MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE
K963783 · ETHICON, Inc. · GEI · Nov 25, 1996 · General, Plastic Surgery
Device Facts
| Record ID | K963783 |
| Device Name | MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE |
| Applicant | ETHICON, Inc. |
| Product Code | GEI · General, Plastic Surgery |
| Decision Date | Nov 25, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 878.4400 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
Intended Use
The Mitek Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
Device Story
Electrosurgical system for arthroscopic procedures; comprises generator, footswitch, handpiece, and five electrode tip configurations. Uses high-frequency electrosurgical current to resect, ablate, excise soft tissue, and achieve hemostasis. Operated by surgeons in clinical settings (OR). Output controlled via footswitch; provides thermal energy to tissue. Benefits include precise tissue management during minimally invasive joint surgery.
Clinical Evidence
No clinical data. Evidence based on preclinical and laboratory cadaveric evaluations comparing subject device to ArthroCare Arthroscopic Electrosurgical System. Testing demonstrated device functions as intended.
Technological Characteristics
High-frequency electrosurgical generator; handpiece with cable; five electrode tip configurations. Uses single pair of electrodes. Energy source: high-frequency electrosurgical current.
Indications for Use
Indicated for soft tissue resection, ablation, excision, and hemostasis of blood vessels in patients undergoing arthroscopic surgery of the knee, shoulder, ankle, elbow, or wrist.
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
- ArthroCare Arthroscopic Electrosurgical System
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Submission Summary (Full Text)
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NOV 25 1996 k 963783
# SECTION 7
## SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Summary of Safety and Effectiveness
Information supporting claims of substantial equivalence as defined under the Federal Food, Drug and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency.
**NEW DEVICE NAME:** Mitek Electrosurgical System for Arthroscopic Use
**PREDICATE DEVICE NAME:** ArthroCare Arthroscopic Electrosurgical System
510(K) SUMMARY
Device Description
The Mitek Electrosurgical System is comprised of four components: the electrosurgical generator, a footswitch, a handpiece with a cable to connect to the generator and five types of electrode tip configurations are used in the arthroscopic procedure.
Intended Use
The Mitek Electrosurgical System is intended for resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
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Mitek Electrosurgical System for Arthroscopic Use
Mitek Products
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SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Indications Statement
The Mitek Electrosurgical System is intended for soft tissue resection, ablation, and excision and hemostasis of blood vessels in patients requiring arthroscopic surgery of the knee, shoulder, ankle, elbow and wrist.
Technological Characteristics
The new device is technologically the same as the predicate device. Both devices use high frequency electrosurgical current to achieve the intended clinical purpose. A single pair of electrode is used in the new device, while the predicate device uses multiple electrodes. This difference does not raise any new question of safety and effectiveness.
Performance Data
Preclinical and laboratory cadaveric evaluations were conducted to show that the device functions as intended. In preclinical and cadaveric evaluations, the ArthroCare Arthroscopic Electrosurgical System was used for comparison. Clinical data was deemed unnecessary to support the Premarket Notification. Sufficient data has been obtained from preclinical and cadaveric testing to assess safety and effectiveness characteristics of the device when compared to the predicate device.
Conclusions
Based on the 510(k) summaries and 510(k) statements (21 CFR 807) and the information provided herein, we conclude that the new device is substantially equivalent to the Predicate Device under the Federal Food, Drug and Cosmetic Act.
Contact
Mr. Edward F. Kent
Vice President, Regulatory Affairs
Mitek Surgical Products, Inc.
60 Glacier Drive
Westwood, MA 02090
Date
September 19, 1996
Mitek Electrosurgical System for Arthroscopic Use
Mitek Products