(84 days)
Not Found
No
The device description focuses on the physical characteristics and materials of electrosurgical electrodes, with no mention of AI or ML capabilities.
No.
The device is used for cutting and coagulating tissues during surgery, which is a surgical tool function, not therapeutic.
No
These electrodes are used for cutting and coagulating soft tissues, which are therapeutic actions, not diagnostic ones.
No
The device is a physical electrosurgical electrode with a coating, designed for use with an electrosurgical handpiece and generator. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting and coagulating soft tissues during open surgical procedures." This describes a surgical tool used directly on the patient's body.
- Device Description: The description details an electrosurgical electrode that delivers RF energy to tissue. This is a surgical instrument.
- 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 a treatment, or screen for a disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device is a surgical tool used for treatment during a procedure.
N/A
Intended Use / Indications for Use
Boyie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Bovie Resistick™ II Coated Electrosurgical Electrodes consist of coated blade, needle, and ball configured electrodes, sold sterile and bulk non-sterile, and are designed for single-use. These electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and coagulate soft tissues during open surgical procedures. The coating is designed to reduce friction and to minimize the buildup of burned tissue. Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode. Bovie Resistick II Electrosurgical Electrodes include three tip configurations; blade, needle, and ball. Within each configuration there are models that differ by length of the electrode shaft and whether the tips are partially exposed ("modified").
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open surgical procedures
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.
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
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
GENERAL INFORMATION:
| 510k Owner's Name
Address | Bovie Medical
5115 Ulmerton Road
Clearwater, Florida 33760 | DEC 22 2009 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact Person | Richard A. Kozloff
Vice-President; Quality Assurance/Regulatory Affairs
Telephone #: (727) 803-8513
FAX Number: (727) 322-4665 | |
| Date Prepared: | September 25, 2009 | |
DEVICE DESCRIPTION:
Trade Name: Bovie Resistick™ II Coated Electrosurgical Electrodes Common Name: Electrosurgical Electrodes Electrosurgical Cutting and Coagulation Devices and Classification Name: Accessories (21CFR 878.4400; Class II; Product Code GEI) Predicate Devices: Resistick™ II Electrosurgical Electrode (K974735)
1
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
INTENDED USE:
Boyie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.
DEVICE COMPONENTS AND OPERATION:
Bovie Resistick II Electrosurgical Electrodes ("electrodes") consist of coated blade, needle, and ball configured electrodes, sold sterile and bulk non-sterile, and are designed for single-use. These electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and coagulate soft tissues during open surgical procedures. The intended use of these electrodes is the same as that of previously cleared Resistick II electrodes. The coating is designed to reduce friction and to minimize the buildup of burned tissue. Although the coating is chemically different from that of predicate devices, biocompatibility analyses are being performed to demonstrate safety.
Each electrode consists of a stainless steel shaft and tip, a coating, and an insulation on the electrode meets the requirements for electrical safety testing of electrosurgical accessories.
Bovie Resistick II Electrosurgical Electrodes include three tip configurations; blade, needle, and ball. Within each configuration there are models that differ by length of the electrode shaft and whether the tips are partially exposed ("modified"). Eleven electrode configurations are the same shape and size as predicate devices cleared in premarket notification number K974735. There are an additional nine electrode configurations, each comprised of the same materials and having the same intended use. All electrodes are also to be available for sale as non-sterile components for subsequent placement into kits and trays.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract image of an eagle with its wings spread. The eagle is facing to the right.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Bovie Medical % Mr. Richard Kozloff 5115 Ulmerton Road Clearwater, Florida 33760
DEC 22 2009
Re: K093025
Trade/Device Name: Bovie Resistick™ II Coated Electrosurgical Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: September 25, 2009 Received: September 29, 2009
Dear Mr. Kozloff:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the includions for use stated in the enclosure) to legally marketed predicate devices market (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, Dr to and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your davine can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
3
Page 2 - Mr. Richard Kozloff
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the election in product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1000.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucr1118001/phn flast the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark N. Melke Director Division of Surgical, Orthopedic. and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Bovie Resistick™ II Coated Electrosurgical Electrodes Device Name:
Indications for Use:
Bovie Resistick™ II Coated Electrosurgical Electrodes are used for cutting and coagulating soft tissues during open surgical procedures.
Prescription Use _ V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
FOR M.MELKERSON
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K093025