(65 days)
Not Found
No
The description focuses on standard electrosurgical generator technology, waveform characteristics, and user-selectable modes, with no mention of AI or ML.
No
The device is used to cut and coagulate tissue using radiofrequency energy, which are surgical functions, not therapeutic treatments in the sense of healing or curing a disease without surgical intervention.
No
The device is an electrosurgical generator designed to cut and coagulate tissue using radiofrequency energy, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly states it is a "Generator" that "operates by delivering high frequency radiofrequency (RF) energy" and is used "in conjunction with other electrosurgical accessories." This indicates a hardware component responsible for generating and delivering energy, which is not characteristic of a software-only medical device.
Based on the provided information, the Bovie ICON GI Generator is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues." This describes a surgical procedure performed directly on the patient's body, not a test performed on a sample taken from the body (which is the definition of an IVD).
- Device Description: The description focuses on the delivery of energy for surgical purposes (cutting and coagulation) and mentions electrosurgical accessories. This aligns with surgical equipment, not diagnostic testing equipment.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.), detecting biomarkers, or providing diagnostic information based on laboratory testing.
Therefore, the Bovie ICON GI Generator is a surgical device, specifically an electrosurgical generator, and not an IVD.
N/A
Intended Use / Indications for Use
The Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Bovie ICON GI (the Generator) operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other electrosurgical accessories, is used to cut and coagulate tissue. 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 functions in any of seven user selectable modes:
- Cut a)
- Blend b)
- c) Smart Cut
- d) Pinpoint Coagulation
- Soft Coagulation e)
- Bipolar Coagulation f)
- Gentle Bipolar Coagulation g)
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards.
The Generator uses technology substantially equivalent to the predicate devices, the Aaron IDS-300 (K022856) and the ERBE USA ERBOTOM ICC 200 (K933157). The generator incorporates an ergonomically designed user interface screen for the selection of device settings. Although different from the user interface of the predicate devices, the difference does not affect the safety and effectiveness and may provide improved visualization of the device settings.
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): 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
Image /page/0/Picture/0 description: The image shows the logo for Bovie Medical. The word "Bovie" is written in a stylized, cursive font, with a line drawn underneath it. Below the line, the word "MEDICAL" is written in block letters.
Page 1 of 2
KO61884
SEP - 6 2006
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
GENERAL INFORMATION:
| 510k Owner's Name
Address | Bovie Medical
3200 Tyrone Boulevard, Suite A
St. Petersburg, Florida 33710-2902 | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|---------|
| Contact Person | Richard A. Kozloff
Vice-President; Quality Assurance/Regulatory Affairs
Telephone #: (727) 803-8513
FAX Number: (727) 347-9144 | |
| Date Prepared: | June 30, 2006 | |
| DEVICE DESCRIPTION: | | |
| Trade Name: | Bovie ICON GI 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: | | |
| Aaron Medical | IDS-300 High Frequency
Electrosurgical Generator | K022856 |
| ERBE USA, Inc. | Erbotom ICC 200 | K933157 |
1
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
DEVICE OPERATION:
The Bovie ICON GI (the Generator) operates by delivering high frequency radiofrequency (RF) energy which, when used in conjunction with other electrosurgical accessories, is used to cut and coagulate tissue. 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 functions in any of seven user selectable modes:
- Cut a)
- Blend b)
- c) Smart Cut
- d) Pinpoint Coagulation
- Soft Coagulation e)
- Bipolar Coagulation f)
- Gentle Bipolar Coagulation g)
The generator is designed to comply with applicable Medical Electrical Equipment safety standards, including electromagnetic compatibility and other safety standards.
The Generator uses technology substantially equivalent to the predicate devices, the Aaron IDS-300 (K022856) and the ERBE USA ERBOTOM ICC 200 (K933157). The generator incorporates an ergonomically designed user interface screen for the selection of device settings. Although different from the user interface of the predicate devices, the difference does not affect the safety and effectiveness and may provide improved visualization of the device settings.
There are no new hazards presented with the use of the Bovie ICON GI generator as compared with the named predicate devices.
INTENDED USE:
The Bovie ICON GI Generator is used to deliver high frequency radiofrequency. energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized representation of a human figure. The figure is composed of three abstract profiles facing to the right, symbolizing the department's focus on health and human well-being. The seal is in black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bovie Medical % Mr. Richard Kozloff 3200 Tyrone Boulevard, Suite A St. Petersburg, Florida 33710
Re: K061884
Trade/Device Name: Bovie ICON GI Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting coagulation device and accessories Regulation Class: Class II Product Code: GEI Dated: June 30, 2006 Received: July 3, 2006
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.
SEP - 6 2006
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 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); 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.
3
Page 2 - Mr. Richard Kozloff
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K061884
Device Name: Bovie ICON GI Generator
Indications for Use:
The Bovie ICON GI Generator is used to deliver high frequency radiofrequency energy in conjunction with other surgical devices to cut and coagulate different kinds of tissues.
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)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K061 8842