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

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 an actuating handle, a tube to accommodate the optics, and a mechanism to which the disposable Roei Cutting Loops are attached. The proximal end of the Roei Working Element has a connection port for connection of a resectoscope optics element. The opposite end of the Roei Working Element has a connection port that accommodates a resectoscope sheath used to encase the tube and the Roei Cutting Loop. Additionally, the Roei Working Element 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. Furthermore, the Roei Working Element allows for a linear motion of the loop allowing complete retraction of the loop within the sheath during surgical procedures.

AI/ML Overview

The provided text describes a 510(k) summary for the Roei Working Element and Roei Cutting Loops, focusing on substantial equivalence to a predicate device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria. The document explicitly states that the substantial equivalence is confirmed by the company's design control system requirements and compliance with recognized consensus standards (IEC 6061-2-2 and AAMI/ANSI HF 18).

Therefore, the requested information, particularly regarding specific numerical acceptance criteria and a study with detailed performance metrics, sample sizes, expert ground truth, adjudication methods, or comparative effectiveness, is not present in the provided text.

Here's an overview of what is available based on your request, and what is absent:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not provide a table of acceptance criteria or quantitative performance metrics for the device. It relies on substantial equivalence to a predicate device and compliance with standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: No information regarding a specific test set, its sample size, or data provenance is provided. The document highlights the company's design control system as confirmation of safety and efficacy.

3. 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 Available: No information on experts establishing ground truth is present, as there is no mention of a formal test set with expert adjudicated ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Available: No adjudication method is mentioned, as there is no specific test set or associated ground truth establishment process described.

5. 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 / Not Available: This device is a urological medical instrument (resectoscope accessories), not an AI diagnostic/imaging device. Therefore, an MRMC study related to human reader performance with or without AI assistance is not relevant and not mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Available: This device is a physical medical instrument, not an algorithm. Standalone algorithm performance is not relevant and not discussed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Available: No ground truth type is mentioned as there is no specific study or test set with a defined ground truth in the provided text.

8. The sample size for the training set

Not Available: No information about a training set or its sample size is provided.

9. How the ground truth for the training set was established

Not Available: No information about how ground truth for a training set was established is provided.

Summary of Device Acceptance Rationale from Text:

The device's acceptance (clearance in this case) is based on:

Substantial Equivalence: The modified Roei Working Element and Roei Cutting Loops are deemed substantially equivalent to a previously cleared predicate device (K050910). The document states they have a similar intended use, indications for use, and principles of operation.
Minor Technological Differences: The minor differences (longitudinal movement mechanism and adjustment of cutting wire connection) are claimed not to raise new questions of safety or efficacy, as confirmed by the company's design control system requirements.
Compliance with Recognized Consensus Standards: The device will be in compliance with IEC 6061-2-2 (Safety of High Frequency Surgical Equipment) and AAMI/ANSI HF 18 (Electrosurgical devices) prior to marketing.

This 510(k) summary focuses on regulatory clearance through the substantial equivalence pathway, rather than reporting on a clinical or performance study with detailed acceptance criteria and results.

Summary

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Ko53322

JAN 6 2006

510(k) SUMMARY

Roei Medical Technologies 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 Phone: 202-637-5794 Facsimile: 202-637-5910

Contact Person: Jonathan S. Kahan

Date Prepared: November 21, 2005

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 Phone: 011-972-9-970-1822 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.

Predicate Devices

Roei Working Elements and Roei Cutting Loops (K050910)

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Intended Use

Technological Characteristics

Substantial Equivalence

The modified Roei Working Element and Roei Cutting Loops have a similar intended use and indications for use as the previously cleared Roci Working Element and Roei Cutting Loops. In addition, the modified Roei Working Element and Roei Cutting Loops have the same principles of operation as its predicate. The minor technological differences between the modified Roei Working Element and

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Roei Cutting Loops and the predicate, namely the longitudinal movement mechanism and adjustment of the distal end of the cutting wire connection, do not raise new questions of safety or efficacy as confirmed by the company's design control system requirements. Furthermore, similar to its predicate, the modified 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. Thus, the modified device is substantially equivalent.

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Image /page/3/Picture/2 description: The image shows a circular logo with a stylized bird in the center. The bird is composed of three curved lines, suggesting movement or flight. Encircling the bird is text that reads 'DEPARTMENT OF HEALTH & HUMAN SERVICES' in a sans-serif font. The text is arranged to follow the curve of the circle, with the bird positioned to the right of the text.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 6 2006

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

Re: K053322

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: Class II Product Code: FAS Dated: December 19, 2005 Received: December 19, 2005

Dear Mr. Kahan:

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.

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 nanufacturing practice requirements as set forth in the quality systems (0S) regulation (21 CFR Part 820); 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) This letter with anow you to objin maing of substantial equivalence of your device to a legally prematicated 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 If you desire specific active for your ac rest 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 Also, prease note the regulation entition on your responsibilities under the Act from the 807.77). Tou may obtain outer general missance 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 yours,

Nancy C. Hogdon

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

510(k) Number (if known): Κιδ 3822

Device Name: Roei Working Element and Roei Cutting Loops

Indications for Use:

The Roei Working Element and Roei Cutting Loops are device I he reserved intended for use with monopolar resector of the resection accessories intended for use with moneyestar reveetheral bladder tumor resection of soft tissue and are mucated for asc in vialed in the morethral resection of the prostate (TURP).

Prescription Use _X (Per 21 C.F.R. 801.109) OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Bryson

(Division Sign-Off) (Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

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).