K970987 · Fusion Medical Technologies, Inc. · GEI · May 5, 1997 · General, Plastic Surgery
Device Facts
Record ID
K970987
Device Name
ELECTROSURGICAL ELECTRODE
Applicant
Fusion Medical Technologies, Inc.
Product Code
GEI · General, Plastic Surgery
Decision Date
May 5, 1997
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 878.4400
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
Device Story
Fusion Ball Tip Electrode; reusable monopolar electrosurgical accessory. Input: electrical energy from standard electrosurgical generator via electrosurgical pencil/chuck. Operation: delivers high-frequency current to tissue via 99% pure silver ball tip for electrocautery. Used by clinicians in surgical/clinical settings. Output: thermal tissue effect (coagulation/cautery). Benefits: provides large surface area electrocautery; reusable design via autoclave sterilization.
Clinical Evidence
Bench testing only; no clinical data provided. Equivalence based on design, material biocompatibility, and intended use similarity to predicate.
Indicated for use by practitioners for electrocautery over a large surface area in patients requiring electrosurgical procedures.
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
Electrosurgical Electrode by Premier Dental Products (K923332)
Submission Summary (Full Text)
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K970987
510(k) Summary
Fusion Medical Technologies, Inc.
Ball Tip Electrode
MAY - 5 1997
1. Sponsor: Fusion Medical Technologies, Inc.
1615 Plymouth Street
Mountain View, CA 94043
Contact Person: Debera Brown
Vice President, Regulatory and Clinical Affairs
2. Device Name:
Trade Name: To Be Determined
Common/Usual Name: Electrosurgical Electrode
Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories
3. Identification of the Predicate or Legally Marketed Devices to Which Equivalence is being Claimed:
Electrosurgical Electrode by Premier Dental Products
4. Device Description:
The Fusion Ball Tip Electrode is a reusable electrode for use in monopolar electrosurgical accessories.
5. Intended Use:
Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface.
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6. A Statement of How the Technological Characteristics of the Device Compare to Those of the Predicate or Legally Marketed Device.
| Parameter | Fusion Ball Tip Electrode | Premier Dental Electrode K923332 |
| --- | --- | --- |
| Indications for Use | Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended to provide electrocautery over a large surface. | Intended for use by practitioners in a manner identical to similar electrosurgical electrodes of this type presently in commercial distribution. It is intended for cutting and coagulation of tissue. |
| Use Profile | Provided Sterile; reusable after cleaning and autoclave sterilization | Provided non-sterile; first use and reuse after autoclave or ETO sterilization |
| Compatibility | Standard 3/32 inch (2.4 mm) shaft fits most electrosurgery chucks and pencils | 44 different configurations provided, all standard 3/32 shaft to fit most electrosurgery chucks and pencils |
| Material Composition | Stainless Steel shank, Polyphenylsulfone for insulation, 99% Pure Silver as electrode tip | Stainless Steel shank, Korvex 4X Teflon TFE heat shrinkable tubing, Type 304 stainless steel electrode tip |
| Sterilization | Provided sterile by gamma irradiation for first use | Provided non-sterile, must be sterilized by user before first use |
| Biocompatibility | Materials used in other medical devices; ISO 10993-1 | Materials used in other devices |
