The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.

transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
tumor diagnostics and / or biopsy
removal of foreign bodies .

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

Device Description

Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.

The uretero-renoscope may be inserted with the introduction sheath, 8706.042 to view the renal pelvis. The introduction sheath remains stationary while the ureterorenoscope may be removed and replaced by a flexible uretero-renoscope when reaching the upper calyx group.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Compact Operating Uretero-Renoscope with Insertion Sleeve":

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, the device did not have explicit, quantifiable acceptance criteria or associated performance metrics. The submission focuses on demonstrating substantial equivalence to a predicate device rather than meeting specific performance benchmarks.

Acceptance Criteria (Stated/Implied)	Reported Device Performance
Safe and Effective when used according to instructions manual	"These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual." (Conclusion Drawn)
Technological characteristics: - Atraumatic tip - Sharp, brilliant image quality - Autoclavable/steam sterilizable (134°C / 273°F)	"atraumatic tip for problem free introduction into the uteri ostium." "sharp, brilliant quality over the entire image." ". autoclavable / steam sterilization 134°C / 273°C"
Substantially equivalent to predicate device (K963855)	"The submitted devices are substantially equivalent to existing devices sold by Richard Wolf."

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size for Test Set: Not applicable. No clinical or performance tests were conducted on a 'test set' as defined for typical device performance studies (e.g., diagnostic accuracy, efficacy).
Data Provenance: Not applicable. No data from a test set was generated from specific countries or in a retrospective/prospective manner.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Not applicable. No ground truth was established for a test set, as no clinical performance studies were performed. The submission relies on design and testing to assure safety and effectiveness, and claims substantial equivalence.

4. Adjudication Method for the Test Set:

Not applicable. No clinical performance studies were performed that would require an adjudication method for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was done. The document explicitly states, "Clinical tests performed were not performed." Therefore, there is no effect size reported for human readers with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study:

No standalone performance study was done. This device is a physical medical instrument (uretero-renoscope), not an algorithm or AI-powered system, so a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used:

Not applicable in the context of clinical performance or diagnostic accuracy. The "ground truth" for the device's claims of safety and effectiveness, and substantial equivalence, appears to be based on:
- Engineering design and testing ("These devices are designed and tested to assure their safety and effectiveness...")
- Comparison to a predicate device already on the market (K963855).

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI/ML algorithm that would require a training set of data.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As this is not an AI/ML device, there is no training set or ground truth for it.

Summary

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3/26/99

990050

Pg 1 of 2

353 Corporate Woods Parkway Vernon Hills, Illinois 60061 Phone: 847.913.1113 Fax: 847.913.1488

RICHARD WOLF
MEDICAL INSTRUMENTS CORPORATION

510(k) Summary of Safety and Effectiveness

Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.	Date of Preparation:	January 5, 1999
Division name (if applicable):	N.A.	FDA establishment registration number:	14 184 79
Street address:	353 Corporate Woods Parkway	Phone number (include area code):	(847) 913-1113
City:	Vernon Hills	State/Province:	Illinois	FAX number (include area code):	(847) 913-0924
Country:	USA	ZIP / Postal Code:	60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager

Product Information:

Trade name:	Model number:
Compact Operating Uretero-Renoscope by Gautier	8706.402 / .042
Common name:	Classification name:
Uretero-Renoscopes	Ureteroscopes

Information on devices to which substantial equivalence is claimed:

	510(k) Number	Trade or proprietary or model name	Manufacturer
1	K963855	Uretero-renoscope	Richard Wolf
2	2	2	2

1.0 Description

Uretero-rensoscope 8706.402 is a thin endoscope with a rod lens system, a channel for irrigation and for the simultaneous use of an instrument.

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K990050 pg 2 of r

2.0 Intended Use

The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible uretero-renoscope and for evacuation of irrigation solution.

3.0 Technological Characteristics

atraumatic tip for problem free introduction into the uteri ostium .
sharp, brilliant quality over the entire image .
. autoclavable / steam sterilization 134°C / 273°C

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices. The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing devices sold by Richard Wolf.

5.0 Performance Data

No performance standards are known.

6.0 Clinical Tests

Clinical tests performed were not performed.

7.0 Conclusions Drawn

These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual.

By: Robert J. Casassa

Robert L. Casarsa Quality Assurance Manager

Date: Jan 4, 99

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 6 1999

Mr. Robert L. Casarsa Quality Assurance Manager RICHARD WOLF Medical Instruments Corp. 353 Corporate Woods Parkway Vernon Hills, IL 60061

Re: K990050

Compact Operating Uretero-Renoscope with Insertion Sleeve Dated: January 5, 1999 Received: January 7, 1999 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FGB

Dear Mr. Casarsa:

We have reviewed vour Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz. M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):_

Device Name: _ Compact Operating Uretero-Renoscope with Insertion Sleeve

Intended Use:

The compact operating Uretero-Renoscope 8706.402 is used to examine the ureter and kidney. Various diagnostic and therapeutic procedures can be performed by using additional accessories.
- · transurethral extraction and lithotripsy of ureteroliths and kidney stones via electrohydraulic, laser, pneumatic, or ultrasonic technology.
- . tumor diagnostics and / or biopsy
- removal of foreign bodies .

The insertion sleeve, 8706.042 is used as a guide during insertion of the flexible ureterorenoscope and for evacuation of irrigation solution.

Contraindications:

For all submitted ureteroscopes and ureter-renoscopes:

Comply with contraindications for the patient which result findings and are described in relevant literature, for example:

· acute hypertrophy of the prostate
· stenosis of the ureter

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

David C. Seggern

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices

510(k) Number

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ર - I

Over-The Counter

Regulation Number and Section

§ 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.