LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433

K951832 · Vasamedics, LLC · DPT · Mar 21, 1996 · Cardiovascular

Device Facts

• Record ID: K951832
• Device Name: LASERFLO BLOOD PERFUSION SINGLE USE PROBES MODELS SUP-440, SUPR-434 SUP-433
• Applicant: Vasamedics, LLC
• Product Code: DPT · Cardiovascular
• Decision Date: Mar 21, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2120
• Device Class: Class 2

Intended Use

The Single Use Probes are intended for extravascular monitoring of microcirculation blood flow in buried tissues. An example of this application is the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction. Another example is monitoring soft tissue microcirculation following reconstructive surgery, such as in oral and facial reconstruction. Yet another example is monitoring cerebral blood flow during and following neurosurgery for head trauma.

Device Story

Fiber optic probes (SUP-440, SUPR-434, SUP-433) designed for use with Vasmedics BPM2 Blood Perfusion Monitor; input: laser light reflected from microcirculatory tissue; output: blood perfusion measurements; used in clinical settings (OR, post-op) by physicians; probes interface with BPM2 via fiber optic cable; provides real-time microvascular flow data to assist clinical assessment of tissue viability; benefits patient by enabling early detection of compromised blood flow in buried tissue grafts or post-neurosurgical sites.

Clinical Evidence

Bench testing only; no clinical data provided. Equivalence established through design comparison and performance characteristics consistent with predicate devices.

Technological Characteristics

Fiber optic probes; stainless steel tubing; soft flexible encapsulation materials; right-angle light emission; connects to BPM2 monitor via fiber optic interface; single-use design.

Indications for Use

Indicated for patients requiring extravascular monitoring of microcirculation blood flow in buried tissues, including post-operative monitoring of free muscle transfers, esophageal reconstruction, oral/facial reconstructive surgery, and cerebral blood flow monitoring during/following neurosurgery for head trauma.

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

• Model P-433 Needle Probe (K875179)
• Model PR-434 Implantable Prism Probe (K875179)
• Model P-440 Soflex Probe (K912446)

Reference Devices

• BPM2 Blood perfusion Monitor (K896515)

Submission Summary (Full Text)

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Vasamedics LLC. 510(k) Submission Single Use Laser Doppler Probes 4/18/95

# Section [2] 510(k) Summary

K951832

## Device Name:

Laserflo Blood perfusion Single Use Probes Models SUP-440, SUPR-434, SUP-433

## Predicate Device:

The SUP-440, SUPR-434 and the SUP-433 are accessories to the Vasmedics’ BPM2 Blood perfusion Monitor, K896515 and equivalent to the Vasamedics’ Model P-433 Needle Probe, K875179, the Model PR-434 Implantable Prism Probe, K875179, and the P-440 Soflex Probe, K912446.

## 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 P-433 Needle Probe, Model PR-434 Implantable Prism Probe, and Model P-440 Implantable Soflex Probe are fiber optic probes designed for use with the BPM². These probes are labelled so as to be used for monitoring buried tissue, such as buried muscle following free muscle transfers and cerebral cortex following neurosurgical procedures. Permission to market the Model PR-434 and Model P-433 probes was granted by FDA on September 19, 1988 (Ref K875179). Permission to market the P-440 was granted by FDA on December 12, 1991 (Ref K912446).

The single use probes, SUP-440 Disposable Flat Profile Probe, SUP-433 Disposable Right Angle Needle Probe, and SUPR-434 Disposable Blunt End Needle probe are also fiber optic probes designed for use with the BPM². They connect to the BPM² Probe Connector. Port on the BPM² front panel via a fiber optic interface cable. The tip of the SUP-440 Disposable Flat Profile Probe is similar to the P-440 Soflex Probe in that it includes the termination of the optical fiber which provides right angle light emission, and an outer encapsulation of soft, flexible material. The tip of the SUP-433 Disposable Right Angle Needle Probe and the SUPR-434 Disposable Blunt End Needle Probe are similar to the P-433 Needle Probe in that it includes the termination of the optical fiber in a stainless steel tube and similar to the PR-434 Implantable prism probe in that the probes provide right angle light emission.

## Intended Use:

The Single Use Probes are intended for extravascular monitoring of microcirculation blood flow in buried tissues. An example of this application is the monitoring of buried muscle or esophagus following free muscle transfer or esophageal reconstruction. Another example is monitoring soft tissue microcirculation following reconstructive surgery, such as in oral and facial reconstruction. Yet another example is monitoring cerebral blood flow during and following neurosurgery for head trauma.