(159 days)
Playground For All Love Sesh is a personal lubricant, for penile and/or vaginal 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.
Playground For All Love Sesh is a non-sterile, unscented, water-based personal lubricant that provides lubrication during intimate sexual activity. The subject device is compatible with natural rubber latex and polyisoprene condoms and is not compatible with polyurethane condoms. Its formulation consists of Water. Glycerin, Propanediol, Bamboo Bioferment PF, Sodium Hyaluronate, CMC Cellulose, Citric Acid, Carubba Blend, Tocopheryl Acetate, Sodium Benzoate, Potassium Sorbate. Playground For All Love Sesh is for over-the-counter (OTC) use and is offered in 3.7 fl. oz PET bottles and 0.17 fl. oz PET/Foil packettes.
The provided document describes the "Playground For All Love Sesh" personal lubricant (K222567) and its clearance by the FDA based on substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device specifications outlined in Table 1 (page 4) indicate the acceptance criteria, and the "Summary of Non-Clinical Performance Testing" (pages 5 and 6) reports that the device meets these.
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Appearance | Gel | Gel (as per Table 1) |
| Color | Clear to hazy white cream | Clear to hazy white cream (as per Table 1) |
| Odor | Characteristic | Characteristic (as per Table 1) |
| Viscosity (per USP) | 1000 – 6000 cps | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| pH (per USP) | 4.0 - 5.5 | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Osmolality (per USP) | 2000 – 6000 mOsm/kg | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Total Aerobic Microbial Count (TAMC, per USP ) | ) | criteria for category 2. No less than 2.0 log reduction from initial count at 14 days and no increase from the 14-day count at 28 days |
| Antimicrobial Effectiveness Testing (Yeast and Molds) | No increase from the initial calculated count at 14 and 28 days | Device maintains specifications (as shown in Table 1) over its shelf-life, implying it meets this. |
| Biocompatibility (Cytotoxicity) | Non-cytotoxic | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. (Implies non-cytotoxic based on ISO 10993-5 testing) |
| Biocompatibility (Sensitization) | Non-sensitizing | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Biocompatibility (Vaginal Irritation) | Non-irritating | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Biocompatibility (Acute Systemic Toxicity) | Not acutely, systemically toxic | Results demonstrate the device is non-irritating, non-sensitizing, and not acutely, systemically toxic. |
| Shelf-Life | 6 months (maintains specifications) | Results from real-time testing demonstrated that the device maintains its specifications (as shown in Table 1) over the duration of its shelf-life (6 months). |
| Condom Compatibility (Natural Rubber Latex) | Compatible | The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms. |
| Condom Compatibility (Polyisoprene) | Compatible | The results of this test showed Playground For All Love Sesh is compatible with natural rubber latex and polyisoprene condoms. |
| Condom Compatibility (Polyurethane) | Not compatible | Results showed Playground For All Love Sesh is not compatible with polyurethane condoms. (This is stated as a product characteristic and consistent with the predicate, rather than a failure of an acceptance criterion for broader compatibility, as the device's indications of use already specify incompatibility). |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., how many batches were tested for viscosity, or how many samples for biocompatibility).
- Biocompatibility: Performed according to the 2020 FDA guidance document Use of International Standard ISO 10993-1. These are standard in-vitro and in-vivo tests that follow established protocols, but specific sample numbers (e.g., number of cells for cytotoxicity, number of animals for sensitization/irritation/toxicity) are not provided.
- Shelf-Life: "Real-time testing" was used, but the number of samples or batches tested longitudinally over the 6-month shelf-life is not specified.
- Condom Compatibility: Evaluated in accordance with ASTM D7661-10(R) 2017. This standard specifies methodological details, but the specific number of condoms or lubricant applications tested is not detailed in this summary.
Data Provenance: The studies are described as "Non-Clinical Performance Testing" conducted by the manufacturer or their designated labs as part of the submission to the U.S. FDA. The country of origin of the data is not explicitly stated but is implicitly tied to the U.S. regulatory process. The data is prospective in the sense that these tests were conducted specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For non-clinical tests like those conducted for a personal lubricant, the "ground truth" is typically established by objective, standardized laboratory measurements and interpretations by trained laboratory personnel or toxicologists, rather than a panel of clinical experts.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple readers or clinicians, to reach a consensus for ground truth. The tests performed here are laboratory-based, objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. This type of study is relevant for medical devices, particularly AI-driven diagnostic tools, where multiple human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a personal lubricant, which does not involve human readers for interpretation.
6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance)
A standalone performance study was not done in the context of an "algorithm only" as this is not an AI/software device. The entire performance evaluation summarized (biocompatibility, shelf-life, condom compatibility, physical/chemical/microbiological specifications) represents the "standalone" performance of the product itself, without human-in-the-loop interaction in an interpretive sense.
7. Type of Ground Truth Used
The ground truth for the performance claims (e.g., viscosity, pH, microbial counts, biocompatibility outcomes, condom compatibility) is based on objective laboratory measurements and internationally recognized standard test methods (e.g., USP, ISO, ASTM). These standards define specific procedures and criteria for determining whether a product meets a particular specification.
8. Sample Size for the Training Set
This information is not applicable and therefore not provided. The "Playground For All Love Sesh" is a physical product (a personal lubricant), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
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.
§ 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.