HARMONIC SCALPEL BLADES AND SHEARS

K053056 · Ethicon Endo-Surgery, Inc. · LFL · Jan 19, 2006 · SU

Device Facts

• Record ID: K053056
• Device Name: HARMONIC SCALPEL BLADES AND SHEARS
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Jan 19, 2006
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The Harmonic Scalpel Shears 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, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures. The Harmonic Scalpel 5 mm Instruments with Protective Sleeve is 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, plastic, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Harmonic Scalpel 10cm Sharp Curved Blade instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, and thoracic surgery. The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA). The Harmonic Scalpel 5 mm 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, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Device Story

Ultrasonic surgical system comprising generator/footswitch, handpiece, and various blades/shears; converts electrical energy into mechanical ultrasonic vibration for cutting and coagulating soft tissue; used in OR by surgeons for open and endoscopic procedures; provides precise tissue dissection with reduced thermal spread compared to traditional electrosurgery; benefits include improved hemostasis and reduced collateral tissue damage.

Clinical Evidence

Clinical literature search performed to support use in plastic surgery; no new clinical trials conducted for this submission.

Technological Characteristics

Ultrasonic surgical instrument; energy source: electrical generator; system components: generator, footswitch, handpiece, and interchangeable blades/shears; materials and construction identical to predicate; sterilization: standard medical device protocols.

Indications for Use

Indicated for soft tissue incisions requiring bleeding control and minimal thermal injury in general, plastic, pediatric, gynecologic, urologic, ENT, and thoracic surgery (including IMA mobilization); for use in open and endoscopic procedures as an adjunct or substitute for electrosurgery, lasers, or steel scalpels.

Predicate Devices

• UltraCision Harmonic Scalpel Blades and Shears

Submission Summary (Full Text)

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K053056

## 510(k) Summary

Ethicon Endo-Surgery, Inc. Company 4545 Creek Road Cincinnati, OH 45242

- Contact Elizabeth Miller Regulatory Affairs Associate II Telephone: [phone] Fax: [phone] Email: [e-mail]
Date Prepared October 28 , 2005

- Trade Name: Harmonic Scalpel Blades and Shears Device Name Common or Usual Name: Instrument, Ultrasonic Surgical Classification Name: Electrosurgical Cutting and Coagulation Device [21 CFR 878.4400 (LFL)]
Predicate Device UltraCision Harmonic Scalpel Blades and Shears

Device Description The Harmonic Scalpel Blades and Shears are ultrasonic surgical instruments for the cutting and coagulation of soft tissue incisions when bleeding control and minimal thermal injury are desired. The device system has three essential parts: the generator/ footswitch, the hand piece and the instruments, which are available in various lengths shapes and types. The selection of the appropriate instrument is a matter of surgeon preference.

Indications for Use The Harmonic Scalpel Shears 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, plastic, pediatric, gynecologic, urologic and other open and endoscopic procedures.

The Harmonic Scalpel 5 mm Instruments with Protective Sleeve is 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, plastic, gynecologic, ENT (Ears, Nose, Throat), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

The Harmonic Scalpel 10cm Sharp Curved Blade instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general. plastic, gynecologic, and thoracic surgery.

The Harmonic Scalpel 10cm Curved Blade Instrument is intended to cut and coagulate soft tissue. It is to be used when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, ENT (Ears, Nose, Throat) and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

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The Harmonic Scalpel 5 mm 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, plastic, gynecologic, and thoracic surgery, including mobilization of the Internal Mammary Artery (IMA).

Technological Characteristics The Harmonic Scalpel Blades and Shears technological characteristics are the same as the predicate device. No changes (materials construction, specifications, manufacturing or sterilization processes) to the currently marketed device. The device differs only in the indications.

Performance Data A clinical literature search was performed to show the use of the devices in plastic surgery.

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Image /page/2/Picture/1 description: The image shows a circular logo with text around the perimeter and a symbol in the center. The text reads "DEPARTMENT OF HEALTH AND HUMAN SERVICES, INC." The symbol in the center appears to be a stylized representation of a human figure or a caduceus-like design, consisting of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 9 2006

Ms. Elizabeth Miller Regulatory Affairs Associate Ethicon Endo-Surgery, Inc. 4545 Creek Road Cincinnati, Ohio 45242

Re: K053056

Trade/Device Name: Harmonic Scalpel Blades and Shears Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Il Product Code: LFL Dated: October 28, 2005 Received: October 31, 2005

Dear Ms. Miller:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 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 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 comply 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.

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## Page 2 - Ms. Miller

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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely vours

Barbara Buehrs
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

## Harmonic Scalpel Blades and Shears

Indications for Use:

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Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative,
and Neurological Devices
(Posted November 13, 2003)

| 510(k) Number | K053056 |
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