(114 days)
MEGADYNE™ Telescoping Soft Tissue Dissectors are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag). The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization. The electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU's Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU's Geometric Electron Modulation (GEM) mode.
MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissectors and MEGADYNE Telescoping Smoke Evacuation Pencils are monopolar devices designed for general electrosurgical applications including cutting and coagulation (coag) and for removing smoke generated by electrosurgery when used in conjunction with a smoke evacuation system. The devices conduct an electrosurgical current from an electrosurgical unit (ESU) and deliver it to the target tissue to achieve the desired surgical effect. The [Megadyne PTFE coated] electrosurgical active electrodes are intended to conduct radio frequency (RF) current for cutting and coagulation from the ESU to target soft tissue in a broad range of surgical procedures requiring the use of electrosurgery for cutting and cauterization.
The [MEGADYNE™ Telescoping Smoke Evacuation Soft Tissue Dissector] electrosurgical active electrodes have a specific geometry that minimizes blanching and thermal damage in skin incisions when used in conjunction with the MEGADYNE™ ESU's Advanced Cutting Effect (ACE) mode or the MEGADYNE™ ESU's Geometric Electron Modulation (GEM) mode.
The Megadyne™ Telescoping Soft Tissue Dissectors, Megadyne Telescoping Smoke Evacuation Pencils, and Megadyne™ Telescoping Smoke Evacuation Soft Tissue Dissectors are sterile, single-use, hand-held electrosurgical pencils. These monopolar devices are designed for general electrosurgical applications including cutting and coagulation of tissue. The Megadyne™ Telescoping Smoke Evacuation Pencil and Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector offer an additional design feature to remove smoke generated by electrosurgery, when used in conjunction with a smoke evacuation system.
The printed circuit board in the device and electrical cable provide the means for powering the devices. The device dome switch, with over-molded buttons, operate the cut and coagulate functions of the device. The yellow button controls the cut function of the device, the blue button controls the coagulate function of the device.
Within the pencil nozzle, there is a collet that holds the electrode in place. The Megadyne™ Telescoping Smoke Evacuation Pencil, and Megadyne Telescoping Smoke Evacuation Soft Tissue Dissector have a clear tube connected to the nozzle, which provides a route to remove captured electrosurgical smoke. The tubing terminates at a connector on the smoke evacuation system.
The devices are available in 10 ft. cord/tubing and 15 ft. cord/tubing. The packaged device includes:
- The pencil or handle with the attached power cord,
- A holster which may be used to hold the device when it is not in use during a surgical . procedure, and
- An electrode, which may be exchanged by the user as needed. Additional electrodes are ● distributed separately.
The provided document is a 510(k) summary for the Megadyne™ Telescoping Smoke Evacuation Pencils, Megadyne™ Telescoping Smoke Evacuation Soft Tissue Dissectors, and Megadyne™ Telescoping Soft Tissue Dissectors. It does not describe an AI/ML powered device or a study assessing algorithm performance against ground truth or human readers.
Therefore, the requested information regarding acceptance criteria, device performance measures like sensitivity, specificity, or AUC, sample sizes for test and training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or type of ground truth is not present in this document.
The document focuses on substantiating equivalence to a predicate device through:
- Bench performance testing: Including button cycling, device continuity, leakage current, fluid ingress, electrode extraction and retention, tube extension force, tube bend, biocompatibility, electrical safety, high frequency dielectric withstand, mains frequency dielectric withstand, button force, holster puncture force, thermal transfer of heat, summative usability validation, thermal spread of the electrode, electromagnetic compatibility, and package evaluations.
- Biocompatibility assessments: Including pyrogenicity, cytotoxicity, sensitization, irritation/intracutaneous reactivity, and acute systemic toxicity.
- Compliance with consensus standards: K200253 states that "All components... are in accordance with the following standards: ANSVA/AAMI/ISO 11137-2:2016, IEC 60601-1-2 ed 4 2014, ANSI AAMI 60601-1:2005, IEC 60601-2-2: 2017-03."
No specific quantitative acceptance criteria or reported values are provided for these tests within the excerpt. The document states that "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."
§ 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.