(24 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, training/test sets, or performance studies related to AI/ML indicate no AI/ML technology is incorporated.
Yes
The device is used for the simultaneous cutting and cauterization of soft tissue during surgery, which is a therapeutic function.
No
The device is described as a power supply for cautery instruments used for cutting and cauterization, which are therapeutic functions, not diagnostic ones.
No
The device description clearly states it is a reusable, AC powered unit with physical components like an on/off switch, LED indicator, and outlets, indicating it is a hardware 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 is "For the simultaneous cutting and cauterization of soft tissue during surgery." This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient's body.
- Device Description: The description details a power supply for surgical instruments used for cutting and cauterization. This aligns with a surgical device, not a diagnostic device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely surgical.
N/A
Intended Use / Indications for Use
For the simultaneous cutting and cauterization of soft tissue during surgery.
Product codes
HOO
Device Description
The Starion Instruments Universal Power Supply (UPS) is a reusable, AC powered unit intended for use with cautery instruments incorporating Starion technology for the simultaneous cutting and cauterization of soft tissue during surgery.
The Starion Instruments Universal Power Supply (UPS) features an on/off switch, green power-on LED indicator, outlet(s) for connection to Starion cautery instruments and/or optional footswitch, and an audible tone to indicate activation of the instrument heating element.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgery
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
§ 886.4115 Thermal cautery unit.
(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.
0
DEC - 9 2004
Summary - 510(k) __ |