Reduce intracranial pressure (ICP), e.g., pre-, intra- or postoperative;
Monitor CSF chemistry, cytology, and physiology;
Provide temporary CSF drainage in patients with infected cerebrospinal fluid shunts.
Monitoring of intracranial pressure (ICP) is indicated in selected patients with:
Severe head injury
Subarachnoid hemorrhage graded III, IV. or V preoperatively
Reyes syndrome or similar encephalopathies
Hydrocephalus
Intracranial hemorrhage
Miscellaneous problems when drainage is to be used as a therapeutic maneuver.
Monitoring can also be used to evaluate the status pre- and postoperatively for space-occupying lesions.

Device Description

The Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.
Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.
The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.
The main system section located on the mounting panel includes:
Mounting bracket for height adjustment of system
Optional self-adjusting cord with lock for adjustment of system height
Main system stopcock with optional transducer attachment location
Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking bracket
Two drainage line slide clamps for flow monitoring and sampling
Drainage bag connection line
Needleless Injection Site (Interlink or Smartsite)
Instructions for Use
The system does not contain any latex components.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting study for the Becker External Drainage and Monitoring System, based on the provided FDA 510(k) summary:

This device is not an AI/ML device, so many of the requested fields are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Visual and Dimensional Inspection	Meet volumetric capacity and approximate volumetric graduations.	The Becker EDMS device met the acceptance criteria for visual and dimensional inspection.
Leakage of Drainage Bag	Withstand inversion without leaking.	The Becker EDMS device met the acceptance criteria for drainage bag leakage.
Flow Initiation Pressure	(Not explicitly stated, but implies a specific pressure range)	The Becker EDMS device met the acceptance criteria for flow initiation pressure.
Drainage Bag Seal Weld	No leaks in the drainage bag.	The Becker EDMS device met the acceptance criteria for drainage bag seal weld.
Tensile Strength of Drainage Bag Inlet Port	(Not explicitly stated, but implies meeting a minimum strength)	The Becker EDMS device met the acceptance criteria for tensile strength of drainage bag inlet port.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size for each specific bench test. However, the testing was conducted as part of the design verification process for a modified component (the disposable drainage bag) within the Becker EDMS. The data provenance is from bench testing, which is a controlled laboratory environment, not derived from human patients or specific geographical regions.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the studies were bench tests evaluating physical properties and functional performance against engineering specifications, not clinical outcomes requiring expert interpretation of medical data.

4. Adjudication Method for the Test Set

This information is not applicable as the studies were bench tests against predetermined engineering specifications, not studies involving subjective interpretation of data that would require an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical medical device, not an AI-assisted diagnostic or therapeutic tool for which such studies are typically performed.

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

This information is not applicable. This is a physical medical device, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the bench tests was based on engineering specifications and design requirements for the physical properties and functional performance of the modified drainage bag.

8. The Sample Size for the Training Set

This information is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable. There is no training set for this type of device.

Summary of the Study Proving Device Meets Acceptance Criteria:

The device is the "Becker External Drainage and Monitoring System" (Becker EDMS), with specific modifications to its disposable drainage bag component. The study proving the device meets acceptance criteria was a series of "Performance Data - Bench" tests.

The modifications to the disposable bag primarily involved changes in its design (approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port, and a hydrophobic/anti-microbial vent).

The performance testing was conducted in accordance with a risk assessment of these changes, which determined that dimensional verification and design verification testing of the bag were necessary. The specific tests performed included:

Visual and Dimensional Inspection: To ensure the printed graduations met volumetric capacity.
Leakage of Drainage Bag: To confirm the bag could withstand inversion without leaking.
Flow Initiation Pressure: To record the pressure at which fluid flow begins.
Drainage Bag Seal Weld: To ensure the bag's seals were intact and leak-free.
Tensile Strength of Drainage Bag Inlet Port: To evaluate the durability of the connection point.

The results of all these bench tests showed that the Becker EDMS device met the specified acceptance criteria for each test. Based on these successful results, the manufacturer concluded that the changes introduced by the modified disposable bag do not raise new questions of safety and effectiveness, thus supporting the substantial equivalence to the predicate device (Medtronic PS Medical Becker External Drainage and Monitoring System, K984053).

No animal or clinical testing was deemed necessary for these specific modifications, as the determination of substantial equivalence was based solely on the design verification bench testing.

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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".

March 26, 2020

Medtronic, Inc. Nancy Hampton, Ph.D. Principal Regulatory Affairs Specialist 125 Cremona Drive Goleta, California 93117

Re: K200456

Trade/Device Name: Becker External Drainage and Monitoring System Regulation Number: 21 CFR 882.1620 Regulation Name: Intracranial Pressure Monitoring Device Regulatory Class: Class II Product Code: GWM, HCA Dated: February 20, 2020 Received: February 25, 2020

Dear Dr. Nancy Hampton:

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 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

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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 mediation-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

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Indications for Use

510(k) Number (if known) K200456

Device Name

Becker External Drainage and Monitoring System

Indications for Use (Describe)

Draining and monitoring of 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.

