SORING GMBH, SONOCA 300

K992026 · Soring GmbH Medizintechnik · BTA · Sep 23, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K992026
• Device Name: SORING GMBH, SONOCA 300
• Applicant: Soring GmbH Medizintechnik
• Product Code: BTA · General, Plastic Surgery
• Decision Date: Sep 23, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.

Device Story

Ultrasonic surgical dissector; utilizes longitudinal vibrating probe tip to transmit power to tissue for selective dissection, fragmentation, and emulsification. Integrated aspiration/irrigation function removes tissue fragments and fluids from surgical site. Operated by surgeons in clinical settings; supplementary tool to conventional scalpel. Provides simultaneous cutting, irrigation, and suction. Benefits include selective tissue removal and site management. Device is an upgraded version of Sonoca III.

Clinical Evidence

Bench testing only. Device compliance with electrical safety (IEC 601-1, IEC 950) and electromagnetic compatibility (CISPR 22, IEC-801-2/3) standards demonstrated. No clinical data provided.

Technological Characteristics

Ultrasonic surgical dissector; longitudinal vibrating probe tip; integrated aspiration/irrigation. Complies with IEC 601-1, IEC 601-2-2, IEC 950, CISPR 22, IEEE 1003.1, and DIN EN 61847. Connectivity includes standard data communications controls for error detection.

Indications for Use

Indicated for ultrasound dissection, fragmentation, emulsification, and aspiration of human tissue, with adjunctive irrigation and suction, in general, neuro, pediatric, thoracic, urological, and gastrointestinal surgery. Contraindicated for cardiovascular, ENT, orthopedic, or suction lipectomy procedures.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Sonoca III (K942095)

Submission Summary (Full Text)

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

992026

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

#### Date Prepared:

17 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: | Sonoca 300 |
|----------------------|---------------------------------|
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | General & Plastic Surgery |

## Predicate Device:

| Applicant: | Söring GmbH |
|----------------|-------------|
| 510(k) Number: | K942095 |
| Device: | Sonoca III |

## Device Description:

SONOCA 300 is an upgraded version of the SONOCA III having K9942095.

During the use of an ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue. The probe with the integrated aspiration/irrigation function collects the cell and tissue fragments.

The SONOCA 300 is not an alternative to conventional surgery but a supplementary tool for the selective dissection of human tissue.

Where as the scalpel and other methods of cutting are basically limited to cutting tissue. The SONOCA 300 can be used to cut, irrigate, and suction at the surgical site.

#### Indications for Use:

The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.

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

# 510(k) Summary of Safety & Effectiveness

(as required by 21 CFR 807.92c)

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

## Performance Data:

The subiect 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 - Ultrasonic surgical devices, DIN EN 61847

### Conclusion:

Similar to the predicate device, the Sonoca 300 does not control any life sustaining functions or services. The device and the predicate device share the same conformance to performance standards and both function as Ultrasonic Dissectors. Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 3 1999

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

K992026 Re: Trade Name: Sonoca 300 Regulatory Class: II Product Code: LFL and BTA Dated: August 16, 1999 Received: August 16, 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.

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

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,

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

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

510(k) Number: K992026

Device Name: Soering, SONOCA 300

Indications for Use:

The SONOCA 300 is an instrument intended for selected ultrasound dissection, fragmenting, emulsifying, and aspiration of human tissue and adjunctive irrigation and suction at the operation site during multi-medical discipline surgery including: General Surgery, NE, PED, Thoracic, UR, and GI modalities but not including CV, Ent, Ortho or suction Lipectomy.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use */ OR Over-The-Counter Use* _
(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K992026
510(k) Number