(66 days)
Not Found
None
No
The summary describes a standard electrosurgical system for tissue manipulation and hemostasis, with no mention of AI, ML, image processing, or data-driven decision-making. The performance studies are based on preclinical and cadaveric evaluations, not on training or testing of algorithms.
Yes
The device is described as being used for "resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery," which are therapeutic interventions.
No
The device is described as an electrosurgical system intended for resection, ablation, excision, and hemostasis of soft tissue, which are therapeutic procedures, not diagnostic ones.
No
The device description explicitly lists hardware components: electrosurgical generator, footswitch, handpiece, cable, and electrode tips. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "resection, ablation and excision of soft tissue, and hemostasis of blood vessels in patients requiring arthroscopic surgery". This describes a surgical procedure performed directly on the patient's body.
- Device Description: The components listed (generator, footswitch, handpiece, electrode tips) are all consistent with a surgical electrosurgical system used during a procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information. IVDs are used to diagnose diseases or conditions based on the analysis of biological samples.
Therefore, the Mitek Electrosurgical System is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
knee, shoulder, ankle, elbow and wrist
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1-963783
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
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1
SUMMARY OF SAFETY AND EFFECTIVENESS, Continued
Indications Statement
Technological Characteristics
Performance Data
Conclusions
Contact
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.
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.
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.
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.
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