(38 days)
Not Found
No
The summary describes a standard electrosurgical generator and does not mention any AI or ML capabilities.
Yes
The device is intended for electrosurgical "cut, blend, coagulation, fulguration, and bipolar procedures," which are therapeutic interventions.
No
The device is described as an "Electrosurgical Generator" intended for surgical procedures (cut, blend, coagulation, fulguration, bipolar procedures), which are therapeutic, not diagnostic. There is no mention of it being used to identify or analyze medical conditions.
No
The device description explicitly states it is an "Electrosurgical Generator," which is a hardware device that generates high-frequency current. There is no mention of software being the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures." These are all procedures performed directly on a patient's tissue, not on samples taken from the body.
- Device Description: The description details a "high frequency electrosurgical generator" that generates current for surgical procedures. This aligns with surgical equipment, not diagnostic testing of samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
In summary, the Aaron 950 High Frequency Electrosurgical Generator is a surgical device used for treating tissue, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
The Aaron 950 High Frequency Electrosurgical Generator models are intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures.
Product codes
GEI
Device Description
The Aaron 950 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current.
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
Testing performed on the Aaron 950 indicates that the device is substantially equivalent in its performance and method of operation.
Hazard analysis evaluations are performed on the Aaron 950. There are no new hazards presented with the use of the Aaron 950 as compared with the predicate devices.
Key Metrics
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
JUL 11 2002
1021817
510(k) SAFETY AND EFFECTIVENESS SUMMARY
| Trade Name: |
|---|
| Common Name: |
| Classification Name: |
Aaron 950 High Frequency Electrosurgical Generator Electrosurgical Generator Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)
The Aaron 950 High Frequency Electrosurgical Generator is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current.
The Aaron 950 High Frequency Electrosurgical Generator is intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures,
The Aaron 950 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron Medical Aaron 1200 High Frequency Electrosurgical Generator (K980366) in operation, intended use, materials, energy source, output, method of preparation, and performance claims and is substantially equivalent to the Aaron 900 High Frequency Electrosurgical Dessicator in terms of remote power selection via handpiece. The Aaron 950 High Frequency Electrosurgical Generator incorporates rotary dial or handpiece selected energy output, allowing independent setting of cut and coagulation mode energy. Preset mode and output power button have also been incorporated into the Aaron 950.
Testing performed on the Aaron 950 indicates that the device is substantially equivalent in its performance and method of operation.
Hazard analysis evaluations are performed on the Aaron 950. There are no new hazards presented with the use of the Aaron 950 as compared with the predicate devices.
In conclusion, the Aaron 950 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices (Aaron A900 and Aaron A1200) in methods of operation, intended use, and results derived from operation.
| Submitted By: | Richard Kozloff
Vice-President ; Quality Assurance/Reg. Affairs
Aaron Medical Industries
7100 30th Avenue North
St. Petersburg, FL 33710 |
|-----------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Richard Kozloff |
| Date: | May 30, 2002 |
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, a symbol often associated with healthcare. The caduceus-like symbol has three lines that curve and flow, creating a sense of movement and dynamism.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 11 2002
Mr. Richard Kozloff Vice President Quality Assurance Aaron Medical Industries 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K021817
Trade/Device Name: Aaron A950 High Frequency Electrosurgical Generator Regulation Number: 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: II Product Code: GEI Dated: May 30, 2002 Received: June 3, 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, 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.
2
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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.
A. Hpt Rhodes
Celia M. Wittels, Ph.D., M.D.
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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AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON 950 HIGH FREQUENCY GENERATOR
INDICATIONS FOR USE
510(k) Number (if known): K021811
Device Name: Aaron A950 High Frequency Generator; Model A950 and A950-220
Indications for Use:
The Aaron 950 High Frequency Electrosurgical Generator models are intended to be used for all electrosurgical cut, blend, coagulation, fulguration, and bipolar procedures.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stytz Pluode
Division of General, Restorative and Neurological Devices
(Optional Format 3-10-98)
510(k) Number ________________________________________________________________________________________________________________________________________________________________