(273 days)
I-D Glide lubricant is intended enhance the comfort and ease of intimate activity and is compatible with latex and polyurethane condoms.
Personal lubricant for penile and vaginal use only. Compatible with latex and polyurethane condoms.
I-D Glide Personal lubricant is a water-based non-sterile personal lubricant containing purified water, glycerin, propylene glycol, cellulose polymer, PEG 90m, Carbomer 981, various antifungal preservatives, pH adjuster, and chelating agent.
This document is a 510(k) summary for the I-D Glide Lubricant, indicating it is a premarket notification to the FDA to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe a study with acceptance criteria and device performance in the way typically associated with medical imaging or diagnostic AI. Instead, it demonstrates equivalence through a comparison of product characteristics and intended use.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it's not:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative performance metric sense (e.g., sensitivity, specificity, AUC). Instead, the "acceptance criteria" can be inferred as satisfying the characteristics of the predicate devices. The "reported device performance" is the device's characteristics aligning with those of the predicates.
| Characteristic | "Acceptance Criteria" (Predicate Devices) | Reported Device Performance (I-D Glide) |
|---|---|---|
| Common Name: Lubricant | Yes (for both predicates) | Yes |
| Product Code: 80 MMS | Yes (for both predicates) | Yes |
| Intended Use: Enhance ease and comfort of intimate activity, compatible with latex condoms | Yes (for both predicates) | Yes |
| Over the Counter Use | Yes (for both predicates) | Yes |
| Water-soluble | Yes (for both predicates) | Yes |
| Contains purified water | Yes (for both predicates) | Yes |
| Contains Preservatives | Yes (for both predicates) | Yes |
| Biocompatibility Tested | Yes (for both predicates) | Yes |
| Antimicrobial Tested | Yes (for Instead Intimate) / No (for Personal Lubricating Gel) | Yes |
Note: The I-D Glide exceeds one predicate (Qualis, Inc.'s Personal Lubricating Gel) by being "Antimicrobial Tested" while still being substantially equivalent to the other predicate (Instead, Inc's Instead Intimate Lubricant) which is also antimicrobial tested.
2. Sample size used for the test set and the data provenance
This is not applicable as this is a comparison to predicate devices based on product characteristics and general testing (biocompatibility, antimicrobial), not a clinical study with a "test set" in the context of an AI device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable. The "ground truth" here is the established characteristics and testing performed on the predicate devices and the new device, not expert interpretation of data.
4. Adjudication method for the test set
This is not applicable.
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
This is not applicable. This document pertains to a personal lubricant, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as this is not an algorithm or AI device.
7. The type of ground truth used
The "ground truth" used for this submission is based on the characteristics and testing performed on the device itself (I-D Glide) and the established characteristics and testing of the predicate devices (Instead Intimate Lubricant and Qualis Personal Lubricating Gel). This includes:
- Intended Use: As defined by the manufacturer and accepted by the FDA for similar products.
- Compositional Analysis: Listing of ingredients.
- Physical Properties: Water-solubility.
- Safety Testing: Biocompatibility testing, antimicrobial testing.
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" for a personal lubricant.
9. How the ground truth for the training set was established
This is not applicable.
Summary of Device Meeting Acceptance Criteria:
The device, I-D Glide Lubricant, meets the inferred acceptance criteria by demonstrating substantial equivalence to two legally marketed predicate devices (Instead, Inc.'s Instead Intimate Lubricant and Qualis, Inc.'s Personal Lubricating Gel). This is "proven" by a detailed comparison table showing that I-D Glide shares the same common name, product code, intended use, over-the-counter status, water-solubility, presence of purified water and preservatives, and has undergone biocompatibility testing, just like the predicate devices. Furthermore, I-D Glide also underwent antimicrobial testing, aligning with one predicate and exceeding the other, thus not raising new questions of safety or effectiveness. The FDA's 510(k) clearance letter (K051295) confirms that the FDA reviewed the submission and determined the device is substantially equivalent to the predicates for its stated indications for use.
§ 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.