(66 days)
No
The device description details a simple electrical circuit for heating a tip, with no mention of AI or ML terms, image processing, or data-driven performance metrics.
Yes
The device is used to stop bleeding (hemostasis), which is a therapeutic intervention.
No
The device is used for stopping bleeding (hemostasis) by heating tissue to cause clotting. It does not provide information about a patient's health status or condition, which is the function of a diagnostic device.
No
The device description explicitly states it is a "single use, battery operated device" with an "internal circuit" and "internal battery" that heats a "cautery tip." This clearly indicates a hardware component is central to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "stopping small bleeders in hemostasis and other similar uses." This describes a therapeutic or surgical procedure performed directly on a patient's body.
- Device Description: The description details a device that uses heat to cauterize tissue and blood vessels. This is a physical intervention, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample (blood, urine, tissue, etc.)
- Providing diagnostic information about a disease or condition
- Using reagents or assays
IVDs are used to examine specimens from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device directly interacts with the body to achieve hemostasis.
N/A
Intended Use / Indications for Use
Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.
Product codes
GEI, HQP
Device Description
Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.
Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared. The patient contacting tip component and the cautery handle materials remain the same. Cautery tip configurations (shapes) are also unchanged from those previously cleared. A change to improve manufacturability was made to eliminate the cautery head component and to install cautery tip tubes directly into the cautery handle. The previous cautery head design was not patient contacting. Warnings and Cautionary labeling are carried through to the new design. Device packaging is also unchanged.
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)
K945757, K945765, K945492, K945764, K810909
Reference Device(s)
K810017, K945760, K945759, K945493, K945762, K945763
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 20 2012
K 121441
Page 1 of 3
510(k) SUMMARY
(As Required per 21 CFR 807.92(c))
Bovie Medical Corporation
GENERAL INFORMATION:
510k Owner's Name
Address
Telephone Number: FAX Number:
Contact Person
5115 Ulmerton Road Clearwater, Florida 33760-4004 (727) 384-2323 (727) 322-4465
Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs
Date Prepared:
May 9, 2012
DEVICE DESCRIPTION:
| Trade Name: | Bovie® Cautery Device |
|---|---|
| Common Name: | Battery Operated Cautery; Cauterizer |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and |
| Accessories | |
| Classification: | 21CFR 878.4400; Class II; Product Code GEI |
| Legally Marketed | |
| Predicate Device(s): | Various Hand Held, Battery Operated Cautery Devices |
| (K945757, K945765, K945492, K945764, K810909) |
K810017, K945760, K945759, K945493, K945762, K945763)
1
510(k) SUMMARY
. Pge 2 of 3
(As Required per 21 CFR 807.92(c))
DEVICE FUNCTION, TECHNOLOGY, AND INTENDED USE:
Bovie Cauteries are single use, battery operated devices. The device is activated by pressing the green button on the cautery body and is deactivated by releasing the button (in the default position, the cautery does not operate). Once the button is pressed, an internal circuit is completed that directs power from an internal battery to the cautery tip which in turn heats. The heated tip is introduced to the surgical site and the heat vaporizes the water component in blood/tissue, causing a clot that halts the bleeding.
Cautery device technology remains mostly unchanged from those manufactured and sold over the last 30 years. These devices incorporate one or two 1.5 volt batteries as a power source and an internal conductor strip to direct power to the tip. The devices that are the subject of this submission have been designed with additional safety enhancements, including a recessed activation button (to prevent inadvertent activation if the device is placed on a surface without the protective cap in place) and easily removable batteries that prevents activation of the device after its disposal. The batteries may also be recycled rather than discarded in the user facility biohazard waste stream. Safety enhancements were made to prevent inadvertent device activation in the event that the user does not comply with the recommended disposal instructions after use.
Apart from the added safety features, these cautery devices remain mostly unchanged from those previously cleared. The patient contacting tip component and the cautery handle materials remain the same. Cautery tip configurations (shapes) are also unchanged from those previously cleared. A change to improve manufacturability was made to eliminate the cautery head component and to install cautery tip tubes directly into the cautery handle. The previous cautery head design was not patient contacting. Warnings and Cautionary labeling are carried through to the new design. Device packaging is also unchanged.
INTENDED USE:
Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.
2
K 1 2 1 4 4 1
:4
510(k) SUMMARY
Page 3 of 3
(As Required per 21 CFR 807.92(c))
| Characteristics | Bovie® Cauteries | Battery Operated Cauteries |
|---|---|---|
| (This Submission) | (Various Submissions) | |
| Indications for | ||
| Use | Bovie® Cautery Devices are | |
| used for stopping small | ||
| bleeders in hemostasis and | ||
| other similar uses. | Used for stopping small | |
| bleeders in hemostasis and | ||
| other similar uses. | ||
| Disposal | ||
| Instructions | Cut tip or remove tip using | |
| hemostats. Replace the cover | ||
| cap to prevent button | ||
| activation. |
Twist the battery
compartment to remove and
separate batteries. | Cut tip or remove tip using
hemostats. Replace the cover
cap to prevent button
activation. |
| Sterility | Single Use; Sterilized by
Ethylene Oxide; Sterility
Assurance Level of 10-6. | Single Use; Sterilized by
Ethylene Oxide; Sterility
Assurance Level of 10-6. |
| Design for
Safety | Easily removal battery pack
and recessed activation
button. | Non-removable batteries and
non-recessed activation
button. |
| Materials | Patient contacting tips
constructed of Nichrome 80
and Kanthal A-1. Cautery
handles constructed of
Acrylonitrile Butadiene
Styrene (ABS). | Patient contacting tips
constructed of Nichrome 80
and Kanthal A-1. Cautery
handles constructed of
Acrylonitrile Butadiene
Styrene (ABS). |
| | Cautery tip tubes are
embedded in the handle. | Cautery tip tubes are
embedded in a Delrin®
cautery head that is placed
into the handle. |
| Energy Source | Device is powered by one or
two 1.5 volt alkaline
batteries. | Device is powered by one or
two 1.5 volt alkaline batteries. |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Bovie Medical Corporation % Mr. Richard Kozloff Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760
JUL 2 0 2012
Re: K121441
Trade/Device Name: Bovie® Cautery Device Regulation Number: 21 CFR 886.4115 Regulation Name: Thermal cautery unit Regulatory Class: Class II Product Code: HQP Dated: July 05, 2012 Received: July 06, 2012
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 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) 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 device 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
4
Page 2- Mr. Richard Kozloff
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 electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/CDRH/CDRHOffices/icm115809.htm for 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/ReportalProblem/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,
Sincerely, yours,
Erich Keith
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K121441
Device Name: Bovie® Cautery Device
Indications for Use:
Bovie® Cautery Devices are used for stopping small bleeders in hemostasis and other similar uses.
Neil R.P. Ogle Forman
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number j