(30 days)
The Synchro? 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.
Like the primary predicate device, the Synchro2 Support Guidewire is a single-use product with a shapeable tip in straight and pre-shape configurations used to gain intravascular access to and 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.
This document describes the testing performed for the Stryker Neurovascular Synchro2 Support Guidewire (K190843) to demonstrate its substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tip Stiffness | Not explicitly stated in the provided text, but implied as a quantitative measure. | "Met established acceptance criteria" |
| Fracture | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Tip Integrity | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Particulate Characterization | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Coating Integrity Visual Inspection | Not explicitly stated in the provided text. | "Met established acceptance criteria" |
| Biocompatibility | Meet biological safety requirements per EN ISO 10993-1:2009 for externally communicating medical devices with circulating blood contact for less than 24 hours. | Met biological safety requirements (based on previous clearance of predicate device using same materials and processes). |
| Sterilization | Adopted into a validated sterilization process in accordance with EN ISO 11135: 2014/AC: 2014 principles. | Validated sterilization process in accordance with EN ISO 11135: 2014/AC: 2014 principles. |
| Shelf Life | Not affected by aging; no changes to existing shelf life. | "No changes to existing shelf life." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each of the confirmatory tests (Tip Stiffness, Fracture, Tip Integrity, Particulate characterization, Coating integrity). The tests are described as "confirmatory testing."
The data provenance is not explicitly stated in terms of country of origin, nor is it specified whether the studies were retrospective or prospective. Given the nature of a 510(k) submission for a medical device modification, these are likely laboratory-based, in-vitro performance tests conducted by the manufacturer (Stryker Neurovascular) in a controlled environment.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This type of submission (510(k) for a guidewire) relies on engineering and material performance testing rather than clinical expert evaluation of images or patient data to establish ground truth. Therefore, the concept of "experts" as in radiologists or physicians establishing ground truth for a test set is not applicable here. The ground truth for these tests is based on established engineering and material science principles, industry standards, and the performance of the predicate device.
4. Adjudication Method for the Test Set
Not applicable. This is not a study involving human readers or subjective interpretation where adjudication would be necessary. The tests are objective, quantifiable measurements of physical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not explicitly mentioned or presented in the provided document. This type of study is typically associated with AI/CAD devices or diagnostic tools where human interpretation plays a significant role. The submission is for a physical medical device (guidewire) and focuses on engineering equivalence.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
Not applicable. There is no algorithm or AI component in this device. The testing focuses on the physical performance of the guidewire itself.
7. The Type of Ground Truth Used
The ground truth used for the performance testing is based on:
- Established engineering specifications and design requirements: Each test would have a defined pass/fail criterion based on the device's intended function and safety.
- Performance of the Primary Predicate Device (K053268): The goal is to demonstrate that the modified device performs "as well as" the predicate device. Performance standards are likely derived from the predicate's known characteristics and regulatory clearance.
- Relevant industry standards: Such as ISO standards mentioned for biocompatibility (EN ISO 10993-1:2009) and sterilization (EN ISO 11135: 2014/AC: 2014).
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device. The testing describes verification and validation of a physical medical device.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
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May 1, 2019
Stryker Neurovascular Lorraine Mazzeo Senior Regulatory Affairs Specialist 47900 Bayside Parkway Fremont, California 94538
Re: K190843
Trade/Device Name: Synchro2 Support Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF, DQX Dated: March 29, 2019 Received: April 1, 2019
Dear Lorraine Mazzeo:
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
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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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
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
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Indications for Use
510(k) Number (if known) K190843
Device Name Synchro2 Support Guidewire
Indications for Use (Describe)
The Synchro? 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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
| Device Trade Name: | Synchro² Support Guidewire |
|---|---|
| Common Name: | Wire, Guide, Catheter |
| Classification Name: | Wire, Guide, Catheter, 21CFR 870.1330, Class I |
| Product Code: | MOF, DQX |
| Submitter: | Stryker Neurovascular47900 Bayside ParkwayFremont, CA 94538Facility Registration #300853977 |
| Contact: | Lorraine MazzeoSenior Regulatory Affairs SpecialistTel 510 – 413-2676 |
E-mail: lorraine.mazzeo@stryker.com
March 29, 2019 Date Prepared:
| Primary Predicate Device | |
|---|---|
| K053268(clearance granted 13 Mar 2006) | Synchro² Guidewires |
| Reference Predicate Devices | |
| K002907(clearance granted 03 Mar 2001) | Synchro 14 Guidewires |
| K971254(clearance granted 01 Jul 1997) | Transend Guidewires |
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Device Description
Like the primary predicate device, the Synchro2 Support Guidewire is a single-use product with a shapeable tip in straight and pre-shape configurations used to gain intravascular access to and 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.
