(192 days)
ID Free® Personal Lubricant is for or penile, anal and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. This product is compatible with natural rubber latex and polyisoprenecondoms. This product is not compatible with polyurethane condoms.
ID Free® Personal Lubricant is a personal lubricant, for penile, anal and/or vaginal application intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is intended for over-the-counter use.
The device is a non-sterile water based personal lubricant with a clear, odorless formulation. The device is packaged in nonsterile 8.5 fl. oz/250 ml plastic/PET bottles with a screw-on cap and flip top closure, or in 0.14 fl. oz/4 ml foil sachets.
The device is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. This product is not a contraceptive and does not contain a spermicide.
The device formulation consists of water, propanediol, hydroxyethyl cellulose, carbomer, PEG-45M, tetrahydroxypropyl ethylenediamine, EDTA, caprylhydroxamic acid, and sucralose.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device: ID Free® Personal Lubricant
Regulation Name: Condom (as a personal lubricant, product code NUC)
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Specification) | Reported Device Performance (as implied by successful testing) |
|---|---|---|
| Color | No color to slight yellow tint | Met specification (implied, no specific value given) |
| Appearance | Clear viscous gel | Met specification (implied, no specific value given) |
| Odor | Odorless | Met specification (implied, no specific value given) |
| Viscosity (Spindle #63 @ 30 RPM) | 2,200 - 4,400 cps | Met specification (implied, no specific value given) |
| pH | 5.0 - 5.5 | Met specification (implied, no specific value given) |
| Osmolality | 250 - 500 mOsm/kg | Met specification (implied, no specific value given) |
| Total yeast/mold count (TYMC) (USP ) | acceptance criteria for Category 2 products" implies passing USP as well) | |
| Total aerobic microbial count (TAMC) (USP ) | acceptance criteria for Category 2 products" implies passing USP as well) | |
| Presence of Pathogenic Organisms (USP ) (Staphylococcus aureus, Pseudomonas aeruginosa, and Candida albicans) | Absent | Met specification (implied, no specific value given, "Met USP acceptance criteria for Category 2 products" implies passing USP as well) |
| Antimicrobial effectiveness (USP ) | Meets USP acceptance criteria for Category 2 products | Met specification (explicitly stated: "Meets USP acceptance criteria for Category 2 products") |
| Biocompatibility: Cytotoxicity (ISO 10993-5:2009) | Non-cytotoxic | Demonstrated non-cytotoxic |
| Biocompatibility: Guinea Pig Maximization Sensitization (ISO 10993-10:2010) | Non-sensitizing | Demonstrated non-sensitizing |
| Biocompatibility: Vaginal Irritation (ISO 10993-10:2010) | Non-irritating | Demonstrated non-irritating |
| Biocompatibility: Acute Systemic Toxicity (ISO 10993-11:2017) | Not systemically toxic | Demonstrated not systemically toxic |
| Shelf Life (24 months at 25°C) | Device met specifications in Table 1 at all time points | Met specifications in Table 1 across 24-month shelf-life |
| Condom Compatibility (Natural Rubber Latex) (ASTM D7661-18) | Compatible | Compatible |
| Condom Compatibility (Polyisoprene) (ASTM D7661-18) | Compatible | Compatible |
| Condom Compatibility (Polyurethane) | Not compatible (stated directly) | Not compatible |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify exact sample sizes for each test in phrases like "The results of this testing demonstrate..." or "The results of the testing demonstrate that...". It refers to the standards (e.g., USP , USP , USP , ISO 10993 series, ASTM D7661-18) which would define the sample sizes required for each specific test.
- Data Provenance: The studies are non-clinical performance tests conducted for regulatory submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in terms of patient data, as these are in vitro and in vivo animal (for some biocompatibility) tests, not human trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for this medical device (a personal lubricant) is established by adherence to recognized international and national standards and test methods (e.g., ISO, ASTM, USP) for specific physical, chemical, microbiological, and biological properties, rather than expert consensus on a diagnostic outcome. The "experts" would be the scientists and technicians conducting the tests according to the specified methodologies.
4. Adjudication Method for the Test Set
Not applicable for this type of device and testing. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies or human-reader performance evaluations, particularly for image-based diagnostics. The performance of this device is determined by quantitative and qualitative measurements against established specifications in laboratory settings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for this device. It is a type of study used to evaluate diagnostic imaging systems where multiple human readers interpret cases, often with and without AI assistance, to assess the impact of AI on diagnostic performance. This device is a personal lubricant, not a diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is a physical product (personal lubricant), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established by:
- Defined Specifications: Physical and chemical properties (color, appearance, odor, viscosity, pH, osmolality) have explicit numerical ranges or descriptions that must be met.
- Standardized Test Methods and Criteria:
- Microbiological: Adherence to USP (Total microbial counts) and USP (Absence of specified objectionable microorganisms), and USP (Antimicrobial Effectiveness Test) acceptance criteria. These standards define the "ground truth" for microbiological safety.
- Biocompatibility: Adherence to ISO 10993 series standards outcomes (non-cytotoxic, non-sensitizing, non-irritating, not systemically toxic).
- Condom Compatibility: Adherence to ASTM D7661-18 for compatibility with specific condom materials.
- Real-time Stability Data: The device maintained its specifications over a 24-month shelf-life at a specified condition (25°C).
8. The Sample Size for the Training Set
Not applicable. This is a physical product, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.