ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))

K980099 · Ethicon Endo-Surgery, Inc. · LFL · Apr 9, 1998 · SU

Device Facts

• Record ID: K980099
• Device Name: ULTRACISION LAPAROSONIC COAGULATING SHEARS (LCS-5(LCSK5 AND LCSB5))
• Applicant: Ethicon Endo-Surgery, Inc.
• Product Code: LFL · SU
• Decision Date: Apr 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic, Pediatric

Intended Use

The UltraCision® LCS-5 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 scalpels in abdominal, pediatric, gynecologic and other endoscopic procedures.

Device Story

UltraCision LCS-5 are handheld ultrasonic shear instruments; used for cutting and coagulating soft tissue. Device attaches to an ultrasonic handpiece and generator to convert electrical energy into mechanical ultrasonic energy. Operated by surgeons in clinical settings (abdominal, pediatric, gynecologic, endoscopic). Provides hemostasis during tissue incision; minimizes thermal injury compared to traditional electrosurgery. Benefits include precise cutting and reduced bleeding during surgical procedures.

Clinical Evidence

Bench and animal studies performed. Results demonstrated satisfactory performance in cutting and coagulation. No human clinical trial data provided.

Technological Characteristics

Ultrasonic cutting and coagulation device. Constructed of biocompatible materials compliant with ISO 10993-1. Operates via ultrasonic energy activation. Handheld form factor for endoscopic use.

Indications for Use

Indicated for soft tissue incisions in patients requiring bleeding control and minimal thermal injury. Applicable for abdominal, pediatric, gynecologic, and other endoscopic procedures as an adjunct or substitute for electrosurgery, lasers, or scalpels.

Predicate Devices

• UltraCision LaparoSonic Coagulating Shears (K925699)
• United States Surgical Corporation's ULTRASHEARS (K971861)

Submission Summary (Full Text)

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K 980099

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

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APR - 9 1998

| Submitter | Ethicon Endo-Surgery, Inc.<br>4545 Creek Road<br>Cincinnati, Ohio 45242 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Larry Carrier |
| Date prepared | January 9, 1998 |
| Name of Device | Classification Name: Electrosurgical cutting and coagulation device and<br>accessories; Common Name: Ultrasonic cutting and coagulation device and<br>accessories; Trade Name/ Proprietary Name :UltraCision® LaparoSonic<br>Coagulating Shears (LCS-5 (LCSK5 and LCSB5)). |
| Predicate<br>devices | Ethicon Endo-Surgery's UltraCision LaparoSonic Coagulating Shears -<br>K925699; United States Surgical Corporation's ULTRASHEARS - K971861 |
| Device<br>description | The UltraCision® LCS-5 are hand held shear instruments which cut and<br>coagulate tissue when attached to the ultrasonic hand piece and generator. |
| Intended use | The UltraCision® LCS-5 instruments are indicated for soft tissue incisions<br>when bleeding control and minimal thermal injury are desired. The<br>instruments can be used as an adjunct to or substitute for electrosurgery,<br>lasers, and scalpels in abdominal, pediatric, gynecologic and other endoscopic<br>procedures. |
| Technological<br>characteristics | The technological characteristics of the LCS-5 are the same as the predicate<br>devices. Ultrasonic technology is the method of activation. The LCS-5 are<br>constructed wholly of biocompatible materials which are in compliance with<br>ISO 10993-1 for their intended patient contact profile. |
| Performance<br>data | Preclinical testing was performed to ensure the device performs as intended.<br>All bench and animal studies demonstrated satisfactory performance in<br>cutting and coagulation. |
| | Ethicon Endo-Surgery, Inc.<br>23 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Mr. Larry Carrier ·Project Manager, Regulatory Affairs Ethicon Endo-Surgery, Incorporated 4545 Creek Road 45242 Cincinnati, Ohio

K980099 Re: UltraCision LaparoSonic Coagulating Shears Trade Name: (LCSK5 and LCSB5) Regulatory Class: II Product Code: LFL January 9, 1998 Dated: Received: January 12, 1998

Dear Mr. Carrier:

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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as setforth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation 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 Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Carrier

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

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## Appendix B: Indications for Use Statement

Statement

Indications for Use Statement:

510(k) Number: K_

Device Name: UltraCision® LCS-5

Indications for Use: The UltraCision® LCS-5 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 scalpels in abdominal, pediatric, gynecologic and other endoscopic procedures.

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

Acoley 3

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