(85 days)
The PerfIC Cath™ is intended for use in adult male and adult female patients requiring bladder drainage as determined by their physician. This device is indicated for those individuals who are unable to promote natural urine flow or for those individuals who have a significant volume of residual urine following a natural bladder-voiding episode.
The PerfiC Cath™ is a straight single-use urinary catheter for intermittent use. The catheter is made of a simple piece of polyvinylchloride (PVC) tubing approximately 450 millimeters in fength, with two (2) oval eyelet holes for intra-bladder urine collection at the proximal tip. The tip, to be inserted through the urethra, is sealed and rounded for patient comfort and safety. Liquid enters the catheter only via the lateral eyelets. The distal end of the catheter is connected to a PVC urine collection bag (volume = 900 ml). Thus, the PerfiC Cath™ device facilitates its essential function by providing a channel for the drainage of urine from the bladder into a collection bag, via a straight piece of PVC tubing. Adapta Medical, Inc. supplies the PerfIC Cath™ in one size, 14 Fr.
The provided text describes the 510(k) summary for the PerfIC Cath™ urinary catheter. It mainly focuses on demonstrating substantial equivalence to a predicate device and fulfilling biocompatibility, sterilization, packaging, and basic bench testing requirements.
This document describes a medical device (a urinary catheter), not an AI/algorithm-driven device. Therefore, many of the requested criteria related to AI/algorithm performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth, MRMC studies, or standalone algorithm performance, are not applicable to this submission.
However, I can extract information related to the acceptance criteria and supporting "study" (bench and biocompatibility testing) for the PerfIC Cath™ as described in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity | Met acceptance criteria |
| Irritation | Met acceptance criteria | |
| Dermal Sensitization | Met acceptance criteria | |
| Acute Systemic Toxicity | Met acceptance criteria | |
| Sterilization | Sterility Assurance Level (SAL) of 10⁻⁶ | Achieved via electron beam radiation, validated per ISO 11137 series. |
| Packaging | Package integrity | Met device design specifications |
| Bench Testing | Device dimensions | Met device design specifications |
| Mechanical integrity | Confirmed substantial equivalency to predicate | |
| Force to advance catheter | Confirmed substantial equivalency to predicate |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated for any of the tests. The document refers to "bench testing" and "biological reactivity tests" without specifying the number of units or samples used for each test.
- Data Provenance: Not explicitly stated. These would typically be laboratory tests conducted by the manufacturer or contracted labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. For a physical medical device submission, ground truth is established through validated laboratory tests and engineering specifications, not expert interpretation of data in the way it is for AI algorithms.
4. Adjudication method for the test set
Not applicable. Adjudication methods like "2+1" are relevant for reviewing human-interpreted data, not for laboratory or bench test results.
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 device is a urinary catheter, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used
For the PerfIC Cath™, the "ground truth" is defined by:
- Established Biocompatibility Standards: As defined by ISO 10993-1:2009 for externally communicating devices with limited patient contact.
- Established Sterilization Standards: As defined by the ISO 11137 series of standards.
- Device Design Specifications: Internal engineering specifications for dimensions, mechanical integrity, etc.
- Predicate Device Performance: Used as a benchmark for substantial equivalency in mechanical integrity and force to advance the catheter.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of medical device submission.
§ 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.