(264 days)
JO Premium Personal Lubricant 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.
JO Premium Personal Lubricant is a clear, colorless, semi-viscous silicone-based lubricant that is compatible with condoms made of natural rubber latex and polyisoprene. The device is not compatible for use with polyurethane condoms. The device is a non-sterile lubricant designed to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. The product is provided in Polyethylene (PET) bottles fitted with Polypropylene caps. The bottles are sealed using an induction seal constructed of aluminized mylar. There is a 16 fl. Oz./480 mL bottle with a different configuration. This consists of a clear Polyethylene (PET) bottle with a Polypropylene lotion pump. This bottle is also fitted with a shrink band.
The provided text describes a 510(k) summary for a medical device called "JO Premium Personal Lubricant." It details the device, its intended use, and various performance studies conducted to demonstrate its safety and effectiveness for substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" with numerical thresholds in a table format. However, it describes various tests performed and their outcomes, which serve as the implicit acceptance criteria for demonstrating safety and performance.
| Test Property (Implicit Acceptance Criteria) | Reported Device Performance |
|---|---|
| Biocompatibility | |
| Acute Systemic Toxicity (no biological reactivity) | All test group animals survived and exhibited no biological reactivity. |
| Vaginal Irritation (non-irritant or minimal irritant) | Considered a minimal irritant. |
| Cytotoxicity (non-cytotoxic) | Not considered to have a cytotoxic effect. |
| Sensitization (no sensitization reactions) | Did not elicit sensitization reactions. |
| Shelf Life | |
| Shelf Life Duration (e.g., 3 years demonstrated) | Three-year shelf life based on real-time aging study. |
| Condom Compatibility | |
| Compatibility with Natural Rubber Latex Condoms | Compatible. |
| Compatibility with Polyisoprene Condoms | Compatible. |
| Compatibility with Polyurethane Condoms | Not compatible. |
| Preservation Effectiveness | |
| Antimicrobial Effectiveness (maintains effectiveness through shelf life) | Preservative effective through the proposed three-year shelf life. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of an AI/algorithm-based device. Instead, it describes various laboratory and in-vivo animal studies.
- Acute Systemic Toxicity: Performed on "mice." The exact number of mice is not specified but usually involves a control group and multiple test groups.
- Vaginal Irritation Testing: Performed on animals (not specified, but often rabbits or other suitable models). The exact number is not specified.
- Cytotoxicity: Performed using "cell culture." No specific sample size (number of replicates or cell lines) is mentioned.
- Sensitization: Performed on "Guinea Pig," referring to the ISO Guinea Pig Maximization Test. The exact number of guinea pigs is not specified.
- Shelf Life: "Real time aging study." No specific number of product samples or batches are stated.
- Condom Compatibility: Tested with various condom types (natural rubber latex, polyisoprene, and polyurethane). No specific number of condoms tested or replicates are mentioned.
- Preservative Effectiveness Testing: "Samples of JO Premium Personal Lubricant samples that have been aged for 1-year, 2-years, and 3-years." No specific number of samples or batches are mentioned.
Data Provenance: The studies were conducted by "Independent third-party laboratories." The country of origin of the data is not explicitly stated. The studies are prospective in nature, as they involve testing the actual product under controlled conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the device is a personal lubricant, not an AI/algorithm-based diagnostic or prognostic device requiring expert ground truth for interpretation of images or other data. The "ground truth" for the performance studies is based on standardized laboratory test methods and animal models (e.g., observing biological reactivity, irritation scores, cell viability, antimicrobial effectiveness).
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Standardized protocols were followed for each test, and results were interpreted according to the specific methodology (e.g., ISO, ASTM, USP standards).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This information is not applicable as the device is a personal lubricant and not an AI-assisted diagnostic or imaging device that would involve human readers or comparative effectiveness studies with human-in-the-loop performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This information is not applicable as the device is not an algorithm or AI. All performance studies described are "standalone" in the sense that they evaluate the product's inherent properties and performance against established standards.
7. Type of Ground Truth Used
The "ground truth" for the various studies is established based on:
- Standardized Biological Endpoints: For biocompatibility tests (systemic toxicity, irritation, cytotoxicity, sensitization), the ground truth is determined by observing specific biological reactions in live animals or cell cultures, interpreted against established criteria outlined in ISO 10993 or ASTM F895-11.
- Physical and Chemical Properties: For shelf life, condom compatibility, and preservative effectiveness, the ground truth is determined by laboratory measurements and observations based on recognized standards such as ASTM D7661-10 and USP 36-2013.
8. Sample Size for the Training Set
This information is not applicable as the device is not an AI/machine learning model that requires a training set. The performance studies evaluate the manufactured product's inherent characteristics.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
§ 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.