Synchro SELECT Guidewire

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September 25, 2020 Stryker Neurovascular Hailey Hinkle Staff Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538 Re: K202522 Trade/Device Name: Synchro SELECT Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: August 31, 2020 Received: September 1, 2020 Dear Hailey Hinkle: 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 mediation-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). Sincerely, Naira Muradyan, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K202522 Device Name Synchro SELECT Guidewire #### Indications for Use (Describe) The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neurovasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------------------------------------|------------------------------------------------------------------------------| | <div> <span> </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 PRAStaff(@fda.hhs.gov "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}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire ## 510(k) Summary ### Submitter Name, Address and Content: | Submitter: | Stryker Neurovascular<br>47900 Bayside Parkway<br>Fremont, CA 94538-6515<br>(FDA Registration Number: 3008853977) | |----------------|-------------------------------------------------------------------------------------------------------------------| | Contact: | Hailey Hinkle<br>Staff Regulatory Affairs Specialist<br>Phone: 510-413-2500<br>Email: hailey.hinkle@stryker.com | | Date Prepared: | August 31, 2020 | ## Device Name and Classification: | Trade/Proprietary Name: | Synchro SELECT™™ Guidewire | |-------------------------|--------------------------------------------------| | Common Name: | Wire, Guide, Catheter | | Classification Name: | Wire, Guide, Catheter, 21 CFR 870.1330 – Class I | | Product Code: | MOF, DQX | {4}------------------------------------------------ ### Legally Marketed Predicate Device | Primary Predicate Device | | |----------------------------|-------------------------------| | K053268* | PV 2000 Synchro2<br>Guidewire | | Reference Predicate Device | | | K190843 | Synchro2 Support Guidewire | | K971254 | Transend EX Guidewire | *K053268 was submitted to the FDA by Precision Vascular which was acquired by Boston Scientific which was then acquired by Stryker. #### Device Description Like the primary Predicate device, the Synchro SELECT Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Synchro SELECT Guidewire comes in three stiffness profiles: Soft, Standard, and Support. The primary Predicate, PV 2000 Synchro2 Guidewire (K053268), is only available in the Soft and Standard profiles. Therefore, the reference device, Synchro2 Support (K190843), was included to support the similarity in technical characteristics to the Synchro SELECT Support stiffness profile. Certain design inputs and associated acceptance criteria for PV 2000 Synchro2 (K053268) and Synchro2 Support (K190843) were based on the reference device, Transend EX (K971254). #### Accessories The Synchro SELECT Guidewire is shipped with a Torque Device that is commercially available from Merit Medical (K936032), and a Guidewire Introducer that is commercially available from B. Braun (K760389). {5}------------------------------------------------ ### Indications for Use The Indications for Use for the Synchro SELECT Guidewire are the same as the primary Predicate PV 2000 Synchro2 Guidewire and the reference Predicate Synchro2 Support Guidewire and are as follows: The Synchro SELECT Guidewire series is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures. ### Technological Characteristics and Product Feature Comparison The Synchro SELECT Guidewire is substantially equivalent to the Predicate device, the PV 2000 Synchro2 Guidewire, cleared under K053268, based on the following: - Same indications for use . - Same fundamental materials and manufacturing process ● - Same fundamental design and technology - Same operating principles - Same biocompatibility information - Same materials and processes for packaging - . Same sterilization method and process for devices A comparison of the Subject device with the Predicate device is summarized in Table 1 below. {6}------------------------------------------------ | | Predicate Device PV 2000<br>Synchro2 Guidewire (K053268) | Subject Device<br>Synchro SELECT Guidewire | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------| | Classification Name: | Wire, Guide, Catheter, 21 CFR<br>870.1330 - Class II | Same | | Product Code | DQX | MOF, DQX | | Review Panel | Neurology | Same | | 510(k) Submitter1: | Stryker Neurovascular<br>47900 Bayside Pkwy<br>Fremont, CA<br>94538-6515 | Same | | Indications for Use | The PV 2000 Synchro2<br>Guidewire series of products are<br>intended for general intravascular<br>use, including the neuro and<br>peripheral vasculature. The<br>device can be used to selectively<br>introduce and position catheters<br>and other interventional devices<br>within the peripheral and<br>neurovasculature. This device<br>should be used only by<br>physicians trained in<br>percutaneous, intravascular<br>techniques and procedures. | Same | | | Predicate Device PV 2000<br>Synchro2 Guidewire (K053268) | Subject Device<br>Synchro SELECT Guidewire | | Device<br>Description/Principle<br>of Operation | The PV 2000 Synchro2 Guidewire<br>series is a single-use product with a<br>shapeable tip, used to gain<br>intravascular access to and facilitate<br>the positioning and exchange of<br>interventional devices in small<br>diameter, tortuous vasculature for<br>neuro and peripheral diagnostic and<br>interventional procedures. The<br>wire can be torqued to facilitate<br>navigation through the vasculature. | Same | | Target Population | The PV 2000 Synchro2<br>Guidewire series will be used in<br>patients undergoing endovascular<br>treatment including<br>neurovascular and peripheral<br>vasculatures. | Same | | Accessories | Guidewire Introducer, Torque<br>Device | Same | | Core Wire | 304 Stainless Steel, PTFE Coated<br>on the proximal section | Same | | Core Wire Length | 200cm Access Length<br>300cm Exchange Length | 215cm Access Length<br>300cm Exchange Length | | Guidewire Tip | Nickel-Titanium,<br>Micro-Machined Nitinol | Same | | Radiopaque Coil | Platinum, 10cm | Standard and Soft: Platinum,<br>10cm<br>Pre-shaped Support: Platinum,<br>7cm<br>Straight Support: Platinum, 6cm | | | Predicate Device PV 2000<br>Synchro² Guidewire (K053268) | Subject Device<br>Synchro SELECT Guidewire | | Adhesive | UV Curable Adhesive | Same | | Primer | Parylene Dimer | Same | | Hydrophilic Top<br>Coat | Proprietary Hydrophilic Top<br>Coat | Same | | Hydrophilic Base<br>Coat | Proprietary Hydrophilic Base<br>Coat | Same | | Guidewire<br>Introducer | Commercially available per<br>K760389 | Same | | Torque Device | Commercially available per<br>K936032 | Same | | Dispenser Hoop | High Density Polyethylene | Same | | Accessory Card | Clay Coated Solid Bleached<br>Sulfate (CCSBS) | Same | | Sterile Pouch | Tyvek® - Polyethylene | Same | | Shipping Carton | Solid Bleached Sulphate (SBS) | Same | | Sterilization Method | 100% Ethylene Oxide | Same | | How Supplied | Single Use/Sterile | Same | ### Table 1. Product Feature Comparison of Subject Device to Predicate Device ¹ K053268 was submitted to the FDA by Precision Vascular which was acquired by Boston Scientific which was then acquired by Stryker. {7}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire {8}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire The differences between the devices do not raise new questions of safety and effectiveness. {9}------------------------------------------------ #### Risk Assessment Risk assessment of the Synchro SELECT Guidewire has been conducted in accordance with ISO 14971:2007. The risk documentation was updated to support the modifications, and Stryker Neurovascular has determined that the modifications to the primary Predicate device raise no new questions of safety or effectiveness. The modifications did not result in any new failure modes nor were there any changes to existing failure modes. Results of confirmatory testing have demonstrated the Subject device is substantially equivalent to the primary Predicate device. #### Testing Summary Well-established test methods were used to evaluate the Subject device. All design inputs and associated acceptance criteria are identical to that of the primary Predicate (PV 2000 Synchro2 Guidewire, K053268) and the reference device (Synchro2 Support Guidewire, K190843). Some of the design inputs and associated acceptance criteria for PV 2000 Synchro? (K053268) and Synchro2 Support (K190843) were based on the reference device, Transend EX (K971254). The results of confirmatory testing conducted on the Subject device demonstrate that it performs as designed and is suitable for its intended use. A summary of the tests performed on the Subject device is provided below in Table 2. | Test | Test Method Summary | Conclusions | |-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Coating Lubricity | Hydrophilic coating lubricity<br>was assessed after 15 pull<br>cycles through silicone pads. | All Synchro SELECT<br>Guidewires met the specified<br>coating lubricity requirements. | | Coating Durability | Coating durability was<br>assessed after repeated pull<br>cycles through silicone pads<br>(comparing degradation between<br>Cycle 1-2 and Cycles 31-45). | All Synchro SELECT<br>Guidewires met the specified<br>coating durability<br>requirements. | | Test | Test Method Summary | Conclusions | | Torque Response | Track the guidewire through a<br>tortuous simulated use model<br>and evaluate the steerability<br>and torque response compared<br>to the predicate. | All Synchro SELECT<br>Guidewires demonstrated<br>acceptable torque response.<br>The torque response of the<br>subject device was comparable<br>to that of the predicate device. | | Tip Shape-ability | Shape and un-shape the<br>guidewire for a total of five<br>times then visually inspect the<br>distal tip for any fractures at<br>40x magnifications. | All Synchro SELECT<br>Guidewires met the specified<br>tip shape-ability requirements. | | Tip Shape-ability | Shape the tip of the guidewire<br>to 90 degrees and record the<br>tip shaping rating. | All Synchro SELECT<br>Guidewires demonstrated<br>acceptable tip shape-ability.