(261 days)
Vielle™ personal lubricant is intended for personal lubrication, lubrication of a body orifice to facilitate use of diagnostic or therapeutic, to enhance condom use and for vaginal use.
Vielle™ is a clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals are used in the formulation.
The provided text describes the 510(k) summary for a personal lubricant, Vielle™ Lubricant, and focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative acceptance criteria in a typical AI/software medical device context.
Therefore, many of the requested sections regarding AI/software studies (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission.
However, I can extract the relevant information regarding the device's characteristics and the non-clinical testing performed to establish its substantial equivalence.
Here's the breakdown of what is available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, "acceptance criteria" are implied by the characteristics of the predicate devices and the non-clinical tests performed to demonstrate similar safety and effectiveness. There are no explicit numerical acceptance criteria for a lubricant's performance, but rather characteristics and test results showing its safety and compatibility.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Vielle™ Lubricant Reported Performance |
|---|---|---|
| Common Name | Lubricant | Lubricant |
| Product Code | 80 MMS | 80 MMS |
| Intended Use | Personal lubrication, diagnostic/therapeutic use, condom compatibility, vaginal use | Personal lubrication, diagnostic/therapeutic use, condom compatibility, vaginal use |
| Over the Counter Use | Yes | Yes |
| Water-soluble | Yes | Yes |
| Contains Preservatives | Not required if inert & cannot support microbial contamination | No - Product is inert & cannot support Microbial contamination |
| Latex compatible Tested | Yes (to show compatibility with condoms) | Yes |
| Biocompatibility Tested | Yes (irritation and sensitization) | Yes |
| Antimicrobial Tested | Yes | Yes |
| Sterile | No (for similar non-sterile personal lubricants) | No |
| Chemical Composition | Water-soluble, silicone-based gel, no fragrances or petroleum-based chemicals | Clear, water-soluble, silicone based gel. No fragrances or petroleum-based chemicals. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical tests (e.g., how many condoms were tested for compatibility, or how many tests for biocompatibility).
- Data Provenance: Not explicitly stated, but the submission is from the UK (CST Medical Ltd, Antrobus House, Petersfield, Hants, GU31 4AD UK). The non-clinical testing was likely conducted in accordance with relevant standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a physical device (lubricant) and not an AI/software device that requires expert ground truth for interpretation or classification. The "ground truth" for its properties would be established via standard laboratory testing and compliance with relevant ASTM, ISO, or other recognized standards.
4. Adjudication Method for the Test Set
- Not Applicable. As above, this is for physical device testing, not for expert consensus or image interpretation.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. This type of study is specifically for evaluating the effectiveness of a diagnostic or interpretive AI/software system with human readers. It is not relevant for a personal lubricant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is for AI/software algorithms.
7. The Type of Ground Truth Used
- The "ground truth" for the device's properties (e.g., water-soluble, latex compatible, biocompatible) would have been established through laboratory testing according to recognized industry standards (e.g., ISO, ASTM for condom compatibility and biocompatibility) for physical and chemical properties.
8. The Sample Size for the Training Set
- Not Applicable. This refers to AI/machine learning models, which are not involved in this device submission.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As above.
§ 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.