(29 days)
The LoFric® Primo™ Single Use Urinary Catheter is intended for intermittent catheterization of the urethra.
The LoFric Primo Single Use Urinary Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a catheter, coated with a hydrophilic low-friction coating. The surface is hydrophilic and when the catheter is activated with the water integrated in the package, it becomes slippery and ready to use. The catheter is provided in a variety of lengths and sizes. The catheter and the activation water is separated, sealed in one bag. By holding the product upright and exerting a light pressure on the folded water pocket, the water will run down and wet the catheter. The bag is opened and the catheter is inserted into the patient's urethra.
The provided document is a 510(k) summary for the Astra Tech AB LoFric Primo Single Use Urinary Catheter, dated May 5, 2005. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not include detailed information regarding specific acceptance criteria, a comprehensive study proving device performance against those criteria, or the methodology typically associated with AI/ML device studies (such as sample sizes for test/training sets, ground truth establishment, or expert involvement).
Based on the provided text, here's what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance | Study to Prove Acceptance Criteria Met |
|---|---|---|
| Material Properties: | ||
| Biocompatibility | Met via laboratory testing. | Conducted against design input requirements. |
| Functionality | Met via laboratory testing. | Conducted against design input requirements. |
| Sterilization: | ||
| Efficacy of new sterilization method | No specific performance metrics provided, but it states "Laboratory data demonstrates this." | Laboratory testing. |
| Comparison to predicate device: | ||
| Substantial equivalence in intended use and design | Achieved. | Comparison of technological characteristics and laboratory data. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document mentions "Laboratory data" and "biocompatibility testing" but does not provide numbers of units tested or details on test methodologies.
- Data Provenance: Not specified. It's a medical device submission, so the testing would have been performed in a controlled laboratory setting, likely by the manufacturer or a contracted lab.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable to this type of device submission. The device is a physical catheter, not an AI/ML diagnostic tool. Ground truth would be based on validated laboratory methods and specifications, not expert consensus on interpretations of data.
4. Adjudication method for the test set
- Not applicable. This device does not involve human interpretation or subjective assessment of results in the way an AI/ML diagnostic device would. Performance is measured against predefined physical and chemical specifications.
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-assisted device, and no human reader studies are mentioned or relevant to this type of product.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- The ground truth for this device would be established by:
- Validated laboratory methods: For physical properties (e.g., strength, flexibility, lubricity after activation), chemical properties (e.g., integrity of coating), and sterility.
- Biocompatibility standards: Industry and regulatory standards for material safety in contact with human tissue.
- Device specifications: Engineering and design requirements for the catheter's functionality and performance.
8. The sample size for the training set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The document states:
"Laboratory testing was conducted to determine device functionality and conformance to design input requirements."
And specifically regarding the change in packaging concept and sterilization method:
"The difference between the LoFric Primo Single Use Urinary Catheter and the predicate is the packaging concept, which includes the addition of water. The method of sterilization is changed. This difference does not raise new questions of safety and effectiveness. Laboratory data demonstrates this."
This indicates that internal laboratory testing, likely based on established protocols for medical devices of this type, evaluated the device's performance against its design specifications and relevant safety standards. The FDA's 510(k) clearance implies that they found this evidence sufficient to establish substantial equivalence to the predicate device. However, the details of these laboratory tests, specific performance metrics, and sample sizes are not provided in this summary.
§ 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.