StrataMR guider tool

K181622 · Medtronic Neurosurgery · JXG · Oct 1, 2018 · Neurology

Device Facts

• Record ID: K181622
• Device Name: StrataMR guider tool
• Applicant: Medtronic Neurosurgery
• Product Code: JXG · Neurology
• Decision Date: Oct 1, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

StrataMR system manages hydrocephalus by draining CSF from brain ventricles to the peritoneal cavity or right atrium. System includes implantable valve and external magnetic adjustment tools. Physician uses locator, indicator, and adjustment tools to noninvasively read and set valve pressure. New 'guider tool' component added to adjustment kit to ensure proper rotor foot positioning and prevent it from resting on MRI resistance walls. Used in clinical/office settings by neurosurgical staff. Guider tool provides defined distance for rotating adjustment tool, ensuring reliable valve setting without radiographic confirmation. Benefits include reduced risk of improper valve adjustment and improved procedural reliability.

Clinical Evidence

Bench testing and human factors validation only. Bench testing (n=29) confirmed guider tool functionality and reliability (95% confidence/90% reliability). Human factors study (n=14 clinicians, 84 adjustment cycles) using anatomical models validated that users can successfully adjust valve settings without the rotor foot residing on the resistance wall.

Technological Characteristics

System components: locator tool, indicator tool, adjustment tool, guider tool. Materials: Clear Polycarbonate (locator, guider), Aluminum (adjustment). Non-sterile, reusable. Cleaning: warm water and mild detergent. Connectivity: None (mechanical/magnetic). Biocompatibility per ISO 10993-5, 10993-10, 10993-11.

Indications for Use

Indicated for patients requiring continuous CSF flow from brain ventricles to the right atrium or peritoneal cavity for hydrocephalus management. Intended for use by neurosurgical personnel (neurosurgeons, residents, physician assistants, clinical staff) to noninvasively adjust valve pressure settings.

Regulatory Classification

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.

Predicate Devices

• Medtronic StrataMR Valves and Shunts (K152700)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for 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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

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

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# 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) | |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------|
| <div> <span>X</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 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 [phone] [phone] [e-mail] 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 Component<br>21 CFR 882.5550 Class II |
| Product Code | JXG |

