Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire

K193548 · Micro Therapeutics, Inc. d/b/a ev3 Neurovascular · DQX · Jan 18, 2020 · Cardiovascular

Device Facts

• Record ID: K193548
• Device Name: Mirage Hydrophilic Guidewire, X-pedion Hydrophilic Guidewire
• Applicant: Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
• Product Code: DQX · Cardiovascular
• Decision Date: Jan 18, 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 selective catheter placement. Operated by physicians during diagnostic/therapeutic procedures. Includes pin vise for manipulation and introducer needle for catheter entry. Device navigates tortuous vessels; provides torque response and distal flexibility. Benefits patient by enabling precise catheter positioning for minimally invasive interventions.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including biocompatibility (ISO 10993-1), sterilization (ISO 11135/11737), and mechanical performance (ISO 10555-1, ISO 11070).

Technological Characteristics

Stainless-steel wire; radiopaque platinum distal coil; hydrophilic coating. Dimensions: 200 cm length, 0.008" (Mirage) or 0.010" (X-pedion) diameter. Sterilized via Ethylene Oxide (EO). Complies with ISO 10993-1 (biocompatibility), ISO 11070 (sterile guidewires), and ISO 10555-1 (intravascular catheters).

Indications for Use

Indicated for patients requiring selective catheter placement in peripheral, visceral, and 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 (K124007)

Reference Devices

• React™ 68 Catheter (K180715)
• Meridian™ Guidewire (K093681)

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

January 18, 2020

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Ryan Kennev Manager, Regulatory Affairs 9775 Toledo Way Irvine, California 92618

Re: K193548

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: MOF, DOX Dated: December 18, 2019 Received: December 20, 2019

Dear Ryan Kenney:

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

{1}------------------------------------------------

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 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 (QS) 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 medical devices and radiation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Xiaolin Zheng, Ph.D., M.S. 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K193548

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) | |
|--------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| <span style="font-size: 10pt;"> <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

### 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 [e-mail]

"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) Summary

| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular<br>9775 Toledo Way<br>Irvine, CA 92618<br>Establishment Registration: 2029214 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s): | Prerana Gurubasavaraj<br>Specialist, Regulatory Affairs<br>Telephone: [phone]<br>Email: [e-mail]<br>Ryan Kenney<br>Manager, Regulatory Affairs<br>Telephone: [phone]<br>Email: [e-mail] |
| Date Summary Prepared: | January 17, 2020 |
| Trade Name of Device: | Mirage™ Hydrophilic Guidewire<br>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(s): | Mirage™ and X-pedion™ Hydrophilic Guidewires<br>510(k): K124007 |
| Reference Device(s): | React™ 68 Catheter<br>510(k): K180715<br>Meridian™ Guidewire<br>510(k): K093681 |

### 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}------------------------------------------------

| Device Comparison: | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Legally Marketed Predicate Device<br>(K124007) | Mirage™ and X-pedion™<br>Hydrophilic Guidewires |
| Indication for Use<br>Statement | The Exchange™, Mirage™, SilverSpeed™, X-celerator™, and X-pedion™ Hydrophilic Guidewires are 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. | 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. |
| Dimensions | | |
| Nominal Wire<br>Diameter | Mirage™: 0.008"<br>X-pedion™: 0.010" | Same |
| Device Length | 200 cm ± 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 | Equivalent |
| 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 | 36 Months | 12 Months |

## Biocompatibility:

The Mirage™ and X-pedion™ Hydrophilic Guidewires are categorized as external communicating devices contacting circulating blood for limited exposure (≤ 24 hours). The following biocompatibility testing was performed for the Mirage™ and X-pedion™ Hydrophilic Guidewires:

| Test Description | Results | Conclusions |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Chemical<br>Characterization<br>(Extractables/<br>Leachables) | None of the Chemical(s) of Potential Concern<br>(COPC) for the test article present a risk to the<br>patient. | The extractables/leachables found<br>in Mirage™ and X-pedion™<br>Hydrophilic Guidewires are<br>acceptable. |
| Cytotoxicity | The test article extract showed no evidence of<br>causing cell lysis or toxicity in any of the test<br>wells. The test article met the requirements of<br>the test since the grade was less than Grade 2<br>(Mild). | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires are<br>considered non-cytotoxic. |
| Test Description | Results | Conclusions |
| Sensitization | The test article extracts showed no evidence of causing delayed dermal contact sensitization in the guinea pig. | The MirageTM and X-pedionTM Hydrophilic Guidewires do not elicit a sensitization response. |
| Irritation | The difference between each test article extract overall mean score and corresponding control extract overall mean score was 0.0 and 0.0 for the sodium chloride and sesame oil test article extracts. | The MirageTM and X-pedionTM Hydrophilic Guidewires are considered a non-irritant. |
| Acute Systemic Toxicity | There was no mortality or evidence of systemic toxicity from the extracts injected into the mice. | The MirageTM and X-pedionTM Hydrophilic Guidewires do not indicate signs of toxicity. |
| Hemocompatibility | The hemolytic index for the test article in direct contact with blood was 0.5% and the hemolytic index for the test article extract was 0.6%. | The MirageTM and X-pedionTM Hydrophilic Guidewires are considered non-hemolytic. |
| Hemocompatibility | The test article results were statistically significantly (p<0.05) lower than the negative reference material. | The control and test articles are not considered to be potential activators of the complement system. |
| Hemocompatibility | The test article results were statistically significantly (p<0.05) greater than the control article. However, the test article results were within the historical range for an expected response of the negative reference material. | |
| Hemocompatibility | The thrombogenic potential of the control article was evaluated in comparison to the test article. In the absence of systemic anticoagulation, the test article has less thrombogenic potential in comparison to the control article. | The MirageTM and X-pedionTM Hydrophilic Guidewires demonstrates moderate thrombus formation. |
| Pyrogenicity | No animal showed a temperature rise of 0.5°C or more above its baseline temperature. The total rise of the animal's temperature during the three (3) hour observation period was 0.5°C and within acceptable requirements. | The MirageTM and X-pedionTM Hydrophilic Guidewires are considered non-pyrogenic. |

