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 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.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Mirage™ Hydrophilic Guidewire and X-pedion™ Hydrophilic Guidewire. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, rather than a study on an AI/ML-based medical device.

Therefore, the information required to answer most of your questions about acceptance criteria for an AI/ML device, sample sizes for AI test sets, expert ground truthing, MRMC studies, standalone performance, training sets, and ground truth establishment for AI/ML models is not present in this document.

However, I can extract information related to the acceptance criteria and performance data for the physical medical device as described:

Acceptance Criteria and Device Performance (Based on Non-Clinical Bench Testing):

The document details numerous non-clinical bench tests performed to demonstrate the safety and performance of the guidewires. The results consistently state that "The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for [Test Name]."

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

Test Category	Specific Test / Parameter	Acceptance Criteria (Implied by positive outcome)
Biocompatibility
Chemical Characterization (Extractables/Leachables)	No risk to the patient from Chemicals of Potential Concern (COPC).	The extractables/leachables found are acceptable.
Cytotoxicity	No evidence of cell lysis or toxicity; grade < 2 (Mild).	Considered non-cytotoxic.
Sensitization	No delayed dermal contact sensitization.	Does not elicit a sensitization response.
Irritation	Difference between test and control mean score = 0.0.	Considered a non-irritant.
Acute Systemic Toxicity	No mortality or systemic toxicity from extracts.	Do not indicate signs of toxicity.
Hemocompatibility (Hemolytic Index)	Hemolytic index for direct contact < threshold (e.g., 0.5% / 0.6%).	Hemolytic index was 0.5% (direct contact) and 0.6% (extract).
Hemocompatibility (Complement System)	Not considered to be potential activators of the complement system.	Control and test articles are not considered to be potential activators.
Hemocompatibility (Thrombogenic Potential)	Acceptable thrombogenic potential.	Demonstrates moderate thrombus formation (less than control article).
Pyrogenicity	No temperature rise of 0.5°C or more above baseline.	No animal showed a temperature rise of 0.5°C or more.
Microbial
Ethylene Oxide (EO) Residual	Met criteria per ISO 10993-7.	Met the acceptance criteria for ethylene oxide residual.
Ethylene Chlorohydrin (ECH) Residual	Met criteria per ISO 10993-7.	Met the acceptance criteria for ethylene chlorohydrin residual.
Bioburden Recovery	Met criteria per ISO 11737-1.	Met the acceptance criteria for bioburden recovery.
Bioburden	Met criteria per ISO 11737-1.	Met the acceptance criteria for bioburden.
Bacterial Endotoxin	Met criteria per ANSI/AAMI ST72, USP <161>, and USP <85>.	Met the acceptance criteria for bacterial endotoxin.
Packaging
Terminally Sterilized Medical Devices	Met criteria per ISO 11607.	Met the acceptance criteria for packaging terminally sterilized medical devices.
Performance (Bench)
Device Compatibility/Distal Access	Compatible with ancillary devices, navigates tortuous vessels.	Met the acceptance criteria for device compatibility/distal access.
Distal Flexibility	Navigates through tortuous vessels.	Met the acceptance criteria for distal flexibility.
Visual Fracture	Met criteria per ISO 10555-1 and ISO 11070.	Met the acceptance criteria for visual fracture.
Radiopacity	Clearly visible during use.	Met the acceptance criteria for radiopacity.
Tip Buckling	Withstands forces typical of clinical use.	Met the acceptance criteria for tip buckling.
Tip Retention	Satisfactory tip retention.	Met the acceptance criteria for tip retention.
Tip Shapeability	Satisfactory tip shapeability.	Met the acceptance criteria for tip shapeability.
Torque Response	Distal tip responds to proximal manipulations.	Met the acceptance criteria for torque response.
Turns to Failure	Withstands torsional forces typical of clinical use.	Met the acceptance criteria for turns to failure.
Visual Inspection and Dimensional Verification	Meets specified dimensions.	Met the acceptance criteria for visual inspection and dimensional verification.
Particulate	Meets criteria per USP <788> for particulate counts and sizes.	Met the acceptance criteria for particulate counts and sizes.
Friction Force	Satisfactory friction force.	Met the acceptance criteria for friction force.
Flexing	Met criteria per ISO 11070.	Met the acceptance criteria for flexing.
Corrosion Resistance	Met criteria per ISO 11070.	Met the acceptance criteria for corrosion resistance.
Tensile Strength	Met criteria per ISO 11070.	Met the acceptance criteria for tensile strength.

