ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS
Device Facts
| Record ID | K050910 |
|---|---|
| Device Name | ROEI WORKING ELEMENT AND ROEL CUTTING LOOPS |
| Applicant | Roei Medical Technologies, Ltd. |
| Product Code | FAS · Gastroenterology, Urology |
| Decision Date | Jun 16, 2005 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 876.4300 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Indications for Use
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 Story
Roei Working Element and Cutting Loops are endoscopic electrosurgical accessories for monopolar resectoscope systems. Device consists of handle, rod, and disposable cutting loops. Handle connects to resectoscope optics, sheath, and electrosurgical generator via cable. Principle of operation: axial motion of handgrip translates into circular axis movement of cutting loop, allowing side-to-side clockwise or counterclockwise resection of soft tissue. Used in clinical settings by surgeons during urological procedures. Output is mechanical resection of tissue via electrical current. Benefits include precise tissue removal during TURBT, biopsy, and TURP.
Clinical Evidence
Animal testing demonstrated safe and effective soft tissue resection. Device complies with IEC 6061-2-2 (1998-09) and AAMI/ANSI HF 18 (2001) consensus standards.
Technological Characteristics
Monopolar electrosurgical accessory. Components: handle, rod, disposable cutting loops. Features connection ports for optics, sheath, and electrosurgical generator. Mechanism: axial-to-circular motion translation for loop movement. Complies with IEC 6061-2-2 and AAMI/ANSI HF 18 standards.
Indications for Use
Indicated for patients requiring transurethral resection of soft tissue, including bladder tumor resection (TURBT), bladder biopsy, and 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
- 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 (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)
Submission Summary (Full Text)
{0}------------------------------------------------
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
\\\DC - 23186/0001 - 2053522 v1
{1}------------------------------------------------
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
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.
## 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.
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
{2}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
# 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 .
\\\DC - 23186/0001 - 2053522 v1
