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.

Device Description

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.

AI/ML Overview

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.

Summary

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Exhibit 6 "N" Tech Cystoscopes 510(k)

$$\text{מאַנון אַראַל}$$

APR 28 1998

Page 1 of 1

(Section 807.93) 510(k) Summary

Application: Cystoscopes

A. Summary of Safety and Effectiveness

We compared our Cystoscope prototypes in detail to much older equipment, manufactured by R. Wolf and other Manufacturers and we conclude that our Cystoscopes are as safe and effective as all other devices earlier and currently on the market. Our designs, lens-systems, materials, glues and epoxies are commonly used by the endoscope industry.

B. Parts of finding Substantial Equivalence

We compared our manufacturing drawings with corresponding devices from R.Wolf. We found substantial equivalence in all significant details.

C. Descriptive Information

D. Performance Testing

Our Prototypes underwent extensive mechanical and thermic stress testing to asure safe and long term use.

E. Adverse Health Effects

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.

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Image /page/1/Picture/0 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH &" is visible along the left side of the image. The logo is simple and recognizable, representing the department's role in protecting the health of Americans.

"….

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 8 1998

Mr. Nick Suro President "N" Tech Instrument Repair, Inc. 25775 A Hillview Court Mundelein, IL 60060

Re: K980592

"N" Tech Cystoscopes Dated: February 12, 1998 Received: February 17, 1998 Regulatory Class: II 21 CFR 876.1500/Procode: 78 FAJ

Dear Mr. Suro:

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 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, narket 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 Ouality System Regulation (OS) for Medical Devices: General regulation (2) 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 510Ks 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/dsmaldsmamain.html".

Sincerely yours

Lillian Yin, Ph D

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): K980592 Page 1 of 1 Device Name: Cystoscope

K980592

Indications for Use:

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.

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

Concurrance of CDRH, Office of Device Evaluation (ODE)

	Robert Q. Ratliff (Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K980592

Prescription Use	(Per 21 CFR 801.1091 ✓	OR	Over-The-Counter Use
			(Optional Format 1-2-96)

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.