Who is the manufacturer of Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire?

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular filed the 510(k) submission for Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire (K201690).

What is the FDA product code for Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire?

510(k) clearance (submission type: Special).

What are the predicate devices for Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire?

Mirage™ and X-pedion™ Hydrophilic Guidewires (K193548).

Who can help prepare an FDA 510(k) submission like Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire

K201690 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQX · Jul 21, 2020 · Cardiovascular

Device Facts

Record ID	K201690
Device Name	Mirage Hydrophilic Guidewire; X-pedion Hydrophilic Guidewire
Applicant	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
Product Code	DQX · Cardiovascular
Decision Date	Jul 21, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1330
Device Class	Class 2

Intended 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.

Device Story

Stainless-steel guidewire with radiopaque platinum distal coil; hydrophilic coating on distal 170 cm. Used in peripheral, visceral, and cerebral vasculature to facilitate catheter placement. Operated by physicians during diagnostic/therapeutic procedures. Includes pin vise for manipulation and introducer needle for catheter entry. Device provides mechanical guidance for catheter navigation; benefits patient by enabling access to target vascular sites. Bench testing confirms performance characteristics.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing including visual inspection, dimensional verification, friction force, flexing (ISO 11070), particulate (USP <788>), tensile strength (ISO 11070), and corrosion resistance (ISO 11070).

Technological Characteristics

Stainless-steel core; platinum distal coil; hydrophilic coating. Dimensions: 200 cm length, 10 cm tip, 0.008" (Mirage) or 0.010" (X-pedion) diameter. Sterilized via Ethylene Oxide (EO). Accessories: pin vise, introducer needle. Packaging: Polyester/Tyvek pouch, solid bleached sulfate carton.

Indications for Use

Indicated for patients requiring selective catheter placement in peripheral, visceral, or cerebral vasculature during diagnostic or therapeutic intravascular procedures.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Mirage™ and X-pedion™ Hydrophilic Guidewires (K193548)

Reference Devices

React™ 68 Catheter (K180715)

Related Devices

K193548 — Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · Jan 18, 2020
K993257 — .010 SILVERSPEED HYDROPOPHILIC GUIDEWIRE, .014 SILVERSPED HYDROPHILIC GUIDEWIRE, .016 SILVERSPEED HYDROPHILIC GUIDEWI · Micro Therapeutics, Inc. · Oct 21, 1999
K161584 — ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 · Asahi Intecc Co., Ltd. · Oct 6, 2016
K253746 — Enroute 0.014'' Transcarotid Guidewire · Lake Region Medical · Mar 19, 2026
K982543 — SILVERSTREAK HYDROPHILIC GUIDEWIRE · Micro Therapeutics, Inc. · Dec 11, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {2}------------------------------------------------ # 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) #### 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}------------------------------------------------ | 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. {4}------------------------------------------------ | | 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. | {5}------------------------------------------------ | 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 <788>. | 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.