RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES

K082902 · Rz Medizintechnik GmbH · GEI · Dec 10, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082902
• Device Name: RZ ENDOSCOPIC (MINIMALLY INVASIVE) INSTRUMENTS AND ACCESSORIES
• Applicant: Rz Medizintechnik GmbH
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Dec 10, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories.

Device Story

RZ Endoscopic Instruments are a suite of surgical tools for minimally invasive procedures. The product line includes modular forceps (reusable and with disposable tips), single-piece forceps, electrodes, resectoscopic instruments, and electrosurgical cables. These devices are used by surgeons in clinical settings to perform grasping, cutting, and coagulation during endoscopic surgery. The instruments function as mechanical or electrosurgical tools; they do not involve automated processing or software. The devices are provided either sterile (single-use components) or non-sterile (requiring user-performed autoclave steam sterilization). By providing a range of modular and specialized instruments, the system facilitates various endoscopic surgical interventions.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Modular and single-piece endoscopic instruments including forceps, electrodes, and cables. Materials include medical-grade components suitable for autoclave sterilization. Energy source: electrosurgical (for electrodes and cables). Sterilization: ethylene oxide for single-use components; autoclave steam sterilization for reusable components. No software or electronic algorithms.

Indications for Use

Indicated for patients undergoing various endoscopic procedures requiring electrical or non-electrical surgical instruments.

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

• Jakoubek Gmbh
• Ackermann Instrumente GmbH
• Gimmi GmbH
• Pajunk GmbH
• Sutter Medizintechnik GmbH
• Guenter Bissinger Medizintechnik GmbH

Submission Summary (Full Text)

{0}------------------------------------------------

K 08 2902

Page 1 of 2

. :

:

## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

:

: 上一篇: 上一篇:

| Date: | December 2, 2008 | DEC 10 2008 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Submitter: | Name: RZ MEDIZINTECHNIK GmbH<br>Address: Unter Hasslen 20<br>78532 Tuttlingen<br>Germany | |
| | Contact Person: Rainer Zubrod<br>Telephone: [phone]<br>Fax: [phone] | |
| Product: | Trade Name: RZ Endoscopic (Minimally Invasive) Instruments and Accessories<br>Classification: Class II<br>Common Name: Electrosurgical Instruments and Accessories<br>Classification: - Electrosurgical Cutting & Coagulation Device & Accessories<br>Name: - Endoscopic Grasping/Cutting Instrument, Non-Powered | |
| Predicate Device: | Predicate devices are manufactured by Jakoubek Gmbh Ackermann Instrumente GmbH Gimmi GmbH Pajunk GmbH Sutter Medizintechnik GmbH Guenter Bissinger Medizintechnik GmbH | |
| Device Description: | RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables | |
| Intended Use: | RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories. | |
| Performance Data: | Testing was performed to support substantial equivalence to the predicate devices. The RZ Endoscopic (Minimally Invasive) Instruments and Accessories met all specified design and performance requirements. | |
| Sterilization | The single-use resectoscope electrodes and modular tips are offered sterile by ethylene oxide sterilization. All remaining devices are offered non-sterile for autoclave | |

{1}------------------------------------------------

K082902

Page 2 of 2

steam sterilization by user.

Conclusion:

Based upon the product technical information provided, intended use and performance information provided in this premarket notification, as well as similarity to legally marketed devices, RZ Endoscopic (Minimally Invasive) Instruments and Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.

{2}------------------------------------------------

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is black and composed of thick, curved lines. Encircling the eagle is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA". The text is arranged in a circular fashion around the eagle.

#### Public Health Service

DEC 10 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

RZ Medizintechnik GmbH % Business Support International Ms. Angelika Scherp Amstel 320-I Amsterdam 1017AP Netherlands

Re: K082902

Trade/Device Name: RZ Endoscopic (Minimally Invasive) Instruments and Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 29, 2008 Received: September 30, 2008

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.

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 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 manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 - Ms. Angelika Scherp

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.

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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,

Mark N Millman

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

Enclosure

{4}------------------------------------------------

### INDICATIONS FOR USE

510(k) Number (if known):

# KO82902 Device Name: RZ Endoscopic (Minimally Invasive) Instruments and

Accessories Indications for Use: RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and

include both electrical and non-electrical accessories.

Prescription Use X (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)

Neil R.P. Ogden-Grinton

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** K092902