INSTRUMENT, ULTRASONIC, SCALPEL

K990362 · Ethicon Endo-Surgery, Inc. · GEI · Sep 17, 1999 · General, Plastic Surgery

Device Facts

• Record ID: K990362
• Device Name: INSTRUMENT, ULTRASONIC, SCALPEL
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose,Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Device Story

Ultracision Harmonic Scalpel is a surgical instrument system for cutting and coagulating soft tissues. System components include a generator/footswitch, handpiece, and various blade configurations. Device utilizes ultrasonic energy for tissue activation; provides alternative to electrosurgery, lasers, or steel scalpels. Used in clinical settings (general, gynecologic, ENT, thoracic surgery) by surgeons. Ultrasonic vibration at the blade tip facilitates simultaneous cutting and coagulation, minimizing thermal injury to surrounding tissue. Benefits include precise tissue management and reduced bleeding compared to traditional methods.

Clinical Evidence

Bench and animal studies only. Testing demonstrated satisfactory performance in cutting and coagulation capabilities. No human clinical trial data provided.

Technological Characteristics

Ultrasonic energy activation. Constructed of biocompatible materials compliant with ISO 10993-1. System consists of generator, footswitch, handpiece, and interchangeable blades of various configurations/sizes. No software or electronic algorithm described.

Indications for Use

Indicated for patients requiring soft tissue cutting and coagulation where bleeding control and minimal thermal injury are desired. Applicable for general, gynecologic, ENT, and thoracic surgical procedures, including Internal Mammary Artery (IMA) mobilization.

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

• Ultracision Harmonic Scalpel (K983316, K941897, K924281)
• Valley Labs Electrocautery Pencils (K955109, K962044, K964602)
• Colorado Microdissection Needle (K881763)
• Arthrocare Electrosurgery System (K971532)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows a black and white logo. The logo features a circle with a comet-like object inside. The comet has a bright, textured head and a tail consisting of four streaks that extend upwards and to the right. The overall design is simple and graphic.

THICON ENDO-SURGERY, INC.

K 990362

4545 CRFFK ROAD CINCINNATI. OH 45742-2839

## SUMMARY OF SAFETY AND EFFECTIVENESS

| Submitter: | Ethicon Endo-Surgery, Inc<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Ruth Ann Wood |
| Date: | February 5, 1999 |
| Device Name: | Ultracision Harmonic Scalpel |
| Predicate Devices: | Ultracision Harmonic Scalpel K983316, K941897,<br>K924281<br>Valley Labs Electrocautery Pencils K955109, K962044,<br>K964602<br>Colorado Microdissection Needle K881763<br>Arthrocare Electrosurgery System K971532 |
| Device Description: | The Ultracision Harmonic Scalpel is a cutting and<br>coagulating surgical instrument. The device sys-<br>tem has three essential parts: the generator/foot-<br>switch, the hand piece, and the blades. The blades<br>are offered in a variety of configurations, shapes<br>and sizes. |

## Intended Use/Indications for Use:

The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose,Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Technological Characteristics:

The technological characteristics of the Ultracision Harmonic Scalpel are the same as the predicate

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devices. Ultrasonic technology is the method of activation. The Harmonic Scalpel is constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.

Performance Data: Preclinical testing was performed to ensure the device performs as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized representation of a human figure, composed of three curved lines that suggest a person's head and torso.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 7 1999

Ms. Ruth Ann Wood Senior Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K990362 Trade Name: Ultracision Harmonic Scalpel Regulatory Class: II Product Code: LFL, GEI Dated: June 25, 1999 Received: June 28, 1999

Dear Ms. Wood:

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 -- Ms. Ruth Ann Wood

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,

Salie M. Wittwer, Ph.D., M.D.

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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Page

K990362

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STO(K) WUMBER (IF KNOWN) : Ultracision Harmonic Scalpel DEVICE NAME:

INDICATIONS FOR USE:

...

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The Harmonic Scalpel is intended to cut and coagulate soft tissues. It is to be used when bleeding control and minimal thermal injury is desired. These instruments can be used as an adjunct to or substitute for electrosurgery, lasers and steel scalpels in general, gynecologic, ENT (Ears, Nose, Throat), thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAG IF NEEDED.)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Us
(Optional Format:

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K990362