VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT

K962700 · Vasamedics, LLC · DPT · Apr 9, 1997 · Cardiovascular

Device Facts

• Record ID: K962700
• Device Name: VENTRICULAR CATHETER BLOOD FLOW MONITORING PROBE KIT AND VENTRAFLO BLOOD FLOW MONITORING PROBE KIT
• Applicant: Vasamedics, LLC
• Product Code: DPT · Cardiovascular
• Decision Date: Apr 9, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

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.

Device Story

Ventraflo Blood Flow Monitoring Probe Kit combines standard ventricular catheter with embedded laser Doppler blood perfusion probe. Device placed in brain ventricle by neurosurgeon; enables simultaneous CSF drainage, intracranial pressure monitoring (via external transducer), and parenchymal blood flow measurement. Laser Doppler technology measures microcirculatory blood flow in buried tissues. Used in neurosurgical clinical settings. Provides real-time perfusion data to clinicians to assess cerebral ischemia risk and guide neurosurgical management.

Clinical Evidence

No clinical data provided. Substantial equivalence based on design, material, and technological similarity to predicate devices.

Technological Characteristics

Ventricular catheter made of biocompatible silicone; embedded laser Doppler fiber optic probe. Sterilization via ETO gas (AAMI guidelines, SAL 10^-4). Residual limits: EO 25ppm, ECH 25ppm, EG 250ppm. Standalone device; requires external transducer for pressure monitoring and BPM² monitor for flow data.

Indications for Use

Indicated for patients at risk of cerebral ischemia requiring monitoring of cerebral blood flow and intracranial ventricular pressure, or CSF drainage.

Regulatory Classification

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.

Predicate Devices

• Vasamedics model SUPR-434 Single use Blunt Needle Probe (K951832)
• PS Medical Becker Ventricular Catheter (not specified)
• PS Medical Ventriculostomy Kit (not specified)

Reference Devices

• Vasamedics Model BPM² Laser Doppler Blood Perfusion Monitor (K896515)

Submission Summary (Full Text)

{0}

Vasamedics 510(k) Ventricular Catheter/Laser Doppler Probe Kits 7/9/96
K962700
APR - 9 1997

Section [2] 510(k) Summary

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 $1 \times 10^{-4}$. 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

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Vasamedics 510(k) Ventricular Catheter/Laser Doppler Probe Kits 7/9/96

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
Director of Operations
Vasamedics
April 8, 1996

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