(141 days)
The Dukal Sterile Lubricating Jelly is a medical device intended for medical purposes, to lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required.
The Dukal Sterile Lubricating Jelly is a clear, greaseless, water soluble jelly.
The provided document, K113689, describes a 510(k) premarket notification for the Dukal Sterile Lubricating Jelly. This is not for a software or AI-powered medical device, but rather a physical medical device. Therefore, many of the requested criteria (like sample size for test set, number of experts for ground truth, MRMC studies, standalone algorithm performance, training set size, etc.) are not applicable in this context, as they relate to studies of diagnostic accuracy or performance of AI/software in interpreting data.
However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria, aligning with the information that is present in the 510(k) submission for a non-AI device.
Acceptance Criteria and Device Performance for Dukal Sterile Lubricating Jelly
The submission for the Dukal Sterile Lubricating Jelly demonstrates substantial equivalence to a predicate device (Dynarex Sterile Lubricating Jelly, K092488) based on comparable technological characteristics, intended use, and safety/effectiveness profiles. The "acceptance criteria" here are implicitly the criteria for demonstrating substantial equivalence, primarily through direct comparison of features and performance to a legally marketed predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
For this non-AI medical device, the acceptance criteria are based on exhibiting similar technological characteristics and performance to the predicate device.
| Characteristic / Acceptance Criteria | Dukal Sterile Lubricating Jelly (Reported Performance) | Predicate Device (Dynarex Sterile Lubricating Jelly) |
|---|---|---|
| Intended Use | To lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required. | To lubricate body orifices to facilitate entry of diagnostic devices when a sterile field is required. |
| Composition | ||
| Purified Water | Yes | Yes |
| Carbomer Thickeners | Yes | Yes |
| Methylparabens | Yes | Yes |
| Labeled Water Soluble | Yes | Yes |
| Labeled Non Staining | Yes | Yes |
| Labeled Alcohol & Fragrance Free | Yes | Yes |
| Container Material | Plastic/Film Laminate | Plastic/Film Laminate |
| Sterile | Yes | Yes |
| Biocompatibility Testing | ISO 10993 compliant | ISO 10993 compliant |
| In-Vitro Cytotoxicity | Pass | Pass |
| Implantation | Pass | Pass |
| Irritation & Hypersensitivity | Pass | Pass |
| Systemic Toxicity | Pass | Pass |
| Sterilization Method | Gamma irradiation (validated per ISO/AAMI 11137 with SAL of 10⁻⁶) | (Not explicitly detailed for predicate in this document, but implied to be equivalent for a sterile product.) |
| Physical Tests | (Not explicitly detailed, but implied to be comparable to predicate for "Physical Tests") | (Not explicitly detailed, but implied to be comparable.) |
2. Sample Size for Test Set and Data Provenance
For physical medical devices undergoing a 510(k) submission based on substantial equivalence, the "test set" does not typically refer to a dataset of patient cases. Instead, it refers to samples of the device itself undergoing various physical, chemical, and biological tests.
- Sample Size for Test Set: Not specified in terms of number of units, but implies a sufficient number of samples of the Dukal Sterile Lubricating Jelly were used for the listed biocompatibility and sterilization validation tests.
- Data Provenance: The data arises from internal testing performed on the Dukal Sterile Lubricating Jelly and comparison to the publicly available characteristics of the predicate device (Dynarex Sterile Lubricating Jelly). It is retrospective in the sense that the predicate device's characteristics are already established.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This criterion is not applicable for this type of medical device submission. Ground truth, in the context of interpretation by experts, is relevant for diagnostic devices interpreting outputs like images or signals. For a lubricating jelly, "ground truth" is established through standardized laboratory testing (e.g., ISO standards for biocompatibility) and direct chemical/physical characterization, rather than expert interpretation of a test set.
4. Adjudication Method for the Test Set
This criterion is not applicable. Adjudication methods (like 2+1, 3+1) are for resolving discrepancies in expert interpretations of data in diagnostic studies. For a physical device, performance is evaluated against objective standards and test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. These types of studies are for evaluating the performance of diagnostic systems (often AI-assisted) and human readers in interpreting clinical cases. This device is a lubricating jelly, not a diagnostic system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. This applies to software algorithms without human intervention. The Dukal Sterile Lubricating Jelly is a physical product directly applied by a human user as part of a medical procedure.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on:
- Objective Laboratory Testing: Adherence to established standards for biocompatibility (ISO 10993 series for In-Vitro Cytotoxicity, Implantation, Irritation & Hypersensitivity, Systemic Toxicity).
- Sterilization Validation: Conformance to ISO/AAMI 11137 requirements for gamma irradiation sterilization with a specified Sterility Assurance Level (SAL).
- Chemical and Physical Characterization: Verification of ingredients and properties (e.g., water-soluble, non-staining, alcohol/fragrance-free) as listed on the label and compared to the predicate.
8. The Sample Size for the Training Set
Not applicable. This criterion refers to the dataset used to train an AI model. This submission is for a physical medical device and does not involve AI or machine learning.
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set for an AI model, this criterion does not apply.
§ 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.