(201 days)
Clinijel is specially formulated to provide vaginal moisture, Clinijel is specially formarated to projection of tampons, rectal thermometers, enaema and douche nozzles.
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The provided document is a 510(k) notification for a medical device called "Clinijel Lubricating Jelly." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance criteria through a study.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study demonstrating the device meets those criteria. The 510(k) process focuses on comparing the new device's characteristics and intended use to a predicate device, not on presenting novel performance study data against pre-defined acceptance criteria.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for a test set.
- A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
- A standalone (algorithm-only) performance study.
- The type of ground truth used for performance evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
Instead, the document details a comparison of Clinijel to existing lubricating jellies (H R Lubricating Jelly, Triad Lubricating Jelly, and K-Y Jelly) based on their:
- Intended Use Statements: Claiming similar intended uses.
- Ingredients: Specifically gelling agents (Hydroxyethylcellulose vs. Hydroxypropyl Methylcellulose and Carbomer 934P).
- Target Population: All target the same population.
- Comparative Features Table (Page 1): Appearance, gelling agent, preservatives, propylene glycol/glycerol, pH adjustment method, container, and shelf life.
The FDA's response (Page 2) confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed, but this is not based on a new performance study with 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.