FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

1. Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative.
1. Monitor CSF chemistry, cytology and physiology.
1. Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.

The monitoring of the intracranial pressure (ICP) is indicated in selected patients with:

1. Severe head injury
1. Subarachnoid hemorrhage graded III, IV or V preoperatively
1. Reye's syndrome or similar encephalopathies
1. Hydrocephalus
1. Intracranial hemorrhage
1. Miscellaneous problems when drainage is to be used as a therapeutic maneuver.

Monitoring can also be used to evaluate the status pre- and postoperative for space-occupying lesions.

Device Description

The Medtronic External Drainage and Monitoring System EDMS is provided as a complete closed system for the drainage and monitoring of cerebrospinal fluid (CSF) flow from the lateral ventricles or the lumbar subarachnoid space. The system is offered in various kit configurations for various clinical applications. The EDMS Drainage Assembly is supplied pre-assembled, sterile and non-pyrogenic in a double wrap package system. A drainage bag with braided cord is also included with each EDMS kit.
The EDMS and components are intended for single (one time) use only and is not designed or intended to be re-used, re-processed, or re-sterilized. Some of the basic features include the following:

. a patient line stopcock with latex-free injection site and non-distensible patient connection line:
a graduated chamber and hanging bracket for I.V. pole suspension; ●
a drainage bag connection line with two slide clamps and latex-free injection site;
a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
pressure scale tape.

AI/ML Overview

The provided text does not describe an AI medical device. It pertains to the Medtronic External Drainage and Monitoring System (EDMS), which is a physical device for draining and monitoring cerebrospinal fluid. Therefore, the questions related to AI device performance metrics, such as ground truth establishment with experts, MRMC studies, or standalone algorithm performance, are not applicable.

However, I can extract information related to the acceptance criteria and the study that proves the device meets those criteria for the Medtronic EDMS.

Acceptance Criteria and Performance for Medtronic External Drainage and Monitoring System (EDMS)

The Medtronic EDMS underwent bench testing to demonstrate its safety and effectiveness, particularly addressing changes made to the disposable drainage bag.

1. Table of Acceptance Criteria and Reported Device Performance:

Test	Acceptance Criteria Summary	Reported Device Performance
Visual and Dimensional Inspection	Printed graduations must meet volumetric capacity (volumetric graduations are approximate).	The EDMS device met the acceptance criteria for visual and dimensional inspection.
Leakage of Drainage Bag	The drainage bag must withstand being inverted without leaking.	The EDMS device met the acceptance criteria for drainage bag leakage.
Flow Initiation Pressure	Pressure at which flow initiates for each drainage bag should meet specified criteria (details not provided in text).	The EDMS device met the acceptance criteria for flow initiation pressure.
Drainage Bag Seal Weld	No leaks in the drainage bag seal weld.	The EDMS device met the acceptance criteria for drainage bag seal weld.
Tensile Strength of Drainage Bag Inlet Port	Tensile strength of the drainage bag inlet port to failure should meet specified criteria (details not provided in text).	The EDMS device met the acceptance criteria for tensile strength of drainage bag inlet port.

2. Sample size used for the test set and the data provenance:

The text does not specify the exact sample size for each bench test conducted.
The tests were bench tests (laboratory-based testing of the physical device or its components). Data provenance is internal to the manufacturer's testing facility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This question is not applicable as the study involved bench testing of a physical medical device, not an AI algorithm requiring expert ground truth for image or data interpretation.

4. Adjudication method for the test set:

This question is not applicable as there was no expert review or adjudication process for bench testing a physical device.

5. 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:

This question is not applicable as the device is not an AI-assisted diagnostic or interpretive tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not applicable as the device is not a standalone algorithm.

7. The type of ground truth used:

The ground truth for the bench tests was based on engineering specifications and established test methods designed to verify the physical properties and functionality of the device components (e.g., verifying volumetric graduations, absence of leaks, strength of seals).

8. The sample size for the training set:

This question is not applicable as this is not an AI device that requires a training set.

9. How the ground truth for the training set was established:

This question is not applicable as this is not an AI device that requires a training set.

Summary

Regulation Number and Section

§ 882.1620 Intracranial pressure monitoring device.

(a)
Identification. An intracranial pressure monitoring device is a device used for short-term monitoring and recording of intracranial pressures and pressure trends. The device includes the transducer, monitor, and interconnecting hardware.(b)
Classification. Class II (performance standards).