(271 days)
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No
The summary does not mention AI, ML, or any related concepts like algorithms, deep learning, or neural networks. The device description focuses on hardware components and their physical functions.
No.
The device is described as a monitoring device that measures blood flow and pressure. It functions as a diagnostic tool rather than directly treating or alleviating a condition.
Yes
The device monitors microcirculation blood flow and measures parenchymal blood flow, specifically in patients at risk of cerebral ischemia. This continuous monitoring of physiological parameters helps clinicians identify and assess a patient's condition, which is a diagnostic function.
No
The device description explicitly states it is a "standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter," indicating it is a physical hardware device.
Based on the provided information, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Ventraflo Catheter/Probe is designed for extravascular monitoring of microcirculation blood flow in buried tissues, specifically within the brain ventricles. It directly measures physiological parameters (blood flow and pressure) within the body.
- Intended Use: The intended use clearly states "extravascular monitoring" and "monitoring cerebral blood flow in patients." This involves direct measurement within the patient's body, not analysis of a sample taken from the body.
Therefore, the Ventraflo Catheter/Probe falls under the category of a medical device used for in-vivo monitoring, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
Product codes
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Device Description
The Ventraflo Catheter/Probe is a standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter. So when the catheter is placed within a brain ventrical the clinician will be able to use the catheter as a CSF drain . measure intracranial ventricular pressure. If connected to an external transducer and measure parenchymal blood flow simultaneously.
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
brain parenchyma, cerebral
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)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).
0
Vasamedics 510(k)
7/9/96
Section [2] 510(k) Summary
APR - 9 1997
Device Name:
Ventraflo Blood Flow Monitoring Probe Kits
Predicate Devices:
The Ventricular Catheter/Probe kits are substantially equivalent to products currently in commercial distribution. Specifically, for the laser Doppler Probe the Vasamedics' model SUPR-434 Single use Blunt Needle Probe, K951832, for kit accessories and ventricular catheter the PS Medical "Becker Ventricular Catheter" and the "PS Medical Ventriculostomy Kit".
Device Description:
The Model BPM2 is a Laser Doppler Blood Perfusion Monitor, which is used to measure microcirculatory blood flow in a variety of clinical applications. Permission to market the BPM2 was granted by FDA on February 13, 1990 (Ref. K896515). The Model SUPR-434 Blunt Needle Probe is a single use fiber optic probe designed for use with the BPM2. These probes are labeled so as to be used for monitoring buried tissue, such as brain parenchyma during and following neurosurgical procedures. Permission to market the Model SUPR-434 ( Note: the SUPR-434 Blunt needle probes model names have since been changed to Trimflo 4314, 4316, 4364 and 4366) was granted on March 21, 1996 (Ref. K951832).
The Ventraflo Catheter/Probe is a standard ventricular catheter with a laser Doppler blood perfusion probe embedded into the side wall of the Catheter. So when the catheter is placed within a brain ventrical the clinician will be able to use the catheter as a CSF drain . measure intracranial ventricular pressure. If connected to an external transducer and measure parenchymal blood flow simultaneously.
Intended Use:
The probes kits are intended for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia.
Biocompatibility:
Materials used in the Probe kits that may come in contact with tissue are all biocompatible. The blood flow probe embedded into the ventricular catheter is equivalent to the Vasamedics SUPR-434 (Trimflo) probes outlined in K951832. The ventricular catheter is made of biocompatible silicone and all accessories contained in the kit are standard items used in neurosurgery and ICP monitoring.
The Probe kits will be sterilized by gas ( ETO ) sterilization methods. The cycle used will be validated in accordance with AAMI guidelines using the overkill method to a sterility assurance level (SAL) of at least 1 x 10 4. Process release will be a combination of biological testing by methods at least as stringent as those described in the USP XXII monograph for sterility testing, combined with process documents review assuring that
5
1
validating conditions are met. At the time of release all residual levels will be at or below those issued in the 1978 FDA guidelines for invasive devices:
- EO 25ppm ECH - 25ppm EG - 250ppm
Substantial Equivalence:
The probes used in the Ventraflo Ventricular Catheter Probe kits are substantially equivalent to the following products currently in commercial distribution:
The laser Doppler probe embedded into the ventricular catheter is equivalent to the Vasamedics' model SUPR-434 Single use Blunt Needle Probe, K951832.
The kit accessories and ventricular catheter are equivalent to components in the currently marketed PS Medical "Becker Ventricular Catheter" and the "PS Medical Ventriculostomy Kit".
Douglas G. Tomasko
D.S. Tono
Director of Operations Vasamedics April 8, 1996