(205 days)
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The provided document is a 510(k) summary for the Instead Intimate Lubricant, establishing its substantial equivalence to predicate devices. It focuses on comparing technological characteristics and presenting non-clinical and in-vivo testing results.
This document is a marketing submission to the FDA, not a study report or clinical trial. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. It presents data to demonstrate that the device is as safe and effective as previously approved devices.
Based on the information provided, here's a breakdown of what can be gleaned, and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" in a quantitative manner as typically seen in a clinical trial or performance study (e.g., "sensitivity ≥ 90%"). Instead, it shows a comparison of technological characteristics to predicate devices and reports on various non-clinical and in-vivo tests that demonstrate safety and performance.
| Characteristic/Feature | Acceptance Criteria (Implied by Predicate & Testing) | Reported Device Performance (Instead Intimate Lubricant) |
|---|---|---|
| Technological Equivalence | ||
| Contains purified water | Yes (Same as predicates) | Yes |
| Contains glycerin | Yes (Same as predicates) | Yes |
| Contains thickening agents | Yes (Same as predicates) | Yes |
| Contains preservatives | Yes (Same as predicates) | Yes |
| Container Material | Plastic (Same as predicates) | Plastic |
| Label Condom Compatible | Yes (Same as predicates) | Yes |
| Sterile | No (Same as predicates) | No |
| Non-Clinical Performance | ||
| pH | Stable/Appropriate for intended use | Had better bioadhesive properties, maintained its initial pH better when mixed with semen. |
| Viscosity | Stable/Appropriate for intended use | Had better bioadhesive properties, maintained its initial viscosity better when mixed with semen. |
| Biometric properties | Maintained sperm motility (similar to or better than other lubricants) | May resulted in maintained sperm motility (Carg, S. 2001) |
| Condom Compatibility | No effect on latex and polyurethane condom performance after 24 hours (ASTM D3492-02) | No effect on condom performance was found. |
| In-vivo Testing | ||
| Penile and anal irritation | Biocompatible (no irritation) | Confirmed the biocompatibility. |
| Vaginal irritation | Biocompatible (no irritation) | Confirmed the biocompatibility (repeated dose vaginal irritation study). |
2. Sample Size for the Test Set and Data Provenance
- Sample Size: Not specified for any of the non-clinical or in-vivo tests. The document refers to studies by Carg, S. (2001) and Amaral, E., et al. (2000), but doesn't provide the sample sizes used within those studies explicitly for Instead Intimate Lubricant.
- Data Provenance:
- The document itself is a K033776 510(k) submission from the US.
- The nature of the non-clinical tests (e.g., pH, viscosity, condom compatibility) suggests laboratory-based testing.
- The in-vivo testing implies human or animal subjects, but specific countries or retrospective/prospective status are not mentioned within this summary. The cited external studies (Carg, S. 2001 and Amaral, E., et al. 2000) would contain this information, but are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the 510(k) summary. The testing described (e.g., pH, viscosity, ASTM D3492-02 for condom compatibility, in-vivo biocompatibility) relies on established scientific methods and instruments, rather than subjective expert assessment to establish "ground truth." The interpretation of results would be done by qualified scientists/technicians, but the document doesn't detail this.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of the tests (physical properties, in-vitro, and in-vivo biocompatibility), traditional adjudication methods (like 2+1 reader consensus for imaging studies) are generally not applicable. The results would be objectively measured and reported.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
No. This is not applicable. The device is an intimate lubricant, not an AI-powered diagnostic or imaging device. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not applicable. The device is an intimate lubricant, not an algorithm.
7. The type of ground truth used
For the non-clinical and in-vivo tests, the "ground truth" is established by:
- Physical and Chemical Measurements: Objective measurements of pH, viscosity, and chemical composition.
- Standardized Tests: Adherence to established standards like ASTM D3492-02 for condom compatibility, which involves objective assessment of burst pressure and elongation.
- Biocompatibility Assessments: In-vivo studies (penile, anal, vaginal irritation) where "ground truth" would be the observed lack of adverse reactions or irritation, often assessed by clinical observation or histological examination in the cited full reports. The provided summary only states "confirmed the biocompatibility."
- Referenced Scientific Literature: The document references studies (Carg, S. 2001; Amaral, E., et al. 2000) that would have detailed methodologies for their assessments.
8. The sample size for the training set
Not applicable. This device is a physical product (lubricant), not an algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this 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.