MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS

K053322 · Roei Medical Technologies, Ltd. · FAS · Jan 6, 2006 · Gastroenterology, Urology

Device Facts

• Record ID: K053322
• Device Name: MODIFICATION TO: ROEI WORKING ELEMENT AND ROEI CUTTING LOOPS
• Applicant: Roei Medical Technologies, Ltd.
• Product Code: FAS · Gastroenterology, Urology
• Decision Date: Jan 6, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

The Roei Working Element and Cutting Loops are urological resectoscope accessories used with monopolar electrosurgical generators. The device consists of an actuating handle, a tube for optics, and a mechanism for attaching disposable cutting loops. It connects to a resectoscope sheath and an electrosurgical cable. During surgery, the surgeon uses the handle to translate axial motion into circular axis movement of the cutting loop, allowing side-to-side resection of soft tissue; the device also enables linear retraction of the loop into the sheath. The device is operated by a physician in a clinical setting. It facilitates tissue resection by delivering electrical current to the target site, aiding in tumor removal and biopsy procedures.

Clinical Evidence

Bench testing only. Compliance with IEC 6061-2-2 (1998) and AAMI/ANSI HF 18 (2001) standards for electrosurgical safety was verified.

Technological Characteristics

Monopolar electrosurgical accessory; includes actuating handle, optics tube, and cutting loop mechanism. Operates via manual mechanical translation of axial motion to circular loop movement. Complies with IEC 6061-2-2 and AAMI/ANSI HF 18 standards. Connects to standard monopolar electrosurgical generators.

Indications for Use

Indicated for patients requiring transurethral bladder tumor resection (TURBT), transurethral prostatic and bladder biopsy, or transurethral resection of the prostate (TURP).

Regulatory Classification

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.

Predicate Devices

• Roei Working Elements and Roei Cutting Loops (K050910)

Submission Summary (Full Text)

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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: [phone] 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: [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.

### Predicate Devices

Roei Working Elements and Roei Cutting Loops (K050910)

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# Intended Use

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).

# 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 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.

# 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 [phone] or [phone] 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