(81 days)
Not Found
No
The summary describes a standard electrosurgical electrode and does not mention any AI or ML capabilities.
Yes
The device is used to "cut and excise tissue or to coagulate blood vessels during arthroscopic surgical procedures", which are therapeutic actions.
No
The device is described as an electrosurgical electrode used to cut and excise tissue or coagulate blood vessels during surgical procedures, which are therapeutic actions rather than diagnostic ones.
No
The device description clearly states it is a physical electrode used with hardware (handpiece and generator) to deliver RF energy. It is not software.
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 during arthroscopic surgical procedures to cut and excise tissue or coagulate blood vessels. This is a direct intervention on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
The Aaron Arthroscopy Electrodes are surgical tools used in vivo (within the living body), not for testing samples in vitro (in glass or outside the body).
N/A
Intended Use / Indications for Use
Aaron Arthroscopy Electrodes are sterile, single-use 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 arthroscopic surgical procedures.
Product codes
HRX, GEI
Device Description
Aaron Arthroscopy Electrodes sterile, single-use electrodes that 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 arthroscopic surgical procedures.
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 Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.
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
MAY 13 2002
AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON ARTHROSCOPY ELECTRODE
510 (K) NOTIFICATION PAGE 24 OF 24
510(k) SAFETY AND EFFECTIVENESS SUMMARY KO20579
Trade Name: Common Name: Classification Name:
AARON ARTHROSCOPY ELECTRODE Electrosurgical Electrode Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)
Aaron Arthroscopy Electrodes sterile, single-use electrodes that 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 arthroscopic surgical procedures.
Aaron Arthroscopy Electrodes are substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in operation, intended use, energy source, and method of preparation.
Testing performed on Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.
In conclusion, Aaron Arthroscopy Electrodes are substantially equivalent to predicate devices in methods of operation, intended use, and results derived from operation.
| Submitted By: | Richard Kozloff
Vice-President; Quality Assurance
Aaron Medical a Bovie Company
St. Petersburg, FL 33710 |
| --------------- | ------------------------------------------------------------------------------------------------------------------- |
|---|
Richard Kozloff Contact Person: Date: February 19 2002
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal 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
MAY 1 3 2002
Mr. Richard Kozloff Vice President, Quality Assurance Aaron Medical Industries 7100 30th Avenue North St. Petersburg, FL 33710-2902
Re: K020579
Trade/Device Name: Aaron Arthroscopy Electrodes Regulation Number: 888.1100 and 878.4400 Regulation Name: Arthroscope; Electrosurgical cutting and coagulation device and accessories
Regulatory Class: II Product Code: HRX, GEI Dated: February 19, 2002 Received: February 21, 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 (OS) 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 vour 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,
Muriam C. Provost
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
3
INDICATIONS FOR USE
510(k) Number (if known): KO20579
Device Name: Aaron Arthroscopy Electrodes
(Arthroscopy Hook Electrode; 90° Angle, Arthroscopy Hook Electrode; 45° Angle, Arthroscopy Blade Electrode; Insulated, Arthroscopy Blade Electrode; Non-Insulated)
Indications for Use:
Aaron Arthroscopy Electrodes are sterile, single-use 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 arthroscopic surgical procedures.
uriam C. Provost
Division of General, Restorative and Neurological Devices
510(k) Number_K020579
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)