TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES

K060232 · Trokamed GmbH · GEI · Jul 12, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K060232
• Device Name: TROKAMED GMBH ELECTROSURGICAL INSTRUMENTS & ACCESSORIES
• Applicant: Trokamed GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jul 12, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Trokamed GmbH Resectoscope & Accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used. The instruments are reusable; they are intended to be cleaned, sterilized and reused.

Device Story

Trokamed GmbH electrosurgical instruments include resectoscopes, monopolar electrodes, and bipolar electrodes. Devices function as accessories to electrosurgical generators to perform cutting and coagulation of tissue during minimally invasive surgery. Instruments are reusable and require cleaning and steam sterilization by the user between procedures. Operated by surgeons in clinical/OR settings. Biocompatibility verified per ISO 10993 standards.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 parts 1, 5, and 10.

Technological Characteristics

Reusable electrosurgical instruments (resectoscopes, monopolar/bipolar electrodes). Materials validated for biocompatibility per ISO 10993. Sterilization via steam-autoclave (134°C/270°F, 3 bar, 10 minutes).

Indications for Use

Indicated for resection of prostate tissue and for use in minimally invasive surgical procedures requiring unipolar or bipolar electrosurgical cutting and coagulation.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Unipolar electrodes (K973341)
• Valleylab coated electrodes (K964602)
• Leris (K040699)
• BiTech Bipolar Scissors (K042077)
• Karl Storz Ureter Resectoscope (K960757)
• Comeg Resectoscope and... (K971881)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo is black and white and features the word "TROKAMED" in a bold, sans-serif font. The "O" in TROKAMED is stylized as a circle with a break in the upper left quadrant. To the right of the word "TROKAMED" is the text "GmbH" in a smaller font, rotated 90 degrees clockwise, with a registered trademark symbol.

K 060232

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# 510(K) Summary of Safety and Effectiveness In Accordance with SMDA of 1990

JUL 1 2 2006

DATE OF APPLICATION: 2006-01-25

Trokamed GmbH Submitted by: Kleine Breite 17 78187 Geisingen Germany Tel.: [phone] Fax: [phone] E-Mail: [e-mail] Homepage: www.trokamed.de

# 1. Device Description

electrosurgical instruments and accessories Trade Name: electrosurgical instruments and accessories Common Name:

# 2. Classification

| Device: | Electrosurgical cutting and coagulation device and accessories |
|--------------------|----------------------------------------------------------------|
| Panel: | 878 General and Plastic surgery |
| Product Code: | GEI |
| Device Class: | 2 |
| Regulation Number: | 878.4400 |

C:\Documents and Settings\\xc\Local Settings\Temporary Internet Files\OLK6F\510(k) Summary.doc Erstelldatum 21.09.2005 10:15:00 Seite 1 von 2

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Image /page/1/Picture/1 description: The image shows the logo for TROKAMED GmbH. The logo is in black and white and features the company name in a bold, sans-serif font. The "O" in TROKAMED is stylized with a circular design. The letters "GmbH" are smaller and vertically stacked to the right of the main name, with a registered trademark symbol next to them.

Kobo232

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# 3. Intended Use

The Trokamed GmbH Resectoscope & Accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used.

The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.

The instruments are reusable; they are intended to be cleaned, sterilized and reused.

| Manufacturer | 510(k) Number | Device name |
|-------------------|---------------|--------------------------------|
| A Richard Wolf | K 973341 | Unipolar electrodes |
| B Valleylab | K 964602 | Valleylab coated electrodes |
| C Megadyne | K 040699 | Leris |
| D Bissinger | K042077 | BiTech Bipolar Scissors |
| E Karl Storz | K960757 | Karl Storz Ureter Resectoscope |
| F COMEG Endoscopy | K 971881 | Comeg Resectoscope and... |

## 4. Substantial Equivalence

# 5. BIOCOMPATIBILITY

The biocompatibility has been approved based on ISO 10993 parts one, five and ten by the accredited Laboratory Bioservice.

# 6. Sterilization by User

Trokamed GmbH delivers all unipolar electrodes in Non-Sterile conditions. The user may sterilize these devices by using a validated and applicable sterilization process.

Trokamed GmbH recommends to use a steam-sterilizer that uses a validated sterilization cycle of 134°C / 270°F, 3 bar, for 10 minutes.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trokamed GmbH % Karlheinz Trondle General Manager Kleine Breite 17 78187 Geisingen Germany

JUL 1 2 2006

Re: K060232

Trade/Device Name: Electrosurgical instruments and accessories Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulation Class: II Product Code: GEI Dated: June 26, 2006 Received: June 28, 2006

Dear Mr. Trondle:

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 (PMA), 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 complics with other requirements of the Act or any Federal statutes and regulations administered by other Federal avencies. 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 manufacturing practice requirements as set forth in the quality systems (QS) 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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Page 2 – Mr. Karlheinz Trondle

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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 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/industry/support/index.html.

Sincerely yours,

Hubert Humphrey

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K 060232

Device Name: Electrosurgical instruments and accessories

Indications For Use:

The Trokemed GmbH Resectoscope & accessories are indicated for the resection of prostate tissue. The Trokamed GmbH Monopolar Electrodes are intended for use in minimal invasive techniques where unipolar electrosurgical cutting and coagulation are normally used. The Trokamed GmbH Bipolar Electrodes are intended for use in minimal invasive techniques where bipolar electrosurgical cutting and coagulation are normally used.

The instruments are reusable; they are intended to be cleaned sterilized and reused.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division Sign-Off

Division of General, Restorative 1 of ________________________________________________________________________________________________________________________________________ and Neurological Devices

510(k) Number_1060232