(201 days)
Not Found
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" field is explicitly "Not Found".
Yes
The device is used to provide a temporary bypass during a medical procedure (carotid endarterectomy) which is a therapeutic intervention.
No
Explanation: The device's intended use is to provide a temporary bypass during carotid endarterectomy by channeling and diverting blood, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical, implantable medical device (a dual lumen balloon shunt) made of specific materials, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide a temporary bypass during carotid endarterectomy." This is a surgical procedure performed directly on the patient's body to treat a medical condition.
- Device Description: The description details a physical device (a shunt) designed to channel and divert blood within the carotid artery. This is an invasive medical device used in vivo (within a living organism).
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The provided description does not mention any testing of samples or diagnostic purposes.
Therefore, the Pruitt-Inahara Carotid Shunt and Inahara-Pruitt Carotid Shunt are medical devices used for surgical intervention, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The intended use of these devices is to provide a temporary bypass during carotid endarterectomy. The 8 French Pruitt Shunts are identical in both materials and intended use to the 9 French Pruitt-Inahara Shunts. The smaller OD of the shaft will allow it to be used in smaller arteries.
Product codes (comma separated list FDA assigned to the subject device)
Unknown
Device Description
The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine's shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibiltiy. Every lot is supplied sterile and non-pvrogenic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid artery
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): 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.
Not Found
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
§ 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
Ideas for Medicine, Inc. Pruitt-Inahara Carotid Shunt (Model 400-40-8F) Inahara-Pruitt Carotid Shunt (Model 500-50-8F) 510(k) Notification
SAFETY and EFFECTIVENESS SUMMARY
PROPRIETARY NAME:
Pruitt-Inahara Carotid Shunt and Inahara-Pruitt Carotid Shunt
SEP - 9 1996
COMMON USUAL NAME:
Vascular Balloon Catheter
CLASSIFICATION:
Class II
CLASSIFICATION NUMBER:
Unknown
DEVICE DESCRIPTION:
The Pruitt-Inahara Carotid Shunt (Model 400-40-8F) and the Inahara-Pruitt Carotid Shunt (Model 500-50-8F) are dual lumen balloon shunts which channel and divert blood in the carotid artery during endarterectomy. The 8 French shunts are for use in arteries too small to accommodate a 9 French shunt. Both the 400-40-8F and 500-50-8F have a T Port to confirm patency and allow back-bleeding after insertion. There is an external safety balloon on the inflation port for the balloon which lies in the internal carotid artery. The safety balloon is designed to inflate when the internal carotid balloon reaches 17 psi; this reduces the possibility of balloon overinflation and resultant vessel damage. All the materials are identical to those used in other models of Ideas for Medicine's shunts. These materials have been used for years and were certified to meet the requirements of the USP Class VI testing for biocompatibiltiy. Every lot is supplied sterile and non-pvrogenic.
SUBSTANTIAL EQUIVALENT:
The intended use of these devices is to provide a temporary bypass during carotid endarterectomy. The 8 French Pruitt Shunts are identical in both materials and intended use to the 9 French Pruitt-Inahara Shunts. The smaller OD of the shaft will allow it to be used in smaller arteries.