(77 days)
The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market. The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation.
A sterile water pre-filled syringe for use in inflating foley catheter balloon
The device is a 10cc and 30cc syringe pre-filled with USP purified water and gamma irradiated. The syringe is produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover.
The provided text is a 510(k) summary for a medical device: "Primary Care Solutions Prefilled 10cc and Prefilled 30cc Inflation Syringes with Sterile Water."
This document does not describe an AI/ML powered device, nor does it detail a study proving the device meets acceptance criteria in the way typically expected for such technologies. Instead, it is a submission for a conventional medical device (pre-filled syringes for foley catheter balloon inflation) seeking clearance based on substantial equivalence to an existing predicate device.
Therefore, many of the requested elements for describing an AI/ML study (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of regulatory submission.
The "acceptance criteria" here refer to meeting the requirements for substantial equivalence to a predicate device, primarily focusing on materials, intended use, and general performance characteristics rather than complex performance metrics like sensitivity or specificity.
Here's a breakdown of the relevant information provided:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a substantial equivalence submission for a simple medical device, there aren't explicit quantifiable "acceptance criteria" and "reported device performance" in the way one would see for diagnostic AI. Instead, the "performance" is implicitly demonstrated by the device's identical materials and intended use compared to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device "Performance" / Characteristics |
|---|---|
| Material Composition: Must be identical or acceptably equivalent to the predicate device. | "The predicate device contains exactly the same material components as the pre-market notice subject device...produced using polypropylene for the device barrel and plunger and pharmaceutical grade latex free rubber for both the plunger gasket and syringe tip cover." |
| Intended Use: Must be identical to the predicate device. | "The 10cc and 30cc pre-filled syringes are intended to be used for foley catheter balloon inflation. The intended use of the device is identical to that of the predicate device and other similar devices in the market." |
| Sterility: Must be sterile (as it's a pre-filled syringe with sterile water for medical use). | "gamma irradiated." and "A sterile water pre-filled syringe..." |
| Performance for Stated Use: Must be capable of inflating foley catheter balloons effectively. | "The syringe is employed by connecting the syringe tip to the valve on the side arm of foley catheter and forcing sterile water through a lumen into the balloon for inflation." (Implied to perform this function reliably given material and design equivalence). |
| Compliance with Special Controls: Must meet any applicable mandatory performance standards or special controls. | "No applicable mandatory performance standards or special controls exist for these devices." |
Regarding the study that "proves the device meets the acceptance criteria":
The "study" in this context is the comparison to the identified predicate device (K943836 - Pre-Filled 10cc Inflation Syringe with Sterile Water from Orion Medical Products, Inc.) and the determination of substantial equivalence by the FDA. The document explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices..."
The core "proof" is the detailed comparison in the submission (summarized here) highlighting the identical material components and identical intended use.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable. This is a substantial equivalence submission for a non-AI/ML device. There is no "test set" in the context of data for an algorithm. The evaluation is based on device design, materials, and intended use comparison to a predicate.
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. No expert consensus "ground truth" for a test set is involved. The FDA regulatory body makes a determination of substantial equivalence based on the submitted application and its comparison to the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or expert adjudication is relevant to this type of device submission.
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. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. For this submission, the "ground truth" (if one could even call it that) is the legally marketed status and characteristics of the predicate device to which substantial equivalence is claimed.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML device.
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.