(185 days)
No
The document describes a Laser Doppler Blood Perfusion Monitor and associated probes, with predicate devices from 1990 and 1996. There is no mention of AI, ML, or any related technologies in the device description or other sections.
No
The device is described as a monitor used to measure blood flow, not to provide therapy or treatment.
Yes
The Intended Use / Indications for Use explicitly states that the device is "for extravascular monitoring of microcirculation blood flow in buried tissues, specifically, in monitoring cerebral blood flow in patients at risk of cerebral ischemia." This monitoring provides information about a patient's condition, which is a key characteristic of a diagnostic device.
No
The device description explicitly states it is a "Laser Doppler Blood Perfusion Monitor" and describes physical components like "probes kits" and "fiber optic probe," indicating it is a 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. They are performed outside of the body.
- Device Function: The description clearly states the probes are intended for "extravascular monitoring of microcirculation blood flow in buried tissues," specifically "monitoring cerebral blood flow in patients." This involves directly measuring a physiological process within the living body.
Therefore, this device falls under the category of an in vivo diagnostic or a monitoring device, not an in vitro diagnostic.
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
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 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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
buried tissues, brain parenchyma
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
4/8/96
Vasamedics 510(k)
Single Use Laser Doppler Probe Kits
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 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 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
4
1
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
Dalston
Director of Operations Vasamedics April 8, 1996