The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.
Various diagnostic and therapeutic procedures can be performed, for example:

transurethral extraction of uretero calculi
biopsy for tumor diagnostics
removal of foreign bodies, e.g. ureteral stents
The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.
The forceps are used for endoscopically controlled grasping and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. They are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.
Various electrodes are used for controlling bleeding and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
The bougies are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.
The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.

Device Description

The submitted auxiliary instruments for URS are accessories for the ureterrenoscopy. These are rigid or flexible biopsy, grasping, and foreign body forceps, stone extractors, unipolar electrodes for high frequency applications, and bougies.

AI/ML Overview

The provided K971315 submission describes auxiliary instruments for ureteroscopes and uretero-renoscopes. It is a 510(k) premarket notification for traditional medical devices rather than an AI/ML-enabled device, thus the standard acceptance criteria for AI devices and associated studies are not directly applicable.

However, I can extract the performance data and the methods used to demonstrate substantial equivalence for these instruments.

Here's an interpretation based on the provided text:

Acceptance Criteria and Reported Device Performance

The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical and sterilization testing to ensure the new design maintains safety and efficacy.

Acceptance Criteria (Implied)	Reported Device Performance
No breakage or functional impairment under normal use conditions (mechanical integrity)	Mechanical load test of the forceps and stone graspers show that there is no breakage of the jaw or other parts of the instrument if used normally.
No adverse effect on functional performance after sterilization (sterilization compatibility)	The steam sterilization in clinical use and tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted instruments when using the fractional method.
Performance similar to predicate devices despite design changes (e.g., smaller diameter, shorter jaws)	The basic design is "similar to devices sold prior to 1976 and to competitor's products." Changes (smaller diameter, shorter jaws) were made to "ensure the same stability" and adapt to anatomy. Performance data indirectly supports this by showing no breakage and functional integrity after sterilization.

Study Details (Interpreted for traditional device testing)

Sample size used for the test set and the data provenance:
- The document does not explicitly state the sample sizes (number of instruments tested) for the mechanical load tests or sterilization tests.
- Data Provenance: The tests were "performed by Richard Wolf," indicating internal company testing. The country of origin for the data is implicitly the USA, where the company is located. The study is prospective in the sense that the tests were conducted specifically for this submission.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is not an AI/ML-enabled device requiring expert ground truth for classification or detection. The "ground truth" here is the objective measurement of mechanical failure or functional performance.
- The "experts" involved would be the engineers and technicians conducting the mechanical and sterilization testing, presumably qualified in those fields.
Adjudication method for the test set:
- Not applicable for this type of mechanical/sterilization testing. Performance is measured against engineering specifications or established protocols rather than expert consensus on diagnostic outcomes.
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 is not an AI/ML-enabled device.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML-enabled device. The performance tests evaluate the physical device's integrity and function, not an algorithm.
The type of ground truth used:
- For mechanical tests: "Ground truth" is the objective state of the device (intact vs. broken, functional vs. non-functional) under specified load conditions.
- For sterilization tests: "Ground truth" is the objective state of the device's functional performance after sterilization.
The sample size for the training set:
- Not applicable. This is not an AI/ML-enabled device and does not involve training data.
How the ground truth for the training set was established:
- Not applicable.

Summary

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K 971315 pg 1982

353 Corporate Woods Parkway Vernon I lills, Illinois 60061 Phone: 847.943.4443 Fax: $47,913,1488

SEP 1 5 1007

RICHARD WOL

MEDICAL INSTRUMENTS CORPORATION

Submitter:	Date of Preparation:
Company / Institution name:	March 14, 1997
RICHARD WOLF MEDICAL INSTRUMENTS CORP.	FDA establishment registration number:
Division name (if applicable):	14 184 79
N.A.	Phone number (include area code):
Street address:	(847) 913-1113
353 Corporate Woods Parkway	FAX number (include area code):
City:	(847) 913-0924
Vernon Hills	State/Province:
Contact name:	Illinois
Mr. Robert L. Casarsa	Country:
Contact title:	USA
Quality Assurance Manager	ZIP / Postal Code:
Product Information:
Trade name:	Model numbers: See section 1: 'Submitted Devices: Auxiliary Instruments for URS'
Auxiliary Instruments for URS	Classification name:
Common name:	Endoscope and accessories
Rigid and flexible forceps, stone extractors, electrodes, bougies
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 pre-enact.	1 various instruments for urological endoscopes, see equivalent devices	1 Richard Wolf M.I.C.
2	2 various instruments for urological endoscopes, see equivalent devices	2 Circon
3	3 various instruments for urological endoscopes, see equivalent devices	3 Karl Storz
4	4	4

1.0 Description

{1}------------------------------------------------

K 9-7, 3,15 Pg 2 of 2

SEP 1 5 1997

2.0 Intended Use

The auxillary instruments for ureteroscopes and uretero-renoscopes are used for preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.

Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.

Various diagnostic and therapeutic procedures can be performed, for example:

transurethral extraction of uretero calculi .
biopsy for tumor diagnostics .
removal of foreign bodies, e.g. ureteral stents .

The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.

· The forceps are used for endoscopically controlled grasping, and obtaining tissue specimens for diagnosis. Both flexible and rigid forceps are available.
· The stone extractors (graspers) are used to grasp stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.
· Various electrodes are used for controlling bleedings and for removing or destruction of tissue by use of unipolar high-frequency current under endoscopic view.
· The bougies (dilators) are used for the atraumatic distention of tubular organs. The flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.

3.0 Technological Characteristics

The basic design of the submitted instruments is similar to the devices sold prior to 1976 and to competitor's products. The diameter of the submitted forceps is smaller, the mouth of the jaws is designed shorter to ensure the same stability.

The submitted forceps, stone extractors, and HF electrodes are adapted to the anatomy in ureterorenoscopy, the working length becomes smaller and longer.

Substantial Equivalence 4.0

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 of the forceps and stone graspers show that there is no breakage of the jaw or other parts of the instrument if used normally.
· The steam sterilization in clinical use and tests performed by Richard Wolf show that the steam sterilization has no influence on the functional performance of the submitted instruments when using the fractional method.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Robert L. Casarsa Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway Vernon Hills, Illinois 60061

SFP 1 5 1997

Re: K971315

Auxiliary Instruments for Ureteroscopes and Uretero-Renoscope (URS) Dated: July 1, 1997 Received: July 2, 1997 Regulatory Class: II 21 CFR 8876.4300, 876.1075, 876.1500, 876.5520, and 876.4680 Product Code: 78 FAS, FCL, KOG, FAX, and FFL

Dear Mr. Casarsa:

We have reviewed vour Section 5100k) 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 interstated 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, market the device, subject to the general controls provisions of 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 II (Special Controls) or 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 submission does not 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. 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

{3}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name:__________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The auxiliary instruments for ureteroscopes and uretero-renoscopes are used for General: preliminary procedures in the ureter and kidney, as well as for procedures in the urethra and bladder.
Flexible and rigid auxiliary instruments can be used in connection with single or double instrument ports.

Various diagnostic and therapeutic procedures can be performed, for example:

· transurethral extraction of uretero calculi
· biopsy for tumor diagnostics
· removal of foreign bodies, e.g. ureteral stents

The interventions are carried out by trained and experienced surgeons who consider the general condition and the anatomic specialties of the patient in their diagnosis.

The forceps are used for endoscopically controlled grasping and obtaining tissue specimens Forceps: for diagnosis. Both flexible and rigid forceps are available.

Stone Extractors: The stone extractors (graspers) are used to grasp stones or stone calculi and extract them out of urological tract. The stone extractor is also used to immobilize the calculus while disintegrating the stone.

The stone extractors are intended for minimally invasive, diagnostic and therapeutic interventions. Thev are used e.g. in conjunction with ureteroscopes and uretero-renoscopes.

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

Concurrence of CDRH Office of Device Evaluation (ODE)

Roler R. Sattling/

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

510(k) Number K971315

Prescription Use
Per 21 CFR 801.109

Over-The Counter

{4}------------------------------------------------

K 97/315 Pg 242

Various electrodes are used for controlling bleeding and for removing or Electrodes: destruction of tissue by use of unipolar high-frequency current under endoscopic view.

The bougies are used for the atraumatic distention of tubular organs. The Bougies (Dilators): flexible hollow dilators can be inserted over a guide wire, for example into the renal pelvis.

The bougies are intended for minimally invasive, diagnostic and therapeutic interventions.

Contraindications resulting from the general findings or described in the Contraindications: relevant literature must be observed.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH Office of Device Evaluation (ODE)

Ruler R. Rathling /
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number K971315

Prescription Use Per 21 CFR 801.109

Over-The Counter

Regulation Number and Section

§ 876.1075 Gastroenterology-urology biopsy instrument.

(a)
Identification. A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments 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 (performance standards).(2) Class I for the biopsy forceps cover and the non-electric biopsy forceps. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.