(217 days)
K-082109
K-092208
No
The description focuses on traditional electrosurgical waveform generation and user-selectable modes, with no mention of AI or ML technologies. The comparison to the predicate device highlights differences in power output and instrument compatibility, not algorithmic capabilities.
Yes
The device is intended for "sealing vessels and cutting tissues," which are therapeutic actions performed to treat or manage a medical condition.
No
The device is an electrosurgical generator designed for "sealing vessels and cutting tissues" by producing characteristic electrical waveforms, which are therapeutic actions, not diagnostic ones.
No
The device description explicitly details a physical electrosurgical generator that produces electrical waveforms and connects to instruments. This is a hardware device, not software only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "sealing vessels and cutting tissues" using electrosurgical energy. This is a direct surgical intervention on the patient's body.
- Device Description: The description details how the device generates electrical waveforms to achieve clinical effects like cutting, coagulation, and sealing. This is a therapeutic and surgical function, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition. IVDs are used to perform tests in vitro (outside the body) to diagnose diseases or conditions.
Therefore, the ICON VS Electrosurgical Generator is a surgical device, not an IVD.
N/A
Intended Use / Indications for Use
The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.
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)
K-082109
Reference Device(s)
K-092208
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.
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Page 1 of 2
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
383
GENERAL INFORMATION:
け
.
MAR 1 0 2010
. . . .
| 510k Owner's Name | Bovie Medical |
|---|---|
| Address | 5115 Ulmerton Road |
| Clearwater, Florida 33760-4004 | |
| Contact Person | Richard A. Kozloff |
| Vice-President; Quality Assurance/Regulatory Affairs | |
| Telephone #: (727) 803-8513 | |
| FAX Number: (727) 322-4465 | |
| Date Prepared: | 07/31/2009 |
| DEVICE DESCRIPTION: | |
| Trade Name: | Bovie ICON VS Electrosurgical Generator |
| Common Name: | Electrosurgical Generator |
| Classification Name: | Electrosurgical Cutting and Coagulation Devices and |
| Accessories (21CFR 878.4400; Class II; Product Code GEI) | |
| Predicate Devices: |
Bovie Medical
Bovie ICON GP General Purpose RF Generator (K-082109)
1
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
DEVICE OPERATION:
The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.
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, and seal). The shape and duration of waveforms are comparable between the generator and the predicate device.
The Generator functions in any of the following user selectable modes:
-
- Pure Cut 2. Blend Mode 1
-
- Blend Mode 2 4. Blend Mode 3
-
- Special Cut 6. Laparoscopic Cut
-
- Pinpoint Coagulation 8. Gentle Coagulation
- Spray Coagulation 9. 10. Laparoscopic Coagulation
-
- Macro Bipolar 12. Micro Bipolar
-
- Gentle Bipolar 14. Auto Stop Bipolar
-
- Vessel Seal with Optional Power Cut
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards.
Like the predicate device, the ICON VS incorporates an ergonomically designed user interface screen for the selection of device settings. The ICON VS uses identical technology to the predicate device and the waveform profiles for all cut, coagulation, and bipolar modes are identical. The ICON VS differs from the predicate device in that 1) it is designed to work with Bovie Seal and Cut Instruments (K-092208 pending review), 2) the vessel sealing mode on the ICON VS is less aggressive than the predicate device (90 watts of power versus 400 watts of power), and 3) the power cut mode on the ICON VS delivers 100 watts of power versus the predicate device which delivers 80 watts of power.
There are no new hazards presented with the use of the Bovie ICON VS generator as compared with the named predicate device.
INTENDED USE:
The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a bird or abstract human figures, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Bovie Medical Corporation % Mr. Richard A. Kozloff Vice President, Quality Assurance/ Regulatory Affairs 5115 Ulmerton Road Clearwater, Florida 33760-4004
MAR 1 0 2010
Re: K092383
Trade/Device Name: Bovie ICON VS 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: February 05, 2010 Received: February 12, 2010
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
3
Page 2 - Mr. Richard A. Kozloff
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/ucm115809.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/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 vours.
Sincerely yours,
Mark N. Melkerson
Director
Division of Surgical, Orthopedic
DED DIRECTOR
3/10/0
And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bovie ICON VS Electrosurgical Generator
Indications for Use:
The ICON VS Electrosurgical Generator is intended to be used with Bovie Seal and Cut Instruments for sealing vessels and cutting tissues.
イ 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)
Neil R. Osada Csr mxm
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K092383