(191 days)
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No
The device description focuses on mechanical components (balloon catheter, safety balloon) and material properties. There is no mention of AI, ML, image processing, or data-driven algorithms.
No.
The device is used for occlusion of the internal carotid artery during a surgical procedure (endarterectomy), which is an intervention performed by a surgeon. While it aids a therapeutic procedure, the device itself is an accessory for the surgery, not directly providing therapy itself.
No
The device's intended use is for occlusion of the internal carotid artery, and its description as a catheter points to a therapeutic or interventional function, rather than diagnosing a condition.
No
The device description clearly states it is a "single lumen balloon catheter" and describes physical components like balloons and materials, 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 "occlusion of the internal carotid artery during endarterectomy." This is a surgical procedure performed directly on a patient's body.
- Device Description: The device is a "single lumen balloon catheter" designed for physical manipulation within the body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
This device is clearly intended for use within the body during a surgical procedure, not for testing specimens outside the body.
N/A
Intended Use / Indications for Use
The intended use of this device is for occlusion of the internal carotid artery during endarterectorny.
Product codes
74.DXG
Device Description
The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. (1) Every lot is supplied sterile and nonpyrogenic.
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
internal carotid artery
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
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Key Metrics
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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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§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).
0
AUG - 7 1996
Ideas for Medicine, Inc. Pruitt Safety Occlusion Catheter 510(k) Notification
SAFETY and EFFECTIVENESS SUMMARY
PROPRIETARY NAME:
Pruitt Safety Occlusion Catheter
COMMON USUAL NAME:
Vascular Catheter
CLASSIFICATION:
Class II
CLASSIFICATION NUMBER:
74.DXG
DEVICE DESCRIPTION:
The Pruitt Safety Occlusion Catheter is a single lumen balloon catheter. There is an external safety balloon designed to inflate when the intraluminal balloon reaches 17 psi. This reduces the possibility of balloon overinflation. All materials have been used by Ideas for Medicine, Inc. for many years to manufacture other Class II devices. All materials have been subject to Biocompatibility testing. (1) Every lot is supplied sterile and nonpyrogenic.
SUBSTANTIAL EQUIVALENT:
The intended use of this device is for occlusion of the internal carotid artery during endarterectorny. The Pruitt Inahara Shunt is a balloon shunt that provides a temporary bypass during carotid endarterectomy and features the external safety balloon. The Pruitt Occlusion Catheter provides vessel occlusion without shunting. The Pruitt Safety Occlusion Catheter combines the 2 devices and provides an alternative to clamping during carotid endarterectomy where the surgeon chooses not to shunt.
" "Use of International Standard ISO-10993, Biological Evaluation of Medical Device, Part I, Evaluation and Testing" for Devices in Contact with Blood (short term duration).