The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic control, through percutaneous or transurethal passages, in conjuction with intercorporeal pneumatic, ultrasound, electrohydraulic or laser lithotriptors.

For diagnosis and therapy with endoscopic accessories in the upper and lower urogenital tract when performed by trained and qualified medical personnel.

Device Description

The universal nephroscope has a reduced sheath diameter and an expanded working channel to accommodate auxiliary instruments and irrigation. The submitted nephroscope design has been modified to optimize user handling.

The submitted nehproscope can be held by the elongated right angled light connected which has been designed with a recessed grip and a thumb ring. An automatic valve for instrument insertion and an automatic locking mechanism between the endoscope and sheath is part of the submitted design. Accessory instruments have been adapted to the longer nephroscope.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the K994223 Nephroscope Set:

Based on the provided K994223 510(k) summary, the device is a conventional medical instrument, not a software algorithm or AI-driven diagnostic device. Therefore, many of the typical performance study elements requested for AI/ML devices (like sample sizes for training/test sets, ground truth establishment, MRMC studies, standalone performance, etc.) are not applicable to this submission.

The 510(k) process for traditional devices primarily focuses on demonstrating substantial equivalence to legally marketed predicate devices, meaning it has the same intended use, technological characteristics, and raises no new safety or effectiveness questions.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For traditional medical devices like this nephroscope, "acceptance criteria" and "device performance" are typically demonstrated through design verification and validation (often in-house testing) and adherence to recognized standards, rather than clinical performance metrics like sensitivity, specificity, or AUC as would be seen for AI/ML diagnostic tools. The document explicitly states "Clinical tests were not performed."

Acceptance Criteria Category	Specific Criteria (as implied or stated)	Reported Device Performance (as stated in the document)
Safety & Effectiveness	Device is safe and effective when used according to instructions.	"These devices are designed and tested to assure their safety and effectiveness when used according to the instructions manual."
Technological Characteristics	No diminished safety or effectiveness compared to predicates due to new features (reduced sheath diameter, expanded working channel, elongated right-angled light connector with recessed grip and thumb ring, automatic valve, automatic locking).	"The new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k) devices..."
Material Conformance	Conforms to relevant international electrical safety and European medical device standards.	"The devices conform to international standards IEC 601-2-18 and to the relevant provisions of the European Device Directive 93/42/EEC."
Intended Use	Suitable for disintegration and removal/extraction of kidney and bladder stones under endoscopic control.	The device is intended for this use, and its design supports this functionality (e.g., expanded working channel for auxiliary instruments).
Substantial Equivalence	Device is substantially equivalent to predicate devices.	Claimed substantial equivalence to: 1. Fiber Kight Operating Laparoscope 4937 (Richard Wolf, pre-enactment) 2. Pylescope System (Richard Wolf, K770729) 3. Operating Syet for Percutaneous Removal of Kidney Stones 27090 / 27092 / 27093 (Karl Storz) 4. Rigid Percutaneous Nephroscope MRO-20 (Circon ACMI)

2. Sample size used for the test set and the data provenance

Not applicable. This device is a surgical instrument. There is no "test set" in the context of data for an AI/ML algorithm. Performance is demonstrated through in-house lab testing, design verification, and adherence to standards, not human data sets. The document explicitly states "Clinical tests were not performed" and "No known performance standards" in the context of human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. There is no "ground truth" establishment in the context of human data for this type of device submission. The safety and effectiveness are established through engineering design, material selection, manufacturing controls, and bench testing to demonstrate functionality and meet design specifications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no "test set" or human data requiring adjudication for this device type.

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

Not applicable. This device is not an AI/ML diagnostic tool and does not involve "human readers" or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a manual surgical instrument, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. For this type of medical device, "ground truth" is defined by engineering specifications, material properties, and functional performance benchmarks demonstrated through non-clinical testing (e.g., mechanical strength, fluid flow rates, optical clarity, compatibility with accessories).

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML algorithm.

9. How the ground truth for the training set was established

Not applicable. There is no "training set" or "ground truth" in the AI/ML sense for this device.

Summary

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K 994223

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

fg / q 2

	510(k) Summary of Safety and Effectiveness

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

Trade name:Nephroscope Set	Model number:8964.xxx, 8965.xxx
Common name:Nephroscope Set	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-eanctment	1 Fiber Kight Operating Laparoscope 4937			1 Richard Wolf
2K770729	2Pylescope System			2 Richard Wolf
3	3Operating Syet for Percutaneous Removal ofKidney Stones 27090 / 27092 / 27093			3 Karl Stoz
4	4 Rigid Percutaneous Nephroscope MRO-20			4 Circon ACMI

1.0 Description

2.0 Intended Use

The nephroscope, with its accessories, is used, with suction, for the disintegration and removal / extraction of kidney and bladder stones. The stones are removed, under endoscopic crentrol, through percutaneous or transurethal passages, in conjuction with intercorporeal ppeuvoatic, ultrasound, electrohydraulic or laser lithotriptors.

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K994223

Pg 2 of 2

3.0 Technological Characteristics

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 510(k) devices sold by Richard Wolf, Karl Storz, and Circon ACMI.

5.0 Performance Data

No known performance standards.

The devices conform to international standards IEC 601-2-18 and to the relevant provisions of the European Device Directive 93/42/EEC. The EC Certification is pending.

6.0 Clinical Tests

Clinical tests 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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines suggesting hair or movement. The profiles are arranged in a row, slightly overlapping each other. Encircling the image is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

JUN - 5 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K994223 Nephroscope and Accessories Dated: April 7, 2000 Received: April 10, 2000 Requlatory Class: Il 21 CFR §876.1500/Procode: 78 FGA, FEC and FED Requiatory Class: Il Exempt 21 CFR §876.4680/Procode: 78 FFL

Dear Mr. Casarsa:

We have reviewed your 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 Regulations, 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 requlation 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 notfication submission you might have under sections 531 through 542 of the Act for devices under 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) 594-4591. 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" (21CFR 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) 443-5597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

Daniel G. Schultz, M.D.

Captain, USPHS Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure(s)

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Identification: 100% in Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: Endoscopes

Intended Use:

Indications and Fields of Application:

For diagnosis and therapy with endoscopic accessories in the upper and lower urogenital tract when performed by trained and qualified medical personnel.

Contraindications:

Contraindications directly related to the product are presently unknown. The attending physician must determine if the planned application is appropriate based on the patient's general condition. Refer to current technical literature for further instructions.

Combinations:

The nephroscope is used in connection with intracorporeal lithotripsy systems, e.g. ultrasound, EHL, etc., suction and irrigation devices, light sources and flexible light cables, video cameras and objective lenses as well as endoscopics accessories, e.g., grasping forceps, stone extractors, stricture scalpel.

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

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

510(k) Number K994223

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.