(384 days)
ForPlay, SLIP and PrePair personal Lubricants are medical devices intended for medical purposes to lubricate a body orifice to facilitate entry of diagnostic or therapeutic devices. ForPlay SLIP and PrePair Personal Lubricants are recommended as personal lubricants and are principally intended to supplement the body's natural lubrication, to moisturize and enhance the comfort and ease of intimacy with or without a condom.
"ForPlay, SLIP and PrePair Personal Lubricants" are colorless, odorless, non-sticky, non-greasy, nonirritating water based lubricants. They are water-soluble, high viscosity gels and liquids. Because they are water-soluble, ForPlay, SLIP and PrePair Personal Lubricants are easily rinsed off with water leaving NO residue.
The provided document is a 510(k) summary for personal lubricants ("ForPlay, SLIP and PrePair Personal Lubricants"). This type of submission focuses on demonstrating substantial equivalence to pre-existing legally marketed devices rather than establishing novel safety and effectiveness criteria through extensive clinical studies with specified acceptance criteria.
Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the following information is not available in the provided text:
- A table of acceptance criteria and the reported device performance: This document primarily compares the technological characteristics of the new devices to predicate devices. It doesn't define specific performance criteria (e.g., efficacy rates, accuracy metrics) or report performance against such criteria.
- Sample size used for the test set and the data provenance: There is no mention of a "test set" in the context of performance evaluation.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a diagnostic or AI device is not applicable here.
- Adjudication method for the test set: Not applicable.
- 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 is not an AI or diagnostic imaging device; therefore, an MRMC study is irrelevant.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does provide is a comparison of technological characteristics to predicate devices to demonstrate substantial equivalence.
The relevant comparison table (from Section {2}) is formatted below:
| Feature | ForPlay | SLIP | PrePair | Lifestyles | K-Y Liquid |
|---|---|---|---|---|---|
| 510(K) # | N/A | N/A | N/A | K033076 | K955648 |
| Manufacturer | TRIMENSA | ||||
| Pharmaceuticals | TRIMENSA | ||||
| Pharmaceuticals | TRIMENSA | ||||
| Pharmaccuticals | Ansell | ||||
| Healthcare, Inc | McNeil- | ||||
| PPC, Inc | |||||
| Contains | |||||
| Purified Water | Yes | Yes | Yes | Yes | Yes |
| Contains | |||||
| Glycerine | Yes | Yes | Yes | Yes | Yes |
| Contains | |||||
| Cellulose | |||||
| Thickeners | Yes | Yes | Yes | Yes | Yes |
| Contains | |||||
| Methylparaben | Yes | Yes | Yes | Yes | Yes |
| Contains | |||||
| Propylparaben | Yes | Yes | Yes | Yes | Yes |
| Labeled | |||||
| Water soluble | Yes | Yes | Yes | Yes | Yes |
| Labeled | |||||
| Non-Staining | Yes | Yes | Yes | Yes | Yes |
| Labeled | |||||
| Condom | |||||
| Compatible | Yes | Yes | Yes | Yes | Yes |
| Container | |||||
| Material | Plastic | Plastic | Plastic | Plastic | Plastic |
| Sterile | No | No | No | No | No |
This table demonstrates that the new devices share the same key technological characteristics (ingredients, water solubility, non-staining, condom compatibility, container material, non-sterility) as the predicate devices. The "study" for this type of submission is essentially the comparison of these characteristics to establish substantial equivalence, rather than a clinical performance study with defined acceptance criteria.
§ 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.