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510(k) Data Aggregation
(172 days)
This product is intended for penile, vaginal and/or anal application 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.
KY Grosz UltraGel is a personal lubricant that is non-sterile, water-based, and provides lubrication during intimate sexual activity. This device is compatible with natural rubber latex and polyisoprene condoms, and is not compatible with polyurethane condoms. Its formulation consists of Water, Glycerin, Propylene Glycol, Hydroxyethylcellulose, Benzoic acid, Sodium Saccharin, and Sodium Hydroxide. KY Grosz UltraGel is packaged in 1.5 fl. oz. (44 mL) or 4.5 fl. oz. (133 mL) bottles composed of high density polyethylene (HDPE), sealed and fitted with a polypropylene (PP) cap. The individual bottles are packaged in an outer cardboard carton. KY Grosz UltraGel is a personal lubricant for over-the-counter (OTC) use.
Here's an analysis of the provided text regarding the acceptance criteria and study for the KY Grosz UltraGel, structured to answer your specific questions.
1. A table of acceptance criteria and the reported device performance
| Property | Acceptance Criteria (Specification) | Reported Device Performance |
|---|---|---|
| Physical/Chemical Properties | ||
| Appearance | Colorless to slightly yellow, clear to translucent liquid | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this, though no direct measured value is given in summary) |
| Odor | No objectionable odor | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Viscosity | 100-950 cPs | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Osmolality | 780-1180 mOsm/kg | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| pH | 3.5 - 4.5 | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Microbiological Purity | ||
| Total Yeast and Mold Count (TYMC) | < 10 cfu/g (per EP 8.0 Section: 2.6.12) | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Total Aerobic Microbial Count (TAMC) | < 100 cfu/g (per EP 8.0 Section: 2.6.12) | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Specified Organisms (per EP 8.0 Section: 2.6.13) | Pseudomonas aeruginosa AbsentStaphylococcus aureus AbsentCandida albicans Absent | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Preservation Effectiveness | ||
| Preservative Effectiveness Testing (PET) | E. coli, P. aeruginosa, S. aureus: NLT 3.0 log reduction from initial count at 7 days, no increase from 7 days' count at 28 days.C. albicans, A. niger: 2.0 log reduction from initial count at 14 days, no increase from 14 days' count at 28 days (per EP 8.0 Section: 5.1.3). | "can maintain its specifications (as shown in Table 1) over the duration of its shelf life." (Implies it met this) |
| Biocompatibility | ||
| Cytotoxicity (ISO 10993-5: 2009) | No evidence of cytotoxicity | "showed no evidence of cytotoxicity to L-929 cells and therefore is not cytotoxic." |
| Vaginal Irritation (ISO 10993-10: 2010) | Irritation Index of 0 / Non-irritant | "The Irritation Index for the subject device test article was 0. Macroscopically, the vaginal tissue was found to be normal. Therefore, the subject device was considered a non-irritant to vaginal tissue of the rabbit." |
| Sensitization (ISO 10993-10: 2010) | No evidence of causing delayed dermal contact sensitization / Not considered a sensitizer | "showed no evidence of causing delayed dermal contact sensitization in the guinea pig. The test article was not considered a sensitizer in the guinea pig maximization test." |
| Acute Systemic Toxicity (ISO 10993-11: 2017) | No mortality or evidence of systemic toxicity | "There was no mortality or evidence of systemic toxicity for the subject device." |
| Condom Compatibility | ||
| Natural Rubber Latex Condoms | Compatible (per ASTM D7661-10) | "determined to be compatible with natural rubber latex...condoms." |
| Polyisoprene Condoms | Compatible (per ASTM D7661-10) | "determined to be compatible with...polyisoprene condoms." |
| Polyurethane Condoms | Not compatible (per ASTM D7661-10) | "It was determined not to be compatible with polyurethane condoms." (This is a performance characteristic rather than an "acceptance criteria" for passing, but it is a stated outcome of the test that defines its use). |
| Shelf Life | 2 years with maintained specifications | "KY Grosz UltraGel has a shelf-life of 2 years in accordance with the results of an accelerated aging stability study. Results from testing demonstrated that the device can maintain its specifications (as shown in Table 1) over the duration of its shelf life." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: The document does not specify exact sample sizes for each test within the biocompatibility, microbiological, or condom compatibility studies. It refers to standard methods (e.g., ISO, ASTM, EP) which typically implicitly define sample size requirements. For the animal studies (vaginal irritation, sensitization, acute systemic toxicity), these typically involve small numbers of animals (e.g., guinea pigs, rabbits, mice).
- Data Provenance: Not explicitly stated. The studies are described as "performance testing" and "biocompatibility studies were performed." There's no mention of the country of origin of the data or whether it was retrospective or prospective, though performance testing for device clearance is typically prospective for the device under evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This section is not applicable to this device. The KY Grosz UltraGel is a personal lubricant, not an AI/imaging device requiring expert interpretation for ground truth. Its performance is evaluated through physical, chemical, microbiological, and biological compatibility tests, not by expert review of data sets.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This section is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective interpretations, especially in medical imaging. The tests for this device involve objective measurements and standardized protocols without a need for expert adjudication in this context.
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
This section is not applicable. This is not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This is not an algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For this device, "ground truth" refers to the established scientific and regulatory standards and methods by which its properties are evaluated.
- Physical/Chemical Properties (Appearance, Odor, Viscosity, Osmolality, pH): Ground truth is established by analytical chemistry and physical testing methods against defined specifications.
- Microbiological Purity & Preservative Effectiveness: Ground truth is established by standard microbiological plating and challenge tests (e.g., European Pharmacopoeia standards) with specific thresholds for bacterial, yeast, and mold counts, and log reductions.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization, Systemic Toxicity): Ground truth is established by international standards (ISO 10993 series) using in vitro cell line tests and in vivo animal models, with defined endpoints (e.g., cell viability, irritation index, absence of reaction).
- Condom Compatibility: Ground truth is established by standardized material testing methods (e.g., ASTM D7661-10) that assess the degradation or impact of the lubricant on condom materials.
- Shelf Life: Ground truth is established by accelerated aging stability studies which project long-term stability based on short-term data under stressed conditions, confirming retention of all specified properties over time.
8. The sample size for the training set
This section is not applicable. This device does not use machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
This section is not applicable for the same reason as point 8.
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