← Product Code [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI) · K963783 # MITEK ELECTROSURGICAL SYSTEM FOR ARTHROSCOPIC USE (K963783) _ETHICON, Inc. · GEI · Nov 25, 1996 · General, Plastic Surgery · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963783 ## Device Facts - **Applicant:** ETHICON, Inc. - **Product Code:** [GEI](/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI.md) - **Decision Date:** Nov 25, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 878.4400 - **Device Class:** Class 2 - **Review Panel:** General, Plastic Surgery - **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. ## Regulatory 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 ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} 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. Continued on next page Mitek Electrosurgical System for Arthroscopic Use Mitek Products 142 {1} 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963783](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/GEI/K963783) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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