(62 days)
The Guardian Urethral Sheath is intended to facilitate the introduction of catheters or instruments into the urethra. The Guardian Urethral Sheath is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
The Solace Guardian Urethral Sheath is an everting sleeve sheath with a backflow valve for the establishment of a protective tract to the bladder to facilitate atraumatic insertion of catheters and instruments through the urethra. The sheath consists of a thin-walled rigid plastic tube, an obturator, and an everting sleeve that deploys from the obturator during insertion to reduce friction. Improvements from the Generation I sheath include a silicone disc to improve patient comfort at the external contact point, a single handed fluid management system, and independent fill and waste lines.
The Urethral Sheath is supplied sterile and is single use. The working channel is sized to accommodate instruments up to 19 French. The sheath outside size is 24 French with a working length of 4.7 cm.
The Sheath helps the patient by protecting the urethra and reducing abrasion or tenderness resulting from instruments passing through the urethra.
This 510(k) summary describes a medical device, the Guardian Urethral Sheath, and its testing for substantial equivalence to a predicate device. However, it does not involve an AI/ML device, and therefore, many of the requested criteria related to AI/ML performance studies, such as sample sizes for test and training sets, ground truth establishment, expert adjudication, and MRMC studies, are not applicable.
Here's an analysis of the provided text based on your prompt, highlighting the available information and noting where AI/ML-specific criteria are not met:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from text) | Reported Device Performance |
|---|---|
| Biocompatibility in accordance with ISO 10993:2009: |
- Cytotoxicity
- Sensitization
- Irritation or Intracutaneous reactivity | Biocompatibility tests were conducted on the Guardian Urethral Sheath according to the requirements of ISO 10993:2009. The following were completed: Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity. (Implies satisfactory completion as it supports the conclusion of substantial equivalence). |
| In Vitro Performance Testing: - Simulated Use Testing
- Design Verification Testing
- Process Validation Testing | In vitro performance tests were performed on the Guardian Urethral Sheath. The following were performed: Simulated Use Testing, Design Verification Testing, Process Validation Testing. (Implies satisfactory completion as it supports the conclusion of substantial equivalence). |
| Substantial Equivalence: Material, design, and function to the Generation 1 Guardian Urethral Sheath K052298. | "The Generation 2 Guardian Urethral Sheath is substantially equivalent in material, design and function to the Generation 1 Guardian Urethral Sheath K052298 (formerly CYSTOGLIDE INTRODUCER SHEATH)."
"Based upon these biocompatibility and in vitro performance tests, the Guardian Urethral Sheath has been shown to be substantially equivalent to the currently marketed Guardian Urethral Sheath K052298." |
2. Sample size used for the test set and the data provenance
- Not Applicable (N/A) for AI/ML context. The testing described is for a conventional hardware medical device (a urethral sheath), not an AI/ML diagnostic or predictive algorithm. Therefore, there isn't a "test set" in the sense of a dataset for algorithm evaluation.
- The performance data provided are for physical and biological characteristics (biocompatibility, in vitro performance). The text does not specify sample sizes for these tests (e.g., number of devices tested for simulated use, number of animal subjects for biocompatibility, etc.).
- Data Provenance: Not specified for the general performance testing. Biocompatibility tests are standardized. "Simulated Use Testing" implies a lab setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A for AI/ML context. Ground truth in the context of expert consensus for image or data interpretation is not relevant for this device. The "ground truth" for this device would be established by physical and chemical testing standards and clinical performance expectations. The text does not specify experts involved in establishing these test criteria or evaluating the results, beyond the implied expertise in conducting ISO standard tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A for AI/ML context. Adjudication methods like 2+1 are used for resolving disagreements among human readers or labelers in AI/ML performance evaluation. This concept does not apply to the physical and biological testing of a conventional medical device.
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
- No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed or described.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For Biocompatibility: The ground truth is established by adherence to the ISO 10993:2009 standards for material safety (cytotoxicity, sensitization, irritation).
- For In Vitro Performance: The ground truth is established by Design Verification Testing, Simulated Use Testing, and Process Validation Testing, which would compare the device's performance against pre-defined engineering specifications and functional requirements. These are objective measures based on engineering and manufacturing standards.
8. The sample size for the training set
- N/A for AI/ML context. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
- N/A for AI/ML context. As there is no training set for an AI/ML model, this question is not applicable.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a series of biocompatibility tests and in vitro performance tests.
- Biocompatibility Testing: Conducted according to ISO 10993:2009 standards, which include tests for Cytotoxicity, Sensitization, and Irritation or Intracutaneous reactivity. The positive outcome of these tests implies that the device materials are safe for their intended use.
- In Vitro Performance Testing: This encompassed Simulated Use Testing, Design Verification Testing, and Process Validation Testing. These tests would evaluate the device's functional integrity, design specifications, and manufacturing consistency under controlled, laboratory conditions. For instance, simulated use testing would assess how the sheath performs during insertion and withdrawal of instruments, and how well the backflow valve functions, within a simulated anatomical environment. Design verification would confirm that the device meets its specified dimensions, material properties, and operational characteristics. Process validation would ensure that the manufacturing process consistently produces devices that meet these specifications.
The conclusion drawn from these tests is that the Guardian Urethral Sheath (Generation 2) has been shown to be substantially equivalent to its predicate device (Guardian Urethral Sheath K052298) in terms of material, design, and function. The FDA's 510(k) clearance further confirms this determination of substantial equivalence, based on the provided data.
§ 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.