TROKAMED MORCELLATOR

K091010 · Trokamed GmbH · HET · Mar 1, 2011 · Obstetrics/Gynecology

Device Facts

• Record ID: K091010
• Device Name: TROKAMED MORCELLATOR
• Applicant: Trokamed GmbH
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 1, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

Device Story

Motorized surgical instrument for tissue morcellation and extraction during laparoscopic procedures. System components: control unit, grip module, foot pedals, power/control cables, flexible shaft, cutting modules, trocar sheaths, trocars, and forceps. Operated by surgeons in clinical settings (OR). Device transforms electrical power into mechanical rotation for cutting modules to excise and remove tissue. Benefits include efficient tissue extraction through small laparoscopic incisions. Healthcare providers use device to facilitate minimally invasive surgical removal of myomas, uterus, or kidneys.

Clinical Evidence

Bench testing only. Device complies with IEC 60601-1 (electrical safety) and IEC 60601-1-2 (electromagnetic compatibility). Manufactured in ISO 13485 certified facility.

Technological Characteristics

Motorized morcellator system. Components include control unit, grip module, flexible shaft, cutting modules, trocars, and forceps. Electrical energy source. Non-sterile components (control unit, cables, pedals) for disinfection; steam-sterilizable components (shaft, grip, trocars); single-use sterile components (cutting modules, valve unit).

Indications for Use

Indicated for patients undergoing laparoscopic procedures in general surgery, gynecology (myoma removal, hysterectomy), and urology (nephrectomy) requiring tissue morcellation and extraction.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Gynecare Laparoscopic Morcellator (K993801)
• Storz KSEA Rotocut GI (K061180)
• Morce Scope Set - Morcellator (K041610)
• S*E*M*M* Set for Moto Drive WISAP (K960640)

Submission Summary (Full Text)

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K09101C page 1 of 2

ーで

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

MAR - 1 20il

| Date: | February 9, 2011 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | |
| Name: | Trokamed GmbH |
| Address: | Kleine Breite 17<br>78187 Geisingen<br>Germany |
| Contact Person: | Harald Merkt |
| Telephone: | +49.7704.92440 |
| Fax: | +49.7704.924444 |
| Product: | |
| Trade Name: | TROKAMED MORCELLATOR |
| Classification: | HET, GCJ (Class II) |
| Common Names: | Morcellator |
| Classification Names: | Endoscopic Cutting Accessory |
| Predicate Device: | <ul><li>K993801, Gynecare Laparoscopic Morcellator</li><li>K061180, Storz KSEA Rotocut GI</li><li>K041610, Morce Scope Set - Morcellator</li><li>K960640, S*E*M*M* Set for Moto Drive WISAP</li></ul> |
| Device Description: | The TROKAMED MORCELLATOR is comprised of a control unit, a grip module, two foot pedals, a power cord, a control cable and a flexible shaft, in addition to cutting modules, trocar sheaths, trocars, and forceps. |
| Intended Use: | The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy. |
| Performance Data: | The device complies with applicable requirements of recognized consensus standards IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (Electromagnetic Compatibility) and Medical Device Directive 93/42/EEC, and is manufactured at an ISO 13485 facility. |
| Sterilization | The control unit, power cable and foot pedals are provided non-sterile for disinfection only. |
| | The flexible shaft, control cable, grip module, trocar sheaths, trocars, and forceps are provided non-sterile for steam sterilization. |
| | The cutting modules and the valve unit are provided sterile for single use only. |

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KD91010 page 2 of 2

Conclusion: The basic features, design and intended uses of the TROKAMED MORCELLATOR are similar or identical to those of the predicate devices. The minor differences in design and dimensions have no effect on the performance, function or intended use of the device and do not raise any new issues of safety and effectiveness. In summary, the applicant considers the TROKAMED MORCELLATOR to be substantially equivalent to the predicate devices.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Trokamed GmbH % Ms. Angelika Scherp Regulatory Affairs Consultant Business Support International Amstel 320-I 1017 AP Amsterdam NH 1017AP THE NETHERLANDS

- 1 2011

Re: K091010

Trade Name: Trokamed Morcellator Regulation Number: 21 CFR 8884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET and GCJ Dated: August 9, 2010 Received: August 19, 2010

Dear Ms. Scherp:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related

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adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21. CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Hichard Lemmer us

Herbert P. Lerner, M.D., Director (Acting) Division of Reproductive, Gastro-Renal and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health.

Enclosure

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# INDICATIONS FOR USE

### 510(k) Number (if known): K091010

### Device Name: TROKAMED MORCELLATOR

Indications for Use: The TROKAMED MORCELLATOR is a motorized unit for morcellating and extracting tissue during laparoscopic procedures, in general surgery, gynecology including the removal of myomas and hysterectomy, and urology including nephrectomy.

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)

Tom K. Whing

Division of Reproductive, Gastro-Renal, and
Urological Devices
510(k) Number K091010.

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