(336 days)
No
The document describes a Laser Doppler Blood Perfusion Monitor and associated fiber optic probes, focusing on their physical design and intended use for measuring microcirculation. There is no mention of AI or ML in the device description, intended use, or any other section. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is described as a "Laser Doppler Blood Perfusion Monitor" used to "measure microcirculatory blood flow" and "extravascular monitoring of microcirculation blood flow." Its purpose is diagnostic monitoring, not delivering therapy.
Yes
The device is described as a "monitor" intended for "extravascular monitoring of microcirculation blood flow" in various buried tissues, which is a key part of medical diagnostics to assess physiological states and potential issues.
No
The device description clearly details hardware components, specifically fiber optic probes (SUP-440, SUP-433, SUPR-434) designed for use with a Laser Doppler Blood Perfusion Monitor (BPM2). This indicates it is a hardware device with associated software for data processing, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The description clearly states that the device is a Laser Doppler Blood Perfusion Monitor and associated probes used for extravascular monitoring of microcirculation blood flow in buried tissues. This involves direct measurement within the body, not the analysis of specimens taken from the body.
- Intended Use: The intended uses listed (monitoring buried muscle, esophagus, soft tissue, and cerebral blood flow) all involve direct measurement within the patient's body.
Therefore, the device falls under the category of in vivo diagnostic or monitoring devices, not in vitro diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
Not Found
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 BPM- 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 Probe, SUP-433 Disposable Right Angle Needle Probe, and SUPR-434 Disposable Blumt End Needle probe are also fiber optic probes designed for use with the BPM2 They connect to the BPM2 Probe Connector Port on the BPM 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 Implantible prism probe in that the probes provide right angle light emission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
buried muscle, esophagus, soft tissue, cerebral cortex
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.
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
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
Section [2] 510(k) Summary
1951832
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 BPM- 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 Probe, SUP-433 Disposable Right Angle Needle Probe, and SUPR-434 Disposable Blumt End Needle probe are also fiber optic probes designed for use with the BPM2 They connect to the BPM2 Probe Connector Port on the BPM 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 Implantible 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.