(190 days)
Not Found
No
The description focuses on the mechanical and optical properties of the endoscope, with no mention of AI/ML, image processing, or data analysis beyond basic visualization.
Yes
The device is described as being used for "therapeutic procedures" such as "disintegration of ureteroliths and kidney stones" and "removal of foreign bodies," which are treatments.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are used for "biopsy for tumor diagnosis," which is a diagnostic procedure.
No
The device description clearly outlines physical hardware components (endoscopes, fiber image bundle, channels, instrument ports, guide) and performance studies related to mechanical load and sterilization, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that these ureteroscopes and uretero-renoscopes are used to examine the ureter and kidney inside the body. They are used for direct visualization and to facilitate therapeutic procedures within the body.
- Lack of Sample Analysis: There is no mention of the device analyzing samples taken from the patient. Its function is based on direct visualization and the manipulation of instruments within the body.
Therefore, based on the provided information, this device is an endoscope used for internal examination and procedures, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ureter and kidney
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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.