(57 days)
The Williams Cystoscopic Injection Needle is used for cystoscopic injection into the urethra, bladder neck, and bladder wall.
The Williams Cystoscopic Injection Needle is a semi-rigid injection needle. It is provided in 3.7 or 5.0 French sizes with 35 or 45 centimeters long polyurethane catheter, which ends with a 7 or 8 millimeter length stainless steel beveled tip cannula that is available in 20 to 25 needle gages. The subject device is sterilized with EtO and is intended for one-time use.
The provided text describes a medical device, the Williams Cystoscopic Injection Needle, and its substantial equivalence application (K171602) to the FDA. The submission focuses on demonstrating that the device meets design and performance requirements through a series of tests.
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | Acceptable for intended uses per ISO 10993-1 and FDA Guidance. | Biological risks evaluated and determined to be acceptable. |
| Shelf Life | Maintain device performance for a three-year shelf life. | All predetermined acceptance criteria were met after accelerated aging to the equivalence of three years. |
| Functional Verification | Device functions as intended. | Acceptance criteria were met. |
| Dimension Verification | Device functions as intended (implies meeting dimensional specifications). | Acceptance criteria were met. |
2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for the Biocompatibility, Shelf Life, Functional Verification, or Dimension Verification tests. It also does not mention the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the involvement of experts to establish a "ground truth" for the performance tests. The tests described (biocompatibility, shelf life, functional, dimensional) typically rely on standardized laboratory procedures and measurements against predetermined specifications, rather than expert interpretation of a 'truth' in a clinical context.
4. Adjudication Method for the Test Set:
Given the nature of the performance tests described (laboratory-based measurements and compliance with standards), an "adjudication method" like 2+1 or 3+1 is not applicable or mentioned. Acceptance is typically based on whether measured values fall within predefined ranges or meet specific pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
An MRMC comparative effectiveness study was not performed or described. The device is an injection needle, and the testing focuses on its physical and functional properties, not on diagnostic or interpretive accuracy that would typically involve human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This concept is not applicable to the Williams Cystoscopic Injection Needle. This device is a manual, single-use medical instrument and does not involve algorithms or AI. Therefore, no standalone algorithm performance was assessed.
7. Type of Ground Truth Used:
For the performance tests mentioned, the "ground truth" implicitly refers to:
- Biocompatibility: Adherence to established biological safety standards (ISO 10993-1).
- Shelf Life: Stability of physical and functional properties over time, measured against initial design specifications.
- Functional Verification: The device performing its mechanical and operational actions as designed.
- Dimension Verification: Adherence to the specified dimensional blueprints and tolerances.
These are not "expert consensus, pathology, or outcomes data" in the traditional sense, but rather objective compliance against engineering specifications and international standards.
8. Sample Size for the Training Set:
The document does not mention a training set. This is because the device is a physical instrument, not a learning algorithm or AI, therefore, a training set is not relevant.
9. How the Ground Truth for the Training Set Was Established:
This question is not applicable as there is no training set for this device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.