(167 days)
Not Found
No
The summary describes a standard electrosurgical generator with various cutting and coagulation modes. There is no mention of AI, ML, image processing, or data-driven decision-making. The performance studies focus on substantial equivalence to predicate devices, not on AI/ML performance metrics.
No
A therapeutic device is one that treats a disease or condition. This device is an electrosurgical generator used to cut and coagulate tissue during surgery, which are operational functions rather than therapeutic ones.
No
Explanation: The device is an electrosurgical generator designed to perform surgical functions like cutting and coagulation, not to diagnose medical conditions.
No
The device description clearly states it is an "Electrosurgical Generator," which is a hardware device that produces high-frequency electrical current for surgical procedures. It describes physical functions like "monopolar cut" and "bipolar," indicating a hardware component is essential to its operation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is a "High Frequency Electrosurgical Generator" designed to perform "monopolar and bipolar functions in the operating arena." This describes a surgical tool used directly on a patient during a procedure, not a device used to test samples (like blood, urine, or tissue) in vitro (outside the body) to diagnose a condition.
- Device Description: The description reinforces its use in the "operating arena" for surgical functions like cutting, coagulation, and fulguration.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is entirely focused on performing surgical procedures.
N/A
Intended Use / Indications for Use
The Bovie IDS 300 High Frequency 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 (comma separated list FDA assigned to the subject device)
GEI
Device Description
The IDS 300 High Frequency Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator for use in the operating arena which features both monopolar and bipolar functions which meet surgical demands for safety, flexibility, and convenience. Functions which the IDS 300 performs includes: monopolar cut; monopolar cut with hemostasis (blend); force coagulation; fulguration; and bipolar.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Operating arena
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: Testing which has been performed on the IDS 300 indicates that this device is substantially equivalent in performance and method of operation.
HAZARD ANALYSIS: Hazard analysis evaluations were performed on the IDS 300. Test results indicated that there are no new hazards presented with the use of the IDS 300 High Frequency Electrosurgical Generator as compared with the predicate devices.
In conclusion, the IDS 300 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices in methods of operation, intended use, and results derived from operation.
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.
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FEB 1 0 2003
510(K) SAFETY AND EFFECTIVENESS SUMMARY
IDS 300 High Frequency Electrosurgical Generator TRADE NAME: COMMON NAME: Electrosurgical Generator CLASSIFICATION Electrosurgical Cutting and Coagulation Devices and Accessories (21 CFR NAME: 878.4400)
The IDS 300 High Frequency Electrosurgical Generator is a non-sterile, reusable multi-purpose electrosurgical generator for use in the operating arena which features both monopolar and bipolar functions which meet surgical demands for safety, flexibility, and convenience. Functions which the IDS 300 performs includes: monopolar cut; monopolar cut with hemostasis (blend); force coagulation; fulguration; and bipolar.
SUBSTANTIAL EQUIVALENCE: The IDS 300 is substantially equivalent to the Aaron 2100 Electrosurgical Generator (K001382) and the Valleylab Electrosurgical Generator, Model Force FX (K944602) in design, operation, intended use, materials, components, energy source, and performance claims.
TESTING: Testing which has been performed on the IDS 300 indicates that this device is substantially equivalent in performance and method of operation.
HAZARD ANALYSIS: Hazard analysis evaluations were performed on the IDS 300. Test results indicated that there are no new hazards presented with the use of the IDS 300 High Frequency Electrosurgical Generator as compared with the predicate devices.
In conclusion, the IDS 300 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices in methods of operation, intended use, and results derived from operation.
Submitted By: Richard A. Kozloff
Vice President, Quality Assurance and Regulatory Affairs Aaron Medical Industries, a Bovie Company 7100 30th Avenue North St. Petersburg, FL 33710-2902 (727) 384-2323
Contact Person: Richard A. Kozloff August 23, 2002 Date:
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
FEB 1 0 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aaron Medical Industries Richard A. Kozloff Vice President, Quality Assurance & Regulatory Affairs 7100 30th Avenue, North St. Petersburg, Florida 33710-2902
Re: K022856 Trade/Device Name: Bovie IDS-300 High Frequency Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation devices and accessories Regulatory Class: Class II Product Code: GEI Dated: December 3, 2002 Received: December 4, 2002
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. Iisting 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.
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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 Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT
510(K) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Bovie IDS 300 High Frequency Electrosurgical Generator
Model: IDS-300
Indications For Use:
ﺗﻮ ﺐ ﻧﺔ
The Bovie IDS 300 High Frequency Electrosurgical Generator is a non-sterile reusable multi-purpose electrosurgical generator that is designed to perform monopolar and bipolar functions in the operating arena.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Optional Format 3-10-98)
Muriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K022856