(103 days)
Not Found
No
The summary describes a mechanical valve and magnetic adjustment tools. There is no mention of any computational analysis, learning, or adaptive algorithms.
Yes
The device is 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 to manage hydrocephalus, which serves a therapeutic purpose.
No
This device is an implantable medical device designed to manage hydrocephalus by draining cerebrospinal fluid. It is a therapeutic device, not a diagnostic one. While it has adjustment tools that allow the physician to "determine the pressure/performance level setting," this is to configure the device's function, not to diagnose a patient's condition.
No
The device description clearly states that the device is an implantable adjustable valve and associated catheters, which are hardware components. The submission also describes physical adjustment tools.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
- Device Function: The Medtronic StrataMR™ Valves and Shunts are implantable devices designed to manage hydrocephalus by draining cerebrospinal fluid. The adjustment tools are used to modify the pressure/flow characteristics of the implanted valve.
- Lack of Specimen Analysis: The description does not mention the collection, preparation, or analysis of any specimens from the human body for diagnostic purposes. The device is a therapeutic implant and its associated tools are for adjusting the implant's function.
Therefore, this device falls under the category of an implantable medical device and its associated tools, not an In Vitro Diagnostic.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
JXG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ventricles of the brain, right atrium of the heart, peritoneal cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician; office setting (post-operative adjustment)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Non-Clinical Test:
Sample size: 29 guider tools used with locator tool and adjustment tool on 29 StrataMR valves.
Data source: Pre-established acceptance criteria. Study involved varying configuration to represent a worst-case scenario involving misalignment and off-centering.
Annotation protocol: Not explicitly stated, but results determined if the guider tool could remove the rotor foot from an MRI resistance wall and position it to a pressure-level-setting well after adjustment, and if the guider tool inadvertently changed the pressure level setting.
Human Factors Test:
Sample size: 14 clinician users, performing 6 adjustments each, for a total of 84 adjustment cycles.
Data source: Two plastic anatomical model heads with imitation skin, with the valve positioned under the imitation skin.
Annotation protocol: Not explicitly stated, but intended to validate that users can adjust the setting with the new guider tool and that the rotor foot does not reside on an MRI resistance wall.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Performance Testing:
Study type: Verification and Validation Testing
Sample size: 29 guider tools and 29 StrataMR valves.
Key results: Results met pre-established acceptance criteria, demonstrating 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 that the guider tool did not inadvertently change the pressure level setting. Demonstrated 95% confidence and 90% reliability interval.
Human Factors Study:
Study type: Design Validation Study (simulated use conditions)
Sample size: 14 clinician users, 84 total adjustment cycles.
Key results: Intended to validate that users can adjust the setting of the StrataMR valve with the new guider tool together with existing adjustment tools, and that the rotor foot does not reside on an MRI resistance wall at the end of the adjustment procedure. (Outcomes for this study are not explicitly stated as 'met' or 'passed' but implied by being part of the successful submission).
Biocompatibility Testing:
Study type: Biocompatibility leveraging predicate device
Sample size: Not applicable
Key results: No new biocompatibility testing was conducted as the guider tool was fabricated from similar materials as the predicate. Leveraged ISO 10993-5, ISO 10993-10, and ISO 10993-11 testing from predicate device (K152700).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
95% confidence and 90% reliability interval for non-clinical testing.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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 (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
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K181622 510(k) Summary
Submitter Name Submitter Address Medtronic Neurosurgery 125 Cremona Drive Goleta, CA 93117-5503 USA
| Contact Person |
|---|
| Telephone |
| Fax |
| 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 Component |
| 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
Subject Device | K152700
Predicate Device | Discussion |
|--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | 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. | Identical |
| Components | 4 – locator tool, indicator tool,
adjustment tool, guider tool | 3 – locator tool, indicator tool,
adjustment tool | Similar.
The only difference
between the modified
device and the predicate
is that an additional
guider Tool is added to
the system, which is
intended to be used
together with the locator
Tool and adjustment Tool
during the adjustment
process, in order to
reduce the risk of rotor
foot being positioned on
top of the wall. Risk
assessment shows
introduction of the guider
tool does not introduce
new unacceptable risk.
Design verification and
validation studies
demonstrated that the
proposed modified device
meets the performance
requirement. |
| | K181622
Subject Device | K152700
Predicate Device | Discussion |
| Feature | | | |
| Patient -
contacting
materials | Locator Tool: Clear
Polycarbonate Indicator Tool:
polycarbonate
Adjustment Tool: Aluminum
Guider tool: Clear Polycarbonate | Locator Tool: Clear
Polycarbonate Indicator Tool:
polycarbonate
Adjustment Tool: Aluminum | Similar.
The only difference
between the modified
device and the predicate
is that an additional
guider tool is added to the
system. However, the
patient contacting
material from the guider
tool is identical with the
patient contacting
material of the locator
tool in formulation,
processing, geometry, and
no other chemicals
have been added.
Therefore, the modified
StrataMR adjustment tool
is substantially equivalent
to the original device,
from a biocompatibility
perspective. |
| Packaging | Reusable, magnetically shielded
case. Foam insert is updated to
accommodate the guider tool | Reusable, magnetically shielded
case with foam insert | Similar.
The only difference is the
addition of the guider
tool to the package, and
the foam insert update to
accommodate the guider
tool.
Transportation study was
conducted to demonstrate
that the packaging can
protect the device from
damage, and product
passed functional
requirements after
transportation simulation. |
| Operating
Principal | Guider Tool provides a defined
distance for the users to rotate
adjustment tool in order to
prevent the rotor foot from being
positioned on top of wall.
Indicator Tool is used with
locator tool to couple with valve
magnet to read the valve setting.
Adjustment Tool is used to
couple with valve magnet and
rotate to the designed valve
setting. | Indicator Tool is used with
locator tool to couple with valve
magnet to read the valve setting.
Adjustment Tool is used to
couple with valve magnet and
rotate to the designed valve
setting.
At the end of the adjustment,
indicator tool is used with
locator tool to confirm the valve
setting. | The operation principle to
adjust the valve setting is
similar. The operation
principle for the
StrataMR valve setting
reading and adjustment is
equivalent between the
predicate and proposed
device.
The difference is the
supplementary steps after
the pressure level setting
steps, which includes
turning the adjustment
tool (which is attached to
the guider tool) clockwise |
| Feature | K181622
Subject Device | K152700
Predicate Device | Discussion |
| | At the end of the adjustment,
indicator tool is used with locator
tool to confirm the valve setting. | | and counter-clockwise at
a certain distance above
the valve to remove the
rotor foot from the MRI
resistance wall, if the
rotor foot was left on top
of the wall from the
previous adjusting steps.
The distance above the
valve is controlled by the
guider tool. This
supplementary step does
not change the
fundamental operation
principle. Design
verification and
validation studies
demonstrated that the
modified StrataMR
adjustment tools meet the
functional requirement of
adjusting the pressure
level of StrataMR valves. |
| Cleaning &
Sterilization | Non-sterile and reusable. Tools
can be cleaned with warm water
and mild detergent (5% Dawn
soap/95% DI water) before use. | Non-sterile and reusable. Tools
can be cleaned with warm water
and mild detergent (5% Dawn
soap/95% DI water) before use. | Similar.
The only difference is the
addition of the guider
Tool. Design verification
study was conducted to
demonstrate that the
guider Tool can
withstand the cleaning
with warm water and
mild detergent, without
exhibiting cracking or
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.