(87 days)
FuckWater is a water-based personal lubricant for penile and/or rectal and/or rectal application, intended to moisturize and lubricate, 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.
FuckWater is a non-sterile, home-use, water-based, personal lubricant. It is packaged in 20z, 40z, 8oz and 16oz bottles. The device is intended to be applied to the penis, vagina or rectum to reduce friction during sexual activity. The device is compatible with natural rubber latex and polyisoprene condoms. The device is not compatible with polyurethane condoms.
This document is a 510(k) Premarket Notification for a personal lubricant called "FuckWater." It does not describe a study involving human readers or AI assistance, nor does it establish ground truth with experts in the context of medical image analysis or similar diagnostic tasks.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/human reader performance are not applicable to this document. This document details the non-clinical performance testing for a personal lubricant to demonstrate its substantial equivalence to a predicate device, as required for FDA clearance.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
The document presents mechanical and chemical specifications for the personal lubricant, which serve as acceptance criteria for the product's quality and performance.
1. Table of Acceptance Criteria and Reported Device Performance:
| Parameter | Specification (Acceptance Criteria) | Reported Device Performance (Implied Met) |
|---|---|---|
| Appearance | Viscous, Semi-Opaque Fluid | (Implied met, as product was cleared) |
| Color | Off-White | (Implied met, as product was cleared) |
| Odor | Light Medicinal | (Implied met, as product was cleared) |
| pH | 7.2 - 7.6 | (Implied met, as product was cleared) |
| Osmolality | 2,300-3,400 mOsm/kg | (Implied met, as product was cleared) |
| Viscosity | 20,000 - 26,000 cP | (Implied met, as product was cleared) |
| Antimicrobial effectiveness (USP ) (Bacteria) | Not less than 2.0 log reduction from the initial count at 14 days, and no increase from the 14 days' count at 28 days | (Implied met, as product was cleared) |
| Antimicrobial effectiveness (USP ) (Yeast & Mold) | No increase from the initial calculated count at 14 and 28 days | (Implied met, as product was cleared) |
| Total Aerobic Microbial Count (USP , ) | , ) | (Not specified, but implies meeting standard limits) |
| Absence of Pathogenic Organisms (USP , ) | (Not specified, but implies complete absence) | (Implied met, as product was cleared) |
| Cytotoxicity | Non-cytotoxic (per ISO 10993-5:2009) | Was demonstrated to be noncytotoxic. |
| Hypersensitivity | Non-sensitizing (per ISO 10993-10:2010) | Results from treated animals support that the test article is non-sensitizing. |
| Vaginal Mucosal Irritation | Non-irritant (per ISO 10993-10:2010) | Was considered a non-irritant to the vaginal mucosa. |
| Rectal Irritation | Non-irritant (per ISO 10993-10:2010) | Was considered a non-irritant to the rectal mucosa. |
| Acute Systemic Toxicity | Not acutely toxic (per ISO 10993-11:2006) | Was demonstrated that the subject device is not acutely toxic. |
| Shelf Life | 522 days (met accelerated aging ASTM F1980-16) | Demonstrated that the device met specifications for the proposed shelf-life. |
| Condom Compatibility | Compatible with natural rubber latex and polyisoprene condoms; Incompatible with polyurethane condoms (per ASTM D7661-10) | Was found to be compatible with male natural rubber latex and polyisoprene condoms and incompatible with male polyurethane condoms. |
Study Details (as applicable to a personal lubricant 510(k))
Since this document describes the clearance of a personal lubricant, the "study" refers to non-clinical performance testing rather than an AI or human reader study for diagnostic purposes.
2. Sample size used for the test set and the data provenance:
- Biocompatibility Testing: The document mentions "New Zealand White rabbits" for irritation tests and "guinea pigs" for hypersensitivity, and "mice" for acute systemic toxicity. Specific numbers of animals (sample sizes) are not provided in this summary.
- Bench Performance Testing: No specific sample sizes (e.g., number of lubricant batches or condom samples) are mentioned for physical property tests or condom compatibility.
- Data Provenance: The tests are standard laboratory tests conducted according to ISO and ASTM standards. The document does not specify the country of origin for the underlying data generation. The submission itself is from a Canadian company with a US consultant. The studies are prospective insofar as they were explicitly performed to support this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This applies to diagnostic studies, not personal lubricant testing. The "ground truth" here is established by the results of standardized, objective laboratory tests against pre-defined scientific and regulatory criteria (e.g., pH values, microbial counts, irritation indices).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. This applies to studies involving subjective assessments, like medical image interpretation. Laboratory tests for a personal lubricant do not typically involve human adjudication in this manner.
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:
- N/A. This document is for a medical device (personal lubricant), not an AI-powered diagnostic tool. The concept of human readers or AI assistance is irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. Not an AI algorithm. The performance is the device's inherent physical and chemical properties and its biological interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective, standardized laboratory measurements and assessments against established physical, chemical, and biological criteria, as defined by USP, ISO, and ASTM standards. For example:
- pH measurement provides a direct value.
- Microbial counts are quantifiable.
- Biocompatibility tests use histological analysis and scoring indices (like Irritation Index) often interpreted by trained toxicologists/pathologists who follow defined protocols.
- Condom compatibility is determined by physical integrity tests.
8. The sample size for the training set:
- N/A. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- N/A. As above, no training set.
§ 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.