Monitoring of intracranial pressure (ICP) is indicated in selected patients with:

1. Severe head injury
1. Subarachnoid hemorrhage graded III, IV. or V preoperatively
1. Reyes 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 postoperatively 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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Becker® External Drainage and Monitoring System

510(k) Summary

March 26, 2020

I. Medtronic, Inc. Company: Medtronic Neurosurgery 125 Cremona Drive Goleta, California 93117 USA
- Contact: Nancy Hampton, PhD Principal Regulatory Affairs Specialist nancy.d.hampton@medtronic.com Telephone Number: 949-490-3773
Establishment Registration Number: 2021898 II.
III. Proprietary Trade Name: Becker® External Drainage and Monitoring System
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 Becker External Drainage and Monitoring System (Becker EDMS) provides the physician with a complete closed system for:

Draining cerebrospinal fluid (CSF) from the lateral ventricles of the brain or the lumbar subarachnoid space.

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Monitoring CSF pressure and flow rate from the lateral ventricles of the brain and the lumbar subarachnoid space.

The Becker EDMS consists of a nondistensible blue or green striped (proximal end) patient connection line, patient line stopcock, mounting panel/main system section, two latex-free injection sites and a removable drainage bag with approximate volumetric graduations and microbial barrier air vent.

The main system section located on the mounting panel includes:

1. Mounting bracket for height adjustment of system
Optional self-adjusting cord with lock for adjustment of system height 2.
1. Main system stopcock with optional transducer attachment location
Sliding, graduated, 50 cc drip chamber with drip former and conical bottom, and locking 4. bracket
1. Two drainage line slide clamps for flow monitoring and sampling
Drainage bag connection line 6.
Needleless Injection Site (Interlink or Smartsite) 7.
Instructions for Use 8.

The system does not contain any latex components.

VII. Indications for Use:

Draining and monitoring of 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.

Monitoring of intracranial pressure (ICP) is indicated in selected patients with:

1. Severe head injury
1. Subarachnoid hemorrhage graded III, IV, or V preoperatively
1. Reyes 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 postoperatively for space-occupying lesions.

VIII. Summary of the Technological Characteristics:

The proposed Becker EDMS modified disposable bag is a sterile nonpyrogenic single use component of the system that is removable from the Becker EDMS mounting panel. The bag has an approximate volume capacity of 600ml with approximate volumetric markings in 50mL increments, an inlet port, an outlet port and a hydrophobic/anti-microbial vent embedded into the body of the bag. The rest of the Becker EDMS system has the same technological characteristics as the predicate device.

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	Subject Device	Predicate Device
		K984053
Intended use /Indications forUse	Draining and monitoring of 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.Monitoring of intracranial pressure (ICP)is indicated in selected patients with:1. Severe head injury2. Subarachnoid hemorrhage graded III,IV, or V preoperatively3. Reyes syndrome or similarencephalopathies4. Hydrocephalus5. Intracranial hemorrhage6. Miscellaneous problems when drainageis to be used as a therapeutic maneuver.Monitoring can also be used to evaluatethe status pre- and postoperatively forspace-occupying lesions.	Draining and monitoring of CSF flow fromthe lateral ventricles or lumbarsubarachnoid space is indicated in selectedpatients to reduce intracranial pressure(ICP), e.g. pre- intra- or postoperative;monitor CSF chemistry, cytology andphysiology;provide temporary CSF drainage inpatients with infected cerebrospinal fluidshunts.The monitoring of the intracranial pressure(ICP) is indicated in selected patients withsevere head injury;subarachnoid hemorrhage graded III, IV orV preoperatively;Reyes syndrome or similarencephalopathies;hydrocephalus;intracranial hemorrhage or miscellaneousproblems when drainage is to be used as atherapeutic maneuver.Monitoring can also be used to evaluate thestatus pre-and postoperatively for spaceoccupying lesions.
OperatingPrinciple	External drainage is temporary drainageof cerebrospinal fluid (CSF) from thelateral ventricles of the brain, or thelumbar space of the spine, into an externalcollection bag. The Becker EDMS drainsCSF by using a combination of gravityand intercerebral pressure. The drainagerate depends on the height at which thesystem is placed relative to the patient'sanatomy.	Same
Materials	There are no materials with direct patientcontact	Same
AnatomicalSites	Drainage and monitoring of CSF flowfrom the lateral ventricles or lumbarsubarachnoid space.	Same
Biocompatibility	No direct patient contact.In contact with CSF	Same
	Subject Device	Predicate DeviceK984053
SterilizationMethod	Ethylene Oxide	Same
Pyrogenicity	Non pyrogenic	Same
Shelf life	2 years	Same

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IX. Identification of Legally Marketing Predicate Devices: Medtronic PS Medical Becker External Drainage and Monitoring System, K984053.

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.

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

Performance Data - Bench

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.

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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 Becker 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 disposable bag do not raise questions of safety and effectiveness. Based on the information provided in this submission the subject Becker 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).