SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600

K993265 · Soring GmbH Medizintechnik · GEI · Oct 22, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K993265
• Device Name: SORING GMBH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600
• Applicant: Soring GmbH Medizintechnik
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Oct 22, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general surgical procedures. Typical users of this system are trained medical professionals.

Device Story

Electrosurgical system (ARCO 3000, 2000, 1000, MBC 601, 600) uses RF energy to cut or coagulate tissue. Inert gas (argon) coagulation utilizes ionized gas beam to transmit electrical energy to tissue. Operated by trained medical professionals in surgical settings. Device provides power via electrode to tissue contact zone. System includes standard data communication controls for error detection. Benefits include precise tissue coagulation during general surgery.

Clinical Evidence

No clinical data. Bench testing only, including 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).

Technological Characteristics

RF electrosurgical unit with inert gas coagulation capability. Complies with IEC 601-1, IEC 601-2-2, IEC 950, CISPR 22, and IEEE 1003.1 standards. Features standard data communication controls for error detection.

Indications for Use

Indicated for cutting and/or coagulating soft biological tissue during general surgical procedures. Intended for use 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

• ARCO MBC, ARCO MC, MBC 500 (K954171)

Submission Summary (Full Text)

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## 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

K993265

#### Date Prepared:

28 July 1999

## Submitter's Information:

Soring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany

Telephone: [phone] Fax: [phone] Email: [e-mail]

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

| Trade name: | Söring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 |
|----------------------|----------------------------------------------------------------|
| Common name: | Electrosurgical conductive gas coagulation |
| Classification name: | General Surgery |

#### Predicate Device:

| Applicant: | Söring GmbH |
|----------------|----------------------------|
| 510(k) Number: | K954171 |
| Device: | ARCO MBC, ARCO MC, MBC 500 |

#### Device Description:

ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 are an upgraded version of the ARCO MBC, ARCO MC, MBC 500 as described in K954171.

During the use of RF surgery devices, power is transmitted via an electrode in the contact zone to tissue. The active electrode then cuts or coagulates (depending upon its design and adjusted power form) the tissue. The inert gas coagulation uses an ionized beam of an inert gas (argon) to transmit the electrical energy to the tissue to achieve a coagulation effect.

#### Indications for Use:

The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general 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. The subject device complies 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

OCT 2 2 1999

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# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

### Conclusion:

The intended use of the modified devices, as described in its labeling, has not changed as a result of the modifications.

Similar to the predicate device, the ARCO 3000 Family do not control any life sustaining functions or services. The devices and the predicate devices 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.

H. Tom

Holger Söring General Manager Söring GmbH Medizintechnik Justus-v.Liebig 10 25451 Quickborn Germany

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 2 1999

Soring GmbH Medizintechnik c/o Mr. Carl Alletto 3200 Dogwood Court North Cincinnati, Ohio 45140

K993265 Re: Trade Name: Soring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601, MBC 600 Regulatory Class: II Product Code: GEI Dated: July 28, 1999 Received: September 29, 1999

Dear Mr. Alletto:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Carl Alletto

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number:

K993265

Device Name: Soring GmbH, ARCO 3000, ARCO 2000, ARCO 1000, MBC 601 and MBC 600

Indications for Use:

The devices are intended to cut and or coagulate (soft) biological tissue with gas enhanced coagulation in ARCO models, e.g. during general 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 ________________________________________________________________________________________________________________________________________________________

coellgs

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K 993265
510(k) Number