The Roei Working Element and Roei Cutting Loops are endoscopic electrosurgical accessories intended for use with monopolar resectoscope systems for the resection of soft tissue in transuretheral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, and transurethral resection of the prostate (TURP) procedures.

Device Description

The Roei Working Element and Cutting Loops use the same fundamental operating characteristics as other resectoscope working elements and electrode cutting loops. The Roei Working Element includes a handle and rod to which the disposable Roei Cutting Loops are attached. One end of the handle has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element handle has a connection port that accommodates a resectoscope sheath used to encase a Roei Cutting Loop. Additionally, the Roei Working Element handle provides an electrical connection box with an inlet receptacle for connection of a resectoscope's electrosurgical cable that is then attached to a monopolar electrosurgical generator. Once the Roei Working Element and Cutting Loop are attached to a resectoscope system, the Roei Cutting Loop receives electrical current from the electrosurgical generator. The electrical current transmitted to the Cutting Loop is then used to resect the targeted soft tissue.

In addition to serving as the housing for the Roei Cutting Loops, optics and electrical connections, the Roei Working Element permits translation of the axial motion of the handgrip into a circular axis movement of the Cutting Loop independent of the resectoscope sheath. This circular axis movement provides the ability for the surgeon to move the Cutting Loop in a side-to-side clockwise or counterclockwise direction through the soft tissue, according to the operating handle position.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Roei Working Element and Roei Cutting Loops:

Acceptance Criteria and Device Performance Study

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Safe and effective resection of soft tissue (functional performance)	Animal testing demonstrated that the device "safely and effectively resects soft tissue."
Compliance with IEC 6061-2-2, Third Ed. (1998-09): Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment (Electrical Safety)	The device "will be in compliance with the following recognized consensus standards prior to marketing the device." This implies an intention to comply, rather than direct reporting of achieved compliance in this document.
Compliance with AAMI/ANSI HF 18 (2001): Electrosurgical devices (Electrosurgical Performance)	The device "will be in compliance with the following recognized consensus standards prior to marketing the device." This implies an intention to comply, rather than direct reporting of achieved compliance in this document.

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "Animal testing" as the basis for performance data.

Sample Size: Not specified. The document only states "Animal testing conducted...".
Data Provenance: The country of origin of the animal testing data is not specified. The study is prospective as it involves active animal testing to evaluate the device.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Number of Experts: Not specified. The document does not provide details on who assessed the animal testing results or how "safely and effectively resects soft tissue" was determined.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Not specified. There is no mention of an adjudication method as the evaluation appears to be based on observed outcomes from animal testing and compliance with standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission is for a medical device (surgical tools) and does not involve image-based diagnosis or human interpretation in the context of an MRMC study. The comparison made is against predicate devices in terms of intended use, technological characteristics, and principles of operation, rather than a comparative effectiveness study with human readers assisted by AI.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a way. The "performance data" section focuses on the device itself (the Roei Working Element and Roei Cutting Loops) functioning independently to resect soft tissue in animal models and its compliance with safety and electrosurgical standards. This can be considered a standalone evaluation of the device's functional and safety characteristics, without human intervention for interpreting results in the way an AI algorithm would be evaluated. It's a standalone test of the physical device's performance.

7. The Type of Ground Truth Used

The ground truth used for the animal testing was the observed outcome of soft tissue resection in an animal model. The statement "safely and effectively resects soft tissue" implies direct observation of the surgical outcome (e.g., successful removal of targeted tissue, lack of excessive collateral damage, appropriate healing). For the standards compliance, the ground truth would be the parameters and requirements outlined in IEC 6061-2-2 and AAMI/ANSI HF 18.

8. The Sample Size for the Training Set

Not applicable. This device is a surgical 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 this device.

Summary

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JUN 1 6 2005

K050910

pg 1 of 3

510(k) SUMMARY

Roei Medical Technology, Ltd.'s Roei Working Element and Roei Cutting Loops

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Jonathan S. Kahan, Esq. Hogan & Hartson, L.L.P. 555 Thirteenth Street N.W. Washington, D.C. 20004

202-637-5794 Phone: 202-637-5910 Facsimile:

Jonathan S. Kahan Contact Person:

April , 2005 Date Prepared:

Name of Device and Name/Address of Sponsor

Roei Working Element and Roei Cutting Loops Roei Medical Technologies, Ltd. The Herzeliyah Business Park 85 Medinat Hayehudim Street Tower G, 8th Floor Israel

011-972-9-970-1822 Phone: Facsimile: 011-972-9-970-1866

Common or Usual Name

Urological Resectoscope Accessories

Classification Name

Resectoscope, Working Element. Endoscope and Accessories. Endoscopic electrosurgical unit and accessories

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K 056910

pg 2 of 3

Predicate Devices

Karl Storz Endoscopy America, Inc.'s Resectoscopes Working Element and . Cutting Loop Components (K954050)
Richard Wolf Medical Instruments Corporation's Resectoscope E-Line series . Working Element and Cutting Loop Components (K980302)
ACMI's Resectoscope Working Elements and Cutting Loop Components . (preamendment and K951972)
Olympus Winter & IBE's Olympus Working Element (K992141) .
American Medical Systems, Inc.'s AMS Coaguloop Resection Electrodes (K991314 and K971512)
ACMI's VaporTrode™ and VaporTome™ Resection Electrodes (K973820) .
Karl Storz's KSEA Vaporization Electrodes (K961706)

