StrataMR II Valves and Shunts

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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. 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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # 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) | | |----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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. {4}------------------------------------------------ #### 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 Valves<br>and Shunts | StrataMR TM Valves and<br>Shunts | Strata TM II Valves and<br>Shunts | | 510k Number | K212641 | K152700 | K060681 | | Indications for Use | The StrataMR TM II<br>valves and shunts are<br>designed to provide<br>continuous cerebrospinal<br>fluid (CSF) flow from<br>the ventricles of the<br>brain into the right<br>atrium of the heart or the<br>peritoneal cavity. The<br>design enables the<br>physician to non-<br>invasively adjust valve<br>pressure/performance lev<br>el pre-and post-<br>implantation by using<br>magnetic adjustment<br>tools without the need<br>for radiographic<br>confirmation. | The Medtronic StrataMR TM<br>valves and shunts are<br>designed to provide<br>continuous cerebrospinal<br>fluid (CSF) flow from the<br>ventricles of the brain into<br>the right atrium of the heart<br>or the peritoneal cavity. The<br>design enables the physician<br>to non-invasively adjust<br>valve pressure/performance<br>level pre- and post-<br>implantation by using<br>magnetic adjustment tools<br>without the need for<br>radiographic information. | The Medtronic PS<br>Medical Strata TM II Valve<br>and Shunt<br>Assemblies with and<br>without BioGlide are<br>shunt components<br>designed to provide<br>continued CSF flow from<br>the ventricles of the brain<br>into the right atrium of<br>the heart or the peritoneal<br>cavity. The design allows<br>the physician to non-<br>invasively adjust valve<br>pressure/performance lev<br>el pre-and post-<br>implantation tool without<br>the need for radiographic<br>confirmation. | | Physical Characteristics/ Principal of operation | | | | | Dimension | Maximum Small: 1.93"<br>Length Regular: 2.29" | Small: 1.93"<br>Regular: 2.29" | Small: 1.89"<br>Regular: 2.25" | | | Maximum Small: 0.37"<br>Height Regular :0.42" | Small: 0.35"<br>Regular :0.40" | Small: 0.30"<br>Regular :0.35" | | | Maximum Small: 0.59"<br>Width Regular: 0.70" | Small: 0.59"<br>Regular: 0.70" | Small: 0.53"<br>Regular: 0.67" | | Pressure settings | 5 discrete pressure<br>settings | Same | Same | {5}------------------------------------------------ | Characteristic | Subject Device | Predicate Device | Reference Predicate<br>Device | |---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Adjustment Tools | Adjustment tool set<br>contains locator tool,<br>indicator tool,<br>adjustment tool<br>and guider tool cleared<br>under K181622 and<br>K152700 | Same | Strata™ II<br>adjustment kit contains<br>locator tool, indicator<br>tool and Adjustment tool<br>cleared under K060681 | | Shunt system<br>components | Valves used with<br>existing, legally<br>marketed shunt<br>components and<br>accessories | Same | Same | | Patient contact and<br>duration | Tissue/bone contact with<br>long term duration (>30<br>days) | Same | Same | | Shelf Life | 22 months | 3 years | 3 years | | Sterilization Method | Ethylene Oxide | Same | Same | | Packaging material | Valves and shunts are<br>packaged in plastic tray<br>sealed with Tyvek lid.<br>Sealed tray is placed in a<br>Tyvek-Nylon peel pouch<br>which is then placed in<br>carton. | Valves and shunts are<br>packaged in plastic<br>tray sealed with Tyvek lid.<br>Sealed tray is placed in a<br>Tyvek-Mylar peel pouch<br>(StrataMR valves model no.<br>42955 & 42965) or Tyvek-<br>Nylon pouch (StrataMR<br>shunt assembly model no.<br>46955 & 46965) which is<br>then placed in carton | Valves and shunts are<br>packaged in plastic tray<br>sealed with Tyvek lid.