#### Subject 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.

# 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.

{4}------------------------------------------------

# 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 | K181622<br>Subject Device | K152700<br>Predicate Device | Discussion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | Medtronic StrataMR™ Valves<br>and Shunts are designed to<br>provide continuous cerebrospinal<br>fluid (CSF) flow from the<br>ventricles of the brain into the<br>right atrium of the heart or the<br>peritoneal cavity. The design<br>enables the physician to<br>noninvasively adjust valve<br>pressure/performance level pre-<br>and post-implantation by using<br>magnetic adjustment tools<br>without the need for radiographic<br>confirmation. | Medtronic StrataMR™ Valves<br>and Shunts are designed to<br>provide continuous<br>cerebrospinal fluid (CSF) flow<br>from the ventricles of the brain<br>into the right atrium of the heart<br>or the peritoneal cavity. The<br>design enables the physician to<br>noninvasively adjust valve<br>pressure/performance level pre-<br>and post-implantation by using<br>magnetic adjustment tools<br>without the need for<br>radiographic confirmation. | Identical |
| Components | 4 – locator tool, indicator tool,<br>adjustment tool, guider tool | 3 – locator tool, indicator tool,<br>adjustment tool | Similar.<br>The only difference<br>between the modified<br>device and the predicate<br>is that an additional<br>guider Tool is added to<br>the system, which is<br>intended to be used<br>together with the locator<br>Tool and adjustment Tool<br>during the adjustment<br>process, in order to<br>reduce the risk of rotor<br>foot being positioned on<br>top of the wall. Risk<br>assessment shows<br>introduction of the guider<br>tool does not introduce<br>new unacceptable risk.<br>Design verification and<br>validation studies<br>demonstrated that the<br>proposed modified device<br>meets the performance<br>requirement. |
| | K181622<br>Subject Device | K152700<br>Predicate Device | Discussion |
| Feature | | | |
| Patient -<br>contacting<br>materials | Locator Tool: Clear<br>Polycarbonate Indicator Tool:<br>polycarbonate<br>Adjustment Tool: Aluminum<br>Guider tool: Clear Polycarbonate | Locator Tool: Clear<br>Polycarbonate Indicator Tool:<br>polycarbonate<br>Adjustment Tool: Aluminum | Similar.<br>The only difference<br>between the modified<br>device and the predicate<br>is that an additional<br>guider tool is added to the<br>system. However, the<br>patient contacting<br>material from the guider<br>tool is identical with the<br>patient contacting<br>material of the locator<br>tool in formulation,<br>processing, geometry, and<br>no other chemicals<br>have been added.<br>Therefore, the modified<br>StrataMR adjustment tool<br>is substantially equivalent<br>to the original device,<br>from a biocompatibility<br>perspective. |
| Packaging | Reusable, magnetically shielded<br>case. Foam insert is updated to<br>accommodate the guider tool | Reusable, magnetically shielded<br>case with foam insert | Similar.<br>The only difference is the<br>addition of the guider<br>tool to the package, and<br>the foam insert update to<br>accommodate the guider<br>tool.<br>Transportation study was<br>conducted to demonstrate<br>that the packaging can<br>protect the device from<br>damage, and product<br>passed functional<br>requirements after<br>transportation simulation. |
| Operating<br>Principal | Guider Tool provides a defined<br>distance for the users to rotate<br>adjustment tool in order to<br>prevent the rotor foot from being<br>positioned on top of wall.<br>Indicator Tool is used with<br>locator tool to couple with valve<br>magnet to read the valve setting.<br>Adjustment Tool is used to<br>couple with valve magnet and<br>rotate to the designed valve<br>setting. | Indicator Tool is used with<br>locator tool to couple with valve<br>magnet to read the valve setting.<br>Adjustment Tool is used to<br>couple with valve magnet and<br>rotate to the designed valve<br>setting.<br>At the end of the adjustment,<br>indicator tool is used with<br>locator tool to confirm the valve<br>setting. | The operation principle to<br>adjust the valve setting is<br>similar. The operation<br>principle for the<br>StrataMR valve setting<br>reading and adjustment is<br>equivalent between the<br>predicate and proposed<br>device.<br>The difference is the<br>supplementary steps after<br>the pressure level setting<br>steps, which includes<br>turning the adjustment<br>tool (which is attached to<br>the guider tool) clockwise |
| Feature | K181622<br>Subject Device | K152700<br>Predicate Device | Discussion |
| | At the end of the adjustment,<br>indicator tool is used with locator<br>tool to confirm the valve setting. | | and counter-clockwise at<br>a certain distance above<br>the valve to remove the<br>rotor foot from the MRI<br>resistance wall, if the<br>rotor foot was left on top<br>of the wall from the<br>previous adjusting steps.<br>The distance above the<br>valve is controlled by the<br>guider tool. This<br>supplementary step does<br>not change the<br>fundamental operation<br>principle. Design<br>verification and<br>validation studies<br>demonstrated that the<br>modified StrataMR<br>adjustment tools meet the<br>functional requirement of<br>adjusting the pressure<br>level of StrataMR valves. |
| Cleaning &<br>Sterilization | Non-sterile and reusable. Tools<br>can be cleaned with warm water<br>and mild detergent (5% Dawn<br>soap/95% DI water) before use. | Non-sterile and reusable. Tools<br>can be cleaned with warm water<br>and mild detergent (5% Dawn<br>soap/95% DI water) before use. | Similar.<br>The only difference is the<br>addition of the guider<br>Tool. Design verification<br>study was conducted to<br>demonstrate that the<br>guider Tool can<br>withstand the cleaning<br>with warm water and<br>mild detergent, without<br>exhibiting cracking or<br>removal of marking. |

{5}------------------------------------------------

{6}------------------------------------------------

# 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.

{7}------------------------------------------------

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.