Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

Device Description

The Medtronic StrataMR™ valves are implantable adjustable valves for the management of hydrocephalus. The valves and their associated catheters drain Cerebrospinal Fluid (CSF) from the ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. Before and after implantation, the pressure/flow characteristics of the Medtronic StrataMRTM valve can by modified by the StrataMR adjustment tool.

The original StrataMR adjustment tools, including handheld locator, and adjustment tool, are designed to allow the user to determine the pressure/performance level setting of StrataMR valves and adjust the setting when needed. In this 510(k) submission, Medtronic is proposing to add an additional component, guider tool, to the StrataMR adjustment tools, to improve the method to reliably adjust the StrataMR valve, cleared in K152700.

AI/ML Overview

The provided text details the acceptance criteria and the study conducted for the Medtronic StrataMR™ Valves and Shunts (Guider Tool), specifically focusing on the addition of a new "guider tool" component.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Non-Clinical:	Non-Clinical:
- When the rotor foot is placed on top of an MRI resistance wall, use of the guider tool can remove the rotor foot from the wall and position it to a pressure-level-setting well after the adjustment procedure.	Met. The tests varied the configuration to represent a worst-case scenario involving misalignment and off-centering, demonstrating the modified StrataMR adjustment tool met the performance specification.
- Use of the guider tool will not inadvertently change the pressure level setting.	Met. Design verification and validation studies demonstrated that the modified StrataMR adjustment tool meets the functional requirement of adjusting the pressure level setting of StrataMR and that use of the guider tool did not inadvertently change the setting.
Human Factors:	Human Factors:
- Validate that under simulated use conditions, users can adjust the setting of the StrataMR valve with the new guider tool together with the existing adjustment tools.	Met. 14 clinician users (neurosurgical personnel like attending neurosurgeons, residents, physician assistants, or clinical staff with experience managing StrataMR or Strata-type valves) successfully performed 84 adjustment cycles (6 per evaluator) on plastic anatomical model heads with imitation skin, demonstrating users can adjust the setting.
- Validate that the rotor foot does not reside on an MRI resistance wall at the end of the adjustment procedure when using the guider tool.	Met. The design validation study's goal was to confirm this, and the conclusion states that the studies demonstrated the modified StrataMR adjustment tool met the functional requirement, implying this condition was met through successful adjustment.
Biocompatibility:	Biocompatibility:
- The guider tool withstands cleaning with warm water and mild detergent without exhibiting cracking or removal of marking.	Met. Design verification study was conducted to demonstrate this. No new biocompatibility testing was conducted as the guider tool's patient-contacting material is identical to the predicate device, leveraging previous biocompatibility testing (ISO 10993-5: cytotoxicity, ISO 10993-10: irritation and skin sensitization, ISO 10993-11: systemic toxicity).
Packaging:	Packaging:
- The packaging can protect the device from damage during transportation, and the product passes functional requirements after transportation simulation.	Met. Transportation study was conducted to demonstrate this. The only difference in packaging was the addition of the guider tool and an updated foam insert.

2. Sample sizes used for the test set and the data provenance

Non-Clinical Test Set: 29 guider tools were used in conjunction with 29 StrataMR valves.
Human Factors Test Set: 14 clinician users performed a total of 84 adjustment cycles (6 adjustments per evaluator).
Data Provenance: Not explicitly stated regarding country of origin. The studies are described as "verification and validation testing" and "design validation study," indicating a prospective nature for the data generation; it was specifically generated to test the device's performance.

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

Non-Clinical: The ground truth for this testing (e.g., whether the rotor foot was correctly positioned, whether the setting inadvertently changed) appears to be established through direct observation and measurement based on engineered specifications and worst-case scenarios, rather than expert interpretation of images or clinical outcomes. No specific "experts" for ground truth establishment were mentioned beyond the design and testing engineers/personnel.
Human Factors: 14 clinician users served as "evaluators" performing the tasks. Their qualifications were described as "neurosurgical personnel (attending neurosurgeons, residents, physician assistants, or clinical staff) with experience managing StrataMR or Strata-type valves." They were the "users" in a simulated setting, and their ability to successfully manipulate the device constituted the "ground truth" for usability.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

No explicit adjudication method (like 2+1 or 3+1 for discordant reads) is mentioned for either the non-clinical or human factors testing. The non-clinical testing appears to be objective pass/fail against predetermined mechanical and functional criteria. The human factors study seems to rely on the direct performance of the evaluators.

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

No MRMC or comparative effectiveness study involving human readers improving with AI assistance was performed. This device is a mechanical tool (guider tool for a shunt valve adjustment) and not an AI-assisted diagnostic or therapeutic system.

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

Not applicable as this is a mechanical medical device, not an algorithm. The "standalone" performance would be equivalent to the non-clinical testing of the tool's mechanical function, which was indeed performed without human interaction, focusing on its ability to correctly guide the adjustment given various conditions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Non-Clinical: Engineering specifications and functional requirements (e.g., rotor foot correctly positioned in a well, no inadvertent change in setting). This is a functional/physical ground truth.
Human Factors: Successful completion of the adjustment task by qualified users in a simulated environment. This is a usability/performance ground truth.

