(76 days)
Not Found
No
The description focuses on standard electrosurgical generator technology, electrical waveforms, and safety features, with no mention of AI or ML.
Yes.
The device is used to "cut and coagulate different kinds of tissue," which is a direct therapeutic intervention.
No
Explanation: The device description clearly states its purpose is to "cut and coagulate different kinds of tissue" using electrosurgical energy. This is a therapeutic function, not a diagnostic one. There is no mention of the device being used to identify or analyze a medical condition.
No
The device description explicitly details hardware components such as a generator, power cord, front panel with buttons and displays, back panel with ports, and internal components like printed circuit boards. It is an electrosurgical generator, which is a physical device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used to "cut and coagulate different kinds of tissue" by delivering RF energy via surgical devices. This is a direct surgical intervention on living tissue, not a test performed on samples taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description details an electrosurgical generator that uses high-frequency electrical current for surgical procedures. It mentions features like different modes for cutting and coagulation, outputs for handpieces and footswitches, and a return electrode system. These are all characteristics of a surgical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, the IDS-310 High Frequency Electrosurgical Generator is a surgical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
Product codes
GEI
Device Description
The IDS-310 Electrosurgical Generator is an electrosurgical device that utilizes High Frequency electrical current, via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The IDS-310 Generator is a high frequency isolated generator featuring cutting up to 300 watts, 4 blend modes, 3 coagulation modes and 4 bipolar modes with an Auto Bipolar option. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The generator offers 2 monopolar handpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use either a split or solid return electrode.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European RoHS directive.
The device consists of a generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet, and internal components (printed circuit boards, speakers, cabling).
Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:
IEC 60601-1: 2005
Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007
Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
IEC 60601-2-2: 2007
Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
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)
Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAR 1 7 2014
K134054
page 1 of 4
510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92(c))
GENERAL INFORMATION:
510k Owner's Name
Bovie Medical Corporation
Establishment Registration Number: 3007593903
Address
5115 Ulmerton Road Clearwater, Florida 33760-4004 United States of America
Telephone Number: FAX Number:
Contact Person:
Richard A. Kozloff Vice-President; Quality Assurance/Regulatory Affairs
Date Prepared:
December 27, 2013
(727) 384-2323
(727) 322-4465
DEVICE IDENTIFICATION:
Trade Name/Model Number:
Common Name:
Classification Name:
Classification:
Legally Marketed Predicate Device(s): Bovie® IDS-310 High Frequency Electrosurgical Generator
Electrosurgical Generator (ESU)
Electrosurgical Cutting and Coagulation Device and Accessories
21CFR 878.4400; Class II; Product Code GEI
510(k) Number: K022856
Primary Predicate Device Name:
Bovie IDS-300 High Frequency Electrosurgical Generator
Manufacturer: Bovie Medical Corporation
510(k) Number: K083452
Secondary Predicate Name: ERBE VIO ESU (Model VIO 300D) Manufacturer: ERBE USA, INC.
1
K134054
510(k) SUMMAR Y
(Submitted As Required per 21 CFR 807.92(c))
Device Description:
The IDS-310 Electrosurgical Generator is an electrosurgical device that utilizes High Frequency electrical current, via an assortment of surgical devices to cut and coagulate different kinds of tissue.
The IDS-310 Generator is a high frequency isolated generator featuring cutting up to 300 watts, 4 blend modes, 3 coagulation modes and 4 bipolar modes with an Auto Bipolar option. There is a characteristic electrical wave form associated with each mode. The electrical properties of the waveform (frequency and duration) produce the clinical effect (i.e. cut, coagulation). The shape and duration of waveforms are comparable between the generator and predicate devices. The generator offers 2 monopolar handpiece outputs, monopolar foot controlled output, bipolar handpiece output, and bipolar foot controlled output. The generator has a return electrode contact and quality monitoring system (NEM) to reduce the risk of patient burns at the return electrode site. The pad-sensing feature allows the user to use either a split or solid return electrode.
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards. It is also designed to meet the requirements of the European RoHS directive.
The device consists of a generator, power cord, and a User's Guide. The main device components are a front panel containing the power button, wattage selection buttons, LED numeric displays, alarm and return electrode indicator lights, and connector ports for accessories, a back panel consisting of footswitch ports, volume controls, a power cord outlet, and internal components (printed circuit boards, speakers, cabling).
Bench testing was performed to demonstrate that the generator met design specifications and to establish substantial equivalence with predicate devices. Device testing and evaluation demonstrated compliance with the following:
IEC 60601-1: 2005
Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2: 2007
Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements and Tests
IEC 60601-2-2: 2007
Medical Electrical Equipment - Part 2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
2
K134054
510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92(c))
Substantial Equivalence:
| Characteristic | Bovie® IDS-310
(This Submission) | Bovie IDS-300
High Frequency
Electrosurgical
Generator
(K022856)
Primary Predicate | ERBE ESU
VIO300D
(K083452)
Secondary Predicate |
|--------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Regulation and
Product Code | 21 CFR 878.4400 /
GEI | Same | Same |
| Intended Use | Is used to deliver RF
energy via an
assortment of surgical
devices to cut and
coagulate different
kinds of tissue | Same | Is intended to deliver
high frequency (HF)
electrical current for
the cutting and/or
coagulation of tissue. |
| Energy Type | High Frequency (RF) | High Frequency (RF) | High Frequency (RF) |
| Output | Monopolar and
Bipolar | Monopolar and
Bipolar | Monopolar and
Bipolar |
Similarities
Each device Uses high frequency RF current to deliver a desired clinical effect.
Each device offers monopolar and bipolar output modes.
The Cut I/II, Blend, Pinpoint Coagulation, and Spray Coagulation modes of the IDS-310 and IDS-300 predicate devices have the same waveform and maximum output power. The Bovie Bipolar mode of the IDS-310 has a similar waveform and the same output power as the VIO 300D BiClamp mode. Other IDS-310 Bipolar modes are similar to VIO 300D Bipolar modes but have lower output power.
Differences
The IDS-310 was designed compliant with both IEC 60601-1 Third Edition and the Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment (RoHS) Directive.
3
K134054.
510(k) SUMMARY
(Submitted As Required per 21 CFR 807.92(c))
Conclusions
The Bovie IDS-310 High Frequency Electrosurgical Generator has the same intended use, operating procedures, principles of operation, and utilizes the same technology as the predicate devices. The Bovie IDS-310 does not raise additional issues of safety or efficacy compared to the predicate devices.
4
Public Health Service
Food und Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MID 20993-0002
DEPARTMENT OF HEALTH & HUMAN SERVICES
March 17, 2014
Bovie Medical Corporated Mr. Richard A. Kozlofí Vice President, Quality Assurance/Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760
Re: K134054
Trade/Device Name: Bowie® IDS-310 High Frequency Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: December 27, 2014 Received: December 31, 2014
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 FIDA'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 of medical
Image /page/4/Picture/11 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 perimeter. In the center of the seal is an abstract image of an eagle.
5
Page 2 - Mr. Richard A. 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aguel
- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
K134054 510(k) Number (if known):
Device Name: Bovie IDS-310 High Frequency Electrosurgical Generator
Indications for Use:
The IDS-310 High Frequency Electrosurgical Generator is used to deliver RF energy via an assortment of surgical devices to cut and coagulate different kinds of tissue.
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) Long H. -A 100.100.1.1 = 1300369054 for BSA (Division Sign-Off) Division of Surgical Devices 4-2 510 (K) Number: K134054