SORING GMBH SONOCA 180/190

K012753 · Soring GmbH Medizintechnik · LFL · Nov 13, 2001 · SU

Device Facts

• Record ID: K012753
• Device Name: SORING GMBH SONOCA 180/190
• Applicant: Soring GmbH Medizintechnik
• Product Code: LFL · SU
• Decision Date: Nov 13, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities. Typical users of this system are trained professionals; physicians, nurses, and technicians.

Device Story

Desktop unit controlling ultrasonic handpieces for surgical tissue dissection/fragmentation. Device transmits power from longitudinal vibrating probe tip to tissue in contact zone. Used in general, neuro, thoracic, urological, and gastro-intestinal surgery. Operated by trained professionals (physicians, nurses, technicians) in clinical/OR settings. Provides selective tissue dissection; assists surgeons in multi-disciplinary procedures. Derived from Sonoca 300 family; utilizes similar hardware/software modules for control.

Clinical Evidence

Bench testing only. Device performance validated through compliance with electrical safety and electromagnetic compatibility standards, including IEC 950, CISPR 22, IEC-801-2/3, IEEE 1003.1, IEC 601-1, IEC 601-2-2, and DIN EN 61847.

Technological Characteristics

Desktop ultrasonic surgical unit. Materials and dimensions not specified. Energy source: ultrasonic power. Connectivity: not specified. Sterilization: not specified. Software: embedded control modules for ultrasonic handpiece operation and error detection. Standards: IEC 950, CISPR 22, IEC-801-2, IEC-801-3, IEEE 1003.1, IEC 601-1, IEC 601-2-2, DIN EN 61847.

Indications for Use

Indicated for selected ultrasound dissection and tissue fragmentation during surgery in general, neuro, thoracic, urological, and gastro-intestinal modalities. Intended for use by trained professionals including physicians, nurses, and technicians.

Predicate Devices

• Sonoca 300 (K992026)

Submission Summary (Full Text)

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

## 510(k) Summary of Safety and Effectivenes

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

August 2, 2001

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 190, Sonoca 180 |
|----------------------|---------------------------------|
| Common Name: | Instrument, Ultrasonic Surgical |
| Classification Name: | General & Plastic Surgery |

Predicate Device:

| Applicant: | Söring GmbH |
|----------------|-------------|
| 510(k) Number: | K992026 |
| Device: | Sonoca 300 |

Device Description:

SONOCA 180 & 190 is a desktop unit that controls ultrasonic handpieces used in general surgery, vascular surgery, and dermatological surgery.

general bargery, vacual carget case; technologically derived from the Sonoca 300 family of units (K992026) with the same general modules (hardware and software).

During the use of this ultrasonic dissector, power is transmitted from a longitudinal vibrating probe tip in the contact zone to tissue and is a supplementary tool for the selective dissection of human tissue.

Indications for Use:

The SONOCA 180/190 is an instrument intended for selected ultrasound dissection and fragmenting of tissue at the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.

Typical users of this system are trained professionals; physicians, nurses, and technicians.

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

## Performance Data:

The subject and predicate devices both use similar software 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 180/190 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}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 3 2001

Soring GmbH Medizintechnik c/o Mr. Carl Alletto 1100 Lakeview Boulevard Denton, Texas 76208

Re: K012753

Trade/Device Name: Soring GmbH, Sonoca 180/190 Regulation Name: Ultrasonic surgical instrument Regulatory Class: Unclassified Product Code: LFL Dated: July 30, 2001 Received: August 16, 2001

Dear Mr. Alletto:

We have reviewed your Section 510(k) premarket notification of intent to market the device we neve roviewed your betermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for are carrer or 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 If your device is elassino (toonal 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 or any I 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.

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

Page 2 - Mr. Carl Alletto

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 and additionally 21 CFR Part 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" (21CFR Part 807.97). 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,

Mark n Millerson

elia 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

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

K012753

## NOV 1 3 2001

Page 1 of -1

(Indications for Use Form)

510(k) Number: JA (12753

Device Name: Soring GmbH, SONOCA 180/190

Indications for Use:

The SONOCA 180/190 is an instrument intended for selected ultrasound THE BONOON Tool foo for the operation site during multi-medical discipline surgery including: General Surgery, Neuro, Thoracic, Urology, and Gastro-intestinal modalities.

Typical users of this system are trained professionals; physicians, nurses, and technicians.

OR

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

NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Mark N. Wilkinson
for Wilkinson Sim Off

eneral. F storative and Neurological Deveres

510(k) Number **__** K012753

(Optional Format 1-2-96)