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 Description

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.

AI/ML Overview

This 510(k) submission for the Vasamedics Ventraflo Blood Flow Monitoring Probe Kits is primarily focused on demonstrating substantial equivalence to predicate devices for its design, materials, and sterilization methods. It does not include a study that details acceptance criteria and device performance in the way typically expected for a software or AI-driven diagnostic device.

Therefore, many of the requested sections (1-9) cannot be filled with relevant information from the provided text, as the document does not describe a clinical performance study with acceptance criteria for device accuracy or effectiveness in measuring blood flow.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

Summary of Device and 510(k) Approach:

The Ventraflo Ventricular Catheter/Probe kit is a combination device. It integrates a laser Doppler blood perfusion probe into a standard ventricular catheter.

Purpose: To allow simultaneous CSF drainage, intracranial ventricular pressure measurement, and parenchymal blood flow measurement (using the embedded probe).
Predicate Device Strategy: The submission argues for substantial equivalence by breaking down the device into its components:
- Laser Doppler Probe: Equivalent to Vasamedics' SUPR-434 Blunt Needle Probe (previously cleared in K951832).
- Ventricular Catheter & Accessories: Equivalent to PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit" (products already in commercial distribution).
Key Focus: Biocompatibility validation and sterilization validation are explicitly mentioned as crucial aspects of this submission, ensuring the new combined device is safe for human use.

Detailed Breakdown of Requested Information (Based on the Provided Text):

A table of acceptance criteria and the reported device performance
- Not provided. The document does not describe any specific performance metrics (e.g., accuracy, sensitivity, specificity for blood flow measurement) or their corresponding acceptance criteria. The equivalence argument is based on the components having been cleared previously.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. There is no performance study described that would involve a test set of data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. No test set or ground truth establishment relevant to device performance (e.g., blood flow measurement accuracy) is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or related adjudication method is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a measurement tool, not an AI-assisted diagnostic. No MRMC study is described.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device (catheter with an embedded probe) used to measure blood flow, not a standalone algorithm. Its performance relies on the physics of laser Doppler measurements, not computational algorithms in the AI sense.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. As no performance study with ground truth for blood flow measurement is detailed, this information is not present. The "ground truth" for this 510(k) is primarily that the individual components (probe, catheter, accessories) have established safety and performance records or are substantially equivalent to marketed devices.
The sample size for the training set
- Not applicable. No training set is mentioned as this is not a machine learning/AI device.
How the ground truth for the training set was established
- Not applicable. No training set or ground truth establishment for a training set is mentioned.

Key Information from the Document that IS Provided:

Intended Use: Extravascular monitoring of microcirculation blood flow in buried tissues, specifically, cerebral blood flow in patients at risk of cerebral ischemia.
Biocompatibility: Materials are biocompatible. The probe part is equivalent to the Vasamedics SUPR-434 (Trimflo) probes (K951832). The ventricular catheter is silicone. All accessories are standard neurosurgery items.
Sterilization: ETO sterilization, validated per AAMI guidelines using an overkill method to a sterility assurance level (SAL) of at least 1 x 10^-4. Residual levels target FDA 1978 guidelines.
Predicate Devices:
- Laser Doppler Probe: Vasamedics' SUPR-434 Single use Blunt Needle Probe (K951832).
- Kit accessories and ventricular catheter: PS Medical "Becker Ventricular Catheter" and "PS Medical Ventriculostomy Kit".

In conclusion, this 510(k) submission relies on the substantial equivalence of its components to previously cleared devices, particularly for safety and efficacy in terms of material compatibility and sterilization. It does not present a new clinical performance study for the integrated device with specific acceptance criteria for blood flow measurement.

Summary

{0}------------------------------------------------

Vasamedics 510(k)

7/9/96

Section [2] 510(k) Summary

APR - 9 1997

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).

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 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

{1}------------------------------------------------

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

D.S. Tono

Director of Operations Vasamedics April 8, 1996

Regulation Number and Section

§ 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).