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K Number
K984352
Device Name
AARON TOP50 REUSABLE ELECTROSURGICAL PENCIL, MODEL #ESPR
Manufacturer
AARON MEDICAL INDUSTRIES
Date Cleared
1999-03-04

(90 days)

Product Code
GEI
Regulation Number
878.4400
Type
Traditional
Panel
SU
Reference & Predicate Devices
K970039,K914400,K955681
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended 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.

Device Description

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.

AI/ML Overview

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.

§ 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.