(55 days)
Simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
This 510(k) submission (K994019) focuses on demonstrating substantial equivalence of the Starion Instruments Thermal Cautery Grasper/Dissector to a predicate device, rather than proving the device meets specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding study design, sample sizes, expert involvement, and ground truth is not applicable.
The submission is a summary of safety and effectiveness data, as required by 21 CFR 807.92, for a Class II device. The core argument for clearance is based on its substantial equivalence to the Starion Instruments thermal cautery forceps (K990728).
Here's a breakdown of the applicable and non-applicable information based on the provided text:
1. A table of acceptance criteria and the reported device performance
Not applicable. The document does not describe specific numerical acceptance criteria for performance metrics (e.g., cutting speed, tissue damage, sealing strength) nor the results of specific tests against such criteria. The "performance" reported is its substantial equivalence to the predicate device in terms of intended use, target population, energy source, and principles of operation.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is not a study comparing the device against a defined acceptance criterion with a test set. This is a regulatory submission for substantial equivalence.
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)
Not applicable. There is no mention of a test set requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
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
Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or imaging tool. MRMC studies are irrelevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it pertains to medical device performance studies (especially for diagnostic or AI devices) is not relevant in this substantial equivalence submission for a surgical tool. The "truth" in this context is that the device functions similarly to a legally marketed predicate.
8. The sample size for the training set
Not applicable. There is no mention of a training set as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth establishment for one.
{0}------------------------------------------------
JAN 2 0 2000
510(k) Summary Subject:
Starion Instruments Thermal Cautery Grasper/Dissector Product:
Summary:
This summary of 510(k) safety and effectiveness data is being submitted in accordance with the requirements of 21 CFR 807.92.
The Starion Instruments thermal cautery grasper/dissector is a single use, hand-held surgical instrument intended for simultaneously cutting and cauterizing soft tissue during surgery. The general and plastic surgery panel of the Food and Drug Administration has classified electrosurgical cutting and coagulating devices and accessories as Class II devices (21 CFR 878.4400).
Instruments thermal cautery grasper/dissector The Starion is substantially equivalent in terms of intended use, target population, energy source, and principles of operation to the Starion Instruments thermal cautery forceps, a legally marketed predicate device which has been granted marketing clearance via K990728.
The Starion Instruments thermal cautery grasper/dissector contains handle controls that allow the surgeon to position the distal jaws of the instrument around the region of tissue to be cut/cauterized. While squeezing the handle, the surgeon depresses a finger switch, which activates a heating element in the jaws. This heat is conducted to the tissue between the jaws to provide cutting/cauterization.
Brian Higgins
Brian Grigsby - Submitter/Contact Person Starion Instruments Corporation 20665 Fourth Street Saratoga, CA 95070 Phone (408) 741-8773 Fax (408) 741-8774
11 (24 (99 Date
{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, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.
Public Health Service
JAN 2 0 2000
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Brian Grigsby Vice President, Quality and Regulatory Affairs Starion Instruments 20665 Fourth Street Saratoga, California 95070
K994019 Re: Trade Name: Cautery Grasper/Dissector Regulatory Class: II Product Code: HQP and GEI Dated: November 24, 1999 Received: November 26, 1999
Dear Mr. Grigsby:
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.
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.
{2}------------------------------------------------
Page 2 - Mr. Brian Grigsby
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,
Stupt Rhodes
James E. Dillard III
Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) NUMBER (IF KNOWN): _K 994019
DEVICE NAME: __ Thermal Cautery Device, Grasper/Dissector
INDICATIONS FOR USE:
Simultaneous cutting and cauterization of soft tissue during surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stephen Rourke
(Division Sign-Off) Division of General Restorative Devices K994019 510(k) Number _
Prescription Use √
(Per 21 CFR 901.109)
OR
Over-The-Counter Use _ (Optional Format 1-2-96)
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.