(60 days)
Sutil Rich 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. The product is not compatible with polyurethane condoms.
Sutil Rich Personal Lubricant is a non-sterile, water-based personal lubricant that is compatible with natural rubber latex and polyisoprene condoms. It is not compatible with polyurethane condoms. Its formulation consists of purified water, propanediol, hyaluronic acid, gluconolactone, sodium benzoate, Nelumbo Nucifera Root Water, Horny Goat (Epimedium Sagittatum) Herb, Siberian Ginseng (Eleuthero) Std. Extract, Jujube (Zizyphus Jujuba) Fruit Powder Extract. The device is provided in tube containers composed of low-density polyethylene (LDPE) with flip-top caps made of high-density polyethylene (HDPE). The packaging configurations range from 0.34 FL OZ (10 mL) to 8 FL OZ (240 mL), depending on the device. The personal lubricant is non-sterile and intended for over-the-counter (OTC) use.
This document is a 510(k) clearance letter for a personal lubricant, not a medical device involving AI or complex clinical studies for diagnosis or treatment. Therefore, many of the typical acceptance criteria and study designs you've asked about (e.g., MRMC studies, expert ground truth establishment for AI, effect size of human readers with AI assistance) are not applicable to this product.
The acceptance criteria here concern physical, chemical, and biological properties of the lubricant, as well as its compatibility with condoms, to ensure it is safe and performs as intended.
Here's an analysis based on the provided text for the Sutil Rich Personal Lubricant:
Device Name: Sutil Rich Personal Lubricant
Device Type: Personal Lubricant (OTC)
Regulatory Class: II
Product Code: NUC (lubricant, personal)
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Test Method | Acceptance Criteria (Specification) | Reported Device Performance (as demonstrated by testing) |
|---|---|---|---|
| Appearance | Visual | Viscous liquid | Met (Implied by successful shelf-life testing where all device specifications were met) |
| Color | Visual | Clear | Met (Implied) |
| Odor | Organoleptic | No scent | Met (Implied) |
| pH | USP | 5.8 – 6.2 | Met (Implied) |
| Viscosity (cps) | USP | 30,000 – 40,000 cps | Met (Implied) |
| Osmolality (mOsm/kg) | USP | 550 - 700 (1:5 dilution) | Met (Implied) |
| Antimicrobial Effectiveness | USP | Meets USP criteria for category 2: Bacteria: No less than 2.0 log reduction from initial count at 14 days, and no increase from the 14-day count at 28 days. Yeast and Molds: No increase from the initial calculated count at 14 days and 28 days. | Met |
| Total Microbial Count (TAMC) | USP | ||
| Shelf-life | Real-time aging | 2 years | Demonstrated 2-year shelf-life, meeting all device specifications throughout this period. |
| Biocompatibility (Cytotoxicity, Skin Irritation/Sensitization, Acute Systemic Toxicity) | ISO 10993-5:2009, HRIPT (alternative to ISO 10993-10:2021 & ISO 10993-23:2021), ISO 10993-11:2017 | Non-cytotoxic, non-irritating, non-sensitizing, not systemically toxic | Demonstrated non-cytotoxicity, non-irritation, non-sensitization, and no systemic toxicity. |
| Condom Compatibility | ASTM D7661-18 | Compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. | Determined to be compatible with natural rubber latex and polyisoprene condoms; not compatible with polyurethane condoms. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (e.g., number of batches, number of units) used for each specific test (e.g., pH, viscosity, microbiological assays, biocompatibility, or condom compatibility). It states "samples" were used for shelf-life testing and that "the subject devices" were evaluated for condom compatibility.
- Sample Size: Not explicitly quantified for each test. General reference to "samples" or "the subject devices".
- Data Provenance: The document does not specify the country of origin of the data. The studies performed are laboratory-based and simulated use (e.g., shelf-life, condom compatibility, biocompatibility). These are prospective tests performed on the manufactured product to demonstrate its properties. There is no indication of retrospective data analsysis.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- This device clearance is for a personal lubricant, not an AI-powered diagnostic device.
- Ground Truth Establishment: The "ground truth" for the performance of this device is established through standardized laboratory test methods (e.g., USP, ASTM, ISO standards) and adherence to predefined specifications. These methods are analytical and rely on measurements and observations, not on expert consensus or interpretation in the way one would for medical image analysis.
- Experts: The tests are conducted by trained technicians or scientists in specialized laboratories (e.g., chemistry, microbiology, toxicology labs). The document does not specify the number or qualifications of individuals who performed or interpreted these specific lab tests, but it's implied they adhere to the requirements of good laboratory practice (GLP) and the specific test methodologies.
4. Adjudication Method for the Test Set
- Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies where human interpretation of data is subjective (e.g., reading medical images).
- For this device, the "adjudication" is inherent in the objective, quantitative nature of the tests. Results are compared directly against the pre-defined numerical or descriptive specifications. Any deviation would lead to a failure to meet the acceptance criteria, not a need for adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC study was NOT done. MRMC studies are designed to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of cases. This is not relevant to a personal lubricant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This question is applicable to AI algorithms.
- No, a standalone algorithm performance study was NOT done because this is not an AI/software device. The performance of the lubricant is intrinsic to its formulation and physical/chemical properties, not an algorithm.
7. The Type of Ground Truth Used
- The "ground truth" for this product is based on defined scientific standards and objective measurements from various laboratory tests (chemical analysis, physical properties testing, microbiological analysis, biocompatibility testing, condom compatibility testing).
- It is not based on expert consensus, pathology, or outcomes data in a clinical sense. For example, the "ground truth" for pH is a specific range measured by a pH meter against a standard, not a subjective interpretation.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is not a machine learning or AI device. The product formulation is developed through research and development, and then tested against established industry standards.
9. How the Ground Truth for the Training Set Was Established
- This question is not applicable. As there is no training set (being a non-AI product), there is no ground truth for a training set to be established.
§ 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.