(146 days)
Patient lubricant intended for medical purposes to lubricate orifices to facilitate the entry of diagnostic and therapeutic devices. The device is intended for use on order of a physician.
Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, nonirritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required. Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use.
The product is packaged in a convenient 4.0 oz laminate tube with a flip top cap and peel seal.
This product is not a contraceptive and does not contain a spermicide.
This document is a 510(k) Summary for Sheffield Pharmaceuticals Sterile LubriGel, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria of the type often found for AI/ML medical devices. The information provided is primarily related to product identification, regulatory classification, intended use, device description, and technological characteristics, as well as biocompatibility testing to show safety.
Therefore, many of the specific questions about acceptance criteria for device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance are not directly applicable or available in this type of submission document. This submission is for a Class I patient lubricant, and the "performance" is largely demonstrated through comparison to existing products and safety testing.
However, I can extract the relevant information that is present in the document.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for a patient lubricant, the "performance" is tied to its physical characteristics and safety. The acceptance criteria aren't explicitly stated in a quantitative table with reported values against thresholds, but rather as qualitative statements of safety and equivalence.
| Characteristic / Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | - Water-based, clear, colorless, odorless, non-sticky, non-greasy, non-staining, non-irritating, water soluble, high viscosity gel-like liquid | "Sheffield Pharmaceuticals Sterile LubriGel patient lubricant is a waterbased, clear, colorless, odorless, non-sticky, non-greasy, non-staining, non-irritating patient lubricant. It is a water soluble, high viscosity gel-like liquid for use as patient lubricant when a sterile field is required." |
| Sterility | Sterile (unless package is opened or damaged) | "Each tube is terminally sterilized. The product is sterile unless package is opened or damaged with label directions to discard after use." |
| Biocompatibility - Dermal Sensitization | Non-sensitizer | "In Delayed Contact Dermal Sensitization Test (Buehler Method) the product was considered a non-sensitizer." |
| Biocompatibility - In Vitro Cytotoxicity | Meet requirements for the test | "In Vitro Cytotoxicity L929 Agar Overlay Test the product meet the requirements for the test." |
| Biocompatibility - Primary Dermal Irritation | Not a dermal irritant | "Primary Dermal Irritation in Rabbits determined that the product is not a dermal . irritant." |
| Biocompatibility - Single Dose Oral Toxicity | Not toxic (e.g., LD50 > 5000 mg/kg) | "Single Dose Oral Toxicity in Rats showed the oral LD50 of Sheffield's Sterile . LubriGel as greater that 5000 mg/kg of body weight. Therefore, the test article is not toxic." |
| "Performance" against Predicate Devices (overall) | Substantially equivalent in safety and effectiveness | "Sheffield Pharmaceuticals Sterile LubriGel has been shown, in laboratory test, to be substantially equivalent to the current marketed E-Z Lubricating Jelly and PDI (Sterile) Lubricating Jelly." and "Laboratory testing conducted on Sheffield Pharmaceutical Sterile LubriGel has provided scientific evidence that this product is safe for its intended use and substantially equivalent to the predicated E-Z Lubricating Jelly (Sterile), and PDI Lubricating Jelly (Sterile)." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in terms of units of lubricant or patient cases. For biocompatibility tests, animal models were used (Buehler Method, L929 Agar Overlay, Rabbits for dermal irritation, Rats for oral toxicity). The number of animals/samples used in these specific tests is not provided.
- Data Provenance: "Biocompatibility Studies on Sheffield's Sterile LubriGel was conducted by outside laboratories, in compliance with Good Laboratory Practices (GLPs)." The country of origin and whether the studies were retrospective or prospective are not specified, though GLP compliance implies a prospective, controlled study design for safety testing.
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)
Not applicable. This device is a Class I lubricant, and its "ground truth" for performance is based on physical/chemical properties and biological safety tests (biocompatibility), not expert interpretation of diagnostic images or clinical outcomes in the same way an AI/ML device would be assessed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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
Not applicable. This is a hardware device (lubricant), not an AI/ML diagnostic or therapeutic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a hardware device (lubricant), not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety and effectiveness is established through:
- Physical and Chemical Properties: Demonstrated internally.
- Biocompatibility Testing: Conducted by outside laboratories following GLP standards, using established laboratory protocols and animal models to assess sensitization, cytotoxicity, dermal irritation, and oral toxicity. The results of these tests (e.g., "non-sensitizer," "meet requirements," "not a dermal irritant," "LD50 > 5000 mg/kg") serve as the evidence or "ground truth" for safety.
- Comparison to Predicate Devices: The overall claim of substantial equivalence is based on similar technological characteristics and the demonstration of equivalent safety profile through testing, aligning with data on the predicate devices (E-Z Lubricating Jelly and PDI Lubricating Jelly).
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 880.6375 Patient lubricant.
(a)
Identification. A patient lubricant is a device intended for medical purposes that is used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.(b)
Classification. Class I (general controls). Except when the device is a vaginal patient lubricant or an oral lubricant, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.