(27 days)
The StrataMR II 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 non-invasively adjust valve pressure/performance level pre-and post-implantation by using magnetic adjustment tools without the need of radiographic confirmation.
The StrataMR™ II adjustable valves are single-use implantable devices which provide a noninvasive method to address changing patient needs in the management of hydrocephalus. The valves and their associated catheters drain cerebrospinal fluid (CSF) from ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. StrataMR™ II valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved, and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Pre- and postimplantation, the performance level of the valve can be modified by StrataMR™ Adjustment Tools: Locator tool, guider tool, indicator tool and adjustment tool cleared under K181622.
The provided text is a 510(k) Summary for the Medtronic StrataMR™ II Valves and Shunts, submitted to the FDA. It details performance testing to demonstrate substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/Machine Learning device or a MRMC comparative effectiveness study involving human readers.
The document primarily focuses on bench testing and biocompatibility testing to show that changes in the device (specifically, the cap material and an additional tantalum marker) do not raise new safety or effectiveness concerns compared to the predicate device.
Therefore, many of the requested criteria, such as those related to AI model performance, human reader studies, ground truth establishment for training sets, and sample sizes for AI test sets, are not applicable to this submission.
Here's a breakdown of the information that can be extracted from the provided text, and where the requested information is not applicable:
1. A table of acceptance criteria and the reported device performance
The document provides a table titled "Performance Data – Bench" which outlines various tests, their summaries, and results. These results implicitly define the acceptance criteria, as all tests "met acceptance criteria."
| Test Category | Test Summary / Implicit Acceptance Criteria | Reported Performance (Results) |
|---|---|---|
| Resistance to Leakage | No leakage for 5 minutes with a differential pressure from inside to outside of 1 m H₂O. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding valve integrity/leakage relative to the predicate device." |
| Reservoir Dome Needle Puncture | No leakage when repeatedly punctured with a non-coring needle under pressure. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding valve integrity/leakage relative to the predicate device." |
| Dynamic Breaking Strength | No break, rupture or disconnection after 100,000 cycles at 1.0 $\pm$ 0.2 Hz (with tension applied in flow direction, leading to elongation of shunt of 10% or max force of 5 N). | (Implicitly "met acceptance criteria" as per the concluding statement: "StrataMR™ II valves and shunts met applicable pre-established acceptance criteria and raised no concerns regarding safety and effectiveness relative to the predicate device.") |
| Opening Pressure | Valve must show patency at a pressure that meets manufacturer's specifications. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding valve opening pressure (patency)." |
| Pressure/Flow | Measured pressure must remain inside the manufacturer's specifications (tested per BS EN ISO 7197:2009). | (Implicitly "met acceptance criteria" as per the concluding statement) |
| Posture Effect | Difference between valve pressure at -50 cm hydrostatic pressure and 0 cm hydrostatic pressure must meet manufacturer's specifications. | (Implicitly "met acceptance criteria" as per the concluding statement) |
| Ability to withstand Overpressure | Valves must meet pre-established pressure/flow specifications after application of positive pressure of 1 m water (per BS EN ISO 7197:2009). | "All valves met acceptance criteria, demonstrating that there are no concerns regarding pressure/flow performance relative to the predicate device." |
| Bursting Pressure | Valves must meet pre-established pressure/flow specifications after application of positive pressure of 2 m water (per BS EN ISO 7197:2009). | "All valves met acceptance criteria, demonstrating that there are no concerns regarding pressure/flow performance relative to the predicate device." |
| Long Term Stability | Valves must maintain pre-established pressure/flow specifications after 28 days in a water bath at 37℃ $\pm$ 5° while pumping water through the valves at an average flow rate of 20 mL/h. | (Implicitly "met acceptance criteria" as per the concluding statement) |
| Flushing Capacity | Flushing volume produced from valve reservoir compressions must meet acceptance criteria. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding reservoir volume relative to the predicate device." |
