(87 days)
Not Found
No
The summary describes a mechanical/ultrasonic cutting and coagulating device with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is indicated for "soft tissue incisions when bleeding control and minimal thermal injury are desired" and can be "used as an adjunct to or substitute for electrosurgery, lasers, and scalpels." This indicates a medical purpose to treat a condition or for patient care.
No
The device description states it is a hand-held shear instrument that cuts and coagulates tissue, indicating a surgical tool, not a diagnostic one. Its intended use is for soft tissue incisions with bleeding control and minimal thermal injury, which are therapeutic functions.
No
The device description explicitly states it is a "hand held shear instrument" which is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being 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.
- Device Description: The device is described as "hand held shear instruments which cut and coagulate tissue." This further reinforces its use in surgical procedures.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The provided information does not mention any such use or interaction with patient specimens.
Therefore, the UltraCision® LCS-5 instruments are surgical devices, not IVDs.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LFL
Device Description
The UltraCision® LCS-5 are hand held shear 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
pediatric
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Preclinical testing was performed to ensure the device performs as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K 980099
Appendix A: 510(k) Summary of Safety and Effectiveness
. *,
APR - 9 1998
| Submitter | Ethicon Endo-Surgery, Inc.
4545 Creek Road
Cincinnati, Ohio 45242 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | Larry Carrier |
| Date prepared | January 9, 1998 |
| Name of Device | Classification Name: Electrosurgical cutting and coagulation device and
accessories; Common Name: Ultrasonic cutting and coagulation device and
accessories; Trade Name/ Proprietary Name :UltraCision® LaparoSonic
Coagulating Shears (LCS-5 (LCSK5 and LCSB5)). |
| Predicate
devices | Ethicon Endo-Surgery's UltraCision LaparoSonic Coagulating Shears -
K925699; United States Surgical Corporation's ULTRASHEARS - K971861 |
| Device
description | The UltraCision® LCS-5 are hand held shear instruments which cut and
coagulate tissue when attached to the ultrasonic hand piece and generator. |
| 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. |
| Technological
characteristics | The technological characteristics of the LCS-5 are the same as the predicate
devices. Ultrasonic technology is the method of activation. The LCS-5 are
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. |
| | Ethicon Endo-Surgery, Inc.
23 |
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the perimeter of the circle. The logo is black and white.
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.
2
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 (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,
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
3
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
980099