(234 days)
Not Found
No
The 510(k) summary describes a physical medical device (guidewire) and its performance and biocompatibility testing. There is no mention of software, algorithms, image processing, AI, ML, or any related concepts.
No
The device is a guidewire that facilitates the placement and exchange of therapeutic devices, but it is not a therapeutic device itself.
No
A diagnostic device is used to identify or analyze a disease or condition. This guidewire is intended to facilitate the placement and exchange of therapeutic devices, which is an interventional or therapeutic function, not a diagnostic one.
No
The device description clearly outlines physical components like a core wire, coils, coatings, a shaping mandrel, and a torque device, indicating it is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Synxess Neurovascular Guidewire Function: The description clearly states the device is a guidewire used within the neuro vasculature to facilitate the placement and exchange of other therapeutic devices. It is a tool used during a medical procedure, not for analyzing samples outside the body.
The intended use and device description are consistent with a surgical or interventional device, not an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes
MOF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Synxess Neurovascular Guidewire passed all performance bench testing in accordance with internal requirements, referenced guidance and international standards. Biocompatibility testing was assessed according to ISO 10993-1, and included Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen, Hemolysis, Complement Activation SC5b-9, and Thromboresistance Evaluation. All tests resulted in "Pass". Sterilization validation was performed per ISO 11135:2014, and sterilant residuals met acceptance criteria per ISO 10993-7:2008. Shelf-life validation of 3 years was performed through accelerated aging. No clinical testing was deemed necessary.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 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.
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November 18, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. The logo is clean and professional, reflecting the organization's role in regulating food and drugs.
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"
1
(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).
2
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
3
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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4
510(k) Summary
Synxess Neurovascular Guidewire K240871
| Submission Sponsor: | Enlight Medical Technologies (Shenzhen) Co., Ltd.
5-6/F, Building A, Xinghui Technology Industrial Park, 52
Huaning Road, Xinshi Community, Dalang Street, Longhua
District, Shenzhen, 518109, P.R.China
Tel: +86-755-2100-4622 |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant Contact: | Eason Zhao
min_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)
5
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 Device
ASAHI CHIKAI | Predicate Device
ASAHI CHIKAI 10 | Subject Device
Synxess Neurovascular
Guidewire |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K110584 | K112979 | K240871 |
| Regulation Number | 21 CFR 870.1330 | | Same |
| Regulation Class | II | | Same |
| Product Code | MOF | | Same |
| Indications for
Use/Intended Use | ASAHI Neurovascular Guide Wire 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 guide wire is
intended for use only in the neuro vasculature. | ASAHI Neurovascular Guide Wire 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 guide wire is
intended for use only in the neuro vasculature. | 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. |
| Anatomical Site | Neuro vasculature | Neuro vasculature | Same |
| Function | The guidewire is used to facilitate the placement
and exchange of therapeutic devices. | The guidewire is used to facilitate the placement
and exchange of therapeutic devices. | Same |
| Proximal Diameter | 0.014 inch | 0.010 inch | GW1410: 0.014 inch
GW1010: 0.010 inch |
6
| Item | Predicate Device
ASAHI CHIKAI | Predicate Device
ASAHI CHIKAI 10 | Subject Device
Synxess Neurovascular
Guidewire |
|-----------------------------|-------------------------------------------------------------------------------------------|-------------------------------------|------------------------------------------------------|
| Distal Diameter | 0.014 inch | 0.010 inch | 0.010 inch |
| Guidewire Length | 200 cm, 300 cm | | 200 cm |
| Core Wire
Configuration | Stainless Steel core wire | | Same |
| Coil Length (Tip
Length) | 30 cm | 9.5 cm | 30 cm |
| Coil Configuration | Platinum/Nickel and Stainless Steel coils | | Platinum/Tungsten and
Stainless Steel coils |
| Tip Type and Shape | Straight, shapeable | | Same |
| Tip Flexibility | Standard | | Same |
| Radiopaque Coil
Location | 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 and
Stainless Steel |
| Coating Material | Distal: Hydrophilic
Proximal: PTFE (only 300 cm guide wire) | | Same |
| Bonding Method | Soldering | | Same |
| Accessory | Inserter, Shaping Device, and Torque Device | | Shaping Tool, Torque
Device |
| Packaging
Configuration | Guidewire is inserted in a tube, placed in
peelable 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 Drug | |
| Administration Staff: Coronary, Peripheral, and | ||
| Neurovascular Guidewires - Performance Tests and | ||
| Recommended Labeling, October 2019 | ||
| (thereinafter, “FDA Guidewire Guidance”) and ISO | Pass |
7
| 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 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 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 ( | 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
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.