| Identification of Shunts in vivo | Valve identification markers must be visible, and valve setting must be readable in X-ray images. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding identification of the valve via X-ray relative to the predicate device." |
| Post-MRI Functional Testing | After MRI exposure, valves must: (1) maintain pre-conditioning pressure setting, (2) be able to be read and adjusted, and (3) meet pre-established pressure/flow specifications. | "All valves met acceptance criteria, demonstrating that there are no concerns regarding performance after MRI exposure relative to the predicate device." |
| MRI Safety Information | Device must be MR conditional and demonstrate no MRI safety concerns when scanned according to MR conditions specified in labeling (testing per ASTM F2052-15, F2213-06, F2182-11a, F2119-07). | "Test results demonstrated that StrataMR™ II valves are MR conditional and that there are not MRI safety concerns relative to the predicate device when scanned according to the MR conditions specified in the labeling." |
Biocompatibility Testing:
| Test | Test Method Summary / Implicit Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity - MEM Elution | Cell culture treated with test sample exhibited no signs of toxicity (Grade 0). | Non-cytotoxic |
| Irritation - Intracutaneous study in rabbits | Animals treated with test sample exhibited no dermal reactions (Grade 0). | Non-irritant |
| Sensitization - Guinea Pig Maximization | Animals treated with test sample exhibited no dermal reactions. | Non-sensitizer |
| Systemic toxicity - Acute systemic toxicity study in mice | Animals treated with test sample exhibited no mortality or evidence of systemic toxicity. | Non-toxic |
| Material Mediated Pyrogenicity - USP Rabbit Pyrogen Study | Individual animals treated with test sample exhibited no temperature rise above 0.5°C. | Non-pyrogenic |
| Genotoxicity / Carcinogenicity | Test article did not show a significantly greater biological reaction than the controls. | Non-mutagenic |
| Implantation | Test did not show a significantly greater biological reaction than the control (Grade 0 - no reaction). | Non-toxic |
| Hemocompatibility | Test article exhibited no hemolysis and was within the control values. | Non-hemolytic |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable as the provided text describes bench and biocompatibility testing of a physical medical device, not an AI/ML system tested on a data set. The sample size for each bench or biocompatibility test would refer to the number of physical device units or animal subjects used, which is not explicitly stated for individual tests but is inherent in standard device testing protocols. No provenance for "data" in the context of AI is relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. Ground truth, in the context of AI, refers to expert-labeled data for model training/testing. This document describes physical device testing against engineering and biological standards, not AI-based image analysis or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are used to establish ground truth from multiple human experts for AI model evaluation. Not relevant to this device submission.
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, a MRMC comparative effectiveness study was not done. This submission is for a physical medical device (shunt and valve), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This describes a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the bench and biocompatibility tests, the "ground truth" or standard for acceptance is based on:
- Pre-established engineering specifications: For pressure, flow, strength, and durability tests.
- International standards (e.g., BS EN ISO 7197:2009, ASTM F2052-15, F2213-06, F2182-11a, F2119-07): For performance and MRI safety.
- Biocompatibility standards (e.g., ISO 10993-1): For biological safety tests in vitro and in vivo.
There is no "expert consensus" or "pathology" in the AI sense.
8. The sample size for the training set
This is not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
This is not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue box, and the full name, "U.S. Food & Drug Administration," is in blue text.
September 16, 2021
Medtronic Neurosurgery Sudeep Nambiar Regulatory Affairs Manager 5290 California Avenue Irvine, California 92617
Re: K212641
Trade/Device Name: StrataMR II Valves and Shunts Regulation Number: 21 CFR 882.5550 Regulation Name: Central Nervous System Fluid Shunt and Components Regulatory Class: Class II Product Code: JXG Dated: August 17, 2021 Received: August 20, 2021
Dear Sudeep Nambiar:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-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).
Sincerelv.
