(70 days)
Not Found
No
The document describes a passive electrosurgical blade and does not mention any computational or learning capabilities.
Yes
The device is described as an electrosurgical blade used for cutting tissue and cauterizing wounds to minimize bleeding during surgical procedures, which are therapeutic actions.
No
The device is an electrosurgical blade intended for cutting and cauterizing tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly describes a physical electrosurgical blade made of materials like ceramic and plastic, intended to be used with an electrosurgical pen and generator. There is no mention of software as the primary or sole component of the device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as being used for making cuts through tissue and cauterizing wounds during surgical procedures. This is an in vivo application (within a living organism), not an in vitro application (outside of a living organism, typically on samples like blood or tissue).
- Device Description: The description reinforces its use in surgical procedures with an electrosurgical generator, again indicating an in vivo application.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
Therefore, the Utah Medical Products, Inc. (UMP) Ceramic Blade Electrodes (CBE) are surgical devices used in vivo, not IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
878.4400
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
Image /page/0/Picture/0 description: The image shows the logo for Utah Medical Products Inc. The logo features the letters "UM" in a stylized, interconnected design. Below the logo, there is a handwritten number "K 960255".
MAR 27 1996
SMDA 510(k) Summary
Ceramic Blade Electrode Trade Name: Common Name: Electrosurgical Blade Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR Classification: 878.4400.
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.
Kevin L. Cornwell President & CEO