(234 days)
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm) and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.
The provided text describes a 510(k) premarket notification for a medical device, the Synxess Neurovascular Guidewire, and details the non-clinical testing performed to establish substantial equivalence to predicate devices. It does not describe an AI/ML-driven device or a study involving human readers and AI assistance. Therefore, many of the requested points in the prompt (e.g., AI performance metrics, MRMC study, expert ground truth establishment for AI, training set details) are not applicable to this document.
However, I can provide information based on the provided text regarding the device's acceptance criteria and the study that proves it meets them, focusing on the non-clinical performance testing conducted for a guidewire.
Here's the breakdown based on the provided document:
Acceptance Criteria and Device Performance for Synxess Neurovascular Guidewire
The acceptance criteria for this non-AI device are based on passing various performance bench tests and biocompatibility tests in accordance with relevant international standards and FDA guidance. The study proving the device meets these criteria is the battery of non-clinical tests performed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implicitly "Pass" or "Met acceptance criteria" as defined by the referenced standards and guidance documents. The reported device performance for all listed tests was successful.
| Test | Standards, Guidance, Test Method | Reported Device Performance |
|---|---|---|
| Visual Inspection | FDA Guidewire Guidance and ISO 11070 | Pass |
| Dimensional Verification | FDA Guidewire Guidance and ISO 11070 | Pass |
| Simulated Use | FDA Guidewire Guidance | Pass |
| Tensile Strength and Tip Pull | FDA Guidewire Guidance and ISO 11070 | Pass |
| Torque Strength | FDA Guidewire Guidance | Pass |
| Torqueability | FDA Guidewire Guidance | Pass |
| Coating Integrity | FDA Guidewire Guidance | Pass |
| Particulate Evaluation | FDA Guidewire Guidance | Pass |
| Lubricity | FDA Guidewire Guidance | Pass |
| Corrosion Resistance | FDA Guidewire Guidance and ISO 11070 | Pass |
| Kink Resistance | FDA Guidewire Guidance | Pass |
| Tip Flexibility | FDA Guidewire Guidance | Pass |
| Radiopacity | FDA Guidewire Guidance and ISO 11070 | Pass |
| Fracture Test | ISO 11070 | Pass |
| Flexing Test | ISO 11070 | Pass |
| Shaping Mandrel Visual and Dimensional Inspection | The shaping mandrel was examined for signs of impurities or defects. The mandrel length and outer diameter were measured. | Met acceptance criteria |
| Shaping Mandrel Corrosion Resistance | ISO 11070 | Pass |
| Shaping Mandrel Tensile Strength | The tensile strength between the shaping mandrel rod and handle was measured. | Met acceptance criteria |
| Torque Device Visual Inspection and Simulated Use | The torque device was examined for signs of impurities or defects. Simulated use evaluated the torque device compatibility and performance. | Met acceptance criteria |
| Biocompatibility Tests | ||
| Cytotoxicity Study Using MTT Method | ISO 10993-5 | Pass |
| Sensitization Study Guinea Pig Maximization Test | ISO 10993-10 | Pass |
| Intracutaneous Reactivity Test In Rabbits | ISO 10993-23 | Pass |
| Acute Systemic Toxicity Study In Mice | ISO 10993-11 | Pass |
| Pyrogen Test In Rabbits | ISO 10993-11 / USP<151> | Pass |
| Hemolysis Assay-Direct Contact And Extract Methods | ISO 10993-4 / ASTM F756-17 | Pass |
| Complement Activation SC5b-9 Assay | ISO 10993-4 | Pass |
| Thromboresistance Evaluation In Dogs | ISO 10993-4 | Pass |
| Sterilization Validation | ||
| EO Sterilization Process Validation | ISO 11135:2014 | Validated |
| Sterilant Residuals | ISO 10993-7:2008 | Met acceptance criteria |
| Shelf-Life Validation | ||
| Shelf-Life (3 years) | Testing of accelerated aged devices | Validated |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of guidewires) used for each individual performance bench test or biocompatibility test. It only states that the device "passed all performance bench testing." For biocompatibility, some tests specify animal models (e.g., guinea pig, rabbits, mice, dogs), but the specific number of animals is not provided.
