REPROCESSED ENDOSCOPIC ELECTRODES

K012685 · Sterilmed, Inc. · NLW · Feb 14, 2002 · Gastroenterology, Urology

Device Facts

• Record ID: K012685
• Device Name: REPROCESSED ENDOSCOPIC ELECTRODES
• Applicant: Sterilmed, Inc.
• Product Code: NLW · Gastroenterology, Urology
• Decision Date: Feb 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.

Device Story

Reprocessed endoscopic electrodes consist of various tip configurations and sizes used for cutting and cauterizing soft tissue. Devices function as accessories to endoscopes and are powered by external RF generators (not included). Used in urological and gynecological surgical procedures; operated by surgeons. Reprocessing involves cleaning, sterilization, and packaging validation to restore single-use devices for reuse. Clinical benefit includes enabling tissue resection, ablation, and coagulation during minimally invasive procedures.

Clinical Evidence

Bench testing only. Includes functional testing of representative samples and process validation for cleaning, sterilization, and packaging. Manufacturing process includes 100% visual and functional inspection.

Technological Characteristics

Electrosurgical electrode accessories; various tip configurations/sizes. Powered by external RF generator. Materials and construction methods are identical to original predicate devices. Sterilization process validated for reprocessed single-use devices.

Indications for Use

Indicated for vaporization, ablation, coagulation, and resection of soft tissue in the prostate and bladder, and for ablation and coagulation in gynecological and urological surgical procedures.

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

• KSEA Vaporization Electrodes (K961702)
• Vaportrode Vaporization Electrodes (K890328B)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bruce Lester, Ph.D. Vice President, Research and Development SterilMed. Inc. 11400 73rd Avenue North MINNEAPOLIS MN 55369

Re: K012685 - Supplemental Validation Submission Trade/Device Name: See Enclosed List Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic electrosurgical unit and accessories Regulatory Class: II Product Code: NLW Dated: December 6, 2001 Received: December 7, 2001

Dear Dr. Lester:

The above-referenced premarket notification (510(k)) was cleared by the Office of Device Evaluation (ODE) on February 14, 2002. We have received your supplemental validation data as required for reprocessed single-use devices by the Medical Device User Fee and Modernization Act of 2002. After reviewing your supplemental validation data, we have determined the devices listed in the enclosure accompanying this letter are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (PMA) they 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 devices in the Federal Register.

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Page 2 - Bruce Lester, Ph.D.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your devices comply 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 applicable 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in classification for your devices and thus, permits you to legally market the devices. This letter will allow you to continue marketing the devices listed in the enclosure accompanying this letter.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.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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Page 3 – Bruce Lester, Ph.D.

### Attachment - Reprocessed Endoscopic Electrodes (K012685)

Karl Storz 26050 G 26050 J 26050 N 26050 NK 26050 NX 26050 NW 26050 I 26050 Gr Circon ACMI VE-B VE-F VE-S VE-LG CE-24° CE-26° CE-28° PE-24° PE-26° PE-28° RB-24° RB-26° RE-24° RE-26° RE-28° KE-24° KE-26° KE-28° RAK-24° RAK-26° RAK-28° RKE-24° RKE-26° RKE-28° MLE-24-010 MLE-26-010 MLE-28-010 MLE-24-012 MLE-26-012 MLE-28-012 MLE-24-015

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## Page 4 - Bruce Lester, Ph.D.

·

. . . . . . .

MLE-26-015 MLE-28-015
MLES-24-015 MLES-26-015

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## Indications for Use

510(k) Number (if known):

K012685

Device Name:

Reprocessed Endoscopic Electrodes

Indications For Use:

Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 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 C Brogdon

(Division Sign -OH Division of Reproduc and Radiological Devi 510(k) Number

Page 1 of _ _ _

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FEB 1 4 2002

K012685

# SECTION 2. SUMMARY AND CERTIFICATION

#### 510(k) Summary A.

Submitter:

SterilMed, Inc.

August 13, 2001

Contact Person:

Patrick Fleischhacker 11400 73rd Avenue North Minneapolis, MN 55369 Ph: 763-488-3400 Fax: [phone]

Date Prepared:

Trade Name:

Classification Name and Number:

Product Code:

Predicate Device(s):

Device Description:

Intended Use:

Reprocessed Endoscopic Electrodes

Active Electrosungical Electrode Class II, 21 CFR 876.4300, and 21 CFR 884.4120 Panel 85

FAS, and HGI

Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) manufactured by Karl Storz Endoscopy, and the Vaportrode Vaporization Electrodes (K890328B) manufactured by Circon/ACMI.

Reprocessed endoscopic electrodes are electrosurgical electrode devices that have a wide variety of tip configurations and sizes. The device is used to cut and cauterize prostate, bladder, gynecological, and urological tissue. They are used in conjunction with an endoscope and are powered by a separate RF generator. The RF generator component is not included in this submission; only the endoscopic electrodes are reprocessed.

Reprocessed endoscopic electrodes are intended to be used for vaporization, ablation, coagulation and/or resection of soft tissue in the prostate and bladder as well as when ablation and coagulation are required in gynecological and urological surgical procedures.

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K612685

Pg 2 of 2

Functional and Safety Testing:

Conclusion:

Representative samples of reprocessed endoscopic electrodes underwent bench testing to demonstrate appropriate functional characteristics. Process validation testing was done to validate the cleaning and sterilization procedures as well as the device's packaging. In addition, the manufacturing process includes visual and functional testing of all products produced

Reprocessed endoscopic electrodes are substantially equivalent to the KSEA Vaporization Electrodes (K961702) manufactured by Karl Storz Endoscopy, and the Vaportrode Vaporization Electrodes (K890328B) manufactured by Circon/ACMI.

This conclusion is based upon the devices' similarities in functional design, materials, indications for use and methods of construction.