8. The sample size for the training set

Not applicable. This device is a mechanical tool with no AI/ML component; therefore, there is no "training set."

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

Not applicable, as there is no training set for this mechanical device.

Summary

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October 1, 2018

Medtronic Neurosurgery Xiaojian Sun Regulatory Affairs Manager 125 Cremona Drive Goleta, California 93117

Re: K181622

Trade/Device Name: StrataMR Valves and Shunts (Guider Tool) Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: July 2, 2018 Received: July 3, 2018

Dear Xiaojian Sun:

We have reviewed vour 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 Mav 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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

for Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181622

Device Name StrataMRTM Valves and Shunts (Guider Tool)

Indications for Use (Describe)

Medtronic StrataMR™ Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K181622 510(k) Summary

Submitter Name Submitter Address Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117-5503 USA

Contact Person
Telephone
Fax
Email
Date Summary Prepared

Hebe Sun, Regulatory Affairs Manager (805) 571-8758 (805) 571-8480 Xiaojian.sun@medtronic.com September 28, 2018

Subiect Device

Common Name

Product Code

Classification Name

Trade Name

StrataMRTM Valves and Shunts (Guider Tool) Hydrocephalus Shunt Central nervous system fluid shunt and components 21 CFR 882.5550 Class II JXG

Predicate Device K152700

Trade Name	Medtronic StrataMR TM Valves and Shunts
Common Name	Hydrocephalus Shunt
Classification Name	Central Nervous System Fluid Shunt and Component21 CFR 882.5550 Class II
Product Code	JXG

Subject Device Description

Intended Use/Indications for Use

Medtronic StrataMR Valves and Shunts are designed to provide continuous cerebrospinal fluid (CSF) flow from the ventricles of the brain into the right atrium of the heart or the peritoneal cavity. The design enables the physician to noninvasively adjust valve pressure/performance level pre- and post-implantation by using magnetic adjustment tools without the need for radiographic confirmation.

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Summary of Technological Characteristics of the Subject Device Compared to the Predicate Device

The previously cleared StrataMR valve and shunt system, K152700, includes StrataMR valves, shunts, and StrataMR adjustment tools which are designed to read and adjust the pressure/ performance level setting of StrataMR. There is no change to these previously cleared StrataMR valves or shunts.

The difference between the proposed StrataMR adjustment tools and the currently available StrataMR adjustment tools is the following modification: the addition of a fourth component called the guider tool. This tool is intended to improve the ability of users to reliably adjust the StrataMR valve. This change does not affect the intended use of the system.

Feature	K181622Subject Device	K152700Predicate Device	Discussion
Indicationsfor Use	Medtronic StrataMR™ Valvesand Shunts are designed toprovide continuous cerebrospinalfluid (CSF) flow from theventricles of the brain into theright atrium of the heart or theperitoneal cavity. The designenables the physician tononinvasively adjust valvepressure/performance level pre-and post-implantation by usingmagnetic adjustment toolswithout the need for radiographicconfirmation.	Medtronic StrataMR™ Valvesand Shunts are designed toprovide continuouscerebrospinal fluid (CSF) flowfrom the ventricles of the braininto the right atrium of the heartor the peritoneal cavity. Thedesign enables the physician tononinvasively adjust valvepressure/performance level pre-and post-implantation by usingmagnetic adjustment toolswithout the need forradiographic confirmation.	Identical
Components	4 – locator tool, indicator tool,adjustment tool, guider tool	3 – locator tool, indicator tool,adjustment tool	Similar.The only differencebetween the modifieddevice and the predicateis that an additionalguider Tool is added tothe system, which isintended to be usedtogether with the locatorTool and adjustment Toolduring the adjustmentprocess, in order toreduce the risk of rotorfoot being positioned ontop of the wall. Riskassessment showsintroduction of the guidertool does not introducenew unacceptable risk.Design verification andvalidation studiesdemonstrated that theproposed modified devicemeets the performancerequirement.
	K181622Subject Device	K152700Predicate Device	Discussion
Feature
Patient -contactingmaterials	Locator Tool: ClearPolycarbonate Indicator Tool:polycarbonateAdjustment Tool: AluminumGuider tool: Clear Polycarbonate	Locator Tool: ClearPolycarbonate Indicator Tool:polycarbonateAdjustment Tool: Aluminum	Similar.The only differencebetween the modifieddevice and the predicateis that an additionalguider tool is added to thesystem. However, thepatient contactingmaterial from the guidertool is identical with thepatient contactingmaterial of the locatortool in formulation,processing, geometry, andno other chemicalshave been added.Therefore, the modifiedStrataMR adjustment toolis substantially equivalentto the original device,from a biocompatibilityperspective.
Packaging	Reusable, magnetically shieldedcase. Foam insert is updated toaccommodate the guider tool	Reusable, magnetically shieldedcase with foam insert	Similar.The only difference is theaddition of the guidertool to the package, andthe foam insert update toaccommodate the guidertool.Transportation study wasconducted to demonstratethat the packaging canprotect the device fromdamage, and productpassed functionalrequirements aftertransportation simulation.
OperatingPrincipal	Guider Tool provides a defineddistance for the users to rotateadjustment tool in order toprevent the rotor foot from beingpositioned on top of wall.Indicator Tool is used withlocator tool to couple with valvemagnet to read the valve setting.Adjustment Tool is used tocouple with valve magnet androtate to the designed valvesetting.	Indicator Tool is used withlocator tool to couple with valvemagnet to read the valve setting.Adjustment Tool is used tocouple with valve magnet androtate to the designed valvesetting.At the end of the adjustment,indicator tool is used withlocator tool to confirm the valvesetting.	The operation principle toadjust the valve setting issimilar. The operationprinciple for theStrataMR valve settingreading and adjustment isequivalent between thepredicate and proposeddevice.The difference is thesupplementary steps afterthe pressure level settingsteps, which includesturning the adjustmenttool (which is attached tothe guider tool) clockwise
Feature	K181622Subject Device	K152700Predicate Device	Discussion
	At the end of the adjustment,indicator tool is used with locatortool to confirm the valve setting.		and counter-clockwise ata certain distance abovethe valve to remove therotor foot from the MRIresistance wall, if therotor foot was left on topof the wall from theprevious adjusting steps.The distance above thevalve is controlled by theguider tool. Thissupplementary step doesnot change thefundamental operationprinciple. Designverification andvalidation studiesdemonstrated that themodified StrataMRadjustment tools meet thefunctional requirement ofadjusting the pressurelevel of StrataMR valves.
Cleaning &Sterilization	Non-sterile and reusable. Toolscan be cleaned with warm waterand mild detergent (5% Dawnsoap/95% DI water) before use.	Non-sterile and reusable. Toolscan be cleaned with warm waterand mild detergent (5% Dawnsoap/95% DI water) before use.	Similar.The only difference is theaddition of the guiderTool. Design verificationstudy was conducted todemonstrate that theguider Tool canwithstand the cleaningwith warm water andmild detergent, withoutexhibiting cracking orremoval of marking.

