(81 days)
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.
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.
The provided text describes a 510(k) premarket notification for the Aaron Arthroscopy Electrode. The document states that "Testing performed on Aaron Arthroscopy Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance" to the Unimed Arthroscopy Electrode (K970066).
However, the 510(k) summary does not provide specific acceptance criteria or detailed study results in the format requested. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than performing a de novo study against explicit, quantitative acceptance criteria for device performance.
Therefore, many of the requested categories about acceptance criteria, detailed study design, sample sizes, and ground truth establishment cannot be extracted from this document because they are either not publicly available or not part of the standard 510(k) summary provided.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate in method of operation. | "substantially equivalent in method of operation" |
| Substantial equivalence to predicate in safety. | "substantially equivalent in... safety" |
| Substantial equivalence to predicate in performance. | "substantially equivalent in... performance" |
| Substantial equivalence to predicate in intended use. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... intended use" |
| Substantial equivalence to predicate in energy source. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... energy source" |
| Substantial equivalence to predicate in method of preparation. | "substantially equivalent to the Unimed Arthroscopy Electrode (K970066) in... method of preparation" |
| Device functions as intended for cutting, excising tissue, and coagulating blood vessels during arthroscopic procedures. | Implied by substantial equivalence to predicate which performs these functions. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. The testing is internal to Aaron Medical Industries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Not specified. This document pertains to a medical device's functional equivalence, not an AI or diagnostic tool requiring expert ground truth for image interpretation or disease diagnosis.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This is not an AI or diagnostic imaging device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI or diagnostic imaging device. The device is used by a human surgeon.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the context of diagnostic ground truth. The "ground truth" for this device would be its ability to perform its intended functions (cutting, coagulation) reliably and safely, analogous to the predicate device, likely assessed through engineering tests, biocompatibility tests, and performance testing. The specifics are not detailed in this summary.
8. The sample size for the training set
- Not applicable. This is not a machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning device.
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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 KozloffVice-President; Quality AssuranceAaron Medical a Bovie CompanySt. Petersburg, FL 33710 |
|---|---|
| --------------- | ------------------------------------------------------------------------------------------------------------------- |
Richard Kozloff Contact Person: Date: February 19 2002
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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.
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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
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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)
§ 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.