(210 days)
TINGLY WARMTH is a personal lubricant for penile and/or vaginal application, intended to lubricate and moisturize, 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 polyisoprene condoms. Not compatible with polyurethane or other condoms.
The TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is an anhydrous, non-sterile, clear silicone-based personal lubricant composed of dimethicone, dimethiconol, menthol, and vanillyl butyl ether. TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms. This product is not a spermicide or a contraceptive. The product is packaged in a polyethylene terephthalate (PET) bottle with a screw-on, flip top polypropylene (PP) closure constituting the device's primary packaging. One bottle is packaged into a cardboard carton, which constitutes the device outer packaging.
The provided document is a 510(k) Premarket Notification for a personal lubricant, not a device that relies on algorithms or AI for performance. Therefore, many of the requested categories related to algorithm performance, ground truth, experts, and multi-reader studies are not applicable.
Here's a breakdown of the acceptance criteria and supporting studies as described in the document for the TROJAN™ LUBRICANTS Tingly Warmth Personal Lubricant:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993) | Non-cytotoxic | Non-cytotoxic |
| Rabbit Vaginal Irritation (ISO 10993) | Non-irritating | Non-irritating | |
| Rabbit Penile Irritation (ISO 10993) | Non-irritating | Non-irritating | |
| Acute Systemic Toxicity (ISO 10993) | Non-systemically toxic | Non-systemically toxic | |
| Guinea Pig Maximization (ISO 10993) | Non-sensitizing | Non-sensitizing | |
| Primary Rabbit Skin Irritation (ISO 10993) | Non-irritating | Non-irritating | |
| Condom Compatibility | ASTM D7761-10 (modified for pre-lubricated and un-lubricated dry condoms) | Compatible with natural rubber latex and polyisoprene condoms | Compatible with commercially available natural rubber latex and polyisoprene condoms |
| Shelf-life | Accelerated aging study (to be verified by real-time aging study) | 2-year shelf-life | 2-year shelf-life (based on accelerated aging) |
| Substantial Equivalence | Comparison to Predicate Device (K-Y® Brand Intrigue™ Intense Warming Sensation) | Equivalent in technology, intended use, safety, and effectiveness | Equivalent in technology, intended use, safety, and effectiveness |
2. Sample Size Used for the Test Set and Data Provenance
- Biocompatibility: The specific number of animals/samples used for each biocompatibility test (e.g., number of rabbits, guinea pigs) is not specified in the summary. The tests are general biological evaluation tests as per ISO 10993.
- Condom Compatibility: The document states that "Three marketed brands of pre-lubricated and un-lubricated dry natural rubber latex condoms and one brand of polyisoprene condoms were tested." The number of individual condoms tested per brand is not specified.
- Data Provenance: The document does not specify the country of origin of the data. Given it's a US FDA 510(k) submission, it's regulated for the US market. The studies appear to be prospective tests specifically conducted for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This question is not applicable as the device is a personal lubricant, and its performance is evaluated through laboratory and non-clinical (biocompatibility, condom compatibility, shelf-life) testing, not by expert interpretation of data like medical images.
4. Adjudication Method for the Test Set
- This question is not applicable. The tests performed are objective laboratory and physical property evaluations, not subjective assessments requiring adjudication among multiple readers.
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 question is not applicable as the device does not involve AI or human interpretation of data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is not applicable as the device is a physical product (lubricant), not an algorithm or software.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by objective laboratory measurements and standardized test methods.
- For biocompatibility: Standardized ISO 10993 assays with pass/fail criteria (e.g., non-cytotoxic, non-irritating).
- For condom compatibility: ASTM D7761-10 (modified) with criteria for compatibility.
- For shelf-life: Results from accelerated aging studies (and later real-time studies) according to established stability protocols.
8. The Sample Size for the Training Set
- This question is not applicable as there is no "training set" for this type of device. The product is a physical chemical formulation, not an algorithm that requires training data.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable for the reasons stated in point 8.
§ 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.