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Summary of Design Performance Testing

Non-Clinical

Results of verification and validation testing met pre-established acceptance criteria: 1) that when the rotor foot was placed on top of an MRI resistance wall, use of the guider tool can remove the rotor foot from the wall and position it to a pressure-level-setting well after the adjustment procedure and 2) use of guider tool will not inadvertently change the pressure level setting. This was done by varying the configuration to represent a worst-case scenario involving misalignment and off-centering, which demonstrates that the modified StrataMR adjustment tool met the performance specification.

In order to reach 95% confidence and 90% reliability interval, 29 guider tools were used together with locator tool and adjustment tool to conduct the test on 29 StrataMR valves.

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Design verification and validation studies demonstrated that the modified StrataMR adjustment tool meet the functional requirement of adjusting the pressure level setting of StrataMR: use of the guider tool did not inadvertently change the setting.

Human Factors

The design validation study is intended to validate that under simulated use conditions, users can adjust the setting of the StrataMR valve with the new guider tool together with the existing adjustment tools, and the rotor foot does not reside on an MRI resistance wall at the end of the adjustment procedure.

Testing was conducted in an environment similar to an office setting where post-operative adjustment may occur. The evaluators for this validation study were neurosurgical personnel (attending neurosurgeons, residents, physician assistants, or clinical staff) with experience managing StrataMR or Strata-type valves. Two plastic anatomical model heads with imitation skin were used to simulate the clinical use, with the valve positioned under the imitation skin so that it was not visible to the evaluator. 14 clinician users were selected as evaluators and each evaluator was requested to perform 6 adjustments, and the total number of adjustment cycles was 84.

Biocompatibility

No new biocompatibility testing was conducted on the new Guider Tool because it was fabricated from similar materials as the predicate StrataMR Adjustment Tools. Therefore, the following biocompatibility testing was leveraged from the predicate device (K152700).

. ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10 Third Edition 2010-08-01 ● Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
. ISO 10993-11 Second edition 2006-08-15 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity

Conclusion

The performance testing demonstrates that the device is safe, as effective, and performs as well as or better than the predicate. The proposed modification of the StrataMR adjustment tools does not affect the intended use of the device. Therefore, it is concluded that the proposed modification of the StrataMR adjustment tool is substantially equivalent to the original StrataMR adjustment tool.

Regulation Number and Section

§ 882.5550 Central nervous system fluid shunt and components.

(a)
Identification. A central nervous system fluid shunt is a device or combination of devices used to divert fluid from the brain or other part of the central nervous system to an internal delivery site or an external receptacle for the purpose of relieving elevated intracranial pressure or fluid volume (e.g., due to hydrocephalus). Components of a central nervous system shunt include catheters, valved catheters, valves, connectors, and other accessory components intended to facilitate use of the shunt or evaluation of a patient with a shunt.(b)
Classification. Class II (performance standards).