(190 days)
The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.
The submitted devices are thin endoscopes with fiber image bundle and an oval channel for irrigation and for use of one or two instruments simultaneously.
The devices have a direct view, an oblique or an offset eyepiece.
A single or double instrument port is needed for the insertion of the auxiliary instruments. For lithoclast application an additional guide is used.
The longer endoscopes are called uretero-renoscopes and are used for procedures in ureter and kidney. The shorter ones are called ureteroscopes and are used for procedures in ureter (and for procedures in kidney, if the urinary tract is short enough).
The provided text describes a 510(k) summary for "Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes" by Richard Wolf Medical Instruments Corporation.
Based on the provided document, the following observations can be made regarding acceptance criteria and device studies:
1. A table of acceptance criteria and the reported device performance:
The document mentions two performance tests, but does not explicitly state numerical acceptance criteria for them. General statements about performance are made.
| Acceptance Criteria (Explicit) | Reported Device Performance |
|---|---|
| Not explicitly stated | Mechanical Load Test (Bending Test): Shows that there is no fracture of the shaft if normally used. |
| Not explicitly stated | Steam Sterilization: Shows that the steam sterilization has no influence on the optical quality of the Uretero-Renoscopes when using the fractional method. |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not specified. The document states "tests performed by Richard Wolf" for the steam sterilization, implying internal testing, but no number of units tested is given.
- Data provenance: The performance data described (mechanical load test, steam sterilization) appears to be from internal laboratory testing conducted by Richard Wolf Medical Instruments Corporation. The country of origin of the data is implicitly the USA, where the company is located. The tests are retrospective in the sense that they were conducted on the device models being submitted, not as part of a prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The performance tests described (mechanical bending, optical quality after sterilization) are objective engineering tests, not subject to expert interpretation for ground truth.
4. Adjudication method for the test set:
This information is not applicable/provided. The performance tests are objective engineering assessments; adjudication by experts would not typically be relevant for these types of tests.
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:
No MRMC comparative effectiveness study was done. This is a hardware medical device (endoscope), not an AI-powered diagnostic tool. The document explicitly states: "No clinical tests performed."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware medical device, not an algorithm.
7. The type of ground truth used:
The "ground truth" for the reported performance tests seems to be based on:
- Mechanical integrity: The device not fracturing under normal use (for the bending test).
- Optical quality preservation: The optical quality not being influenced by steam sterilization.
These are objective, direct physical measurements or observations.
8. The sample size for the training set:
Not applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established:
Not applicable. See point 8.
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Image /page/0/Picture/0 description: The image shows a handwritten symbol or character. It appears to be a combination of numerical and alphabetic elements. The symbol is dark and bold against a white background, suggesting it was written with a thick marker or pen.
Richard Wolf Medical Instruments Corporation
510(k) Summary of Safety and Effectiveness
APR - 3 1997 K963855
353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Telephone: 847.913.1113 Fax: 847.913.1488
| Date of Preparation: | August 23, 1996 |
|---|---|
| Company / Institution name: | RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
| Division name (if applicable): | N.A. |
| Street address: | 353 Corporate Woods Parkway |
| City: | Vernon Hills |
| State/Province: | Illinois |
| Country | USA |
| ZIP / Postal Code: | 60061 |
| FDA establishment registration number: | 14 184 79 |
| Phone number (include area code): | (847) 913-1113 |
| FAX number (include area code): | (847) 913-0924 |
| Contact name: | Mr. Robert L. Casarsa |
| Contact title: | Quality Assurance Manager |
Product Information:
| Trade name: | Compact Operating Fiber Uretero-Renoscopes and Ureteroscopes |
|---|---|
| Model number: | 8712.402, 8702.402, 8703.402, 8707.402, 8705.402, 8719.401, 8708.401, 8718.401, 8708 403, 8718.403, 8714.401, 8704.401 and accessories: 8952.313, 8954.765, 8954.766, 8708.253 |
| Common name: | Ureteroscopes |
| Classification name: | Endoscope and accessories |
Information on devices to which substantial equivalence is claimed:
| 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---|---|
| 1 pre-enact. | 1 Cysto-Urethroscope 4616 | 1 Richard Wolf M.I.C. |
| 2 pre-enact. | 2 Cysto-Urethroscope 8616.10 | 2 Richard Wolf M.I.C. |
| 3 K 94 04 64 | 3 Slender Uretero-Renoscope 27023AS | 3 Storz |
| 4 | 4 Ureteroscopes Micro-6 / Micro-6 long | 4 Circon |
| 5 K 94 04 64 | 5 Operating Uretero-Renoscope 27024KE/KB | 5 Storz |
| 6 | 6 Operating Ureteroscopes MR-7 Series | 6 Circon |
1.0 Description
The submitted devices are thin endoscopes with fiber image bundle and an oval channel for irrigation and for use of one or two instruments simultaneously.
The devices have a direct view, an oblique or an offset eyepiece.
A single or double instrument port is needed for the insertion of the auxiliary instruments. For lithoclast application an additional guide is used.
The longer endoscopes are called uretero-renoscopes and are used for procedures in ureter and kidney. The shorter ones are called ureteroscopes and are used for procedures in ureter (and for procedures in kidney, if the urinary tract is short enough).
Image /page/0/Picture/11 description: The image shows the words "RICHARD WOLF" in a stylized, bold font. The word "RICHARD" is stacked on top of the word "WOLF". To the right of the words is a square box with a stylized image inside. The image inside the box appears to be a drawing of an animal.
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Richard Wolf Medical Instruments Corporation
2.0 Intended Use
ernon Hills Illinois 6006 lephone: 847.913.1113 Fax: 847.913.1488
The submitted ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories, for example disintegration of ureteroliths and kidney stones, biopsy for tumor diagnosis or removal of foreign bodies.
1963855
3.0 Technological Characteristics
- autoclavable (steam sterilization) for high hygiene demands ●
- high resolution image bundle with reduced pixel size, down to 30,000 pixels for realistic . reproduction of the operation site (8702.402 and 8712.402 14,000 pixels)
- atraumatic tip for problem free introduction into the uteric ostium .
- bright wide angle telescope and high flow rate for optimal visualization .
4.0 Substantial Equivalence
These devices are substantially equivalent to existing pre-enactment devices sold by Richard Wolf and 510(k) devices sold by Storz and Circon.
5.0 Performance Data
Mechanical load test (bending test) shows, that there is no fracture of the shaft if normally used. The steam sterilization in the clinical use and the tests performed by Richard Wolf shows, that the steam sterilization has no influence to the optical quality of the Uretero-Renoscopes, when using the fractional method.
6.0 Clinical Tests
No clinical tests performed.
7.0 Conclusions Drawn
These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instruction manual.
By: Robert J. Casassa
Robert L. Casarsa Quality Assurance Manager
Date: Jan 17,92
Image /page/1/Picture/21 description: The image shows the words "RICHARD WOLF" in a bold, sans-serif font. The word "RICHARD" is stacked on top of the word "WOLF". To the right of the words is a square with rounded corners, inside of which is a stylized image that appears to be a logo. The logo is black and white and has a unique design.
§ 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.