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510(k) Data Aggregation
(89 days)
Trojan™ Chain Reaction™ Personal Lubricant 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™ Chain Reaction™ Personal Lubricant is a non-sterile anhydrous, clear silicone-based (Dimethicone, Dimethiconol) personal lubricant with sensate that is compatible with natural rubber latex and polyisoprene condoms. This product is not compatible with polyurethane or other condoms. This product is not a spermicide or contraceptive.
The document describes the Trojan™ Chain Reaction™ Personal Lubricant (K161544) and its substantial equivalence to a predicate device, the Trojan™ Tingly Warmth Personal Lubricant (K120706). The acceptance criteria for the new device are established through a comparison of its technological characteristics and performance testing against the predicate device and relevant standards.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (Trojan™ Chain Reaction™ Personal Lubricant) |
|---|---|---|
| Intended Use | 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. Compatible with natural rubber latex and polyisoprene condoms. Not compatible with polyurethane or other condoms. | Identical to Predicate Device: "Trojan™ Chain Reaction™ Personal Lubricant 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." |
| Biocompatibility | Meet standards for cytotoxicity, acute systemic toxicity, primary rabbit skin irritation, rabbit vaginal irritation, rabbit penile irritation, and guinea pig maximum sensitization according to ISO 10993 standards. | Passed: Biocompatibility testing performed in accordance with ISO 10993 (specific parts mentioned in the document: -5:2009 for Cytotoxicity, -11:2006 for Acute Systemic Toxicity, -10:2010 for Irritation and Sensitization). The lubricant is biocompatible based on the results. |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms. | Passed: Condom Compatibility Testing performed according to ASTM D7761-10 (with modification to include pre-lubricated and un-lubricated dry condoms). Tested with three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms. "Condom compatibility testing demonstrates that Chain Reaction™ Personal Lubricant is compatible with natural rubber latex and polyisoprene condoms." |
| Shelf Life | Maintain specifications (viscosity, odor, color, appearance, microbial limits, absence of pathogens) for an expected shelf life. | 2 Years: "Chain Reaction™ Personal Lubricant has a two year (24 month) shelf-life based on the results of an accelerated stability study. Evaluation of viscosity, odor, color and appearance was conducted. Microbial evaluation was conducted via USP testing for Total Microbial Count (USP <61> and <1111>, Total Yeast and Mold count (USP <61> and <111)), and Absence of Pathogens (USP <62>). The results were satisfactory for all parameters." |
| Appearance | Clear and colorless | Clear and colorless (consistent with predicate, K120706 describes "Viscous liquid, clear") |
| Odor | Characteristic odor – no malodor | Characteristic odor – no malodor (predicate has "Menthol") |
| Viscosity | 400 – 800 cps | 400 – 800 cps (predicate has 528 – 566 cp, within the range, so considered acceptable) |
| Total Microbial Count | <100 cfu/g (per USP <61> and <1111>) | <100 cfu/g (consistent with predicate) |
| Fungal/Yeast/Mold Limits | <10 cfu/g (per USP <61> and <1111>) | <10 cfu/g (consistent with predicate) |
| Absence of Pathogens | Absent (Pseudomonas aeruginosa, Staphylococcus aureus, Candida albicans per USP <62>) | Absent (consistent with predicate) |
| Sterility | Non-sterile | Non-sterile (consistent with predicate) |
| Base Type | Silicone | Silicone (consistent with predicate) |
| Primary Ingredients | Dimethicone, Dimethiconol, Sensate | Dimethicone, Dimethiconol, Sensate (consistent with predicate) |
2. Sample size used for the test set and the data provenance
The document does not explicitly state "test sets" in the context of human data. The testing described is primarily for physical and chemical properties, biocompatibility, and condom compatibility.
- Biocompatibility Testing: The sample sizes are not specified but would typically involve a small number of animals (e.g., rabbits, guinea pigs) for each test as per ISO 10993 standards. The data provenance would be from laboratory studies conducted by the manufacturer or contracted labs. Specific country of origin is not mentioned but assumed to be from a reputable testing facility. The nature of these tests is prospective, meaning the device was specifically manufactured and tested for these criteria.
- Condom Compatibility Testing: "Three marketed brands of natural rubber latex condoms and two brands of polyisoprene condoms were tested." This refers to the types of condoms used, not a sample size of device units. The number of lubricant units tested on these condoms is not explicitly stated, but common practice would involve multiple samples (e.g., replicates) per condom type as per ASTM D7761-10. This is also prospective lab testing.
- Shelf Life Testing: The document mentions an "accelerated stability study." This type of study involves multiple samples stored under controlled conditions over time to predict long-term stability. The exact number of samples is not provided, but it would be a prospective study conducted in a lab environment.
- Specifications Testing (Appearance, Odor, Viscosity, Microbial): These are routine quality control and stability tests. Sample sizes are not specified but would follow internal quality procedures and pharmacopeial standards (e.g., USP).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information (experts establishing ground truth for human-reviewed test sets) is not applicable to this device. This product is a personal lubricant, and its evaluation focuses on physical, chemical, and biological compatibility properties, rather than diagnostic accuracy or clinical interpretation by human experts. The "ground truth" is established by laboratory measurements, adherence to codified standards (ISO, ASTM, USP), and comparison to a legally marketed predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods involving multiple reviewers (like 2+1, 3+1) are typically used in clinical studies for diagnostic devices where human interpretation is a critical component and there's a need to resolve disagreements among experts. The testing for a personal lubricant relies on objective measurements and established standards, not subjective interpretation requiring adjudication.
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 information is not applicable. An MRMC comparative effectiveness study is used for diagnostic algorithms or medical imaging devices to assess the performance of humans, potentially with AI assistance, across multiple readers and cases. The Trojan™ Chain Reaction™ Personal Lubricant is not a diagnostic device and does not involve AI assistance or human reader interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a personal lubricant, not an algorithm or AI system. Its performance is inherent in its physical and chemical properties when used as intended, not through an automated analytical process.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by:
- Established Standards and Methods: Compliance with internationally recognized standards such as ISO 10993 for biocompatibility, ASTM D7761-10 for condom compatibility, and USP <61>, <62>, <1111> for microbial limits.
- Laboratory Measurements: Objective, quantifiable results from analytical tests (e.g., viscosity, pH, microbial counts, chemical composition).
- Predicate Device Equivalence: Direct comparison to the established safety and effectiveness profile of a legally marketed predicate device (Trojan™ Tingly Warmth Personal Lubricant). The "ground truth" for the predicate device itself would have been established through similar testing and regulatory review.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of an AI/ML algorithm for this product. The development and testing of a personal lubricant involve chemical formulation and engineering, not machine learning model training.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this type of device.
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