(29 days)
No
The description focuses on the physical properties and materials of a guidewire, and the performance studies are bench tests evaluating mechanical characteristics. There is no mention of AI, ML, or any software-driven analytical capabilities.
No
Explanation: The device is a guidewire used to aid in the selective placement of catheters during diagnostic and/or therapeutic procedures, but it does not perform any therapeutic action itself. It is an accessory to therapeutic procedures rather than a therapeutic device.
No
A guidewire is a device used to facilitate the placement of catheters and is not considered a diagnostic device itself. Its purpose is to aid in therapeutic or diagnostic procedures by guiding other devices.
No
The device description clearly describes a physical guidewire made of stainless steel with a platinum coil and hydrophilic coating, along with accessories like a pin vise and introducer needle. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures." This describes a device used within the body for procedural guidance, not for testing samples outside the body to diagnose conditions.
- Device Description: The description details a physical guidewire with a coating and accessories for manipulation and introduction. This aligns with an interventional medical device, not a diagnostic test kit or instrument.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
IVD devices are designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This guidewire does not fit that description.
N/A
Intended Use / Indications for Use
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Product codes
DQX, MOF
Device Description
The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, visceral and cerebral 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
Bench Testing:
- Visual Inspection and Dimensional Verification: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per QP50324. Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for visual inspection and dimensional verification.
- Friction Force: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per TM0047. Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for friction force.
- Flexing: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per ISO 11070. Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for flexing.
- Particulate: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per USP . Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for particulate.
- Tensile Strength: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per ISO 11070. Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for tensile strength.
- Corrosion Resistance: The MirageTM and X-pedionTM Hydrophilic Guidewires were evaluated per ISO 11070. Results: The MirageTM and X-pedionTM Hydrophilic Guidewires met the acceptance criteria for corrosion resistance.
Animal and Clinical Performance Data:
There is no change to the Indication for Use (IFU) Statement for the Mirage™ and X-pedion™ Hydrophilic Guidewires in comparison to the legally marketed predicate device. The differences in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 21, 2020
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Prerana Gurubasavaraj Regulatory Affairs Specialist 9775 Toledo Way Irvine, CA 92618
Re: K201690
Trade/Device Name: Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX, MOF Dated: June 18, 2020 Received: June 22, 2020
Dear Prerana Gurubasavaraj:
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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 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 (Acting) 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) K201690
Device Name
Mirage™ Hydrophilic Guidewire; X-pedion™ Hydrophilic Guidewire
Indications for Use (Describe)
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | ||
|---|---|---|---|
| 9775 Toledo Way | |||
| Irvine, CA 92618 | |||
| Establishment Registration: 2029214 | |||
| Contact Person: | Prerana Gurubasavaraj | ||
| Specialist, Regulatory Affairs | |||
| Telephone: (949) 297-5804 | |||
| Email: prerana.gurubasavaraj@medtronic.com | |||
| Date Summary | |||
| Prepared: | June 18 ,2020 | ||
| Trade Name of | |||
| Device: | Mirage™ Hydrophilic Guidewire | ||
| X-pedion™ Hydrophilic Guidewire | |||
| Device Classification | |||
| Name: | Guide, Wire, Catheter, Neurovasculature | ||
| Regulation Medical | |||
| Specialty: | Cardiovascular | ||
| 510(k) Review Panel: | Neurology | ||
| Classification Product | |||
| Code: | DQX | ||
| Subsequent Product | |||
| Code: | MOF | ||
| Regulation Number: | 870.1330 | ||
| Regulation | |||
| Description: | Catheter Guide Wire | ||
| Device Classification: | Class II | ||
| Predicate Device: | Mirage™ and X-pedion™ Hydrophilic Guidewires | ||
| 510(k): K193548 | |||
| Reference Device: | React™ 68 Catheter | ||
| 510(k): K180715 |
510(k) Summary K201690
Device Description:
The Hydrophilic Guidewire is a stainless-steel guidewire with a radiopaque, platinum distal coil. The guidewire has a hydrophilic coating that spans the distal 170 cm. Included within the sterile pouch is a pin vise to assist in guidewire manipulation and an introducer needle to ease the introduction of the guidewire into the catheter hub and/or hemostasis valve.
Indication for Use Statement:
The Hydrophilic Guidewire is indicated for general intravascular use to aid in the selective placement of catheters in the peripheral, visceral and cerebral vasculature during diagnostic and/or therapeutic procedures.
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| | Legally Marketed Predicate Device
(K193548) | Mirage™ and X-pedion™ Hydrophilic Guidewires |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Indication for Use Statement | The Hydrophilic Guidewire is
indicated for general intravascular use
to aid in the selective placement of
catheters in the peripheral, visceral
and cerebral vasculature during
diagnostic and/or therapeutic
procedures. | Same |
| Dimensions | | |
| Nominal Wire
Diameter | Mirage™: 0.008"
X-pedion™: 0.010” | Same |
| Device Length | $200 cm \pm 2.5 cm$ . | Same |
| Tip Length | 10 cm | Same |
| Tip Type and Shape | Shapeable to 90° | Same |
| Coating Length | 170 cm | Same |
| Material | | |
| Coil | Platinum | Same |
| Wire | Stainless-Steel | Same |
| Coating | Hydrophilic | Same |
| Packaging | | |
| Pouch | Polyester/Tyvek | Same |
| Carton | 0.020" Solid Bleached Sulfate | Same |
| Accessories | | |
| Pin Vise | Yes | Same |
| Introducer Needle | Yes | Same |
| Sterilization | | |
| Method | Ethylene Oxide (EO) | Same |
| Stability | | |
| Shelf Life | 12 Months | 36 Months |
Device Comparison:
Performance Data – Bench:
The following non-clinical bench testing was performed to evaluate the performance of the Mirage™ and X-pedion™ Hydrophilic Guidewires. The successful results of the testing demonstrated that the changes do not raise questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
| Test | Test Method Summary | Results |
|---|---|---|
| Performance | ||
| Visual Inspection and | ||
| Dimensional Verification | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per QP50324. | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for visual | ||
| inspection and dimensional | ||
| verification. | ||
| Friction Force | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per TM0047. | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for friction | ||
| force. |
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| Test | Test Method Summary | Results |
|---|---|---|
| Flexing | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per ISO 11070. | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for flexing. | ||
| Particulate | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per USP . | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for | ||
| particulate. | ||
| Tensile Strength | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per ISO 11070. | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for tensile | ||
| strength. | ||
| Corrosion Resistance | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires were | ||
| evaluated per ISO 11070. | The MirageTM and X-pedionTM | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for corrosion | ||
| resistance. |
Performance Data - Animal:
There is no change to the Indication for Use (IFU) Statement for the Mirage™ and X-pedion™ Hydrophilic Guidewires in comparison to the legally marketed predicate device. The differences in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Performance Data - Clinical:
There is no change to the Indication for Use (IFU) Statement for the Mirage™ and X-pedion™ Hydrophilic Guidewires in comparison to the legally marketed predicate device. The differences in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Conclusion:
There is no change to the Indication for Use (IFU) Statement for the Mirage™ and X-pedion™ Hydrophilic Guidewires in comparison to the legally marketed predicate device. In addition, the differences in technological characteristics do not raise questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods. The information provided in this submission supports a determination of substantial equivalence for the Mirage™ and X-pedion™ Hydrophilic Guidewires.