<br>Sealed tray is placed in a<br>Tyvek-Nylon peel pouch<br>which is then placed in<br>carton. | #### X. Discussion of the Performance testing # Performance Data – Bench | Test | Test Summary | Results | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Resistance to<br>Leakage | Resistance to leakage was measured using air. The<br>valves were required to show no leakage for 5 minutes<br>with a differential pressure from inside to outside of 1<br>m H₂O. | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding valve | | Reservoir dome<br>needle puncture | Reservoir domes were required to show no leakage<br>when repeatedly punctured with a non-coring needle<br>under pressure. | integrity/leakage relative to<br>the predicate device. | | Test | Test Summary | Results | | Dynamic<br>Breaking<br>Strength | Tension was applied in the flow direction, leading to<br>an elongation of the shunt of 10% or a maximum force<br>of 5 N. Shunts were required to exhibit no break,<br>rupture or disconnection after 100,000 cycles at<br>frequency 1.0 $\pm$ 0.2 Hz. | | | Opening Pressure | The test demonstrates valve flow following valve<br>manufacture, the valve was to show patency at a<br>pressure that meets manufacturer's specifications | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding valve opening<br>pressure (patency). | | Pressure/Flow | Pressure/flow performance was tested in accordance to<br>BS EN ISO 7197:2009. The measured pressure has to<br>remain inside the manufacturer's specifications | | | Posture Effect | The test compared valve pressure at -50 cm hydrostatic<br>pressure with valve pressure at 0 cm hydrostatic<br>pressure. The difference was required to meet<br>manufacturer's specifications | | | Ability to<br>withstand<br>Overpressure | After application of positive pressure of 1 m water to<br>the open shunt in accordance with BS EN ISO<br>7197:2009, valves were required to meet pre-<br>established pressure/flow specifications. | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding pressure/flow<br>performance relative to the<br>predicate device. | | Bursting Pressure | After application of positive pressure of 2 m water in<br>accordance with BS EN ISO 7197:2009, valves were<br>required to meet pre-established pressure/flow<br>specifications. | | | Long Term<br>Stability | Valves were placed in a water bath with temperature<br>of 37℃ $\pm$ 5° while pumping water through the valves<br>at an average flow rate of 20 mL/h for 28 days. During<br>this time, valves were required to maintain pre-<br>established pressure/flow specifications. | | | Flushing capacity | Flushing volume that is produced from valve reservoir<br>compressions was tested. | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding reservoir volume<br>relative to the predicate<br>device. | | Identification of<br>shunts in vivo | Valves underwent X-ray imaging. The valve<br>identification markers must be visible, and the valve<br>setting must be readable in the X-ray images. | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding identification of the<br>valve via X-ray relative to the<br>predicate device. | | Test | Test Summary | Results | | Post-MRI<br>Functional<br>Testing | Valves were exposed to multiple MRI exposures in<br>clinically relevant orientations. After MRI exposure,<br>valves were required to: (1) maintain the pre-<br>conditioning pressure setting, (2) be able to be read<br>and adjusted, and (3) meet pre-established<br>pressure/flow specifications. | All valves met acceptance<br>criteria, demonstrating that<br>there are no concerns<br>regarding performance after<br>MRI exposure relative to the<br>predicate device. | | MRI Safety<br>Information | Magnetically induced displacement force testing<br>• per ASTM F2052-15<br>Magnetically induced torque testing per ASTM<br>• F2213-06<br>Radio Frequency induced heating testing per<br>• ASTM F2182-11a<br>Image artifact testing per ASTM F2119-07<br>• | Test results demonstrated that<br>StrataMR ™ II valves are MR<br>conditional and that there are<br>not MRI safety concerns<br>relative to the predicate device<br>when scanned according to<br>the MR conditions specified<br>in the labeling. | {6}------------------------------------------------ {7}------------------------------------------------ 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 | {8}------------------------------------------------ | Test | Test Method Summary | Results | |-------------------|---------------------------------------------------------------------------------|---------------| | | control (Grade 0 - no<br>reaction) | | | Hemocompatibility | The test article exhibited no<br>hemolysis and was within the<br>control 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.