S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:
Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.
Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:
Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.
Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

Device Description

The bipolar S-line Resectoscopes with electrodes have a design similar to the traditional monopolar resectoscopes, but with an additional pin for the neutral pole at the working element. The HF bipolar connection cables have a standard resectoscope connector and in addition a neutral connection to the neutral pin at the neutral pin at the S-line working element and on unit side plugs for connection to bipolar generators.

AI/ML Overview

The provided 510(k) summary for the "S-line" Saline Bipolar Resectoscope does not contain detailed information about specific acceptance criteria or a study designed to prove the device meets those criteria in the way a diagnostic AI/ML device submission would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and states that no performance standards are known and no clinical tests were performed for this specific submission.

However, based on the information provided, we can infer the overarching "acceptance criteria" through the lens of safety and effectiveness, and how the submitter "proved" this through substantial equivalence.

Here's an analysis based on your requested categories:

Acceptance Criteria and Device Performance

Since no specific quantitative performance metrics are provided (e.g., sensitivity, specificity, accuracy), the "acceptance criteria" are implied to be that the device functions safely and effectively for its intended use, comparable to its predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Safe operation for intended use	"Designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual."
Effective for tissue ablation and hemostasis in urological and gynecological procedures	"The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness." (Substantial equivalence claim)
Minimization of adverse effects (e.g., TUR-Syndrome, muscle tremor) compared to monopolar resectoscopes	"The saline used in bipolar resectoscope applications can minimize adverse effects... intra-operative muscle tremor (stimulation of nerve obturatorius) is largely avoided..."
Comparable performance to predicate devices (monopolar and bipolar resectoscopes)	"The submitted devices are substantially equivalent to existing 510(k)-cleared devices sold by Richard Wolf, Gyrus, and ACMI."

Study Details (or lack thereof, in an AI/ML context)

Sample size used for the test set and the data provenance:
- Test set size: Not applicable. No dedicated "test set" in the context of an AI/ML performance study was used. The submission relies on technical characteristics and substantial equivalence, not data from a specific test set.
- Data provenance: Not applicable. No clinical data provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No ground truth establishment in the customary sense for evaluating a diagnostic device's performance.
Adjudication method for the test set:
- Not applicable. No test set or adjudication performed.
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 device is a surgical instrument, not an AI/ML diagnostic aid for human readers.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a surgical resectoscope, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. Ground truth for performance metrics was not established as part of this submission. The "truth" is based on the design and intended function being safe and effective, similar to predicate devices.
The sample size for the training set:
- Not applicable. This device is a hardware instrument, not a learned algorithm.
How the ground truth for the training set was established:
- Not applicable.

Summary of the "Study" provided in Ko62720:

The submission for K062720 does not describe a "study" in the typical sense of a clinical trial or performance evaluation for an AI/ML device. Instead, it follows a 510(k) pathway for medical devices which primarily relies on demonstrating substantial equivalence to already legally marketed predicate devices.

The arguments made are:

Technological Characteristics: The device has a similar design to traditional monopolar resectoscopes but includes an additional pin for the neutral pole, enabling bipolar functionality. It highlights the benefits of using saline over Purisole/Glycine solution (minimizing TUR-syndrome) and avoids intra-operative muscle tremor due to current localization.
Safety and Effectiveness: The conclusion states that the devices are "designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual." This suggests manufacturing controls and design verification/validation (which are typically part of a Quality System) rather than a specific clinical performance study for regulatory submission.
Predicate Devices: Substantial equivalence is claimed to several predicate devices, including resectoscopes from Richard Wolf (K980302, K042523), Olympus, ACMI (K031001, K022480), and a Gyrus system. The device's safety and effectiveness are considered to be comparable to these established devices, with the new technological characteristics not diminishing safety or effectiveness.
No specific performance standards or clinical tests were performed for this submission.

In essence, the "proof" the device meets acceptance criteria is derived from its design, its intended function, and its demonstrated similarity (substantial equivalence) to devices already on the market where safety and effectiveness have been previously established.