Adam D. Pierce -S
Adam D. Pierce, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212641
Device Name StrataMR II Valves and Shunts
Indications for Use (Describe)
The StrataMR II 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 of radiographic confirmation.
| 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
- I. Medtronic, Inc. Company: Medtronic Neurosurgery 5290 California Ave Irvine, California 92617 USA
- Swara Vashi Contact: Regulatory Affairs Specialist swara.vashi@medtronic.com Telephone Number: 267-638-8778
- Alternate Contact: Sudeep Nambiar Regulatory Affairs Manager sudeep.nambiar(@medtronic.com Telephone Number: 607-349-9048
Date of Summary Prepared: 19 August 2021
- II. Proprietary Trade Name: StrataMR™ II Valves and Shunts
- III. Regulatory Class: II
IV. Primary Classification:
Name: Central nervous system fluid shunt and components Product Code: JXG Regulation: 882.5550
V. Product Description
The StrataMR™ II adjustable valves are single-use implantable devices which provide a noninvasive method to address changing patient needs in the management of hydrocephalus. The valves and their associated catheters drain cerebrospinal fluid (CSF) from ventricles in the brain into the peritoneal cavity or the right atrium of the heart, where it is absorbed by the body. StrataMR™ II valve incorporates a ball and cone pressure valve in series with a normally closed siphon control mechanism. Flow control is achieved, and retrograde flow is prevented by combined resistance of the ball and cone and siphon control diaphragm. Pre- and postimplantation, the performance level of the valve can be modified by StrataMR™ Adjustment Tools: Locator tool, guider tool, indicator tool and adjustment tool cleared under K181622.
VI. Indications for Use
The StrataMR™ II 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 non-invasively adjust valve pressure/performance level pre-and post-implantation by using magnetic adjustment tools without the need of radiographic confirmation.
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VII. Summary of the Technological Characteristics
The subject device and the predicate device have the same indications for use, intended use, fundamental technology and operating principle. The primary difference between the subject device StrataMR™ II and the predicate StrataMR™ is in the cap material. The cap material of the subject device StrataMR™ II is same as the reference device, Strata™ II that was cleared under K042465 and K060681. An additional tantalum marker has been included on the valves to noninvasively differentiate between the subject StrataMR™ II and predicate StrataMR™ valves. Outer sterile packaging barrier is changed from Mylar to Nylon with Tyvek.
VIII. Identification of Legally Marketed Predicate Devices
Primary Predicate device: StrataMR™ Valves and Shunts Medtronic (K152700) Reference Predicate: Strata™ II Valve and Shunt (K060681)
IX. Device Comparison
The tables below provide a summary of the device
| Characteristic | Subject Device | Predicate Device | Reference Predicate Device |
|---|---|---|---|
| Device Name | StrataMR TM II Valvesand Shunts | StrataMR TM Valves andShunts | Strata TM II Valves andShunts |
| 510k Number | K212641 | K152700 | K060681 |
| Indications for Use | The StrataMR TM IIvalves and shunts aredesigned to providecontinuous cerebrospinalfluid (CSF) flow fromthe ventricles of thebrain into the rightatrium of the heart or theperitoneal cavity. Thedesign enables thephysician to non-invasively adjust valvepressure/performance level pre-and post-implantation by usingmagnetic adjustmenttools without the needfor radiographicconfirmation. | The Medtronic StrataMR TMvalves and shunts aredesigned to providecontinuous cerebrospinalfluid (CSF) flow from theventricles of the brain intothe right atrium of the heartor the peritoneal cavity. Thedesign enables the physicianto non-invasively adjustvalve pressure/performancelevel pre- and post-implantation by usingmagnetic adjustment toolswithout the need forradiographic information. | The Medtronic PSMedical Strata TM II Valveand ShuntAssemblies with andwithout BioGlide areshunt componentsdesigned to providecontinued CSF flow fromthe ventricles of the braininto the right atrium ofthe heart or the peritonealcavity. The design allowsthe physician to non-invasively adjust valvepressure/performance level pre-and post-implantation tool withoutthe need for radiographicconfirmation. |
