DAN MONOPOLAR LAP ACCESSORIES

K052759 · Dannoritzer Medizintechnik GmbH & Co. KG · GEI · Jun 14, 2006 · General, Plastic Surgery

Device Facts

• Record ID: K052759
• Device Name: DAN MONOPOLAR LAP ACCESSORIES
• Applicant: Dannoritzer Medizintechnik GmbH & Co. KG
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jun 14, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

Device Story

DAN Monopolar Lap Accessories are reusable surgical instruments used in laparoscopic procedures. The system comprises insulated monopolar handles, insulated shafts, and various inserts including forceps, scissors, biopsy cups, needle holders, and electrodes. The device is used by surgeons in an operating room setting to perform electrosurgical cutting and coagulation. The instruments are provided non-sterile and require cleaning and sterilization by the user prior to each procedure. The device functions as a conduit for electrosurgical energy to the surgical site, allowing the surgeon to manipulate tissue and achieve hemostasis or perform dissection as required during surgery.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Reusable monopolar laparoscopic instruments including handles, shafts, and inserts (forceps, scissors, biopsy cups, needle holders, electrodes). Insulated construction for electrosurgical safety. Non-sterile, requires manual cleaning and sterilization. No software or electronic components.

Indications for Use

Indicated for use in general laparoscopic surgical procedures requiring electrosurgical cutting and/or coagulation. No specific patient population, age, or gender restrictions stated.

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

• Miltex Laparoscopic Instruments, Miltex, Inc. (K043013)
• Laparoscopic Electrode, Megadyne Medical Products (K040699)

Submission Summary (Full Text)

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# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

11 - 1994

K052759

| | | K052759 |
|---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Date: | September 28, 2005 | |
| Submitter: | Name: Dannoritzer Medizintechnik GmbH & Co. KG<br>Address: Brenntenstr. 14<br>Tuttlingen, Germany 78532<br>Contact Person: Axel Dannoritzer<br>General Manager<br>Telephone: [phone]<br>Fax: [phone] | |
| Product: | Trade Name: DAN Monopolar Lap Accessories | |
| | Classification: Class II<br>Common Name: Laparoscope Accessories for General & Plastic Surgery<br>Classification Name: Laparoscope, General & Plastic Surgery (GCJ, 21 CFR 876.1500)<br>Electrosurgical Cutting & Coagulation & Accessories (GEI, 21 CFR 878.4400) | |
| Predicate Devices: | <ul><li>Miltex Laparoscopic Instruments, Miltex, Inc., K043013</li><li>Laparoscopic Electrode, Megadyne Medical Products, K040699</li></ul> | |
| Device Description: | DAN Monopolar Lap Accessories consist of <ul><li>Standard insulated monopolar handles</li><li>Insulated shafts</li><li>Class I inserts (forceps, scissors, biopsy cups, needle holders)</li><li>Electrodes</li></ul> The device is reusable and provided non-sterile. It must be cleaned and | |
| | sterilized before use. | |
| Intended Use: | DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation. | |
| Performance Data: | Design analysis and comparison confirm that basic functional characteristics are substantially equivalent to the predicate devices cited and raise no new issues of safety and effectiveness. | |
| Conclusion: | Based upon the product technical information provided, intended use and performance information provided in this premarket notification, DAN Monopolar Lap Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices. | |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three bars representing its wings. The eagle is positioned in the center of a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the border of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 14 2006

Dannoritzer Medizintechnik GmbH & Co. KG % Business Support International Ms. Angelika Scherp Amstel 320-I Amsterdam 1017AP

Re: K052759

Trade/Device Name: DAN Monopolar Lap Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: May 15, 2006 Received: May 18, 2006

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

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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 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 Lenoir

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

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## INDICATIONS FOR USE

## 510(k) Number (if known): K052759

### Device Name: DAN Monopolar Lap Accessories

#### Indications for Use:

DAN Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

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)

Herbert Lehman

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

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