Summary

{0}------------------------------------------------

Ko62720

MAR 2 2 2007

5.0 510(k) Summary of Safety and Effec

Submitter:
Company / Institution name:	RICHARD WOLF MEDICAL INSTRUMENTS CORP.
Division name (if applicable):	N.A.
Street address:	353 Corporate Woods Parkway
City:	Vernon Hills
State/Province:	Illinois
Country:	USA
ZIP / Postal Code:	IL 60061
Contact name:	Mr. Robert L. Casarsa
Contact title:	Quality Assurance Manager
Date of Preparation:	06. February 2007
FDA establishment registration number:	14 184 79
Phone number (include area code):	(847) 913 1113
FAX number (include area code):	(847) 913 0924
Product Information:
Trade name:	"S-line" S(a)line Bipolar Resectoscope, Electrode and Cable
Model number:	8680.xxx / 46XX.xxx / 8108.2xx
Common name:	Bipolar resectoscope
Classification name:	Resectoscope
Information on devices to which substantial equivalence is claimed:
510(k) Number	Trade or proprietary or model name	Manufacturer
1 K980302	1 Resectoscopes E-line	1 Richard Wolf
2 K042523	2 Resection Pump and Resectoscope for Chip Aspiration (Resection Master)	2 Richard Wolf
3. Not known	3. Bipolar resectoscope	3. Olympus
4 K031001	4 ACMI Vista CTR Bipolar Loop Electrode	4 ACMI
5 K022480	5 ACMI Disposable Bipolar Cord	5 ACMI
6 Not known	6 Plasma Kinetic Tissue Management System	6 Gyrus

1.0 Description

2.0 Intended Use

S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:

Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.

2/5/07
1/07

21-18

5-1

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

$\qquad K_{062720}$

Transurethral resection of the prostate (TURP) and bladder neck. 0 Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coagulation of bleeding in the lower urinary tract.

For Gynecology:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hystroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, septa, and benign conditions requiring endometrial ablation.

Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

3.0 Technological Characteristics

Besides the standard HF connection at the working element, which is connected to the active area of the electrode, there is an additional pin for the neutral HF-connection. The neutral pin is connected to the working element that has a conductive connection to the resectoscope sheath, optic and finally to the forks of the electrode.

The saline used in bipolar resectoscope applications can minimize adverse effects. The Purisole or Glycine that is used in monopolar resectoscope applications can cause adverse effects, such as TUR-Syndrome, if the solution enters the blood stream. In addition, intra-operative muscle tremor (stimulation of nerve obturatorius) is largely avoided, because the applied HF current is directed from the active area through the conductive fluid to the forks of the electrode, optic, sheath and working element, without running through the body of the patient to the neutral electrode as in monopolar applications.

4.0 Substantial Equivalence

The submitted devices pose the same type of questions about safety or effectiveness as the compared devices and the new technological characteristics have not diminished safety or effectiveness. The submitted devices are substantially equivalent to existing 510(k)-cleared devices sold by Richard Wolf, Gyrus, and ACMI.

5.0 Performance Data

No performance standards are known.

6.0 Clinical Tests

By:

No clinical tests performed.

7.0 Conclusions Drawn

These devices are designed and tested to guarantee the safety and effectiveness, when used according to the instructions manual,

Robert Hanson

Robert L. Casarsa Quality Assurance Manager

Date: Feb 12, 2007

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

MAR 2 2 2007

Mr. Robert L. Casarsa Quality Assurance Manager Richard Wolf Medical Instruments Corporation 353 Corporate Woods Parkway VERNON HILLS IL 60061-3110

Re: K062720

Trade/Device Name: S-Line Bipolar resectoscopes and bipolar electrodes Regulation Number: 21 CFR §876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Codes: FJL, FDC, FAS and HIH Dated: February 28, 2007 Received: March 2, 2007

Dear Mr. Casarsa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a circular seal with the text "1906-2006" at the top. The letters "FDA" are in the center of the seal, with the word "Centennial" underneath. There are three stars below the word "Centennial". The seal is surrounded by a border of text and stars.

noting Public Hoalth

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html

Sincerely vours.

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

4.0 Indications for Use

510(k) Number (if known): K062720

S-Line Bipolar resectoscopes and bipolar electrodes Device Name:

S(a)line Resectoscopes are used for endoscopically controlled Intended use: removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium.

For Urology:

Urological surgical procedures involving the ablation or removal of soft tissue and where associated hemostasis is required.

Transurethral resection of the prostate (TURP) and bladder neck. Transurethral resection of the bladder tumors (TURBT). Transurethral incision of the prostate. Coaqulation of bleeding in the lower urinary tract.

For Gynecology:

Excision of intrauterine myomas. Excision of intrauterine polyps. Lysis of intrauterine septa. Endometrial ablation.

510(k) Number

Prescription Use _____________________________________________________________________________________________________________________________________________________________ > AND/OR

Over-The Counter Use

(Part 21CFR 801 Subpart D)

(Part 21CFR 801 Subpart C)

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

David A. Symons

ivision Sion-Of Division of Reproductive. Abdomin and Radiological Device

2/5/07 4-1
2/5/00 QL17

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.