| Physical Characteristics/ Principal of operation | |||
| Dimension | Maximum Small: 1.93"Length Regular: 2.29" | Small: 1.93"Regular: 2.29" | Small: 1.89"Regular: 2.25" |
| Maximum Small: 0.37"Height Regular :0.42" | Small: 0.35"Regular :0.40" | Small: 0.30"Regular :0.35" | |
| Maximum Small: 0.59"Width Regular: 0.70" | Small: 0.59"Regular: 0.70" | Small: 0.53"Regular: 0.67" | |
| Pressure settings | 5 discrete pressuresettings | Same | Same |
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| Characteristic | Subject Device | Predicate Device | Reference PredicateDevice |
|---|---|---|---|
| Adjustment Tools | Adjustment tool setcontains locator tool,indicator tool,adjustment tooland guider tool clearedunder K181622 andK152700 | Same | Strata™ IIadjustment kit containslocator tool, indicatortool and Adjustment toolcleared under K060681 |
| Shunt systemcomponents | Valves used withexisting, legallymarketed shuntcomponents andaccessories | Same | Same |
| Patient contact andduration | Tissue/bone contact withlong term duration (>30days) | Same | Same |
| Shelf Life | 22 months | 3 years | 3 years |
| Sterilization Method | Ethylene Oxide | Same | Same |
| Packaging material | Valves and shunts arepackaged in plastic traysealed with Tyvek lid.Sealed tray is placed in aTyvek-Nylon peel pouchwhich is then placed incarton. | Valves and shunts arepackaged in plastictray sealed with Tyvek lid.Sealed tray is placed in aTyvek-Mylar peel pouch(StrataMR valves model no.42955 & 42965) or Tyvek-Nylon pouch (StrataMRshunt assembly model no.46955 & 46965) which isthen placed in carton | Valves and shunts arepackaged in plastic traysealed with Tyvek lid.Sealed tray is placed in aTyvek-Nylon peel pouchwhich is then placed incarton. |
X. Discussion of the Performance testing
Performance Data – Bench
| Test | Test Summary | Results |
|---|---|---|
| Resistance toLeakage | Resistance to leakage was measured using air. Thevalves were required to show no leakage for 5 minuteswith a differential pressure from inside to outside of 1m H₂O. | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding valve |
| Reservoir domeneedle puncture | Reservoir domes were required to show no leakagewhen repeatedly punctured with a non-coring needleunder pressure. | integrity/leakage relative tothe predicate device. |
| Test | Test Summary | Results |
| DynamicBreakingStrength | Tension was applied in the flow direction, leading toan elongation of the shunt of 10% or a maximum forceof 5 N. Shunts were required to exhibit no break,rupture or disconnection after 100,000 cycles atfrequency 1.0 $\pm$ 0.2 Hz. | |
| Opening Pressure | The test demonstrates valve flow following valvemanufacture, the valve was to show patency at apressure that meets manufacturer's specifications | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding valve openingpressure (patency). |
| Pressure/Flow | Pressure/flow performance was tested in accordance toBS EN ISO 7197:2009. The measured pressure has toremain inside the manufacturer's specifications | |
| Posture Effect | The test compared valve pressure at -50 cm hydrostaticpressure with valve pressure at 0 cm hydrostaticpressure. The difference was required to meetmanufacturer's specifications | |
| Ability towithstandOverpressure | After application of positive pressure of 1 m water tothe open shunt in accordance with BS EN ISO7197:2009, valves were required to meet pre-established pressure/flow specifications. | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding pressure/flowperformance relative to thepredicate device. |
| Bursting Pressure | After application of positive pressure of 2 m water inaccordance with BS EN ISO 7197:2009, valves wererequired to meet pre-established pressure/flowspecifications. | |
| Long TermStability | Valves were placed in a water bath with temperatureof 37℃ $\pm$ 5° while pumping water through the valvesat an average flow rate of 20 mL/h for 28 days. Duringthis time, valves were required to maintain pre-established pressure/flow specifications. | |
