ULTRASONIC HAND INSTRUMENTS

K971861 · United States Surgical, A Division of Tyco Healthc · LFL · Jul 1, 1997 · SU

Device Facts

• Record ID: K971861
• Device Name: ULTRASONIC HAND INSTRUMENTS
• Applicant: United States Surgical, A Division of Tyco Healthc
• Product Code: LFL · SU
• Decision Date: Jul 1, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.

Device Story

System comprises endoscopic hand instruments (shear, hook probe, ball probe) connected via acoustic transducer to generator. Device uses ultrasonic energy to perform tissue transection, dissection, and coagulation. Used in open and endoscopic surgical procedures by surgeons. Output is mechanical ultrasonic vibration at the probe tip, enabling surgical tissue manipulation. Benefits include precise tissue handling and hemostasis during surgery.

Clinical Evidence

No clinical data provided; substantial equivalence based on design, intended use, and biocompatibility compliance.

Technological Characteristics

Ultrasonic surgical instrument system. Components: shear, hook probe, ball probe, acoustic transducer, generator. Materials: Biocompatible, compliant with ISO 10993-1. Energy source: Ultrasonic. Connectivity: Wired connection between handpiece and generator.

Indications for Use

Indicated for use in abdominal, pediatric, gynecologic, thoracic, urologic, and general open and endoscopic surgical procedures requiring tissue transection, dissection, and coagulation.

Predicate Devices

• Ethicon Ultracision ultrasonic hand instruments (K961104)

Submission Summary (Full Text)

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

K971861

## United States Surgical Corporation 510(k) Premarket Notification AUTO SUTURE* Ultrasonic Hand Instrument** system

| IX. 510(k)_Summary of Safety and Effectiveness | |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | United States Surgical Corporation<br>150 Glover Avenue<br>Norwalk, CT 06856<br>JUL - 1 199 |
| CONTACT PERSON: | Victor Clavelli |
| DATE PREPARED: | May 19, 1997 |
| CLASSIFICATION NAME: | Ultrasonic Surgical Instrument |
| COMMON NAME: | Ultrasonic hand instruments |
| PROPRIETARY NAME: | Not yet determined |
| PREDICATE DEVICES: | Ethicon Ultracision ultrasonic hand instruments, K961104 |
| DEVICE DESCRIPTION: | The subject instruments consists of three endoscopic hand<br>instruments which connected by an acoustic transducer to a<br>generator. The hand instruments consist of an ultrasonic<br>shear, ultrasonic hook probe and ultrasonic ball probe. |
| INTENDED USE: | The AUTO SUTURE* ultrasonic hand instruments have<br>application in abdominal, pediatric, gynecologic and other<br>open and endoscopic procedures for the transection,<br>dissection and coagulation of tissue(s). The instrument is<br>available with a hook probe, with a shear probe and with a<br>ball probe. |
| MATERIALS: | The AUTO SUTURE* ultrasonic hand instruments are<br>composed entirely of biocompatible materials which are in<br>compliance with ISO 10993-1 for their intended patient<br>contact profile. |

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

Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUL * 1 1997

Mr. Victor Clavelli United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

Re: K971861

Trade Name: AUTO SUTURE* Ultrasonic Surgical Instrument Regulatory Class: II Product Code: LFL Dated: May 20, 1997 Received: May 20, 1997

Dear Mr. Clavelli:

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 requirements , as set forth in the Quality System Regulation (OS) 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.

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

Page 2 - Mr. Victor Clavelli

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

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

## ENCLOSURE II Indications For Use:

510(k) Number (if known): K971861

Device Name: AUTO SUTURE* Ultrasonic Surgical Instrument

Indications For Use:

The AUTO SUTURE* ultrasonic hand instruments have application in abdominal, pediatric, gynecologic, thoracic, urologic and general open and endoscopic procedures for the transection, dissection and coagulation of tissue(s). The instrument is available with a hook probe, with a shear and with a ball probe.

**Prescription Use**
(Per 21 CFR 801.109)