(90 days)
The Aaron Top50 Reusable Electrosurqical Pencil is intended to be used in general electrosurgical applications for cutting and coagulation during surgical procedures. It is provided non-sterile and is intended for reuse.
The Aaron Top50 Handcontrol Pencil is a non-sterile, thirty-time reuse electrosurgical hand-control pencil. It utilizes a solid molded body that encapsulates a printed circuit board, used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.
I am sorry, but the provided text does not contain the information needed to fill out the table and answer the questions regarding acceptance criteria, device performance, and study details like sample sizes, expert qualifications, or ground truth establishment.
The document is a 510(k) premarket notification summary for the "Aaron Top50 Handcontrol Pencil." It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study with specific performance metrics against acceptance criteria.
The key statements in the document that explain its approach are:
- "Testing which has been performed on the Aaron Top50 Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation."
- "Hazard analysis evaluations were performed on the Aaron Top50 Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Top50 Handcontrol Pencil as compared with the predicate devices."
- "In conclusion, the Aaron Top50 Handcontrol Pencil is believed to be substantially equivalent to the predicate devices..."
Therefore, I cannot provide the requested information from the given text.
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3/4/99
AARON MEDICAL INDUSTRIES, INC. Aaron Top50 Handcontrol Pencil
510(K) NOTIFICATION
510(k) SAFETY AND EFFECTIVENESS SUMMARY
TRADE NAME: Aaron Top50 Handcontrol Pencil COMMON NAME: Electrosurgical Handcontrol Pencil CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)
The Aaron Top50 Handcontrol Pencil is a non-sterile, thirty-time reuse electrosurgical hand-control pencil. It utilizes a solid molded body that encapsulates a printed circuit board, used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.
The Aaron Top50 Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for thirty-time reuse.
The Aaron Top50 Handcontrol Pencil is equivalent to the Medtrex Encore Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended use, materials, components and performance claims.
Testing which has been performed on the Aaron Top50 Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation.
Hazard analysis evaluations were performed on the Aaron Top50 Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Top50 Handcontrol Pencil as compared with the predicate devices.
In conclusion, the Aaron Top50 Handcontrol Pencil is believed to be substantially equivalent to the predicate devices, the Medtrex Encore Model 35001-001, the Aaron Medical Industries, Inc Model A801 monopolar handpiece and the Valleylab Model #2502B.
Submitted By: J. Robert Saron President & CEO Official Correspondent
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 4 1999
Mr. J. Robert Saron President and Chief Executive Officer Official Correspondent Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902
Re: K984352
Trade Name: Aaron Top50 Reusable Electrosurgical Pencil Regulatory Class: II Product Code: GEI Dated: December 1, 1998 Received: December 4, 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 (QS) 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 vour 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.
Stupt Rhodes
Celia 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
510(k) Number (if known): K9844352
Device Name: Aaron Top50 Reusable Electrosurgical Pencil
Indications For Use:
The Aaron Top50 Reusable Electrosurqical Pencil is intended to be used in general electrosurgical applications for cutting and coagulation during surgical procedures. It is provided non-sterile and is intended for reuse.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Stuck Rhodes
Division of General Restorati 510(k) Number
OR
Prescription Use (Per 21 CFR 801 109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
§ 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.