- Data Provenance: The document generally indicates that the tests were performed in accordance with "internal requirements, referenced guidance and international standards." The country of origin for the data is implied to be from the manufacturer, Enlight Medical Technologies (Shenzhen) Co., Ltd., located in China. The data would be considered prospective as it was generated specifically for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This question is not applicable as this is a physical medical device (guidewire), not an AI/ML-driven diagnostic device requiring expert clinical interpretation for ground truth. The "ground truth" for these tests is defined by the physical and chemical properties measured against established engineering and biological standards.
4. Adjudication Method for the Test Set
- This question is not applicable for the reasons stated above. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where human interpretation of medical images or patient data requires consensus, which is not relevant here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study was not performed because this is a physical medical device, not an AI/ML-driven system that assists human readers in diagnostic tasks. The document explicitly states: "No clinical testing was deemed necessary to support the substantial equivalence of the subject device."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an algorithm-only device.
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is established by engineering standards (e.g., measurements of tensile strength, torqueability, flexibility, dimensions) and biological/chemical standards for biocompatibility (e.g., cytotoxicity assays, pyrogen tests, hemolysis assays). These are objective, quantifiable measures against predefined acceptance criteria from international standards (e.g., ISO 11070, ISO 10993 series) and FDA guidance.
8. The Sample Size for the Training Set
- Not applicable. This is a physical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. This is a physical device, not an AI/ML model.
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November 18, 2024
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Enlight Medical Technologies (Shenzhen) Co., Ltd. Kason Gui RA Manager 5-6/F, Building A, Xinghui Technology Industrial Park 52 Huaning Road, Xinshi Community, Dalang Street, Longhua District Shenzhen, 518109 China
Re: K240871
Trade/Device Name: Synxess Neurovascular Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: MOF Dated: March 30, 2024 Received: October 15, 2024
Dear Kason Gui:
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 (the 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 available 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 that the Center for Devices and Radiological Health (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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the quality system (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 QS regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the medical device report (MDR) regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-devicesafety/medical-device-reporting-mdr-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).
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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-devices/deviceadvice-comprehensive-regulatory-assistance/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.
Xiaolin Zheng -S
For 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
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Indications for Use
510(k) Number (if known) K240871
Device Name Synxess Neurovascular Guidewire
Indications for Use (Describe)
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
| 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
Synxess Neurovascular Guidewire K240871
| Submission Sponsor: | Enlight Medical Technologies (Shenzhen) Co., Ltd.5-6/F, Building A, Xinghui Technology Industrial Park, 52Huaning Road, Xinshi Community, Dalang Street, LonghuaDistrict, Shenzhen, 518109, P.R.ChinaTel: +86-755-2100-4622 |
|---|---|
| Applicant Contact: | Eason Zhaomin_zhao@enlight-medical.com |
Correspondent Contact: Kason Gui jinpeng gui@enlight-medical.com
Date Prepared: November 14, 2024
| Subject Device | |
|---|---|
| Trade Name: | Synxess Neurovascular Guidewire |
| Common Name: | Catheter Guide Wire |
| Classification Name: | Guide, Wire, Catheter, Neurovasculature |
| Regulation Number: | 21 CFR 870.1330 |
| Product Code: | MOF |
| Classification: | Class II |
Predicate Devices:
Predicate: ASAHI CHIKAI Neurovascular Guide Wire (K110584, product code MOF) Predicate: ASAHI CHIKAI 10 Neurovascular Guide Wire (K112979, product code MOF)
Indications for Use Statement
Synxess Neurovascular Guidewire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guidewire is intended for use only in the neuro vasculature.
Device Description
The Synxess Neurovascular Guidewire is available in diameters of 0.014 inch (0.35 mm)
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and 0.010 inch (0.25 mm) and has 200 cm length. The device is comprised of a core wire, coils, and coatings, and is supplied with a shaping mandrel and a torque device. The guidewire distal tip is straight and shapeable. The device is provided sterile and is for single use.
