(87 days)
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.
The UltraCision® LCS-5 are hand held shear instruments which cut and coagulate tissue when attached to the ultrasonic hand piece and generator.
The provided text is a 510(k) summary for the UltraCision® LaparoSonic Coagulating Shears (LCS-5). This document describes a medical device and its intended use, but it does not contain details about specific acceptance criteria or a study that rigorously proves the device meets those criteria in the way a modern AI/software device submission would.
The "Performance data" section only states: "Preclinical testing was performed to ensure the device performs as intended. All bench and animal studies demonstrated satisfactory performance in cutting and coagulation." This is a very broad statement and lacks the specific details required to answer your questions.
Therefore, I cannot populate the table or answer most of your detailed questions based solely on the provided text. The requested information (acceptance criteria, specific performance metrics, sample sizes, ground truth methodology, expert qualifications, etc.) is not present in this 1998 510(k) summary. These types of detailed studies and reporting requirements have evolved significantly since 1998, especially for software-dependent medical devices and AI.
Here's a breakdown of what can and cannot be answered from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NOT SPECIFIED | "Satisfactory performance in cutting and coagulation." (Very general and qualitative, no specific metrics or thresholds provided.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size (test set): Not specified.
- Data provenance: Not specified (studies were "bench and animal studies").
- Retrospective/Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/not specified, as the studies are described as "bench and animal studies," not expert-based evaluations of data.
- Qualifications of experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/not specified, as the studies are described as "bench and animal studies."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC study: No, this device is a surgical instrument (shears), not an AI/diagnostic imaging device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Not applicable, as this is a surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Not explicitly stated, but for "bench and animal studies," it would typically involve physical measurements, observation of tissue effects, histological analysis, and assessment of bleeding/coagulation effectiveness. No "expert consensus" on imaging or diagnostic interpretation is implied.
8. The sample size for the training set
- Training set sample size: Not applicable/not specified, as this is a physical medical device, not a machine learning model.
9. How the ground truth for the training set was established
- Ground truth for training set: Not applicable/not specified, as this is a physical medical device.
In summary: The provided document is a 1998 510(k) summary for a physical surgical device. It does not contain the detailed, quantitative performance data, sample sizes, ground truth methodologies, or expert-based evaluations that are characteristic of modern AI/software as a medical device (SaMD) submissions. The "Performance data" section is very high-level and does not offer the granular information you are seeking.
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K 980099
Appendix A: 510(k) Summary of Safety and Effectiveness
. *,
APR - 9 1998
| Submitter | Ethicon Endo-Surgery, Inc.4545 Creek RoadCincinnati, Ohio 45242 |
|---|---|
| Contact | Larry Carrier |
| Date prepared | January 9, 1998 |
| Name of Device | Classification Name: Electrosurgical cutting and coagulation device andaccessories; Common Name: Ultrasonic cutting and coagulation device andaccessories; Trade Name/ Proprietary Name :UltraCision® LaparoSonicCoagulating Shears (LCS-5 (LCSK5 and LCSB5)). |
| Predicatedevices | Ethicon Endo-Surgery's UltraCision LaparoSonic Coagulating Shears -K925699; United States Surgical Corporation's ULTRASHEARS - K971861 |
| Devicedescription | The UltraCision® LCS-5 are hand held shear instruments which cut andcoagulate tissue when attached to the ultrasonic hand piece and generator. |
| Intended use | The UltraCision® LCS-5 instruments are indicated for soft tissue incisionswhen bleeding control and minimal thermal injury are desired. Theinstruments can be used as an adjunct to or substitute for electrosurgery,lasers, and scalpels in abdominal, pediatric, gynecologic and other endoscopicprocedures. |
| Technologicalcharacteristics | The technological characteristics of the LCS-5 are the same as the predicatedevices. Ultrasonic technology is the method of activation. The LCS-5 areconstructed wholly of biocompatible materials which are in compliance withISO 10993-1 for their intended patient contact profile. |
| Performancedata | Preclinical testing was performed to ensure the device performs as intended.All bench and animal studies demonstrated satisfactory performance incutting and coagulation. |
| Ethicon Endo-Surgery, Inc.23 |
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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.
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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 (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
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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
980099
N/A