Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are indicated for use in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

Device Description

The Images Cystourethroscopes and accessories transfer light to the surgical site via glass fiber optics and allow visualization of the surgical site through a series of optical lenses and prisms. Sheathes and obturators are offered to allow access to the surgical site.

AI/ML Overview

The provided documents are a 510(k) summary and clearance letter for the Smith & Nephew Images Cystourethroscope and accessories. This submission focuses on establishing substantial equivalence to a predicate device rather than providing a performance study with detailed acceptance criteria and testing results against those criteria.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not available in these documents. The primary "acceptance criterion" in a 510(k) process like this is demonstrating substantial equivalence.

Here's an analysis based on the provided information, noting where data is absent:

Table of acceptance criteria and the reported device performance:

Acceptance Criterion (Implicit)	Reported Device Performance
Substantial Equivalence to Predicate Device (Karl Storz Endoscopy Cystourethroscopes and accessories) in design, materials, and intended use.	The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are deemed "substantially equivalent in design, materials, and intended use" to the Karl Storz Endoscopy Cystourethroscopes and accessories. This determination implies that the Smith & Nephew device meets the safety and effectiveness standards of the predicate device and does not raise new safety or effectiveness concerns. No specific quantitative performance metrics are provided in these documents.
No new safety or effectiveness concerns.	The submission states the device "present no new safety or effectiveness concerns." This is a qualitative assessment made by the manufacturer and accepted by the FDA for substantial equivalence. No specific risk analysis or performance data demonstrating this is included in these documents.

Acceptance Criterion (Implicit)

Reported Device Performance

Substantial Equivalence to Predicate Device (Karl Storz Endoscopy Cystourethroscopes and accessories) in design, materials, and intended use.

The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are deemed "substantially equivalent in design, materials, and intended use" to the Karl Storz Endoscopy Cystourethroscopes and accessories. This determination implies that the Smith & Nephew device meets the safety and effectiveness standards of the predicate device and does not raise new safety or effectiveness concerns. No specific quantitative performance metrics are provided in these documents.

No new safety or effectiveness concerns.

The submission states the device "present no new safety or effectiveness concerns." This is a qualitative assessment made by the manufacturer and accepted by the FDA for substantial equivalence. No specific risk analysis or performance data demonstrating this is included in these documents.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable / Not provided. A formal performance study with a distinct "test set" as typically understood for AI/software devices is not described. The substantial equivalence determination relies on comparison to an existing predicate device rather than new clinical trials with quantifiable performance data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable / Not provided. Ground truth establishment, in the context of a performance study, is not described in these documents as no such study is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. Adjudication methods are not relevant as no formal test set evaluation is outlined.
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. This is a hardware device (cystourethroscope) for direct visualization, not an AI or software-assisted device that would involve human "readers" or an "effect size" of improvement with AI.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a manual medical instrument for direct human use, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable / Not provided. As no formal performance study is detailed, no ground truth type is specified. The "ground truth" for a 510(k) in this context is essentially the established safety and efficacy profile of the predicate device.
The sample size for the training set:
- Not applicable / Not provided. No training set is mentioned as this is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable / Not provided. No training set or ground truth for it is relevant to this 510(k) submission.

Summary of what the document does provide:

Device Name: Smith & Nephew Images Cystourethroscope and accessories
Intended Use: Examination of the bladder, urethra, and distal ureter; and performing various diagnostic and therapeutic procedures with additional accessories.
Predicate Device: Karl Storz Endoscopy Cystourethroscopes and accessories.
Basis for Clearance: Substantial equivalence to the predicate device in design, materials, and intended use, with no new safety or effectiveness concerns.
Function: Transfers light to the surgical site via glass fiber optics and allows visualization through optical lenses and prisms. Sheaths and obturators provide access.
Regulatory Class: II
Product Codes: 78 FBO, 78 KOA

Conclusion: The provided 510(k) documents are for a traditional medical device demonstrating substantial equivalence, not a software or AI device requiring detailed performance studies against specific acceptance criteria using test and training sets with established ground truths. Therefore, most of the requested points are not applicable to this type of regulatory submission.

Summary

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6 1

Endoscopy Division

Smith & Nephew. Inc. 160 Dascomb Road, Ancover, MA 01810 Telephone: 508-749-100)

DEC 11. 1997

510(k) Summary

Smith & Nephew, Inc., Endoscopy Division

Images Cystourethroscope and accessories

972979

Substantial Equivalence:

The Smith & Nephew, Inc. Images Cystourethroscopes and accessories are substantially equivalent in design, materials, and intended use to Cystourethroscopes and accessories offered by Karl Storz Endoscopy.

Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Cystourethroscopes and accessories.

Summary of Device Function:

Intended Use of Device:

Smith & Nephew Images Cystourethroscopes are indicated for use in the examination of the bladder, urethra and distal ureter, and using additional accessories, to perform various diagnostic and therapeutic procedures.

Smith & Nephew Semi-rigid and Flexible Manual Instruments are in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

Comparison of Technological Characteristics of Predicate Device:

The basic design and function of the Images Cystourethroscopes and accessories is substantially equivalent to technologies, design and function of the Karl Storz Endoscopy Cystourethroscopes and accessories and present no new safety or effectiveness concerns.

Delmah J. Connor

Deborah J. Connors Regulatory Affairs Specialist

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | | 1997

Ms. Deborah J. Connors Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810 Re: K972979

Smith & Nephew Images Cystourethroscopes and Accessories Dated: October 30, 1997 Received: October 31, 1997 Regulatory class: II 21 CFR §876.1500/Product code: 78 FBO 21 CFR §876.4730/Product code: 78 KOA

Dear Ms. Connors:

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 Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 requirement, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 does not affect any obligation 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) 594-4613. 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/dsmamain.html".

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

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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6 1

Endoscopy Division

Smith & Nephew. Inc. 160 Dascomb Road, Ancover, MA 01810 Telephone: 508-749-100)

DEC 11. 1997

510(k) Summary

Smith & Nephew, Inc., Endoscopy Division

Images Cystourethroscope and accessories

972979

Substantial Equivalence:

Predicate Device:

The predicate device for this submission is the Karl Storz Endoscopy Cystourethroscopes and accessories.

Summary of Device Function:

Intended Use of Device:

Smith & Nephew Semi-rigid and Flexible Manual Instruments are in the endoscopic examination of the bladder, urethra and distal ureters and to perform various diagnostic and therapeutic procedures.

Comparison of Technological Characteristics of Predicate Device:

Delmah J. Connor

Deborah J. Connors Regulatory Affairs Specialist

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" surrounding it.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC | | 1997

Ms. Deborah J. Connors Regulatory Affairs Specialist Endoscopy Division Smith & Nephew, Inc. 160 Dascomb Road Andover, Massachusetts 01810 Re: K972979

Dear Ms. Connors:

Sincerely yours,

W.Liau Yu
Lillian Yin, Ph.D.

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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972979

Page 1 of 1

510(k) Number: /( 97 2979

Device Name : Smith & Nephew, Inc., Endoscopy Division Images Cystourethroscope and accessories

Indications for Use :

) (PLEASE DO WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	Robert D Sething
	(Division Sign-Off)
	Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K972979

Prescription Use (Per 21 CFR 801.109)	OR	Over-the-Counter
---------------------------------------	----	------------------

(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.