ULTRACISION 5MM INSTRUMENTS

K983316 · Ethicon Endo-Surgery, Inc. · LFL · Oct 21, 1998 · SU

Device Facts

• Record ID: K983316
• Device Name: ULTRACISION 5MM INSTRUMENTS
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Oct 21, 1998
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The UltraCision 5mm Instruments are intended for the cutting and coagulation of soft tissues.

Device Story

Handheld ultrasonic surgical instruments (10cm, 14cm, 32cm lengths) with curved blade or sharp/dissecting hook configurations. Device connects to ultrasonic handpiece and generator; ultrasonic energy enables simultaneous tissue cutting and coagulation. Used by surgeons in OR settings for general, gynecologic, and thoracic procedures. Provides alternative to electrosurgery or lasers, offering reduced thermal injury to surrounding tissue. Benefits include precise dissection and effective hemostasis.

Clinical Evidence

Bench testing only. Studies demonstrated satisfactory performance in cutting, coagulation, access, visibility, blunt and fine dissection, and ease of use.

Technological Characteristics

Ultrasonic activation technology. Handheld instruments available in 10cm, 14cm, and 32cm lengths. Configurations include curved blade or sharp/dissecting hook. Optional blade grip for 14cm models. No software or electronic processing components.

Indications for Use

Indicated for soft tissue incisions in general, gynecologic, and thoracic surgery (including Internal Mammary Artery mobilization) when bleeding control and minimal thermal injury are desired. Used as adjunct or substitute for electrosurgery, lasers, and steel scalpels.

Submission Summary (Full Text)

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OCT 21 1998

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## Appendix A: 510(k) Summary of Safety and Effectiveness

| Statement | Information supporting claims of substantial equivalence, as defined under the<br>Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is<br>summarized below.<br><br>For the convenience of the Reviewer, this summary is formatted in<br>accordance with the Agency's final rule "...510(k) Summaries and 510(k)<br>Statements..." (21 CFR §807) and can be used to provide a substantial<br>equivalence summary to anyone requesting it from the Agency. | Performance<br>data | Preclinical testing was performed to ensure the device performs as intended.<br>All studies demonstrated satisfactory performance in the areas of cutting,<br>coagulation, access, visibility, blunt and fine dissection, and ease of use. |
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| Device<br>description | The UltraCision® 5mm Instruments as described in this special premarket<br>notification are hand held instruments available in a 10cm, 14cm, and 32cm<br>Curved Blade configuration and a 10cm and 14cm Sharp or Dissecting Hook<br>Blade configuration. An optional blade grip is included in the 14cm<br>configurations. When attached to the ultrasonic hand piece and generator,<br>ultrasonic activation of the blade allows the instrument to cut and coagulate<br>tissue.<br> | Contact | Chuck Tabri<br>Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
| Intended use | The UltraCision 5mm Instruments are intended for the cutting and coagulation<br>of soft tissues. | Date | September 18, 1998 |
| Indications<br>statement | The UltraCision 5mm Instruments are indicated for soft tissue incisions when<br>bleeding control and minimal thermal injury are desired. The instruments can<br>be used as an adjunct to or substitute for electrosurgery, lasers, and steel<br>scalpels in general, gynecologic, and thoracic surgery, including mobilization<br> | | |
| Technological<br>characteristics | The technological characteristics of the UltraCision® 5mm Instruments are the<br>same as the predicate devices. Ultrasonic technology is the method of<br>activation. | | |
| | Continued on next page | | |

UltraCision® 5mm Instruments Ethicon Endo-Surgery, Inc

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## Appendix A: 510(k) Summary of Safety and Effectiveness,

Continued

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## OCT 21 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Chuck Tabri Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242-2839

Re: K983316 UltraCision® 5mm Instrument Trade Name: Regulatory Class: II Product Code: LFL Dated: September 18, 1998 September 21, 1998 Received:

Dear Mr. Tabri:

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 The general controls provisions of the Act 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 Requlations, 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 In addition, FDA may publish further announcements action. 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

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Page 2 - Mr. Chuck Tabri

Product Radiation Control provisions, or other Federal laws or requlations.

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,

Colin M. Wittner, Ph.D.

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

Enclosure

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## Appendix B: Indications for Use Statement

Indications for Use Statement: Statement

510(k) Number: K_98 33 16

Device Name: UltraCision® 5mm Instrument

Indications for Use: The UltraCision 5mm Instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Prescription Use (Per 21 CFR 801.109)

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(Division Sign-Off)

Division of General Restorative Devices 510(k) Number

UltraCision® 5mm Instruments Ethicon Endo-Surgery, Inc