(127 days)
Dynarex Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices when a sterile field is required.
Dynarex Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly. Typical packaging configurations for the Dynarex Sterile Lubricating Jelly is 3 g or 5 g foil packs, and 2 oz or 4 oz tubes, Other sizes may become available.
The provided document is a 510(k) summary for the Dynarex Sterile Lubricating Jelly, asserting its substantial equivalence to a predicate device (E-Z Lubricating Jelly, K041060). It does not describe an AI/ML device or a study involving acceptance criteria in the typical sense of measuring device performance against a predefined threshold.
Instead, the "acceptance criteria" here relate to demonstrating substantial equivalence for a Class I medical device (patient lubricant). This process primarily involves comparing the new device's characteristics to those of a legally marketed predicate device.
However, I can extract the information and present it in the requested format, interpreting "acceptance criteria" as the shared characteristics and test results that enable the claim of substantial equivalence.
Here's the breakdown based on the provided text, with "N/A" for information not present or not applicable to this type of device and submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this 510(k) submission, "acceptance criteria" are the characteristics of the predicate device, which the new device (Dynarex Sterile Lubricating Jelly) must match or be substantially equivalent to. "Reported device performance" refers to the new device's characteristics and test results, demonstrating this equivalence.
| Acceptance Criteria (Predicate Device Characteristic) | Reported Device Performance (Dynarex Sterile Lubricating Jelly) |
|---|---|
| Composition/Formulation | |
| Purified water | Yes |
| Carbomer thickeners | Yes |
| Methylparaben | Yes |
| Labeling Claims | |
| Labeled water soluble | Yes |
| Labeled non-staining | Yes |
| Labeled alcohol and fragrance free | Yes |
| Physical Characteristics | |
| Container material (Plastic) | Plastic/Film Laminate |
| Sterile | Yes |
| Physical Tests (Viscosity & pH) | Viscosity & pH |
| Physical Tests (Preservative effectiveness) | Preservative effectiveness |
| Physical Tests (Sterility Test Study) | Sterility Test Study |
| Biocompatibility Testing (ISO 10993) | |
| In-Vitro Cytotoxicity - Pass | In-Vitro Cytotoxicity - Pass* (Grade 2 Result due to preservatives and low concentration of sodium hydroxide, which is common and acceptable for these components) |
| Implantation - Pass | Implantation - Pass |
| Irritation & Hypersensitivity - Pass | Irritation & Hypersensitivity - Pass |
| Systemic Toxicity - Pass | Systemic Toxicity - Pass |
| Sterilization Method | |
| Sterilization Method (similar to predicate, implied by sterility) | Gamma irradiation, validated according to ISO/AAMI 11137 requirements (Method: Vdmax25 with an SAL of 10-6) |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: Not explicitly stated as a "test set" in the context of performance metrics for an AI/ML device. For physical and biocompatibility testing, standard laboratory sample sizes would have been used, but specific numbers are not provided in this summary.
- Data provenance: The data is generated from testing of the Dynarex Sterile Lubricating Jelly and comparison to the predicate device. It is not "data" in the sense of patient records or imaging. The testing would have been conducted by the manufacturer or contracted laboratories. It is prospective testing on the device model. Country of origin not specified for the testing itself, but the submitter is based in the USA.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This concept is not applicable to a submission for a sterile lubricating jelly demonstrating substantial equivalence. There is no "ground truth" established by experts in the sense of clinical annotations or diagnostic interpretations. The "truth" is established by laboratory testing standards (e.g., ISO 10993 for biocompatibility).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. There is no "adjudication" in this context. The determination of "pass" for tests like biocompatibility or sterility would follow established testing protocols and expert interpretation of those results by the testing laboratory, aligning with regulatory standards.
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 not an AI/ML device, nor is it a diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" (or basis for acceptance) primarily stems from established international standards and regulations for medical device safety and performance, specifically:
- ISO/AAMI 11137 for sterilization validation.
- ISO 10993 for biocompatibility testing.
- Pharmacopoeial standards (implied for purity, viscosity, pH, preservative effectiveness).
- The characteristics and regulatory history of the predicate device (E-Z Lubricating Jelly, K041060) serve as the benchmark for "truth" in the context of substantial equivalence.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established
- Not applicable. There is no training set.
§ 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.