(72 days)
The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag that is inserted through the urethra and indicated for the purpose of bladder drainage for males and females. The urinary catheter comes in a variety of sizes packaged sterile for single-use.
The Cure Catheter™ Closed System is an intermittent urinary catheter attached to a collection bag and intended to be used by males and females for the purpose of bladder drainage. It is manufactured with conventional medical grade, latex-free, biocompatible materials. The tip has been designed to eliminate trauma to the urethra and is provided in a variety of sizes in sterile, single-use packages. The Cure Catheter™ Closed System is also offered as part of a complete kit.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Cure Catheter™ Closed System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Biocompatibility | US FDA General Program Memorandum #G95-1 | Met acceptance criteria for all tests conducted | Met the acceptance criteria for all tests conducted |
| Biocompatibility | ISO 10993-1 (Biological Evaluation of Medical Devices) | Considered biocompatible under the conditions tested | Considered biocompatible under the conditions tested |
| Substantial Equivalence | Comparison toPredicate Device (Rusch MMG/O'Neil Catheter) | Similar in function, composition, and intended use | Similar in function, composition, and intended use |
| Functionality | Bladder Drainage (as per Intended Use) | Effective for bladder drainage in males and females | Indicated for the purpose of bladder drainage for males and females |
| Material Safety | Conventional medical grade, latex-free, biocompatible | Composed of these materials | Manufactured with conventional medical grade, latex-free, biocompatible materials |
| Design Safety | Tip designed to eliminate trauma to the urethra | Tip طراحی for atraumatic insertion | The tip has been designed to eliminate trauma to the urethra |
| Sterility | Packaged sterile for single-use | Packaged sterile for single-use | Comes in a variety of sizes packaged sterile for single-use |
Notes on Acceptance Criteria and Performance:
- The document primarily focuses on biocompatibility and substantial equivalence to a predicate device as the key acceptance criteria.
- The "Reported Device Performance" column largely reiterates that the device met the stated criteria or aligns with the design specifications, indicating compliance.
- The document doesn't provide specific numerical thresholds or detailed pass/fail rates for these criteria beyond stating that they were "met."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a sample size for the test set used in the nonclinical testing for biocompatibility. It only states that "Standard biocompatibility tests were performed."
- Data Provenance: The biocompatibility tests were performed by North America Science Associates, Inc. (NAmSA). The country of origin of the data is not explicitly stated but can be inferred to be within North America given the name of the testing organization. The tests were nonclinical, meaning they were not performed on human subjects but rather in a laboratory setting (e.g., in-vitro or in-vivo animal studies as per ISO 10993). Therefore, the data is retrospective in the sense that it's a report on tests already completed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document. For nonclinical biocompatibility testing, ground truth is established by adherence to recognized standards (like ISO 10993-1) and the successful outcome of the tests as interpreted by relevant scientific personnel, but not typically by "experts" in the sense of clinical reviewers establishing a diagnostic ground truth.
4. Adjudication Method for the Test Set
- This is not applicable and not provided as the evaluation involved nonclinical biocompatibility testing and substantial equivalence, not a diagnostic or clinical performance study requiring adjudication of expert opinions.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or data, often comparing AI assistance to unassisted human performance. The Cure Catheter™ is a urological catheter, and its evaluation focuses on material safety, functional design, and substantial equivalence, not diagnostic accuracy.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- This is not applicable. The Cure Catheter™ is a physical medical device, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm doesn't apply. Its performance is inherent in its physical properties and design.
7. The Type of Ground Truth Used
- The "ground truth" for the biocompatibility testing was established by adherence to internationally recognized standards (US FDA General Program Memorandum #G95-1 and ISO 10993-1) and the measured outcomes of the performed tests (e.g., absence of cytotoxicity, irritation, sensitization).
- For the substantial equivalence claim, the ground truth was the characteristics of the predicate device (Rusch MMG/O'Neil Catheter) and the comparison of the Cure Catheter's features, function, and intended use against those characteristics.
8. The Sample Size for the Training Set
- This is not applicable as the Cure Catheter™ is a physical medical device and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
- This is not applicable as the device does not involve a training set.
§ 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.