PENCIL

K965054 · Megadyne Medical Products, Inc. · GEI · Jan 24, 1997 · General, Plastic Surgery

Device Facts

• Record ID: K965054
• Device Name: PENCIL
• Applicant: Megadyne Medical Products, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Jan 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Monopolar electrosurgical pencil; molded plastic housing; mode switch for CUT/COAG selection; 10-foot cable with 3-prong plug for generator connection; includes coated or bare electrode; optional holster. Single-use, disposable, sterile. Used in clinical/surgical settings by physicians to deliver electrosurgical energy to target tissue for cutting and coagulation. Benefits include sterile, disposable convenience, reducing cross-contamination risk compared to reusable alternatives.

Clinical Evidence

Bench testing only. Compliance with ANSI/AAMI HF 18-1993.

Technological Characteristics

Molded plastic housing; monopolar electrosurgical pencil; 10-foot cable; 3-prong connector; coated or bare electrodes; single-use; sterile. Complies with ANSI/AAMI HF 18-1993.

Indications for Use

Indicated for use in surgical procedures requiring monopolar electrosurgical energy for cutting and coagulation of tissue.

Regulatory Classification

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.

Predicate Devices

• MegaDyne Medical Products, Inc pencils and electrodes
• Valleylab pencils and electrodes
• Conmed pencils and electrodes
• E&M Engineering pencils

Submission Summary (Full Text)

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MEGADYNE

510(k) SUMMARY

$k_{96} \leq 0.54$

SAFETY AND EFFECTIVENESS SUMMARY

JAN 24 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
[phone]
[phone] 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

MEGADYNE MEDICAL PRODUCTS, INC. • 11506 South State Street • Draper, Utah 84020 • Phone [phone] • FAX [phone] • Toll Free [phone]

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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. This device is a single use, disposable. It 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 already on the market. There are no new technological characteristics and therefore no new questions of safety and effectiveness.

## Performance Data:

MegaDyne voluntarily complies with ANSI/AAMI HF 18-1993