Intended Use / Indications for Use

Technological Characteristics

The Roei Working Element and Cutting Loops use the same fundamental operating characteristics as other resectoscope working elements and electrode cutting loops. The Roei Working Element includes a handle and rod to which thedisposable Roei Cutting Loops are attached. One end of the handle has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element handle has a connection port that accommodates a resectoscope sheath used to encase a Roei Cutting Loop. Additionally, the Roei Working Element handle provides an electrical connection box with an inlet receptacle for connection of a resectoscope's electrosurgical cable that is then attached to a monopolar electrosurgical generator. Once the Roei Working Element and Cutting Loop are attached to a resectoscope system, the Roei Cutting Loop receives electrical current from the electrosurgical generator. The electrical current transmitted to the Cutting Loop is then used to resect the targeted soft tissue.

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K 0509/10
pg 3 of 3

counterclockwise direction through the soft tissue, according to the operating handle position.

Performance Data

Animal testing conducted using the Roei Working Element and Roei Cutting Loops as a component of a previously 510(k)-cleared device, demonstrated that the device safely and effectively resects soft tissue. Additionally the Roei Working Element and Roei Cutting Loops when used as accessories to resectoscopes and monopolar electrosurgical generators will be in compliance with the following recognized consensus standards prior to marketing the device (1) IEC 6061-2-2, Third Ed. (1998-09): Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment; and (2) AAMI/ANSI HF 18 (2001): Electrosurgical devices.

Substantial Equivalence

The Roei Working Element and Roei Cutting Loops have the same intended uses and similar indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the Roei Working Element and Roei Cutting Loops and the predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the Roei Working Element and Roei Cutting Loop are as safe and effective as the predicate devices. Thus, the Roei Working Element and Roei Cutting Loop are substantially equivalent.

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Food and Drug Administration 9200 Corporate Boulevard Rockville *MD 20050

JUN 1 6 2005

Roei Medical Technologies, Ltd. c/o Jonathan S. Kahan, Esq. Hogan & Hartson L.L.P. 555 Thirteenth Street, N.W. WASHINGTON DC 20004

Re: K050910

Trade/Device Name: Roei Working Element and Roei Cutting Loops Regulation Number: 21 CFR §876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: FAS Dated: June 2, 2005 Received: June 2, 2005

Dear Mr. Kahan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have reviewed your bootion been) problem (for the indications for use stated in above and nave decomminarketed predicate devices marketed in interstate commerce prior to the clerosate) to regally mantely of the Medical Device Amendments, or to devices that have been May 20, 1770, all cliabanent auto of the Federal Food, Drug, and Cosmetic Act (Act) that icclassition in accordation marties approval application (PMA). You may, therefore, market the do not require approvation of a premiums of the Act. The general controls provisions of the Act device, subject to the general volta visting 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 If your device is classified (see as re) mitonal controls. Existing major regulations affecting your Apployal), it thay be subject to such aderal Regulations, Title 21, Parts 800 to 898. In addition, FDA active can be round in nouncements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FICASC oc advisor mart PPT is total.cour 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 rederal statues and regulations accession and listing (21 CFR Part 807); labeling ACL S requirements, moduling, but not need to courements as set forth in the quality systems (QS) (21 CFR Part 801); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k)
10 allegal and the many of aling of substantial sequivalence of your device to a This letter will allow you to begin marketing your antial equivalence of your device of your device to a legally
premarket notification. The FDA indiantify of substantial eq premarket notification. The FDA finaling of substantial equivale in 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
r the regulation of the fillering aumbers, based on the regulation number If you desire specific advice for your device on our labeling regarants (2008).
contact the Office of Compliance at one of the following numbers, based on the regulation numb 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 in the first times to premarket notification" (21 CFR Also, please note the regulation entitled, "Misoration on your responsibilities under the Act from the 807.97). You may obtain other general information on its toll-free number (800)
Division of Small Manufacturers, International and Consumers and consembly html Division of Small Manufacturers, International and Collisation Prosistants of the Products on anain.html

Sincerely yours,

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

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Indications for Use Statement

050910 510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Roei Working Element and Roei Cutting Loops Device Name:

Indications for Use:

The Roei Working Element and Roei Cutting Loops are endoscopic The Roel Working Liement and its vase with monopolar resectoscope systems for electrosurgical accessories intended tor associeties throught of the resection (TURBT),
the resection of soft tissue in transurether and treasurether of the the resection of soft tissue in trailsuretacrus biddes one and transurethral resection of the prostate (TURP) procedures.

Prescription Use
(Part 21 C.F.R. 801 Subpart D)

AND/OR

Over-The-Counter Use_ (21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy Crozdon

(Division Sign-Off) (Division Sign-Off))
Division of Reproductive, Abdominal Division of Radiological Device 510(k) Number .

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Regulation Number and Section

§ 876.4300 Endoscopic electrosurgical unit and accessories.

(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).