The Ultracision Harmonic Scalpel Curved LCS and CS 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 scalpels in abdominal, pediatric, gynecologic and other endoscopic procedures.

Device Description

The UltraCision instruments are hand-held instruments which cut and coagulate tissue when attached to the ultrasonic hand piece and generator.

AI/ML Overview

This document pertains to a 510(k) premarket notification for the UltraCision® Harmonic Scalpel® LCS and CS Curved Shears. It describes the device, its intended use, and states that preclinical testing was performed. However, it does not contain specific acceptance criteria, detailed study designs, or reported performance data in a quantitative format that would allow for a direct comparison against acceptance criteria.

The information provided is typical for a 510(k) summary, which generally focuses on substantial equivalence to predicate devices rather than detailed performance against specific acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or other detailed study information as requested. The document explicitly states:

"Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." (Page 1)

This is a high-level summary and does not include the detailed breakdown required for your request.

Summary of unavailable information from the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The document only offers a general statement that performance was "satisfactory."
Sample sizes used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as detailed ground truth establishment is not mentioned for preclinical studies of this nature.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not performed, as this is a surgical instrument and not an AI-assisted diagnostic device. The context of MRMC studies is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a surgical instrument, not an algorithm.
The type of ground truth used: Not explicitly stated beyond "bench and animal studies."
The sample size for the training set: Not applicable, as this is a surgical instrument, not an AI/ML model that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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

Image /page/0/Picture/0 description: The image shows the logo for Ethicon Endo-Surgery, Inc. The logo consists of a stylized graphic on the left, followed by the text "ETHICON ENDO-SURGERY, INC." on the right. Below the company name, it says "a Johnson & Johnson company" in a cursive font.

Image /page/0/Picture/1 description: The image shows a handwritten string of characters. The string begins with the letter 'K', followed by the numbers '993054'. The characters are written in a simple, clear style, making them easily readable. The image appears to be a close-up of the handwritten string.

4545 CREEK ROAD
CINCINNATI, OH 45242-2839

DEC - 9 1999

SUMMARY OF SAFETY AND EFFECTIVENESS

COMPANY:

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

CONTACT:

Ruth Ann Wood Senior Regulatory Affairs Associate Telephone: 513/483-3468 FAX: 513/483-8539

DATE PREPARED:

September 10, 1999

NAME OF THE DEVICE:

Trade Name: UltraCision® Harmonic Scalpel® LCS and CS Curved Shears Classification: LFL

PREDICATE DEVICES:

UltraCision® Harmonic Scalpel® LCS B-5 and LCSK-5 shears (K980099) UltraCision® Harmonic Scalpel® CS shears (K925699)

DEVICE DESCRIPTION:

The UltraCision instruments are hand-held instruments which cut and coagulate tissue when attached to the ultrasonic hand piece and generator.

INTENDED USE:

These 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

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

substitute for electrosurgery, lasers, and scalpels in abdominal, pediatric, gynecologic and other endoscopic procedures.

TECHNOLOGICAL CHARACTERIZATION:

The technological characteristics of the LCS and CS curved shears are the same as the predicate devices. Ultrasonic technology is the method of activation. The LCS and CS curved shears are constructed wholly of biocompatible materials which are in compliance with ISO 10993-1 for the intended patient contact profile.

PERFORMANCE DATA:

Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation.

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

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. 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 image of three overlapping human profiles, resembling an abstract representation of people.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 9 1999

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

Re: K993054

Trade Name: UltraCision® Harmonic Scalpel® LCS and CS Curved Shears Regulatory Class: II Product Code: LFL Dated: September 10, 1999 Received: September 13, 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.

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

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 (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Russell Sage

رقم James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

Page of

S10(k) NUMBER (IF KNOWN) :	K993054
----------------------------	---------

DEVICE NAME :

INDICATIONS FOR USE:

The Ultracision Harmonic Scalpel Curved LCS and CS 5 mm instruments are indicated The Offractsion Harmonic Scalper Our our Dol minimal themal injury are desired.
for soft tissue incisions when bleeding control and more and comments. Insers, an for son lissue inclisions when blecomiz control and substitute for electrosurgery, lasers, and I he instruments can be used as an adjance to or ease and other endoscopic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

4 Prescription Use Prescripcion 801.109)

Over-The-Counter-(Optional Forma

Noreli J. Perez

(Division Sign-Off) دئل لالح J 2 ) Division of General Restorative Deyices 510(k) Number -

Regulation Number and Section

N/A