{5}------------------------------------------------

The Mirage™ and X-pedion™ Hydrophilic Guidewires have been evaluated to meet requirements specified in ISO 10993-1.

### Performance Data – Bench:

Non-clinical bench testing was used from the predicate device and newly performed to evaluate the performance of the Mirage™ and X-pedion™ Hydrophilic Guidewires.

{6}------------------------------------------------

The following non-clinical bench testing was completed for the predicate Mirage™ and X-pedion™ Hydrophilic Guidewires and justification was provided why these tests are still applicable to support the safety and performance of the modified devices:

| Test | Test Method Summary | Results |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial | | |
| Ethylene Oxide (EO) Residual | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 10993-7. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for ethylene<br>oxide residual. |
| Ethylene Chlorohydrin (ECH)<br>Residual | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 10993-7. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for ethylene<br>chlorohydrin residual. |
| Bioburden Recovery | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 11737-1. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for bioburden<br>recovery. |
| Packaging | | |
| Terminally Sterilized Medical<br>Devices | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 11607. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for packaging<br>terminally sterilized medical<br>devices. |
| Performance | | |
| Device Compatibility/<br>Distal Access | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated to ensure the devices<br>are compatible with ancillary<br>devices to navigate through<br>tortuous vessels. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for device<br>compatibility/distal access. |
| Distal Flexibility | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated to ensure the devices<br>navigate through tortuous<br>vessels. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for distal<br>flexibility. |
| Visual Fracture | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 10555-1 and<br>ISO 11070. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for visual<br>fracture. |
| Radiopacity | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated to ensure the devices<br>are clearly visible during use. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for<br>radiopacity. |
| Tip Buckling | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated to ensure the devices<br>withstand forces typical of<br>clinical use. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for tip<br>buckling. |
| Test | Test Method Summary | Results |
| Tip Retention | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated for tip retention. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for tip<br>retention. |
| Tip Shapeability | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated for tip shapeability. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for tip<br>shapeability. |
| Torque Response | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated to ensure the distal tip<br>of the devices respond to<br>manipulations made at the<br>proximal end. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for torque<br>response. |
| Turns to Failure | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated to ensure the devices<br>withstand torsional forces<br>typical of clinical use. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for turns to<br>failure. |

{7}------------------------------------------------

The following non-clinical bench testing was performed for the modified Mirage™ and X-pedion™ Hydrophilic Guidewires:

| Test | Test Method Summary | Results |
|---------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Microbial | | |
| Bioburden | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ISO 11737-1. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for<br>bioburden. |
| Bacterial Endotoxin | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per ANSI/AAMI<br>ST72, USP <161>, and USP<br><85>. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for bacterial<br>endotoxin. |
| Performance | | |
| Visual Inspection and<br>Dimensional Verification | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>dimensionally evaluated. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for visual<br>inspection and dimensional<br>verification. |
| Particulate | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated per USP <788>. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for<br>particulate counts and sizes. |
| Friction Force | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires were<br>evaluated for friction force. | The Mirage™ and X-pedion™<br>Hydrophilic Guidewires met the<br>acceptance criteria for friction<br>force. |

{8}------------------------------------------------

| Test | Test Method Summary | Results |
|----------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Flexing | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated per ISO 11070. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for flexing. |
| Corrosion Resistance | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated per ISO 11070. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for corrosion<br>resistance. |
| Tensile Strength | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires were<br>evaluated per ISO 11070. | The MirageTM and X-pedionTM<br>Hydrophilic Guidewires met the<br>acceptance criteria for tensile<br>strength. |

## 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. Therefore, no new animal testing was needed.

## 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. Therefore, no clinical performance testing was needed.

## 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 Mirage™ and X-pedion™ Hydrophilic Guidewires are equivalent in terms of technological characteristics 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.