Comparison of Technological Characteristics
The subject device, Synxess Neurovascular Guidewire, is substantially equivalent to the predicate devices in terms of:
- indications for use; .
- . materials;
- technological characteristics; .
- packaging and sterilization of devices. .
The differences in technological characteristics do not raise new questions of safety and effectiveness compared to the predicate devices as outlined in the comparison table below.
| Item | Predicate DeviceASAHI CHIKAI | Predicate DeviceASAHI CHIKAI 10 | Subject DeviceSynxess NeurovascularGuidewire |
|---|---|---|---|
| 510(k) Number | K110584 | K112979 | K240871 |
| Regulation Number | 21 CFR 870.1330 | Same | |
| Regulation Class | II | Same | |
| Product Code | MOF | Same | |
| Indications forUse/Intended Use | ASAHI Neurovascular Guide Wire is intendedto be used in the neuro vasculature to facilitatethe placement and exchange of therapeuticdevices such as cerebral catheters duringintravascular therapy. This guide wire isintended for use only in the neuro vasculature. | ASAHI Neurovascular Guide Wire is intendedto be used in the neuro vasculature to facilitatethe placement and exchange of therapeuticdevices such as cerebral catheters duringintravascular therapy. This guide wire isintended for use only in the neuro vasculature. | Synxess NeurovascularGuidewire is intended to beused in the neurovasculature to facilitate theplacement and exchange oftherapeutic devices such ascerebral catheters duringintravascular therapy. Thisguidewire is intended foruse only in the neurovasculature. |
| Anatomical Site | Neuro vasculature | Neuro vasculature | Same |
| Function | The guidewire is used to facilitate the placementand exchange of therapeutic devices. | The guidewire is used to facilitate the placementand exchange of therapeutic devices. | Same |
| Proximal Diameter | 0.014 inch | 0.010 inch | GW1410: 0.014 inchGW1010: 0.010 inch |
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| Item | Predicate DeviceASAHI CHIKAI | Predicate DeviceASAHI CHIKAI 10 | Subject DeviceSynxess NeurovascularGuidewire |
|---|---|---|---|
| Distal Diameter | 0.014 inch | 0.010 inch | 0.010 inch |
| Guidewire Length | 200 cm, 300 cm | 200 cm | |
| Core WireConfiguration | Stainless Steel core wire | Same | |
| Coil Length (TipLength) | 30 cm | 9.5 cm | 30 cm |
| Coil Configuration | Platinum/Nickel and Stainless Steel coils | Platinum/Tungsten andStainless Steel coils | |
| Tip Type and Shape | Straight, shapeable | Same | |
| Tip Flexibility | Standard | Same | |
| Radiopaque CoilLocation | 5 cm from tip | 3 cm from tip | 3 cm from tip |
| Core Wire Material | Stainless Steel | Same | |
| Coils Material | Platinum/Nickel and Stainless Steel | Platinum/Tungsten andStainless Steel | |
| Coating Material | Distal: HydrophilicProximal: PTFE (only 300 cm guide wire) | Same | |
| Bonding Method | Soldering | Same | |
| Accessory | Inserter, Shaping Device, and Torque Device | Shaping Tool, TorqueDevice | |
| PackagingConfiguration | Guidewire is inserted in a tube, placed inpeelable pack, and then in a packaging box. | Same | |
| Sterilization Method | Ethylene Oxide | Same | |
| Method of Supply | Sterile/Single Use | Same | |
| Shelf Life | 3 years | Same |
Testing Summary
The Synxess Neurovascular Guidewire passed all performance bench testing in accordance with internal requirements, referenced guidance and international standards as shown in the table below to support substantial equivalence of the device.
