(72 days)
The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use.
Not Found
The provided text is a 510(k) premarket notification letter from the FDA to Aaron Medical Industries regarding their Electrosurgical Pencil Holster. This document is related to device clearance rather than the performance study of a device. Therefore, it does not contain the detailed information necessary to answer most of the questions about acceptance criteria and a study proving device performance as it pertains to AI/algorithm-based medical devices.
Specifically, this document does not contain:
- A table of acceptance criteria and reported device performance.
- Information on sample sizes, data provenance, or ground truth establishment for a performance study.
- Details about expert involvement, adjudication methods, or MRMC comparative effectiveness studies.
- Information about standalone algorithm performance or training set details.
The letter explicitly states that the device is "substantially equivalent" to predicate devices, which is the basis for its clearance. This process typically relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. It does not typically involve a de novo clinical performance study with specific acceptance criteria as you would find for a novel diagnostic or AI-driven device.
The "Indications For Use" provided are simply a description of how the device is intended to be used: "The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use." This is not an acceptance criterion related to diagnostic or evaluative performance.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with its wings spread. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written around the edge of the circle. The eagle is facing to the left and has three lines above it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 1998
Mr. J. Robert Saron President & CEO Aaron Medical Industries 7100 30th Avenue North St. Petersburg, Florida 33710-2902
K981614 Re:
Trade Name: Aaron Electrosurgical Pencil Holster Regulatory Class: II Product Code: GEI Dated: May 5, 1998 Received: May 6, 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 (OS) 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,
Cella 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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x 9 81614 )(k) Number (if known):____
Aaron Electrosurgical Pencil Holster Device Name:
Indications For Use:
The Aaron Electrosurgical Pencil Holster is supplied sterile, and is designed to hold an electrosurgical pencil in the operating room when not in use.
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Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sian
Division of
510(k) Numbe
: K981614
es
Prescription Use
- 21 CFR 801.109)
OR
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.