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

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 9, 2020

Medtronic, Inc. Jen Correa Manager, Regulatory Affairs 5290 California Avenue Irvine, California 92617

Re: K200630

Trade/Device Name: Medtronic External Drainage and Monitoring System (EDMS) Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HCA Dated: March 9, 2020 Received: March 10, 2020

Dear Jen Correa:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200630

Device Name

Medtronic External Drainage and Monitoring System (EDMS)

Indications for Use (Describe)

Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

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.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Medtronic External Drainage and Monitoring System (EDMS)

510(k) Summary

April 6, 2020

I. Company: Medtronic Neurosurgery 5290 California Ave Irvine, CA 92617 USA Contact: Jen Correa Manager, Regulatory Affairs Jennifer.L.Correa@medtronic.com Telephone Number: 949-297-5494

II. Establishment Registration Number: 3015531529

III. Proprietary Trade Name: Medtronic External Drainage and Monitoring System (EDMS)
IV. Regulatory Class: II

V. Primary Classification

Name: Intracranial pressure monitoring device Product Code: GWM Regulation: 21 CFR 882.1620 Secondary Classification: Name: Ventricular catheter Product Code: HCA Regulation: 21 CFR 882.4100

VI. Product 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;

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a removable vented drainage bag with approximate volumetric graduations and drainage port; ●
pressure scale tape.

VII. Indications for Use:

Draining CSF and monitoring CSF flow from the lateral ventricles or lumbar subarachnoid space is indicated in selected patients to:

Reduce intracranial pressure (ICP), e.g. pre-, intra- or postoperative. 1.
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
Reye's syndrome or similar encephalopathies 3.
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 spaceoccupying lesions.

VIII. Summary of the Technological Characteristics: The proposed subject drainage bag shares the same technological characteristics as the original predicate drainage bag. The rest of the EDMS device has the same technological characteristics as the predicate device.

	Subject Device	Predicate DeviceK802100
Intendeduse/Indicationsfor Use	Draining CSF and monitoring CSF flowfrom the lateral ventricles or lumbarsubarachnoid space is indicated inselected patients to:1. Reduce intracranial pressure (ICP), e.g.pre-, intra- or postoperative.2. Monitor CSF chemistry, cytology andphysiology.3. Provide temporary CSF drainage inpatients with infected cerebrospinal fluidshunts.The monitoring of the intracranial pressure(ICP) is indicated in selected patients with:1. Severe head injury	The monitoring of intracranial pressure(ICP) is indicated on selected patientswith:1. Severe head injury.2. Status pre- and postoperative forspace-occupying intracranial lesions.3. Subarachnoid hemorrhage graded IVor V preoperatively.4. Reyes syndrome or similarencephalopathies.5. Hydrocephalus.6. Intracranial hemorrhage.7. Miscellaneous problems whenventricular drainage is to be used as atherapeutic maneuver.

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	Subject Device	Predicate Device
		K802100
	2. Subarachnoid hemorrhage graded III, IVor V preoperatively
	3. Reye's syndrome or similarencephalopathies
	4. Hydrocephalus
	5. Intracranial hemorrhage
	6. Miscellaneous problems when drainage isto be used as a therapeutic maneuver.
	Monitoring can also be used to evaluate thestatus pre- and postoperative for space-occupying lesions.
OperatingPrinciple	External drainage is temporary drainage ofcerebrospinal fluid (CSF) from the lateralventricles of the brain, or the lumbar space ofthe spine, into an external collection bag. TheMedtronic EDMS drains CSF by using acombination of gravity and intracerebralpressure. The drainage rate depends on theheight at which the system is placed relativeto the patient's anatomy.	Same
AnatomicalSites	Drainage and monitoring of CSF flow fromthe lateral ventricles or lumbar subarachnoidspace.	Same
Biocompatibility	No direct patient contactIn contact with CSF only	Same
SterilizationMethod	Ethylene Oxide	Same
Pyrogenicity	Non pyrogenic	Same
Shelf life	2 yr.	Same

IX. Identification of Legally Marketing Devices: The Intracranial Pressure Monitoring System, Becker Design, K802100.
X. Discussion of the Performance Testing: In accordance with the risk assessment of the change it was determined that dimensional verification, and design verification testing of the bag was necessary. The successful results of the testing demonstrated that the changes do not raise questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.

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Performance Data - Bench

Test	Test Method Summary / Purpose	Results
Visual andDimensionalInspection	Visual and dimensional inspection demonstrates thatthe printed graduations meet volumetric capacity.Volumetric graduations are approximate.	The EDMS device met theacceptance criteria for visual anddimensional inspection.
Leakage ofDrainage Bag	The drainage bag must withstand being invertedwithout leaking.	The EDMS device met theacceptance criteria for drainagebag leakage.
Flow InitiationPressure	Record pressure at which flow initiates, for eachdrainage bag.	The EDMS device met theacceptance criteria for flowinitiation pressure.
Drainage BagSeal Weld	Ensure there are no leaks in the drainage bag.	The EDMS device met theacceptance criteria for drainagebag seal weld.
Tensile Strengthof Drainage BagInlet Port	Evaluate the tensile strength of the drainage baginlet port to failure.	The EDMS device met theacceptance criteria for tensilestrength of drainage bag inletport.

Performance Data – Animal

The risk assessment of the proposed modifications to the disposable bag did not require animal testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.

Performance Data - Clinical

The risk assessment of the proposed modifications to the disposable bag did not require clinical testing. Determination of substantial equivalence for the design change is based upon the design verification bench testing.

XI. Conclusions: The information provided in this submission demonstrates that the subject device, the Medtronic EDMS, has the same intended use/indications for use as the predicate device and the differences in technological characteristics introduced by the proposed changes to the drainage bag do not raise any questions of safety and effectiveness. Based on the information provided in this submission the subject Medtronic EDMS device is considered substantially equivalent to the previously cleared predicate device.

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).