(90 days)
K 902307
Not Found
No
The description focuses on a simple heating mechanism for cutting and cauterization, with no mention of AI or ML terms or functionalities.
Yes
The device is used for cutting and coagulation of soft tissue during surgery, which is a therapeutic intervention.
No
The device is described as being for "simultaneous cutting and cauterization of soft tissue during surgery," which is a treatment function, not a diagnostic one.
No
The device description explicitly states it is a "single use device" consisting of "Cautery Forceps and Battery Pack Power Supply," which are physical hardware components used for cutting and cauterization.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Simultaneous cutting and cauterization of soft tissue during surgery." This describes a surgical instrument used directly on a patient's tissue in vivo (within the living body).
- Device Description: The description reinforces this by stating it's a "single use device that are intended for the simultaneous cutting and coagulation of soft tissue during surgery" and that "heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument." This is a description of a surgical tool, not a device used to test samples in vitro (outside the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical instrument used for treatment during surgery.
N/A
Intended Use / Indications for Use
Simultaneous cutting and cauterization of soft tissue during surgery.
Product codes (comma separated list FDA assigned to the subject device)
HQP and GEI
Device Description
Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines.
The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical disciplines
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)
Not Found
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.
K 902307
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
§ 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.
0
3 1000 JUN
Image /page/0/Picture/4 description: The image shows the logo for "Starion Instruments". The logo consists of a circular emblem on the left and the company name on the right. The company name is underlined.
22900 Congress Springs Road. Saratoga, California 408.741-8773 fax 408.74
Attachment 1
510(K) SUMMARY
Document Mail Center (HFZ-401) Center for Devices and Radiological Health Food and Drug Administration 1390 Piccard Drive Rockville, MD 20850
This summary of 510(k) safety and effectiveness information is being submitted in accordance with 21 CFR §807.92.
Starion intends to introduce into commercial distribution the Cautery Forceps and Battery Pack Power Supply. The equivalent predicate devices are the Hemostatic Surgical System (#K 902307) by Hemostatic Surgery Corporation and the Accu-Temp disposable hot wire surgical cautery device (preamendment) by Concept, Inc.
The FDA has classified electrically powered surgical instruments for cutting tissue and controlling bleeding as Class II devices (e.g. 21CFR 878-4400, 886-4115). Starion's Cautery Forceps is a Class II medical device. The common name for Starion's device is a thermal cautery device -- forceps.
Starion's Cautery Forceps and Battery Pack Power Supply are single use devices that are intended for the simultaneous cutting and coagulation of soft tissue during surgery, to be used in essentially all major surgical disciplines. Starion's Cautery Forceps are substantially equivalent in terms of intended use, principles of operation, basic technological characteristics and target population of surgical disciplines.
The principle of operation is that heat is conducted to the tissue via a small heater located at the tip of a hand-held, surgical instrument to provide cutting/cauterization.The need to provide cutting and cauterization of tissue is present in virtually all surgical specialties. The device labeling supports the widespread, multispecialty use of these cutting/cauterization devices in surgery.
George D. Human 3/3/99
date George Hermann Regulatory Affairs Starion Instruments Corporation
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird in flight, composed of three curved lines that suggest feathers or wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 3 1999
Mr. George Hermann Regulatory Affairs Starion Instruments 22900 Congress Springs Road Saratoga. California 95070
Re: K990728 Trade Name: Cautery Forceps Battery Pack Power Supply Regulatory Class: II Product Code: HQP and GEI Dated: March 3, 1999 Received: March 5, 1999
Dear Mr. Hermann:
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 (OS) 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.
2
Page 2 - Mr. George Hermann
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
Page_1_of_1_
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Thermal Cautery Device, Forceps
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) | |
|---|---|
| (Division Sign-Off) | |
| Division of General Restorative Devices | K990728 |
| 510(k) Number |
Prescription Use ✓
(Per 21 CFR 801.109) OR Over-The-Counter Use ____
(Optional Format 1-2-96)
ﻴﺴﺎ.