| Flushing capacity | Flushing volume that is produced from valve reservoircompressions was tested. | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding reservoir volumerelative to the predicatedevice. |
| Identification ofshunts in vivo | Valves underwent X-ray imaging. The valveidentification markers must be visible, and the valvesetting must be readable in the X-ray images. | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding identification of thevalve via X-ray relative to thepredicate device. |
| Test | Test Summary | Results |
| Post-MRIFunctionalTesting | Valves were exposed to multiple MRI exposures inclinically relevant orientations. After MRI exposure,valves were required to: (1) maintain the pre-conditioning pressure setting, (2) be able to be readand adjusted, and (3) meet pre-establishedpressure/flow specifications. | All valves met acceptancecriteria, demonstrating thatthere are no concernsregarding performance afterMRI exposure relative to thepredicate device. |
| MRI SafetyInformation | Magnetically induced displacement force testing• per ASTM F2052-15Magnetically induced torque testing per ASTM• F2213-06Radio Frequency induced heating testing per• ASTM F2182-11aImage artifact testing per ASTM F2119-07• | Test results demonstrated thatStrataMR ™ II valves are MRconditional and that there arenot MRI safety concernsrelative to the predicate devicewhen scanned according tothe MR conditions specifiedin the labeling. |
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StrataMR™ II valves and shunts met applicable pre-established acceptance criteria and raised no concerns regarding safety and effectiveness relative to the predicate device. Therefore, bench testing summarized above supports the substantial equivalence of StrataMR™ II and the predicate.
Biocompatibility Testing
The following Biocompatibility tests were conducted per ISO 10993-1 endpoints for tissue/bone/CSF implant device with long-term contact.
| Test | Test Method Summary | Results |
|---|---|---|
| Cytotoxicity- MEM Elution | Cell culture treated with test sample exhibited no signs of toxicity (Grade 0) | Non-cytotoxic |
| Irritation-Intracutaneous study in rabbits | Animals treated with test sample exhibited no dermal reactions (Grade 0) | Non-irritant |
| Sensitization- Guinea Pig Maximization | Animals treated with test sample exhibited no dermal reactions. | Non-sensitizer |
| Systemic toxicity - Acute systemic toxicity study in mice | Animals treated with test sample exhibited no mortality or evidence of systemic toxicity | Non-toxic |
| Material Mediated Pyrogenicity- USP Rabbit Pyrogen Study | Individual animals treated with test sample exhibited no temperature rise above 0.5°C | Non-pyrogenic |
| Genotoxicity/ Carcinogenicity | The test article did not show a significantly greater biological reaction than the controls | Non-mutagenic |
| Implantation | The test did not show a significantly greater biological reaction than the | Non-toxic |
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| Test | Test Method Summary | Results |
|---|---|---|
| control (Grade 0 - noreaction) | ||
| Hemocompatibility | The test article exhibited nohemolysis and was within thecontrol values | Non-hemolytic |
StrataMR™ II valves and shunts passed biocompatibility testing demonstrating that StrataMRTM II material change does not raise biocompatibility concerns relative to predicate device. Therefore, biocompatibility testing summarized above supports the substantial equivalence of StrataMRTM II to the predicate device.
Performance Data - Animal
No animal testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well established acceptable scientific methods.
Performance Data - Clinical
No clinical testing was conducted. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well established acceptable scientific methods.
XI. Conclusion
Based on indications for use, design, technological characteristics, and performance testing conducted on the proposed device, it can be concluded that the StrataMR™ II valves and Shunts are substantially equivalent to StrataMR™ valves and Shunts cleared under K152700.
§ 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).