<br>The tip shape-ability of the<br>subject device was comparable<br>to that of the predicate device. | | Tip Flexibility | Measure the force required to<br>deflect the guidewire to a<br>specified number of degrees at<br>20mm. | All Synchro SELECT<br>Guidewires met the specified<br>tip flexibility requirements. | | Tensile Strength | Measure the force required to<br>break the guidewire tip. | All Synchro SELECT<br>Guidewires met the specified<br>tensile strength requirements. | | Torsional Strength | Record the number of times<br>the proximal end of the wire<br>can be rotated until it exceeds<br>its maximum rotations and<br>fails. | All Synchro SELECT<br>Guidewires met the specified<br>torsional strength<br>requirements. | | Flexure | Testing completed per ISO<br>11070:2014/A1: 2018, Annex<br>G | All Synchro SELECT<br>Guidewires met the specified<br>flexure requirements. | | Test | Test Method Summary | Conclusions | | Fracture | Testing completed per ISO<br>11070:2014/A1: 2018, Annex<br>F | All Synchro SELECT<br>Guidewires met the specified<br>fracture requirements. | | Tip Integrity | Shape, straighten, and re-shape<br>the guidewire in the opposite<br>direction for a total of five<br>times. Inspect at 40X for any<br>fractures or breaks. | All Synchro SELECT<br>Guidewires met the specified<br>tip integrity requirements. | | | Inspect the guidewire for any<br>damage after tracking through<br>a tortuous simulated use<br>model. | All Synchro SELECT<br>Guidewires demonstrated<br>acceptable tip integrity after<br>being tracked through a<br>tortuous simulated use model. | | Particulate Characterization | Count particulates of various<br>size ranges after tracking<br>through a tortuous simulated<br>use model. | Particulate counts were<br>reported and considered<br>acceptable. | | Hydrophilic Coating Integrity | Visually inspect and compare<br>hydrophilic coating before and<br>after tracking through a<br>tortuous simulated use model.<br>Additionally, visually inspect<br>device coating after staining<br>the devices. | All Synchro SELECT<br>Guidewires met the specified<br>hydrophilic coating integrity<br>requirements. | | Tip-shape Retention | Measure the tip shape<br>retention after tracking the<br>guidewire through a tortuous<br>simulated use model. | All Synchro SELECT<br>Guidewires demonstrated<br>acceptable tip-shape retention.<br>The tip-shape retention of the<br>subject device was comparable<br>to that of the predicate device. | | Test | Test Method Summary | Conclusions | | Tip Prolapse | Record the force required for<br>the wire to buckle. | All Synchro SELECT<br>Guidewires met the specified<br>tip prolapse requirements. | | Radiopacity | Subject and predicate<br>guidewires evaluated under<br>fluoroscopy. | All Synchro SELECT<br>Guidewires demonstrated<br>acceptable radiopacity. The<br>radiopacity of the subject<br>device was comparable to that<br>of the predicate device. | Table 2. Confirmation Testing Summary {10}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire {11}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire {12}------------------------------------------------ Premarket Notification, Special 510(k) Synchro SELECT Guidewire ## Performance Data - Animal, Clinical No animal or clinical studies were conducted as there is no change to the indications for use or the fundamental scientific technology. Substantial equivalence of the Subject device has been established to the Predicate devices through the results of bench testing. ### Sterilization and Shelf Life Testing The device and its accessories are sterilized by 100% Ethylene Oxide and have been adopted into a validated sterilization process in accordance with the principles of ISO 11135:2014 ("Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices"). This statement is supported by a standards assessment conducted by Stryker. A sterility assurance level (SAL) of 10-6 has been demonstrated. There are no fundamental material changes compared to the predicate device. All components that are changing are metal, which are not affected by aging. There are no changes to existing shelf life. As with the Predicate device, the Synchro SELECT Guidewire is labeled with a 3-year shelf life. {13}------------------------------------------------ Stryker Neurovascular Premarket Notification, Special 510(k) Synchro SELECT Guidewire #### Biocompatibility Biocompatibility testing was conducted for the Predicate device (K053268). These results apply to the Subject device because it uses the same materials and processes as previously cleared primary Predicate device. The results demonstrate that the Subject device with its accessories meet biological safety requirements per ISO 10993-1:2009 ("Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process ") for externally communicating medical devices with circulating blood contact for less than 24 hours. This statement is supported by standards assessment conducted by Stryker. #### Conclusion The Subject device is substantially equivalent to the Predicate device with regards to device design, materials, intended use, and patient population. The conclusions drawn from the risk assessments and confirmatory testing conducted demonstrate that the Subject device performs as designed, is as safe, as effective, and performs as well as the Predicate device.