TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT

K961368 · Vasamedics, LLC · DPT · Oct 11, 1996 · Cardiovascular

Device Facts

• Record ID: K961368
• Device Name: TRIMFLO PARENCHYMAL BLOOD FLOW MONITORING PROBE KIT
• Applicant: Vasamedics, LLC
• Product Code: DPT · Cardiovascular
• Decision Date: Oct 11, 1996
• Decision: SESK
• 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

Trimflo Parenchymal Blood Flow Monitoring Probe Kit; single-use fiber optic probe kit for use with Vasamedics BPM² Laser Doppler Blood Perfusion Monitor. Input: laser light reflected from microcirculatory blood flow in buried tissue (brain parenchyma). Operation: fiber optic probe transmits laser light to tissue; Doppler shift of backscattered light measured to quantify blood flow. Output: blood perfusion measurements displayed on BPM² monitor. Used in neurosurgical settings (OR/ICU) by neurosurgeons/clinicians. Kit includes probe and standard neurosurgical/ICP monitoring accessories. Benefits: real-time monitoring of cerebral blood flow to detect ischemia.

Clinical Evidence

Bench testing only. Biocompatibility confirmed for tissue-contacting materials. Sterilization validated per AAMI guidelines using overkill method to SAL 10^-6. Residual EO, ECH, and EG levels meet 1978 FDA guidelines for invasive devices.

Technological Characteristics

Fiber optic probe; laser Doppler sensing principle. Kit includes probe and standard neurosurgical/ICP accessories. Sterilization: Gas (ETO) per AAMI guidelines; SAL 10^-6. Biocompatible materials. Single-use.

Indications for Use

Indicated for patients at risk of cerebral ischemia requiring extravascular monitoring of microcirculation blood flow in buried tissues, specifically brain parenchyma.

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)
• Codman disposable ICP system (pre-amendment)

Reference Devices

• Vasamedics BPM² Laser Doppler Blood Perfusion Monitor (K896515)

Submission Summary (Full Text)

{0}

K961368

Vasamedics 510(k)

Single Use Laser Doppler Probe Kits

4/8/96

# Section [2] 510(k) Summary

OCT 11 1996

## Device Name:

Trimflo Parenchymal Blood Flow Monitoring Probe Kit

## Predicate Device:

The Vasamedics’ model SUPR-434 Single use Blunt Needle Probe, K951832 and for kit accessories the Codman disposable ICP system (believed to be a pre-amendment device).

## 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).

## 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 probes used in the kits are the same devices as the SUPR-434 (Trimflo) probes outlined in K951832. 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 $1 \times 10^{-6}$. 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 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

{1}

Vasamedics 510(k)
Single Use Laser Doppler Probe Kits
4/8/96

## Substantial Equivalence:

The probes used in the Single Use Probe kits are substantially equivalent to products currently in commercial distribution, specifically the Model SUPR-434 (Trimflo) Single use Blunt Needle Probes. The only changes made to the product are the addition of probe accessories and the use of a tray for kit packaging. The single use probe kits will be packaged and ETO sterilized prior to shipment and will be labeled for single use only. All other kit components are equivalent to the Codman ICP monitoring kit.

Douglas G. Tomasko

Director of Operations
Vasamedics
April 8, 1996

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