(260 days)
No
The description focuses on standard electrosurgical generator functionality and does not mention AI or ML.
No.
The device cuts and coagulates tissue, which are actions performed during a therapeutic procedure, but the device itself is a generator of electrosurgical energy, not a therapeutic device that directly treats a condition.
No
The device is described as an electrosurgical generator designed to cut and coagulate tissue using radiofrequency energy. Its functions are therapeutic (surgical), not diagnostic.
No
The device description explicitly states it is an "Electrosurgical Generator" which is a hardware device that delivers RF energy. It also mentions "other electrosurgical accessories" which are also hardware.
Based on the provided information, the Bovie IDS-400 Electrosurgical Generator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use/Indications for Use: The device is designed to perform monopolar and bipolar functions in the operating arena to cut and coagulate tissue. This describes a surgical procedure performed directly on a patient, not a test performed on a sample of biological material outside the body (which is the definition of an in vitro diagnostic).
- Device Description: The description reinforces its use in surgery by mentioning the delivery of high-frequency radiofrequency energy to cut and coagulate tissue.
- Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting specific substances, or providing diagnostic information based on laboratory testing.
Therefore, the Bovie IDS-400 Electrosurgical Generator is a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
Product codes
GEI
Device Description
The Bovie IDS-400 (the Generator) operates by dclivering 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 arc comparable between the generator and predicate devices.
The Generator functions in any of six user selectable modes:
Monopolar Cut I/II The cut modes allow the user to utilize electrosurgical current to vaporize or cut tissue.
Blend: The monopolar cutting speed and degree of hemostasis is controlled by the Monopolar blend control.
Coagulation (Pinpoint): Coagulation, also referred to as pinpoint coagulation, is used with forceps, blade, or needle electrodes and endoscopic devices. Coagulation is intended for use of small defined tissue areas. Coagulation is used to activate the generator prior to contacting tissue. Once the desired effect is achieved, the electrode is removed from the tissue area and deactivated. This coagulation mode provides precise control of bleeding in localized areas.
Fulguration (Spray Coagulation): Fulguration, also referred to as spray coagulation provides greater control of bleeding in highly vascularized tissues over broad surface areas. This mode is used with all types of pencil electrodes, endoscopic devices and clamps. Areas are repeatedly sprayed until desired hemostasis is established and can be used on all types of tissue.
The bipolar procedure is activated when performing coagulation with bipolar Bipolar: forceps.
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 cquivalent to the Aaron IDS-300 Electrosurgical Generator (K022856). There are no new hazards presented with the use of the Bovie IDS-400 Electrosurgical Generator as compared with the predicate device.
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)
Reference Device(s)
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
1 of
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
DEVICE OPERATION:
The Bovie IDS-400 (the Generator) operates by dclivering 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 arc comparable between the generator and predicate devices.
The Generator functions in any of six user selectable modes:
Monopolar Cut I/II The cut modes allow the user to utilize electrosurgical current to vaporize or cut tissue.
Blend: The monopolar cutting speed and degree of hemostasis is controlled by the Monopolar blend control.
Coagulation (Pinpoint): Coagulation, also referred to as pinpoint coagulation, is used with forceps, blade, or needle electrodes and endoscopic devices. Coagulation is intended for use of small defined tissue areas. Coagulation is used to activate the generator prior to contacting tissue. Once the desired effect is achieved, the electrode is removed from the tissue area and deactivated. This coagulation mode provides precise control of bleeding in localized areas.
Fulguration (Spray Coagulation): Fulguration, also referred to as spray coagulation provides greater control of bleeding in highly vascularized tissues over broad surface areas. This mode is used with all types of pencil electrodes, endoscopic devices and clamps. Areas are repeatedly sprayed until desired hemostasis is established and can be used on all types of tissue.
The bipolar procedure is activated when performing coagulation with bipolar Bipolar: forceps.
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 cquivalent to the Aaron IDS-300 Electrosurgical Generator (K022856). There are no new hazards presented with the use of the Bovie IDS-400 Electrosurgical Generator as compared with the predicate device.
INTENDED USE:
The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
1
K072041 p. 2 of 2
510(k) SUMMARY (As Required per 21 CFR 807.92(c))
GENERAL INFORMATION:
| 510k Owner's Name | Bovie Medical |
|---|---|
| Address | 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: | July 23, 2007 |
DEVICE DESCRIPTION:
Trade Name:
Common Name: Classification Name: Bovie IDS-400 Electrosurgical Generator
Electrosurgical Generator
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
.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is black, and the text is in a smaller font size.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 0 2008
Bovie Medical % Mr. Richard A. Kozloff Vice President, Quality Assurance/Regulatory Affairs 3200 Tyrone Boulevard, Suite A Saint Petersburg, Florida 33710-2902
Re: K072041
Trade/Device Name: Bovie IDS-400 Electrosurgical Generator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories. Regulatory Class: II Product Code: GEI Dated: March 31, 2008 Received: April 1, 2008
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.
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 A. 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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. Millerson
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
KO72041
Indications for Use
07204 510(k) Number (if known):
Bovie IDS-400 Electrosurgical Generator Device Name:
Indications for Use:
The Bovie IDS-400 Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
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)
ence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number K07204 4-2