MBC SERIES

K024059 · Soring GmbH Medizintechnik · GEI · Jan 8, 2003 · General, Plastic Surgery

Device Facts

• Record ID: K024059
• Device Name: MBC SERIES
• Applicant: Soring GmbH Medizintechnik
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 8, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.

Device Story

Monopolar and bi-polar RF surgical device; performs tissue cutting and coagulation via high-frequency alternating electrical current (>300 kHz). Device utilizes electrical resistance of biological tissue to generate heat for cauterization and cutting. Internal circuitry automatically senses tissue resistivity and adjusts RF signal output accordingly. Used by trained medical professionals in surgical settings. Output affects clinical decision-making by enabling precise tissue removal and hemostasis. Benefits include controlled tissue alteration/destruction during mechanical surgical operations.

Clinical Evidence

Bench testing only. Compliance with electrical safety and electromagnetic compatibility standards (IEC 950, CISPR 22, IEC-801-2/3, IEEE 1003.1, IEC 601-1, IEC 601-2-2) demonstrated to support substantial equivalence.

Technological Characteristics

Monopolar and bi-polar RF electrosurgical unit. Operates at frequencies >300 kHz. Features automatic resistivity sensing and signal adjustment circuitry. Complies with IEC 601-1 and IEC 601-2-2 safety standards.

Indications for Use

Indicated for cutting and/or coagulating soft biological tissue during surgical procedures by trained medical professionals.

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

• Söring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, and MBC Series (K993265)

Submission Summary (Full Text)

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# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

K 024059

#### Date Prepared:

1 December 2002

#### Submitter's Information:

Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany Telephone: [phone]

#### Trade Name, Common Name, Classification:

| Trade name: | Söring GmbH, MBCTM Series |
|----------------------|-------------------------------------------------------------------------|
| Common name: | Electrosurgical conductive gas coagulation |
| Classification name: | 878.4400 - Device, Electrosurgical, Cutting & Coagulation & Accessories |

## Predicate Device:

| Name: | Söring GmbH, ARCO 3000, ARCO 2000, ARCO<br>1000, and MBC Series |
|-------------------|----------------------------------------------------------------------------|
| 510(k) Number | K993265 |
| Regulation Number | 878.4400 - Device, Electrosurgical, Cutting &<br>Coagulation & Accessories |
| Product Code | GEI |
| Decision Date | 10/22/1999 |

#### Device Description:

The Soring GmbH MBC™ Series is a monopolar and bi-polar RF surgical device for cutting and coagulation. RF Surgery is the use of high frequency alternating electrical current (frequency higher then 300 kHz) with the purpose of alteration or destruction of cells and for cutting tissue. The Soring GmbH MBC™ Series is used for tissue removal and cauterization in connection with mechanical operation techniques. The tissue cauterization and cutting effects are accomplished by a combination of heating through the electrical resistance offered by the biological tissue and through the heating of the electrode. Heat production is mainly a result of the fact that biological tissue acts as an electrical resistor for frequencies normally used during RF surgery and that as an electrical resistor biological tissue heats up when electric currents flow through. The amount of heat developed is therefore dependent on the current and the resistance of the conductor (the biological tissue) put up by the patient. From an electrical point of view, the patient is the conductor. As a result, in a closed current loop of metallic conductors and biological tissue of equal cross sectional area the biological tissue heats up significantly more. As can be seen in the table below, different biological tissue types offer a wide range of electrical resistance and thus are affected differently

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# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

by the applied RF signal. The Soring GmbH MBC™ Series internal circuitry automatically senses the resistivity and adjusts the RF signal accordingly for the best results.

## Indications for Use:

The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures. Typical users of this system are trained medical professionals.

### Performance Data:

The subject and predicate devices both use standard data communications controls to detect errors. Both devices comply with IEC 950 - Safety of Information Technology Equipment, CISPR 22, class A - Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility, IEEE 1003.1 - General Electrical Safety for medical devices, IEC 601-1 -Electrical Safety for medical devices using RF-power, IEC 601-2-2 - Special specifications for the safety of RF-surgery units

### Conclusion:

Similar to the predicate device, the Soring GmbH MBC™ Series of devices do not control any life sustaining functions or services. The Soring GmbH MBC™ Series and the predicate device share the same conformance to performance standards and both function as RF surgery units. Based on the information supplied in this 510(k), we conclude that the subject devices are safe, effective, and substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 0 8 2003

Soring GmbH Medizintechnik c/o Mr. Carl Aletto Delta Quality Consulting 1100 Lakeview Boulevard Denton, Texas 76208

Re: K024059

Trade/Device Name: Soring GmbH MBCTM Series Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: November 12, 2002 Received: December 9, 2002

Dear Mr. Aletto:

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 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. Carl Aletto

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]. Additionally, for questions on the promotion and advertising of your device, 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 may be obtained 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,

Muriam C. Provost

for Celia M. Witten, Ph.D., M.D. 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 Form)

510(k) Number:

K024059

# Device Name: Soring GmbH MBC™ Series

Indications for Use:

The devices are intended to cut and or coagulate (soft) biological tissue during surgical procedures.

Typical users of this system are trained medical professionals.

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over - The-Counter Use _______________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Muriam C. Provost

(Division Sign-Off Division of Genera and Neurological L . . . : SS

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