(70 days)
The Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are intended for use in virtually every surgical discipline where flat, paddle-type electrosurgical blades are used for making straight cuts through tissue. The CBE-2XX blades are intended for use in procedures that require precise cuts where only light or no hemostasis is desired. The CBE-1XX blades are intended for use in procedures where a greater level of hemostasis is desired. When an electrosurgical generator blend mode is used for cutting with the CBE-1XX blades, cauterization of the wound will occur while the cut is being made.
The CBE device is substantially equivalent to the UMP DLP-L11 Loop Electrode (K905263), the Mega Dyne E-Z Clean Blade (K913473), and the Aspen Labs Blade Electrode #60-0180-001 (K780977). The posterior end of the CBE device fits snugly into a standard electrosurgical pen which is connected to an FDA-approved electrosurgical generator. The CBE is used in exactly the same way as the Aspen stainless steel blade and Mega Dyne Teflon®-coated blade electrodes are used for cutting tissues and cauterizing the wound to minimize bleeding. The cutting and cauterization takes place in exactly the same way as with the UMP DLP-L11 Loop Electrode.
Materials that comprise the CBE were selected based on properties of strength, biocompatibility, compatibility with gamma sterilization, conformance with commonly used medical grade plastics and other materials, electrical and thermal properties, ease of processing and low cost. Biocompatibility and sterilization information is available from UMP upon request.
This document is a 510(k) summary for a medical device (Ceramic Blade Electrode) and does not contain the acceptance criteria or a study that directly proves the device meets specific acceptance criteria in the format you've requested.
The document focuses on:
- Device Description and Intended Use: Explaining what the Ceramic Blade Electrode (CBE) is and what it's used for (electrosurgery, cutting and coagulating tissue).
- Substantial Equivalence Claim: Stating that the CBE is substantially equivalent to other predicate devices already on the market (UMP DLP-L11 Loop Electrode, Mega Dyne E-Z Clean Blade, and Aspen Labs Blade Electrode). This is the core of a 510(k) submission – demonstrating that a new device is as safe and effective as a legally marketed device.
- Material Information: Briefly mentioning material selection criteria.
- Contact Information.
Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) for a study proving device performance, because such a study is not presented in this 510(k) summary.
For a 510(k) submission, the "proof" often lies in demonstrating substantial equivalence through:
- Comparison of technological characteristics to predicate devices.
- Performance data (e.g., bench testing, sometimes animal or limited clinical data for certain types of devices, but often not full-scale human clinical trials) to show that it performs as intended and is as safe/effective as the predicate.
The document implies that the device "meets" its intended purpose because it's substantially equivalent to predicate devices that are already approved and presumed to meet their acceptance criteria. It doesn't present a standalone study with defined acceptance criteria and performance metrics for the new device in the way a clinical trial report would.
§ 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.