(137 days)
For urological use only. Two-Way Catheter: Urethral catheterization for bladder drainage. Three -Way Catheter: Urethral catheterization for bladder drainage and bladder irrigation. Radiopaque Catheter: Urethral catheterization for bladder drainage with radiopaque substance for radiographic visualization.
The Sewoon Medical Device Corp. Ltd. catheter has a tube with a single drainage eye on the proximal tip. The catheter has an additional eye for irrigation purposes. The catheters are available with a radiopaque option. The catheter is available in a combination of French sizes, capacities and lengths to accommodate pediatric and adult male and female applications. Available catheter lengths are 29 and 41 cm. French sizes from 6 to 26 and balloon sizes 1.5cc to 30cc.
The provided text describes the Sewoon All-silicone Foley Balloon Catheter and its substantial equivalence to a predicate device, Rochester Medical Corp. K981612. The data focuses on the physical and performance characteristics of the catheter, rather than an AI/ML powered medical device. Therefore, much of the requested information regarding AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or cannot be extracted from the given document.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from ASTM F623-99) | Reported Device Performance |
|---|---|
| Clause 4.1 "Flow Rate Through the Drainage Lumen" | Meets ASTM F623-99 Standard |
| Clause 4.2 "Balloon Integrity, Resistance to Rupture" | Meets ASTM F623-99 Standard |
| Clause 4.3 "Inflated Balloon Response to pullout" | Meets ASTM F623-99 Standard |
| Clause 4.4 "Balloon Volume Maintenance" | Meets ASTM F623-99 Standard |
| Clause 4.5 "Balloon size and Shaft size" | Meets ASTM F623-99 Standard |
| Clause 4.6 "Deflation Reliability" | Meets ASTM F623-99 Standard |
| Clause 4.7 "Biocompatibility" | Meets ASTM F623-99 Standard |
2. Sample size used for the test set and the data provenance:
- Not Applicable. The device is a physical medical device (Foley catheter), not an AI/ML powered device that would typically use a "test set" in the context of data. The "testing" referred to is for physical performance criteria of the catheter.
- Data Provenance: Not specified in terms of country of origin or retrospective/prospective. The testing was conducted to meet ASTM standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This information pertains to studies for AI/ML devices where human experts establish ground truth for diagnostic or prognostic tasks. For a physical device like a catheter, the "ground truth" is defined by the objective physical and functional standards set by ASTM F623-99.
4. Adjudication method for the test set:
- Not Applicable. As mentioned above, this applies to AI/ML device studies involving human interpretation and disagreement resolution. The catheter's performance is objectively measured against a standard.
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 physical medical device. There is no AI component or human reader interaction described in the context of its performance evaluation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This section describes an AI/ML algorithm's performance without human intervention. The device is a physical catheter, not an algorithm.
7. The type of ground truth used:
- Objective Standards: The "ground truth" for the device's performance is established by the ASTM F623-99 Standard Performance Specifications for Foley Catheters. This standard defines the acceptable physical and functional characteristics of such devices.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/ML powered device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.
§ 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.