Accessories
The Synchro² Support Guidewire is shipped with a Torque Device, commercially available from Merit Medical (K936032) and a Guidewire Introducer commercially available from B. Braun (K760386).
Indications for Use
The Indications for Use for the Synchro2 Support Guidewire are the same as the primary predicate Synchro² Guidewire and are as follows:
The Synchro2 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.
Technological Characteristics and Product Feature Comparison
The subject device, Synchro2 Support Guidewire is substantially equivalent to the primary predicate device in terms of:
- indications for use
- materials and manufacturing processes
- fundamental scientific technology
- fundamental design
- materials and processes for packaging and sterilization of devices
A tabular comparison of the specific technological characteristics between the predicate devices and subject device is provided below.
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| Feature | Primary Predicate Device (K053268) | Subject Device |
|---|---|---|
| Indications for Use | The Synchro² Guidewire series is intendedfor general intravascular use, includingneurovascular and peripheral vasculatures.It can be used to selectively introduce andposition catheters and other interventionaldevices within the peripheral andneurovasculature. This device should beused only by physicians trained inpercutaneous, intravascular techniquesand procedures. | Same |
| Device Description | The Synchro² Guidewire series is a single-use product with a shapeable tip, used togain intravascular access to and facilitatethe positioning and exchange ofinterventional devices in small diameter,tortuous vasculature for neuro andperipheral diagnostic and interventionalprocedures. The wire can be torqued tofacilitate navigation through thevasculature. | Same |
| Target Population | The Synchro² Guidewire series will beused in patients undergoing endovasculartreatment including neurovascular andperipheral vasculatures. | Same |
| Anatomical Sites | Peripheral and neuro vasculature | Same |
| Regulation Number | 21CFR 870.1330 | Same |
| Regulation Name | Guide Wire | Same |
| Regulatory Class | II | Same |
| Product Code | DQX | MOF, DQX |
| Feature | Primary Predicate Device (K053268) | Subject Device |
| Core Wire | 304 Stainless Steel, PTFE coated on theproximal section | Same |
| Core Wire Length | 200cm Access Length300cm Exchange Length | 215cm Access Length300cm Exchange Length |
| Guidewire Tip | Nickel-Titanium,Micro-Machined Nitinol | Same |
| Radiopaque Coil | Platinum, 10cm | Platinum, 7cm |
| Adhesive | UV Curable Adhesive | Same |
| Primer | Parylene Dimer | Same |
| Hydrophilic Top Coat | Proprietary Hydrophilic Top Coat | Same |
| Hydrophilic Base Coat | Proprietary Hydrophilic Base Coat | Same |
| Guidewire Introducer | Available commercially per K760389 | Same |
| Torque Device | Available commercially per K936032 | Same |
| Dispenser Hoop | High Density Polyethylene | Same |
| Accessory Card | Clay Coated Solid Bleached Sulfate(CCSBS) | Same |
| Sterile Pouch | Tyvek® - Polyethylene | Same |
| Shipping Carton | Solid Bleached Sulphate (SBS) | Same |
| Sterilization Method | 100% Ethylene Oxide | Same |
| How Supplied | Sterile/Single Use | Same |
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Risk Assessment
Risk assessment of the modifications has been conducted in accordance with EN ISO 14971:2012. 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
The results of confirmatory testing conducted on the subject device demonstrate that it performs as designed and is suitable for its intended use. Specifically, the following tests were performed on the subject device.
| Test | Conclusions |
|---|---|
| Tip Stiffness | Met established acceptance criteria |
| Fracture | Met established acceptance criteria |
| Tip Integrity | Met established acceptance criteria |
| Particulate characterization | Met established acceptance criteria |
| Coating integrity visual inspection | Met established acceptance criteria |
Biocompatibility
Biocompatibility testing was completed for the previously cleared devices under 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 EN 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.
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Sterilization and shelf life
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 EN ISO 11135: 2014/AC: 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 standards assessment conducted by Stryker.
There are no material changes. All components that are changing are metal, which are not affected by aging. There are no changes to existing shelf life.
Summary of Substantial Equivalence
The subject device is substantially equivalent to the primary 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.
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.