(126 days)
Solevy Co. LLC Silicone Based Personal Lubricant is a silicone-based 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. This product is not compatible with polyurethane condoms.
Solevy Co. LLC Silicone-Based Personal Lubricant is a clear, colorless, semi-viscous personal lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant, for penile and/or vaginal application, to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in volumes of 1, 2.5, 4.5, 8, and 16 fl. oz in polyethylene bottles. The 1-8 fl. oz. bottles are closed with polypropylene (PP) caps, while the 16 fl. oz. bottle includes a polypropylene lotion pump. The 16 fl. oz. bottle is sealed using tamper-resistant shrink wrap band. The 1-8 fl. oz. bottles are sealed using an induction seal constructed of aluminized mylar.
The provided text is a 510(k) Premarket Notification from the FDA for a personal lubricant. It describes the device, its intended use, comparison to a predicate device, and performance data to support its substantial equivalence.
Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the "Specification" column in Table 1 for device specifications and the successful outcomes of the various performance tests. The reported device performance is indicated by the statement that the device met these specifications and that the tests demonstrated the desired safety and compatibility.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Clear, semi-viscous liquid | Clear, colorless, semi-viscous liquid |
| Color | Colorless | Colorless |
| Odor | Odorless | Odorless |
| Viscosity (cps) – USP | 750 to 950 | Met specification over shelf-life |
| Total aerobic microbial count (TAMC) – USP/USP | Less than 100 cfu/g | Met specification over shelf-life |
| Total yeast and mold count (TYMC) – USP/USP | Less than 10 cfu/g | Met specification over shelf-life |
| Presence of Pathogens: Pseudomonas aeruginosa | Absent | Absent (implied, as specifications were met) |
| Presence of Pathogens: Staphylococcus aureus | Absent | Absent (implied, as specifications were met) |
| Presence of Pathogens: Candida albicans | Absent | Absent (implied, as specifications were met) |
| Biocompatibility: Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Biocompatibility: Sensitization | Non-sensitizing | Non-sensitizing |
| Biocompatibility: Vaginal Irritation | Non-irritating | Non-irritating |
| Biocompatibility: Acute Systemic Toxicity | Non-systemically toxic | Non-systemically toxic |
| Shelf-Life | 3 years | 3 years (based on real-time aging study) |
| Condom Compatibility: Natural Rubber Latex | Compatible | Compatible |
| Condom Compatibility: Polyisoprene | Compatible | Compatible |
| Condom Compatibility: Polyurethane | Not compatible (as per predicate) | Not compatible (consistent with predicate and expectation) |
2. Sample Sizes Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of units tested for viscosity, number of animals/samples for biocompatibility). The studies are performance tests conducted on the final device, not clinical trials with human subjects.
- Data Provenance: The studies were conducted by the manufacturer (Solevy Co. LLC) to support their 510(k) submission. The location or specific laboratory where these tests were performed is not mentioned within the given text. It is implied to be retrospective testing for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Since this is a submission for a personal lubricant, not an AI/imaging device, the concept of "experts establishing ground truth for a test set" in the context of diagnostic interpretation is not applicable here. The "ground truth" for this device comes from established laboratory testing standards (e.g., USP, ASTM D7661-10, ISO 10993-1) and their objective measurements.
4. Adjudication Method for the Test Set
Not applicable. The tests are objective measurements based on defined standards, not subjective interpretations requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study (MRMC) is relevant for diagnostic imaging devices where human readers interpret medical images. This document is for a medical device (personal lubricant) that does not involve image interpretation or human reading of diagnostic outputs.
6. If a Standalone Performance (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithmic or AI device. The "performance" refers to the physical and biological properties of the lubricant itself.
7. The Type of Ground Truth Used
The ground truth for this device is based on:
- Established industry standards and test methods: e.g., USP for viscosity, USP / for microbial counts, ASTM D7661-10 for condom compatibility, and ISO 10993-1 for biocompatibility.
- Defined specifications: The quantitative and qualitative values (e.g., viscosity range, microbial limits, absence of pathogens, non-toxic, non-irritating).
- Predicate device characteristics: The subject device is shown to have "the same technological characteristics" and "the same intended use" as the predicate device (JO Premium Personal Lubricant K132954), implying that the predicate's established safety and effectiveness serve as a practical ground truth for equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" in the context of an AI/ML model for this type of medical device submission. The device is a physical product, and its performance is evaluated through direct testing against predefined standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this product.
§ 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.