(66 days)
Not Found
No
The summary describes a simple electrosurgical electrode and makes no mention of AI or ML.
Yes
Explanation: The device is used to deliver RF energy to cut, excise, or coagulate tissue, which are therapeutic actions.
No
This device is described as delivering RF energy to cut, excise tissue, or coagulate blood vessels during surgery, which are therapeutic rather than diagnostic functions.
No
The device description clearly states it is a physical electrode used with hardware (handpiece and generator) to deliver RF energy, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are used to "cut and excise tissue or to coagulate blood vessels during surgery." This describes a direct surgical intervention on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The description reinforces the surgical application of delivering RF energy to tissue.
The information provided focuses on the surgical function of the electrodes, not on analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
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 performed on Aaron Reusable Electrosurgical Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.
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
AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON REUSABLE ELECTROSURGICAL ELECTRODES
KO14201
FEB 2 5 2002
510(k) SAFETY AND EFFECTIVENESS SUMMARY
Trade Name: Common Name: Classification Name: Aaron Reusable Electrosurgical Electrode Electrosurgical Electrode Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)
Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
Electrosurgical is substantially equivalent to Aaron Reusable The Aaron Electrosurgical Electrodes (K931338 and K942986) in operation, intended use, energy source, and method of preparation. Performance claims for the reusable electrodes differ from the predicate device in that they are not sold sterile and that they may be cleaned and resterilized by steam under pressure. Aaron Reusable Electrosurgical Electrodes in the loop configuration may be cleaned and sterilized up to 5 times. Aaron Reusable Electrosurgical Electrodes in the blade, needle, and ball configurations may be cleaned and sterilized up to 25 times. Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993) and Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers (AAMI TIR 12: 1994). The validated cleaning and sterilization processes are provided in device labeling and instructions.
Testing performed on Aaron Reusable Electrosurgical Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.
In conclusion, Aaron Reusable Electrosurgical Electrodes substantially equivalent to predicate devices (Aaron Electrosurgical Electrodes) in methods of operation, intended use, and results derived from operation.
| Submitted By: | Richard Kozloff
Vice-President ; Quality Assurance
Aaron Medical Industries
7100 30th Avenue North
St. Petersburg, FL 33710 |
| --------------- | ----------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Contact Person: Richard Kozloff Date: December 17, 2001
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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2002
Mr. Richard Kozloff Vice President, Quality Assurance and Regulatory Affairs Aaron Industries 7100 30th Avenue North St. Petersburg, Florida 33710
Re: K014201
Trade/Device Name: Aaron Reusable Electrosurgical Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001
Dear Mr. Kozloff:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterest, mains of the Act include requirements for annual registration, listing of general controls proficituring 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,
Mark A Miller
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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510 (K) NOTIFICATION
AARON MEDICAL INDUSTRIES AARON REUSABLE ELECTROSURGICAL ELECTRODE
INDICATIONS FOR USE
510(k) Number (if known): KO14201
Device Name: Aaron Reusable Electrosurgical Electrodes
Indications for Use:
A aron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of General, Restorative and Neurological Devices Koly201
(Optional Format 3-10-98)
510(k) Number _