(37 days)
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.
This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. TThis device is a single use, disposable. lt is sold sterile.
I am sorry, but based on the provided text, I cannot extract the acceptance criteria and the study details you requested. The document describes an electrosurgical device and its predicate devices, intended use, and technological characteristics. It mentions that "MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993" but does not provide specific performance data, acceptance criteria, or details of a study that proves the device meets such criteria.
The information you are looking for, such as sample sizes, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies, is not present in this 510(k) summary. This document seems to focus on demonstrating substantial equivalence based on existing product characteristics and standards, rather than presenting detailed new performance study results.
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510(k) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
JAN 2 4 1997
This information of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
Submitter's Name/Address:
Drew D. Weaver Director of Regulatory Affairs MegaDyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax
Contact Person:
Same as above
Date Summary Prepared:
December 17, 1996
Device Name:
| Common Name: | Electrosurgical Device, Cutting and Coagulation & Accessories |
|---|---|
| Trade Name: | Not yet established |
| Classification (if known): | Class II, Tier II, 79GEI, General and Plastic Surgery, 21 CFR 878 4400 |
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MegaDyne Medical Products, Inc. 510(k) Notification: Electrosurgical Device, Cutting and Coagulation & Accessories December 11, 1996 Page C.2
Predicate Devices:
MegaDyne Medical Products, Inc pencils and electrodes Valleylab pencils and electrodes Conmed pencils and electrodes E&M Engineering pencils
Applicant Device Description:
This device has a molded plastic housing. The mode switch selects the appropriate electrosurgical function (CUT or COAG). Exiting the housing is a ten foot cable which has a standard 3-prong plug to connect to the generator. The electrode packaged with this pencil will be either a coated electrode or a regular bare electrode, and with or without a holster. TThis device is a single use, disposable. lt is sold sterile.
Applicant Device Intended Use:
The intended use of this device is to conduct monopolar electrosurgical energy from an electrosurgical unit (ESU) or generator, to an electrosurgical electrode and subsequently to the target tissue. The device is disposable and sold sterile.
Technological Characteristics:
This device is substantially equivalent in materials and operation to other pencils There are no new technological characteristics and already on the market. therefore no new questions of safety and effectiveness.
Performance Data:
MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993
§ 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.