Since this is a 510(k) submission for a non-AI/ML medical device, the following information is not applicable or not provided in the document:

Sample sizes used for the test set and the data provenance: Not an AI device, so no "test set" in the AI sense. Bench tests follow specific standards, implying sample sizes per those standards, but not explicitly stated here.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable; ground truth for a physical device is established via standardized physical and chemical tests, not expert human interpretation of data for AI.
Adjudication method for the test set: Not applicable for non-AI bench testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For a physical guidewire, "ground truth" is typically defined by adherence to engineering specifications, material properties, and performance under simulated clinical conditions, verified through empirical testing following established ISO and USP standards.
The sample size for the training set: Not applicable; this is not an AI/ML device.
How the ground truth for the training set was established: Not applicable; this is not an AI/ML device.

In summary, this document is a regulatory submission for a physical medical device demonstrating substantial equivalence, not an AI/ML device requiring clinical validation for diagnostic or prognostic purposes.

Summary

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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

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

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Indications for Use

510(k) Number (if known) K193548

Device Name Mirage™ Hydrophilic Guidewire X-pedion™ Hydrophilic Guidewire

Indications for Use (Describe)

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

510(k) Owner:	Micro Therapeutics, Inc. d/b/a ev3 Neurovascular9775 Toledo WayIrvine, CA 92618Establishment Registration: 2029214
Contact Person(s):	Prerana GurubasavarajSpecialist, Regulatory AffairsTelephone: (949) 297-5804Email: prerana.gurubasavaraj@medtronic.comRyan KenneyManager, Regulatory AffairsTelephone: (949) 297-5489Email: ryan.j.kenney@medtronic.com
Date Summary Prepared:	January 17, 2020
Trade Name of Device:	Mirage™ Hydrophilic GuidewireX-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 Guidewires510(k): K124007
Reference Device(s):	React™ 68 Catheter510(k): K180715Meridian™ Guidewire510(k): K093681

Device Description:

Indication for Use Statement:

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Device Comparison:
	Legally Marketed Predicate Device(K124007)	Mirage™ and X-pedion™Hydrophilic Guidewires
Indication for UseStatement	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 WireDiameter	Mirage™: 0.008"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
ChemicalCharacterization(Extractables/Leachables)	None of the Chemical(s) of Potential Concern(COPC) for the test article present a risk to thepatient.	The extractables/leachables foundin Mirage™ and X-pedion™Hydrophilic Guidewires areacceptable.
Cytotoxicity	The test article extract showed no evidence ofcausing cell lysis or toxicity in any of the testwells. The test article met the requirements ofthe test since the grade was less than Grade 2(Mild).	The Mirage™ and X-pedion™Hydrophilic Guidewires areconsidered 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.

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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.

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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:

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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™Hydrophilic Guidewires wereevaluated per ISO 11737-1.	The Mirage™ and X-pedion™Hydrophilic Guidewires met theacceptance criteria forbioburden.
Bacterial Endotoxin	The Mirage™ and X-pedion™Hydrophilic Guidewires wereevaluated per ANSI/AAMIST72, USP <161>, and USP<85>.	The Mirage™ and X-pedion™Hydrophilic Guidewires met theacceptance criteria for bacterialendotoxin.
Performance
Visual Inspection andDimensional Verification	The Mirage™ and X-pedion™Hydrophilic Guidewires weredimensionally evaluated.	The Mirage™ and X-pedion™Hydrophilic Guidewires met theacceptance criteria for visualinspection and dimensionalverification.
Particulate	The Mirage™ and X-pedion™Hydrophilic Guidewires wereevaluated per USP <788>.	The Mirage™ and X-pedion™Hydrophilic Guidewires met theacceptance criteria forparticulate counts and sizes.
Friction Force	The Mirage™ and X-pedion™Hydrophilic Guidewires wereevaluated for friction force.	The Mirage™ and X-pedion™Hydrophilic Guidewires met theacceptance criteria for frictionforce.

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Test	Test Method Summary	Results
Flexing	The MirageTM and X-pedionTMHydrophilic Guidewires wereevaluated per ISO 11070.	The MirageTM and X-pedionTMHydrophilic Guidewires met theacceptance criteria for flexing.
Corrosion Resistance	The MirageTM and X-pedionTMHydrophilic Guidewires wereevaluated per ISO 11070.	The MirageTM and X-pedionTMHydrophilic Guidewires met theacceptance criteria for corrosionresistance.
Tensile Strength	The MirageTM and X-pedionTMHydrophilic Guidewires wereevaluated per ISO 11070.	The MirageTM and X-pedionTMHydrophilic Guidewires met theacceptance criteria for tensilestrength.

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:

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.

Regulation Number and Section

§ 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.