j) requires that you maintain this data and that it be available for inspection by FDA. Furthermore, §801.435(e) requires that if your real-time test data fails to confirm the shelf life estimated by the methods in §801.435(d), then you must relabel all product to reflect the actual shelf life. Condoms are not to be labeled with an expiration date that gives a shelf life more than five years.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4616. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR §807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.
David A. Helyum
for
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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INDICATIONS FOR USE STATEMENT
KOZ3128 510(k) Number:
Male Natural Rubber Latex Condom [No particular brand name] Device Name:
Indications For Use: The [No particular brand name] condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR § 801.109) OR
1 Over-The-Counter Use
David A. Sejmen
(Division Sign-Off) Division of Reproductive, Abo and Radiological Devices 510(k) Number
§ 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.