(29 days)
Not Found
No
The summary describes a standard electrosurgical generator and does not mention any AI or ML capabilities.
Yes
The device is described as an electrosurgical generator intended for the "removal and destruction of human tissue and the coagulation of bleeders," which directly refers to therapeutic actions.
No
The device is described as an electrosurgical generator used for the removal, destruction, and coagulation of human tissue, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states it is a "non-serile, reusable electrosurgical generator" and mentions a "Handcontrol pencil" as an integral component, indicating it is a hardware device.
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 the "removal and destruction of human tissue and the coagulation of bleeders" using electrosurgery. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description confirms it's an "electrosurgical generator" that generates high-frequency current for surgical purposes.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information about a patient's health status, diagnose, monitor, or screen for diseases.
IVD devices are used to perform tests on samples taken from the body, while this device is used to perform a surgical procedure directly on the body.
N/A
Intended Use / Indications for Use
The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 is intended to be used for all low powered electrosury: cut, blend, coagulation, fulguration and bipolar procedures.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Aaron 1200 High Frequency Electrosurgical Generator is a non-serile, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices.
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
K 980366
AARON MEDICAL INDUSTRIES, INC. Aaron 1200 High Frequency Electrosurgical Generator
510(K) NOTIFICATION Page 132 of 132
FEB 2 7 1998
510(k) SAFETY AND EFFECTIVENESS SUMMARY
Aaron 1200 High Frequency Electrosurgical Generator and Accessories TRADE NAME: Electrosurgical Generator COMMON NAME: CLASSIFICATION NAME: Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878:4400)
The Aaron 1200 High Frequency Electrosurgical Generator is a non-serile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.
The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims.
Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices.
In conclusion, the Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices, the Aaron 800 High Frequency Desiccator and the ValleyLab SSE4 Electrosurgical Generator in methods of operation, intended use and results derived from operation.
Submitted By:
Rob Saron President Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, FL 33710-2902 (813) 384-2323
Contact Person: Date:
Rob Saron January 25, 1998
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 27 1998
Mr. J. Robert Saron President & CEO Aaron Medical Industries, Inc. 7100 3060 Avenue North St. Petersburg, Florida 33710-2902
K980366 Re : Aaron 1200 High Frequency Electrosurgical Trade Name: Generator A1200 and A1200/240 Requlatory Class: II Product Code: GEI Dated: January 25, 1998 Received: January 29, 1998
Dear Mr. Saron:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Mr. Saron
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.
If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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_ @004
Page of
510(k) Number (if known):_ K955681
200 10.20 144 00004121144
ر ته به بي بي بي پي پي پي پ
Device Name: Aaron 1200 High Frequency Electrosurgical Generator, models A1200 & A1200/24(
AAKUN
The Aaron 1200 is intended to be used for all low powered electrosury: Indications For Use: cut, blend, coagulation, fulguration and bipolar procedures.
(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 Devices
| 510(k) Number | K980366 |
|---|---|
| --------------- | --------- |
| Prescription Use | ✓ |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
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