(223 days)
The Kendall Coude Foley Catheter is a urological catheter designed with a bent tip to provide transurethral access to the obstructed bladder in the male patient for irrigation and urine drainage.
The Kendall Ultraner Coude Foley Catheter is a sterile, single use unological catheter composed of natural rubber latex with a 5 cc or 30cc balloon and designed with a beat tip to provide transurethral access to an obstructed bladder, for purposes of irrigation and urine drainage. The Coude catheter is exclusively used in the male patient, typically in a hospital secting. The Kendall Ultramer Coude Foley Catheters will be marketed in 12-24 French sizes.
The provided text describes a medical device, the Kendall Ultramer Coude Foley Catheter, and its 510(k) submission to the FDA. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against defined acceptance criteria in the manner requested for AI/software devices.
As such, many of the requested categories are not applicable to this type of traditional medical device submission. The primary "study" conducted here is nonclinical testing to ensure fundamental safety and equivalence.
Here's a breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What the device must achieve) | Reported Device Performance (What was found) |
|---|---|
| Biocompatibility: Meet ISO-10993 Biological Evaluation of Medical Devices standards. | Materials used in the Kendall Coude Foley Catheter are biocompatible. |
| Functional/Mechanical Performance: Meet ASTM F623-89 Standard Performance Specifications for Foley Catheters for: |
- Flow rates
- Balloon integrity
- Inflated balloon response to traction
- Balloon volume maintenance
- Balloon size
- Shaft size
- Deflation reliability | The Kendall Coude catheter was found to meet ASTM F623-89 Standard Performance Specifications for Foley Catheters for the listed parameters. Testing also verified equivalence to the predicate device. |
| Substantial Equivalence: Fabricated from similar materials, same function, equivalent indications for use, and similar overall design as the predicate device (Bardex Lubricath Coude Foley Catheter, 510(k) #K910195). | The Kendall Ultramer Coude Foley Catheter is equivalent to the referenced predicate device in materials, function, indications for use, and overall design. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in terms of a "test set" for a diagnostic product. The nonclinical testing involves physical samples of the catheter, but the number of units tested for each functional/mechanical test is not provided.
- Data Provenance: The testing was conducted internally by The Kendall Company ("Nonclinical testing was performed on the Kendall cather..."). The country of origin for the data is implicitly the USA (Mansfield, MA). It is a prospective evaluation of newly manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This device is a physical medical catheter, not an AI/diagnostic software. Ground truth for its performance is established through standardized engineering and biocompatibility testing, not expert interpretation of diagnostic data.
4. Adjudication method for the test set
- Not Applicable. See point 3. Testing involves objective measurements against predefined standards.
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 device, not an AI or diagnostic software. Therefore, no MRMC study or AI assistance evaluation was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical device, not an algorithm or software. Its performance is inherent in its design and materials, and demonstrated through physical testing.
7. The type of ground truth used
- Engineering Standards and Biocompatibility Standards:
- ASTM F623-89 Standard Performance Specifications for Foley Catheters: Provides quantifiable benchmarks for functional and mechanical aspects (e.g., flow rates, balloon integrity).
- ISO-10993 Biological Evaluation of Medical Devices: Provides standardized methods and criteria for evaluating the biocompatibility of medical devices.
- Predicate Device Equivalence: The ultimate "ground truth" for regulatory approval in this context is demonstrating substantial equivalence to a legally marketed predicate device, as required for a 510(k) submission.
8. The sample size for the training set
- Not Applicable. This is a physical device, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.