(288 days)
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No
The summary describes a mechanical catheter for stone removal and exploration, with no mention of AI/ML terms, image processing, or data-driven performance metrics.
Yes
The device is intended for the removal of stones and ductal debris, which are therapeutic interventions.
No
The device is intended for the removal of stones and ductal debris, and exploration of the biliary tube, which are therapeutic or interventional actions, not diagnostic.
No
The device description clearly states it is a "radiopaque multi lumen, balloon catheter," which is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The Pruitt Biliary Catheter is a physical device intended for use inside the body to remove stones and debris from the biliary tube. It is a surgical/interventional tool, not a diagnostic test performed on a sample.
The description clearly indicates it's a catheter used for a procedure within the body, which falls under the category of medical devices used for treatment or intervention, not in vitro diagnosis.
N/A
Intended Use / Indications for Use
The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.
Product codes
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Device Description
The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation: another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
biliary tube
Indicated Patient Age Range
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Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.
0
954713
Ideas for Medicine, Inc. 510(k) 954713
SAFETY AND EFFECTIVENESS SUMMARY
PROPRIETARY NAME
JUL 24 1996
Pruitt Biliary Catheter
COMMON/USUAL NAME
Biliary Catheter
CLASSIFICATION: 21 CFR 876.5010
DEVICE DESCRIPTION
The Pruitt biliary catheter is a radiopaque multi lumen, balloon catheter. The ancillary lumen(s) are for injection and/or irrigation: another lumen inflates the balloon. All materials have been used by Ideas for Medicine, Inc. in cardiovascular catheters and/or laparoscopic instruments with no report of adverse events. All materials have been subject to testing per the Biocompatibility testing.
INTENDED USE
The Pruitt Biliary Catheters are intended for use in the removal of stones, ductal debris and the exploration of the biliary tube.
SUBSTANTIAL EQUIVALENCE
The materials used to manufacture these devices are identical to the materials used to manufacture the Pruitt Irrigation-Embolectomy catheters, Pruitt Irrigation Occlusion Catheters, Robiscek Angiography-Embolectomy Catheters, the Reddick Cystic Duct Catheters and the Grice Laparoscopic Sump manufactured by Ideas for Medicine, Inc. The intended use of this device is substantially equivalent in function and intended use to the Fogarty Biliary Balloon Probe, the Edslab Irrigation Catheter, the Ideas for Medicine Trilumen Intravascular Catheter for Gu Use and the Bard Stone Removal Balloon Catheters. These are used to remove ductal debris, stones and exploration of the biliary tree. Irrigation capabilities can facilitate lubrication, flushing and cholangiography.