(162 days)
Not Found
Not Found
No
The summary describes a reusable surgical instrument for bipolar coagulation and does not mention any AI or ML capabilities.
No
Explanation: The device is used for bipolar coagulation and cauterization to achieve hemostasis during surgical procedures. While it interacts with the body to achieve a medical purpose, it does not fit the typical definition of a therapeutic device which generally aims to treat a disease, injury, or other condition to restore health or improve function. It is more accurately described as a surgical instrument used to stop bleeding.
No
The device is described as a surgical instrument for coagulation and hemostasis, which are therapeutic functions, not diagnostic ones. It transmits and applies cauterization to tissue and vessels.
No
The device description clearly states it is a "reusable instrument designed for bipolar coagulation during surgical procedures," indicating it is a physical hardware device (forceps) used for surgical intervention.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "bipolar coagulation during surgical procedures" to "transmit and apply cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis." This describes a surgical instrument used directly on the patient's body during a procedure.
- Device Description: The description reinforces that it's a "reusable instrument designed for bipolar coagulation during surgical procedures."
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, not to directly treat or manipulate tissue during surgery.
N/A
Intended Use / Indications for Use
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis
Product codes
GEI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (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.
Not Found
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 DEC
Mr. Kurt Gampp Executive Vice President Synergetics, Inc. 88 Hubble Drive St. Charles, Missouri 63304-8694
Re: K982212
Trade Name: Veritas Bipolar, Insulated, O.5MM TIP, Model N301-005 Regulatory Class: II Product Code: GEI Dated: November 10, 1998 Received: November 12, 1998
Dear Mr. Gampp:
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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (OS) 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 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Kurt Gampp
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/dsma/dsmamain.html".
Sincerely yours,
p coella
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
2
INTENDED USE
The SYNERGETICS VERITAS... Non-Stick Bipolar Forceps is a reusable instrument designed for bipolar coagulation during surgical procedures. It is designed for use with most available bipolar electrosurgical units, and will provide a means of transmitting and applying cauterization to captured tissue and small bleeding vessels, thereby causing coagulation and hemostasis
pcooe
(Division Sign-Off) Division of General Restorative I 510(k) Numbe
Prescription Use
(Per 21 CFR 801.109)