(70 days)
Our Cystoscopes are used when Operative and/or Diagnostic Cystoscopy is medically indicated. Cystoscopes are used for 2 tasks: Providing an excellent visual image and good illumination of the operating area.
We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting.
The provided text "Exhibit 6 'N' Tech Cystoscopes 510(k)" is a 510(k) summary for "N" Tech Cystoscopes, dated April 28, 1998. It details the company's claim of substantial equivalence to older equipment.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| As safe and effective as other devices earlier and currently on the market. | "Our Cystoscopes are as safe and effective as all other devices earlier and currently on the market." |
| Designs, lens-systems, materials, glues, and epoxies commonly used by the endoscope industry. | "Our designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry." |
| Substantial equivalence in all significant details compared to R. Wolf devices. | "We compared our manufacturing drawings with corresponding devices from R.Wolf. We found substantial equivalence in all significant details." |
| Manufactured under strict GMP Guidelines, including incoming material registration and testing, manufacturing instructions, device master and history filing, and complaint reporting. | "We intend to manufacture our Cystoscopes under strict GMP Guidelines: From incoming material registration and testing to detailed manufacturing instructions and device master and history filing including complaint reporting." |
| Assure safe and long-term use through mechanical and thermic stress testing. | "Our Prototypes underwent extensive mechanical and thermic stress testing to asure safe and long term use." |
| No adverse health effects compared to already marketed devices. | "We are not able to determine any adverse health effects compared to the already marketed devices and can not imagine any possibility of this kind." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a "test set" in the context of clinical or performance data. The performance testing mentioned ("extensive mechanical and thermic stress testing") refers to prototypes, but no specific number of prototypes or test cases (e.g., number of procedures or patients) is given. Similarly, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document does not mention the use of experts to establish ground truth for a test set in the context of clinical or performance data. The comparison drawn is primarily against "older equipment, manufactured by R. Wolf and other Manufacturers" and "corresponding devices from R.Wolf" based on manufacturing drawings.
4. Adjudication Method for the Test Set
No adjudication method is mentioned, as there is no described test set involving human assessment or interpretation of clinical outcomes for ground truth establishment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The submission focuses on device equivalence based on design and mechanical/thermic performance, not on direct comparison of human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This device is a physical medical instrument (Cystoscope), not an algorithm or AI. Therefore, a standalone (algorithm only) performance study is not applicable and not mentioned.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Design and Manufacturing Equivalence: Comparison of manufacturing drawings and general industry practices for designs, lens-systems, materials, glues, and epoxies with predicate devices (R. Wolf).
- Mechanical and Thermic Stress Testing: This implies engineering standards or internal specifications for durability and safety, rather than clinical outcomes or pathology.
- Absence of Adverse Health Effects: A claim based on comparison with existing devices and lack of foreseeable issues, rather than empirical data from a study.
8. Sample Size for the Training Set
Not applicable. The device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm.
§ 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.