(90 days)
The Key West Fragrance & Cosmetic Factory, Inc. Just Between Us™ Personal Lubricant & Condom convenience kit is intended to enhance the comfort and ease of intimate activity. The personal lubricant is compatible with latex condoms.
If used properly, latex condoms will help to reduce the risk of transmission of HIV infection (AIDS) and many other sexually transmitted diseases .
The Just Between Us™ Personal Lubricant and Condom kit is a non-sterile convenience kit that provides a latex condom and a personal lubricant separately wrapped in the same outer package. The condom is legally manufactured and marketed pursuant to 510(k) K910550 by the London International Corporation. Key West Fragrance & Cosmetic Factory, Inc. will manufacture the personal lubricant. The personal lubricant is nonstaining, water-soluble, glycerine and water based lubricant containing Aloe Vera Gel.
Here's an analysis of the provided text regarding the acceptance criteria and study for the "Just Between Us™ Personal Lubricant & Condom" device:
Important Note: The provided document is a 510(k) premarket notification for a medical device. This type of submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical trial to prove de novo efficacy or safety against a specific set of acceptance criteria in the way a pharmaceutical might. Therefore, many of the typical questions for AI model validation or clinical studies won't have direct answers in this context. The "acceptance criteria" here are mainly about meeting specifications and showing similarity to already approved products.
Here's a breakdown based on your request, with N/A for information not present in the document.
Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission for a personal lubricant and condom kit, the "acceptance criteria" are predominantly about demonstrating that the new device's characteristics and performance are comparable to (substantially equivalent to) existing legally marketed predicate devices, and that it meets relevant industry standards.
| Acceptance Criteria (Demonstrated Equivalence/Standard Compliance) | Reported Device Performance |
|---|---|
| Technological Characteristics: | |
| Contains purified water | Yes (matches predicates) |
| Contains glycerine | Yes (matches predicates) |
| Contains Aloe Vera Gel | Yes (matches WonderGel, but not K-Y Brand Liquid) This difference was not deemed significant enough to prevent substantial equivalence. |
| Contains Methylparaben | Yes (matches predicates) |
| Labeled Non-staining | Yes (matches predicates) |
| Labeled odorless and tasteless | Yes (matches WonderGel, but not K-Y Brand Liquid, which is not stated as such) This difference was not deemed significant enough to prevent substantial equivalence. |
| Container Material: Plastic | Plastic (matches predicates) |
| Sterile: No | No (matches predicates) |
| Labeled safe with latex condoms | Yes (matches predicates) |
| Performance with Condoms: | |
| Compatibility with condoms, tested in accordance with ASTM D 3492-97 (Standard Specification for Rubber Contraceptives (Male Condoms)). | The Just Between Us™ Personal Lubricant and Condom did not have a significant effect on the performance of the condom. |
| Biocompatibility: | |
| Meet in vivo test requirements of ISO 10993-1 (Biological evaluation of medical devices-Part 1: Guidance on the selection of tests). | The Just Between Us™ Personal Lubricant was tested and found to meet the in vivo test requirements of ISO 10993-1. |
| Overall substantial equivalence to identified predicates | "The Just Between Us™ Personal Lubricant and Condom is substantially equivalent to K-Y Brand Liquid™ Personal Lubricant manufactured by Ortho Pharmaceutical Corporation pursuant to 510(k) K955648 and WonderGel® Personal Liquid Gel manufactured by Lake Consumer Products, Inc. pursuant to 510(k) K903910." and a finding by the FDA that 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..." |
Detailed Study Information:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for either the ASTM D 3492-97 condom testing or the ISO 10993-1 biocompatibility testing. These standards prescribe sample sizes, but the specific number used in this particular study is not provided in the summary.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The tests were performance/laboratory-based, not patient data studies.
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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):
- N/A. This kind of expert-driven ground truth is not applicable for the type of testing (material compatibility and biocompatibility) performed for this device. The "truth" is established by adherence to recognized international and national standards (ASTM and ISO).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. The testing involves objective measurements against established standard criteria, not subjective human assessment requiring adjudication.
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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:
- N/A. This is a physical device (lubricant and condom kit), not an AI-assisted diagnostic or interpretation tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This concept is not applicable to this physical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for the performance testing is adherence to the specifications and methodologies outlined in recognized industry standards:
- ASTM D 3492-97 (Standard Specification for Rubber Contraceptives (Male Condoms)) for condom compatibility.
- ISO 10993-1 (Biological evaluation of medical devices-Part 1: Guidance on the selection of tests) for biocompatibility.
- The overall "ground truth" for marketing authorization is substantial equivalence to predicate devices already deemed safe and effective by the FDA.
- The "ground truth" for the performance testing is adherence to the specifications and methodologies outlined in recognized industry standards:
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The sample size for the training set:
- N/A. Not applicable, as this is not an AI/machine learning model but a physical medical device.
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How the ground truth for the training set was established:
- N/A. Not applicable.
§ 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.