LogoFDA 510(k) Search
K Number
K991047
Device Name
HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE)
Manufacturer
HARDCOVER PRODUCTS, INC.
Date Cleared
1999-06-18

(80 days)

Product Code
LTZ
Regulation Number
884.5310
Type
Abbreviated
Panel
OB
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

These multiple-brand condoms are used for contraception and for prophylactic purposes to help prevent pregnancy and the transmission of sexually transmitted diseases and HIV (AIDS).

Device Description

Not Found

AI/ML Overview

Based on the provided document, which is an FDA 510(k) clearance letter for the HardCover Condoms™ Male Latex Condoms, there is no information available regarding acceptance criteria, device performance studies, or the methodologies used to establish ground truth.

The document is a regulatory approval letter, confirming that the device is "substantially equivalent" to legally marketed predicate devices. This means the FDA has determined that the new device is as safe and effective as a legally marketed device and does not require a new Premarket Approval (PMA) application.

The letter explicitly states: "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." This indicates that while design and performance testing were conducted by the manufacturer, the detailed results and methodologies are not part of this public clearance letter.

Therefore, I cannot provide the requested information for the following points as they are not contained within the provided text:

  1. A table of acceptance criteria and the reported device performance: Not present.
  2. Sample sized used for the test set and the data provenance: Not present.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
  4. Adjudication method: Not present.
  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 present (and not applicable as this is not an AI/software device).
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not present (and not applicable as this is not an AI/software device).
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not present.
  8. The sample size for the training set: Not present.
  9. How the ground truth for the training set was established: Not present.

The only performance-related requirement mentioned in the document is about expiration dating for latex condoms and spermicidal lubricant shelf life, which must be "supported by test data developed under the conditions specified in 801.435(d)". However, the specifics of these tests and their acceptance criteria are not detailed in this letter.

§ 884.5310 Condom with spermicidal lubricant.

(a)
Identification. A condom with spermicidal lubricant is a sheath which completely covers the penis with a closely fitting membrane with a lubricant that contains a spermicidal agent, nonoxynol-9. This condom is used for contraceptive and prophylactic purposes (preventing transmission of venereal disease).(b)
Classification. Class II (performance standards).