(77 days)
No
The device description and performance studies focus on the adapter's function as a simple electrical connector and do not mention any AI/ML capabilities.
No.
The device is an accessory (adapter) for an electrosurgical generator and is not directly used for cutting or coagulating procedures.
No
The device is an accessory to an electrosurgical generator, intended for cutting or coagulating procedures, and does not perform any diagnostic function. Its purpose is to allow a foot-controlled pencil or suction/coagulator to be used with the generator.
No
The device description explicitly states it is a "non-sterile, reusable device" with an "insert-molded body" and a "foot control adapter plug," indicating it is a physical hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cutting or coagulating procedures" using an electrosurgical generator. This is a surgical procedure performed on a patient, not a test performed on a sample taken from the body.
- Device Description: The device is described as an "accessory to the Aaron 1200 electrosurgical generator" and facilitates the use of foot-controlled pencils or suction/coagulation tubes. This further reinforces its role in surgical procedures.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro 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 does not fit that description.
N/A
Intended Use / Indications for Use
The Aaron ESU Foot-Controll Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures.
Product codes
GEI
Device Description
The Aaron ESU Foot Control Adapter is a non-sterile, reusable device. It utilizes an insert-molded body that allows a foot-controlled pencil or suction/coagulation tube. The foot control adapter plug allows activation of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998. It is an accessory to the Aaron 1200 electrosurgical generator.
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 ESU Foot Control Adapter indicates that the use of the Adapter does not change the operation of either the Aaron 1200 or the foot controlled devices. Consequently, the devices remain substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron ESU Foot Control Adapter. Test results indicated that there are no new hazards presented with the use of the Aaron ESU Foot Control Adapter.
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
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
2/10/99
K 984236
AARON MEDICAL INDUSTRIES, INC. Aaron ESU Foot Control Adapter #A1205A
510(K) NOTIFICATION
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: Aaron ESU Foot Control Adapter #A1205A COMMON NAME: Adapter Plug CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)
The Aaron ESU Foot Control Adapter is a non-sterile, reusable device. It utilizes an insert-molded body that allows a foot-controlled pencil or suction/coagulation tube. The foot control adapter plug allows activation of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998. It is an accessory to the Aaron 1200 electrosurgical generator.
The Aaron ESU Foot Control Adapter is intended to be used with the Aaron 1200 electrosurgical generator. The adapter will allow the use of a disposable foot-controlled pencil or suction irrigator with a single pin connector with the Aaron 1200 electrosurgical generator. It is non-sterile and is reusable.
The Aaron ESU Foot Control Adapter while allowing the use of single pin foot controlled pencils, does not change the design, operation, intended use, materials, components and performance claims of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998.
Testing which has been performed on the Aaron ESU Foot Control Adapter indicates that the use of the Adapter does not change the operation of either the Aaron 1200 or the foot controlled devices. Consequently, the devices remain substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron ESU Foot Control Adapter. Test results indicated that there are no new hazards presented with the use of the Aaron ESU Foot Control Adapter.
In conclusion, the Aaron ESU Foot Control Adapter is an accessory to the Aaron 1200 and will allow the doctor to choose between the reusable pencil included with the Aaron 1200 or a single use disposable foot controlled pencil or suction coagulator.
Submitted By: J. Robert Saron President & CEO Official Correspondent
1
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.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Mr. J. Robert Saron President and Chief Executive Officer, Official Correspondent Aaron Medical Industries 7100 30ª Avenue North St. Petersburg, Florida 33710
K984236 Re: Trade Name: Aaron ESU Foot-Control Adapter #A1205A Regulatory Class: II Product Code: GEI Dated: November 23, 1998 Received: November 25, 1998
Dear Mr. Saron:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. J. Robert Saron
This letter will allow you to begin marketing your device as described in your 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 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 device, 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,
M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
K984236 510(k) Number (if known):
Aaron ESU Foot-Control Adapter Device Name:
Indications For Use:
The Aaron ESU Foot-Controll Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating 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 K984236
510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
510(k) Number
Over-The-Counter Use
(Optional Format 1-2-96)