(87 days)
Not Found
No
The summary describes a surgical instrument that uses ultrasonic energy for cutting and coagulation, with no mention of AI or ML capabilities.
Yes
The device is described as cutting and coagulating tissue for soft tissue incisions with bleeding control and minimal thermal injury, indicating a direct therapeutic action on the patient.
No
The device is described as a surgical tool used for cutting and coagulating tissue, not for diagnosing medical conditions. Its intended use focuses on active surgical intervention rather than diagnostic evaluation.
No
The device description explicitly states the instruments are "hand-held instruments" which are attached to a "ultrasonic hand piece and generator," indicating physical hardware components are integral to the device's function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for "soft tissue incisions" and "cutting and coagulating tissue" during surgical procedures. This is a direct interaction with the patient's body for therapeutic or surgical purposes.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such testing on samples.
- Device Description: The description confirms it's a surgical instrument used to cut and coagulate tissue.
Therefore, the Ultracision Harmonic Scalpel is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ultracision Harmonic Scalpel Curved LCS and CS 5 mm instruments are indicated for soft tissue incisions when bleeding control and minimal themal 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.
Product codes
LFL
Device Description
The UltraCision instruments are hand-held instruments which cut and coagulate tissue when attached to the ultrasonic hand piece and generator.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue, abdominal, pediatric, gynecologic
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Preclinical testing was performed to ensure that the devices perform as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
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.
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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 (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.
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(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)
OR
.
Over-The-Counter-(Optional Forma
Noreli J. Perez
(Division Sign-Off) دئل لالح J 2 ) Division of General Restorative Deyices 510(k) Number -