(93 days)
For Prescription Use: For easing the insertion of medical devices such as scopes and catheters into body orifices.
The subject device is a terminally gamma sterilized 10cc polypropylene plastic syringe filled with United Guardian lubricating jel and capped with a polypropylene plastic cap. United Guardian has a Master File Reference for its lubrication jel, Master File for Devices MAF-613 pertaining to Lubrajel RR. All components of the device are gamma irradiation stable.
The provided document describes a 510(k) premarket notification for a medical device, specifically a "Sterile Lube Jelly Pre-Filled Syringe," asserting its substantial equivalence to a legally marketed predicate device. The information details non-clinical performance data rather than a clinical study involving human patients or a complex AI algorithm. Therefore, many of the requested categories related to clinical trials, AI, ground truth, and expert evaluation are not applicable to this submission.
Here's a breakdown based on the provided text:
Acceptance Criteria and Reported Device Performance
The device, the Nurse Assist Lube Jelly Pre-Filled Syringe, aims to demonstrate substantial equivalence to the predicate device, the Horizon Steri-Lub Lubrication Gel. The acceptance criteria are implicit in showing that the device's characteristics and performance are comparable to the predicate.
| Acceptance Criteria Category | Reported Device Performance (Nurse Assist Lube Jelly Pre-Filled Syringe) | Predicate Device Performance (Horizon Steri-Lub Lubrication Gel) |
|---|---|---|
| Classification Product Code | KMJ | KMJ |
| Intended Use: Lubricating Device Insertion | Yes | Yes |
| Prescription Use | Yes | Yes |
| Sterility | Yes (terminally gamma sterilized) | Yes |
| Shelf Life | 2 years | 2 years |
| Chemical Composition | Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate preserved with methyl and propyl paraben and sodium metabisulfite | Water, Glycerin, Polyacrylic Acid, Propylene Glycol, Sodium Polyacrylate preserved with methyl and propyl paraben and sodium metabisulfite |
| Mechanism of Dispensing | 10cc Plastic Syringe, Oral Tip | 10cc Plastic Syringe, Oral Tip |
| Barrel, Plunger, Tip Cap Material | Polypropylene | Polypropylene |
| Plunger Grommet Material (Latex-Free) | Not made with natural rubber latex | Not made with natural rubber latex |
| Syringe Seal Integrity | Remained sealed when exposed to a 15 In-Hg vacuum. | (Not specified for predicate, but Nurse Assist device met this criterion) |
| Stain Testing | Post sterile lubricant did not stain gloves. | (Not specified for predicate, but Nurse Assist device met this criterion) |
| Viscosity | Post sterile lubricant remained within the pre-sterile 18,000 to 26,500 cps viscosity range. | (Nurse Assist device met this criterion against its own pre-sterile range, implying it's consistent) |
| Volume after Accelerated Aging | Remained within specification. | (Nurse Assist device met this criterion) |
| pH after Accelerated Aging | Remained within specification. | (Nurse Assist device met this criterion) |
| Sterility after Accelerated Aging | Remained within specification. | (Nurse Assist device met this criterion) |
| Biocompatibility | Complied with the requirements of ISO 10993. | (Nurse Assist device met this criterion) |
Study Details
This submission relies on non-clinical performance data and a comparison to a predicate device to demonstrate substantial equivalence, rather than a clinical study the way an AI/software device would.
- Sample size used for the test set and the data provenance: Not applicable. The "test set" here refers to samples of the device undergoing various performance tests (e.g., syringe seal, stain, viscosity, accelerated aging, biocompatibility). The number of units tested for each specific non-clinical test is not provided in this summary. The data provenance is from internal testing conducted by Nurse Assist Incorporated.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance tests is established through standardized testing protocols (e.g., ISO 10993 for biocompatibility, physical property measurements for viscosity, pH, volume, etc.), not expert consensus in the diagnostic sense.
- Adjudication method: Not applicable. Standard laboratory testing procedures would be followed.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. This device is a pre-filled lubricant syringe, not an AI diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
- The type of ground truth used: For the non-clinical performance tests, the "ground truth" is defined by established scientific and regulatory standards (e.g., specific viscosity ranges, pH levels, sterility tests, ISO 10993 for biocompatibility) that the device must meet.
- The sample size for the training set: Not applicable. There is no AI training set.
- How the ground truth for the training set was established: Not applicable. There is no AI 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.