Reduce 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 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 Exacta 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 Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the system to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

AI/ML Overview

This document is a 510(k) summary for the Medtronic Exacta External Drainage and Monitoring System (EDMS). The submission focuses on changes to a laser level accessory and does not involve AI. Therefore, several requested sections, especially those related to AI model evaluation, are not applicable.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are qualitative (e.g., "met the acceptance criteria") rather than quantitative thresholds.

Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Strength	Laser does not present a safety hazard after push test, impact test, and dropping.	The laser level device met the acceptance criteria for mechanical strength.
Beam Uniformity	Beam uniformity meets specified requirements.	The laser level device met the acceptance criteria for beam uniformity.
Laser Accuracy	Laser accuracy meets specified requirements at a set distance.	The laser level device met the acceptance criteria for laser accuracy.
Laser Safety	Laser power output complies with exposure limits for Class 3R Laser (IEC/EN 60825-1:2014 compliant).	The laser level device met the acceptance criteria for laser safety.
Auto Shut Off	Time laser is "on" after activation meets specified requirements.	The laser level device met the acceptance criteria for auto shut off.
Electrical Safety	Compliance with IEC 60601-1:2005 + AMD1:2012.	(Results not explicitly detailed, but implied by overall conclusion of safety and effectiveness)
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2014 / EN 60601-1-2:2015.	(Results not explicitly detailed, but implied by overall conclusion of safety and effectiveness)

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

The document does not specify the sample size for the test set used in the bench testing. It only states that the testing was performed, but not how many units were tested.

Data Provenance: The tests were "design verification bench testing," implying they were conducted in a lab setting by the manufacturer, Medtronic, Inc., located in Irvine, California, USA. The data is retrospective in the sense that it was collected as part of the device development and submission process.

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

Not applicable. The testing described is bench testing of physical device characteristics (mechanical, laser performance, electrical safety) against established engineering and safety standards, not against clinical ground truth requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. This was bench testing against engineering specifications, not a clinical study requiring expert adjudication of results.

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

Not applicable. This submission is for an External Drainage and Monitoring System and its laser level accessory. It is a physical medical device, not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the bench testing was defined by engineering specifications and international standards for mechanical strength, beam uniformity, laser accuracy, laser safety (IEC/EN 60825-1:2014), electrical safety (IEC 60601-1:2005 + AMD1:2012), and EMC (IEC 60601-1-2:2014 / EN 60601-1-2:2015).

8. The Sample Size for the Training Set

Not applicable. This device does not use a training set as it is not an AI/machine learning product.

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

Not applicable.

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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

May 26, 2020

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

Re: K201118

Device Name: Exacta 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: April 24, 2020 Received: April 27, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 -S

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) K201118

Device Name

Exacta External Drainage and Monitoring System (EDMS)

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 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 ICP is indicated in selected patients with:

1. Severe head injury.
1. Subarachnoid hemorrhage graded III, IV or V preoperatively.
1. Reves 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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510(k) Summary

Medtronic Exacta External Drainage and Monitoring System (EDMS)

510(k) Summary

May 19, 2020

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

II. Establishment Registration Number: 3015531529

III. Proprietary Trade Name: Exacta External Drainage and Monitoring System (EDMS)
IV. Regulator Classification: 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 Exacta 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 Exacta EDMS product family is comprised of a single use drainage system, a reusable blue pole clamp and a laser level accessory. The single use drainage assembly is comprised of a patient line, main system stopcock, graduated cylinder and drainage bag. The single use drainage assembly is mounted on the reusable blue pole clamp. The reusable blue pole clamp secures the svstem to an I.V. pole and includes the system pressure scale and holds an optional laser level accessory. The optional laser level accessory assists the user in leveling the single use drainage system to the patient's Foramen of Monro or lumbar catheter exit site.

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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 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 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 subject laser level device shares the same features and use as the predicate laser level. The rest of the Exacta EDMS device has the same technological characteristics as the predicate device.

	Subject Device	Predicate Device
		K983799
Intendeduse/Indicationsfor Use	Draining and monitoring of CSF flow fromthe lateral ventricles or lumbarsubarachnoid space is indicated in selectedpatients to:1. Reduce ICP, e.g., pre-, intra- orpostoperative.2. Monitor CSF chemistry, cytology, andphysiology.3. Provide temporary CSF drainage inpatients with infected cerebrospinalfluid shunts.Monitoring of ICP is indicated in selectedpatients with:1. Severe head injury.2. Subarachnoid hemorrhage graded III,IV or V preoperatively.3. Reyes syndrome or similarencephalopathies.4. Hydrocephalus.	Same
	Subject Device	Predicate Device
		K983799
	5. Intracranial hemorrhage.
	6. Miscellaneous problems whendrainage is to be used as a therapeuticmaneuver.Monitoring can also be used to evaluate thestatus pre- and postoperatively for space-occupying lesions.
OperatingPrinciple	External drainage is temporary drainage ofcerebrospinal fluid (CSF) from the lateralventricles of the brain, or the lumbar spaceof the spine, into an external collectionbag. The Exacta EDMS drains CSF byusing a combination of gravity andintracerebral pressure. The drainage ratedepends on the height at which the systemis placed relative to the patient's anatomy.	Same
Materials	There are no materials with direct patientcontact	Same
Laser LevelAccessoryFeatures andUse	Battery-operated reusable non-sterileaccessory that is used to align the externalreference point with the zero referencepoint of the EDMS device.	Same
Laser LevelAccessoryDesign	Level Bubbles: Two, located at top andbottom of device	Level Bubbles: Same
	Maximum Output: <5.0 mWWavelength: 650nmLaser Classification: 3R	Maximum Output: <1 mWWavelength: 670nmLaser Classification: 2
AnatomicalSites	Drainage and monitoring of CSF flow fromthe lateral ventricles or lumbarsubarachnoid space.	Same
Biocompatibility	No direct patient contactIn contact with CSF only	Same
SterilizationMethod	Ethylene Oxide	Same
Pyrogenicity	Non pyrogenic	Same
Shelf life	2 yr.	Same

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IX. Identification of Legally Marketing Devices: Medtronic PS Medical Niveau Drainage System, K983799.

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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 laser level was necessary. As the changes to the laser level design potentially impact EMC and electrical safety, the design verification testing was completed to demonstrate compliance to the following electrical standards:
- . IEC 60601-1:2005 + AMD1:2012, Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- . IEC 60601-1-2:2014 / EN 60601-1-2:2015. Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests

In addition, laser testing was completed in compliance with IEC/EN 60825-1:2014, Safety of laser products - Part 1: Equipment classification and requirements.

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
MechanicalStrength	Verify laser does not present a safety hazardafter push test, impact test and dropping.	The laser level devicemet the acceptancecriteria for mechanicalstrength.
Beam Uniformity	Measure and record the beam uniformity todetermine offset	The laser level devicemet the acceptancecriteria for beamuniformity
Laser Accuracy	Calculate and record the laser accuracy at a setdistance	The laser level devicemet the acceptancecriteria for laseraccuracy
Laser Safety	Verify laser power output complies withexposure limits for Class 3R Laser	The laser level devicemet the acceptancecriteria for laser safety
Auto Shut Off	Measure and record the time laser is "on" afteractivation	The laser level devicemet the acceptancecriteria for auto shut off

Performance Data – Bench

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Performance Data - Animal

The risk assessment of the proposed modifications to the laser level 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 laser level 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 Exacta 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 laser level device do not raise any questions of safety and effectiveness. Based on the information provided in this submission the subject Exacta 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).