| Test | Standards, Guidance, Test Method | Results |
|---|---|---|
| Visual Inspection | FDA Guidance for Industry and Food and DrugAdministration Staff: Coronary, Peripheral, andNeurovascular Guidewires - Performance Tests andRecommended Labeling, October 2019(thereinafter, “FDA Guidewire Guidance”) and ISO | Pass |
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| 11070 | ||
|---|---|---|
| Dimensional Verification | FDA Guidewire Guidance and ISO 11070 | Pass |
| Simulated Use | FDA Guidewire Guidance | Pass |
| Tensile Strength and Tip Pull | FDA Guidewire Guidance and ISO 11070 | Pass |
| Torque Strength | FDA Guidewire Guidance | Pass |
| Torqueability | FDA Guidewire Guidance | Pass |
| Coating Integrity | FDA Guidewire Guidance | Pass |
| Particulate Evaluation | FDA Guidewire Guidance | Pass |
| Lubricity | FDA Guidewire Guidance | Pass |
| Corrosion Resistance | FDA Guidewire Guidance and ISO 11070 | Pass |
| Kink Resistance | FDA Guidewire Guidance | Pass |
| Tip Flexibility | FDA Guidewire Guidance | Pass |
| Radiopacity | FDA Guidewire Guidance and ISO 11070 | Pass |
| Fracture Test | ISO 11070 | Pass |
| Flexing Test | ISO 11070 | Pass |
| Shaping Mandrel Visual andDimensional Inspection | The shaping mandrel was examined for signs of impurities or defects. The mandrel length and outer diameter were measured. | Met acceptance criteria |
| Shaping Mandrel CorrosionResistance | ISO 11070 | Pass |
| Shaping Mandrel TensileStrength | The tensile strength between the shaping mandrel rod and handle was measured. | Met acceptance criteria |
| Torque Device VisualInspection and Simulated Use | The torque device was examined for signs of impurities or defects. Simulated use evaluated the torque device compatibility and performance. | Met acceptance criteria |
Biocompatibility Testing
The Synxess Neurovascular Guidewire was assessed according to the International Standard ISO 10993-1, "Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process." The subject device is classified as an external communicating device with circulating blood contact for a limited duration (<24 hours). The following tests were performed:
| Test | Standard | Results |
|---|---|---|
| Cytotoxicity Study Using MTT Method | ISO 10993-5 | Pass |
| Sensitization Study Guinea Pig Maximization Test | ISO 10993-10 | Pass |
| Intracutaneous Reactivity Test In Rabbits | ISO 10993-23 | Pass |
| Acute Systemic Toxicity Study In Mice | ISO 10993-11 | Pass |
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| Test | Standard | Results |
|---|---|---|
| Pyrogen Test In Rabbits | ISO 10993-11/USP<151> | Pass |
| Hemolysis Assay-Direct Contact And ExtractMethods | ISO 10993-4/ASTM F756-17 | Pass |
| Complement Activation SC5b-9 Assay | ISO 10993-4 | Pass |
| Thromboresistance Evaluation In Dogs | ISO 10993-4 | Pass |
Sterilization Validation
The Synxess Neurovascular Guidewire is sterilized using Ethylene Oxide (EO). The EO sterilization process of the device has been validated per ISO 11135:2014. The sterilant residuals have also been tested and met the acceptance criteria per ISO 10993-7:2008. The device is labeled as "non-pyrogenic".
Shelf-Life Validation
The shelf-life of the Synxess Neurovascular Guidewire is 3 years and is validated by testing of the accelerated aged devices.
Clinical Data
No clinical testing was deemed necessary to support the substantial equivalence of the subject device.
Conclusion
The Synxess Neurovascular Guidewire has the same intended use and indications for use, and similar technological characteristics compared to the predicate ASAHI CHIKAI Neurovascular Guide Wires. The differences in technological characteristics do not raise different questions of safety and effectiveness compared to the predicate, and the nonclinical testing discussed above demonstrates that the subject device performs as intended. Therefore, the subject device is substantially equivalent to the legally marketed predicate devices ASAHI CHIKAI Neurovascular Guide Wire, K110584, and ASAHI CHIKAI 10 Neurovascular Guide Wire, K112979.
§ 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.