(26 days)
Not Found
No
The summary describes a coagulation system using a generator and catheter, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract to treat various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is described as a "Coagulation System" indicated for the "coagulation of bleeding and non-bleeding sites." Its purpose is to treat or manage bleeding, not to identify or diagnose conditions.
No
The device description explicitly states that the system consists of a generator, catheter, output cable, and optional footswitch, which are all hardware components.
Based on the provided information, the HALO360 Coagulation System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device being used in vivo (within the body) to coagulate bleeding and non-bleeding sites in the gastrointestinal tract. IVDs are used in vitro (outside the body) to examine specimens such as blood, urine, or tissue to diagnose diseases or conditions.
- Device Description: The device description details a system used for a medical procedure performed directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the HALO360 Coagulation System is a therapeutic medical device used for a surgical or procedural intervention, not an IVD.
N/A
Intended Use / Indications for Use
The HALO360 Coagulation System intended use is for the coagulation of bleeding The TITLE -- Coagites in the gastrointestinal tract.
The HALO®60 Coagulation System is indicated for use in the coagulation of bleeding The HALOwo Coagunation System is including but not linited to, the and non-bleeding sites in the gasts geal Ulcers, Mallory-Weiss tears, esophaguis. Indications Include Esophagear Oleers, Escore, Security
Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The HALO360 Coagulation System consists of the HALO360 Coagulation Generator The HALOws Coagulation Dystem conclose of ation Catheter, output cable, and and with a disposable single-use HALO - Coagulation Catheter performance and mode of optional footswitch. The IIIDO - Coag and already cleared HALO®® Coagulation
operation is substantially equivalent to the already cleared by Stallertsch operation is substantially Cquirvation Catheter 2 manufactured by Stellartech Research Co.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
gastrointestinal tract, esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
AUG 2 8 2006 510(k) SUMMARY
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