(36 days)
Not Found
No
The description focuses on a simple remote switch for activating electrosurgical modes, with no mention of AI/ML terms or functionalities.
No
The device is described as a remote hand switch for activating an electrosurgical generator, which operates electrosurgical accessories. It does not deliver therapy itself but rather acts as a control mechanism for another therapeutic device.
No
The device is described as an electrosurgical accessory used to activate an electrosurgical generator for delivering radiofrequency current, which is a therapeutic function, not a diagnostic one. Its purpose is to control the delivery of energy for cutting or coagulation, not to detect, monitor, or identify a medical condition.
No
The device description explicitly states it is a "sterile, single-use electrosurgical accessory" and a "switch," indicating it is a physical hardware component used for activation and connection, not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Bovie Button Remote Hand Switch is used to activate an electrosurgical generator to deliver radiofrequency current for surgical procedures (cutting and coagulation). It acts as a control mechanism and a connection point for a surgical accessory.
- Lack of Biological Sample Analysis: The description clearly states the device's function is related to controlling energy delivery during surgery, not analyzing biological samples.
Therefore, the device's intended use and description do not align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bovie Button Remote Hand Switch is intended for use to remotely activate the CUT and COAGULATION modes of an electrosurgical generator to deliver monopolar Radiofrequency current. The device also serves as the connection between the electrosurgical accessory and the generator.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory that is used to activate the CUT and COAGULATION modes of an electrosurgical generator, which operates an attached monopolar accessory. The switch also serves as the connection between a monopolar electrosurgical accessory and the generator. The Bovie Remote Hand Switch provides an alternative to the use of footswitch control to deliver RF energy to an attached monopolar accessory.
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)
Testing performed on the Bovie Remote Hand Switch indicates that the device is substantially equivalent in its performance and method of operation to the Valleylab Inc. E0520 Trigger Switch and Cord (K970140). Hazard analysis evaluations were performed on the Bovie Remote Hand Switch. There are no new hazards presented with the use of the Bovie Remote Hand Switch as compared with the predicate device. Both the Remote Hand Switch and the predicate device were designed and tested to meet the ANSI/AAMI HF18 Electrosurgical Device standard.
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
FEB 2 2 2005
510K NOTIFICATION BOVIE BUTTON REMOTE HAND SWITCH
AARON MEDICAL Page 38 of 41
ATTACHMENT 5
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Trade Name: | Bovic Remote Hand Switch |
|---|---|
| Common Name: | Hand Switching Device |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and |
| Accessories (per 21CFR 878.4400) |
The Bovie Remote Hand Switch is a sterile, single-use electrosurgical accessory that is used to activate the CUT and COAGULATION modes of an electrosurgical generator, which operates an attached monopolar accessory. The switch also serves as the connection between a monopolar electrosurgical accessory and the generator. The Bovie Remote Hand Switch provides an alternative to the use of footswitch control to deliver RF energy to an attached monopolar accessory.
The Bovie Remote Hand Switch is substantially equivalent to the Valleylab Inc. E0520 Trigger Switch and Cord (K970140) in operation, intended use, materials, energy source, components, and safety/performance claims.
Testing performed on the Bovie Remote Hand Switch indicates that the device is substantially equivalent in its performance and method of operation to the Valleylab Inc. F.0520 Trigger Switch and Cord (K970140). Hazard analysis evaluations were performed on the Bovie Remote Hand Switch. There are no new hazards presented with the use of the Bovie Remote Hand Switch as compared with the predicate device. Both the Remote Hand Switch and the predicate device were designed and tested to meet the ANSVAAMI HF18 Electrosurgical Device standard.
In conclusion, the Bovie Remote Hand Switch is substantially equivalent to the predicate device (Valleylab Inc. E0520 Trigger Switch and Cord (K970140)) in methods of operation, intended use, and results derived from operation.
Submitted By: Richard Kozloff Vice-President; Quality Assurance/Regulatory Affairs
Aaron Medical 7100 30" Avenue North St. Petersburg, FL 33710
| Phone: | (727) 384-2323 |
|---|---|
| Facsimile: | (727) 347-9144 |
| Contact Person: | Richard Kozloff |
| Date: | August 29, 2005 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, with flowing lines representing hair or movement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 2006
Aaron Medical Industries c/o Mr. Neil E. Devine, Jr. Intertek Testing Services 70 Codman Hill Road Boxborough, Massachusetts 01719
Re: K060117
Trade/Device Name: Bovie Button Remote Hand Switch Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: February 14, 2006 Received: February 15, 2006
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your beceived the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use blated in 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). and Cosmotic For (110) the device, subject to the general controls provisions of the Act. The r ou may, diereleve, mains 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 such 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 r reaso oe advised a determination that your device complies with other requirements of the Act that 117 ederal statutes and regulations administered by other Federal agencies. You must or any I valual the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.
2
Page 2 - Mr. Devine
This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter witi anow you to oegin mainential equivalence of your device to a legally prematics notification - 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), please If you desire specific advice for your as (240) 276-0115. Also, please note the regulation entitled, Colliable of Other of Comphalled at (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet and octoss http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Koboll7
510 (K) NOTIFICATION BOVIE BUTTON REMOTE HAND SWITCH AARON MEDICAL Page 7 of 41
Indications for Use
510(k) Number (if known): _ K060|17
Bovie Button Remote Hand Switch Device Name:
Indications for Use:
The Boyie Button Remote Hand Switch is intended for use to remotely activate the CUT and THE DUVE Dation Technological generator to deliver monopolar Radiofrequency current COAOULATION model of an election serves as the connection between the electrosurgical accessory and the generator.
Prescription Use
(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)
Q.Mell
Division Sign-Off Division of General, Restorative, and Neurological Devices
KOGOII7 510(k) Number_