(29 days)
No
The description focuses on the physical characteristics and materials of a guidewire, and there is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device aids in the placement of catheters during diagnostic and/or therapeutic procedures, but it does not directly perform a therapeutic function itself. Its role is supportive for other therapeutic interventions.
No
Explanation: The device is a guidewire used for selective placement of catheters during diagnostic and/or therapeutic procedures, but it is not performing diagnostics itself. It's an accessory to a diagnostic procedure.
No
The device description clearly states it is a physical guidewire made of stainless steel with a platinum coil and hydrophilic coating, and includes physical accessories like a pin vise and introducer needle. There is no mention of software as a component or the primary function of the device.
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 a device used to test 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 an IVD which typically involves reagents, test strips, or analytical instruments for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
Therefore, the Hydrophilic Guidewire is an interventional medical device, not an In Vitro Diagnostic.
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 (comma separated list FDA assigned to the subject device)
MOF, DOX
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The Mirage™ and X-pedion™ Hydrophilic Guidewires met the acceptance criteria for ethylene oxide residual, ethylene chlorohydrin residual, bioburden recovery, packaging terminally sterilized medical devices, device compatibility/distal access, distal flexibility, visual fracture, radiopacity, tip buckling, tip retention, tip shapeability, torque response, turns to failure, bioburden, bacterial endotoxin, visual inspection and dimensional verification, particulate counts and sizes, friction force, flexing, corrosion resistance, and tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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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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 (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)
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) | |
|---|---|
| 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 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person(s): | Prerana Gurubasavaraj
Specialist, Regulatory Affairs
Telephone: (949) 297-5804
Email: prerana.gurubasavaraj@medtronic.com
Ryan Kenney
Manager, Regulatory Affairs
Telephone: (949) 297-5489
Email: ryan.j.kenney@medtronic.com |
| Date Summary Prepared: | January 17, 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(s): | Mirage™ and X-pedion™ Hydrophilic Guidewires
510(k): K124007 |
| Reference Device(s): | React™ 68 Catheter
510(k): K180715
Meridian™ Guidewire
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.
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| Device Comparison: | ||
|---|---|---|
| Legally Marketed Predicate Device | ||
| (K124007) | Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires | ||
| Indication for Use | ||
| 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 | ||
| Diameter | 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 |
|---|---|---|
| Chemical | ||
| Characterization | ||
| (Extractables/ | ||
| Leachables) | None of the Chemical(s) of Potential Concern | |
| (COPC) for the test article present a risk to the | ||
| patient. | The extractables/leachables found | |
| in Mirage™ and X-pedion™ | ||
| Hydrophilic Guidewires are | ||
| acceptable. | ||
| Cytotoxicity | The test article extract showed no evidence of | |
| causing cell lysis or toxicity in any of the test | ||
| wells. The test article met the requirements of | ||
| the test since the grade was less than Grade 2 | ||
| (Mild). | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires are | ||
| 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, and USP | |
| . | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for bacterial | ||
| endotoxin. | ||
| Performance | ||
| Visual Inspection and | ||
| Dimensional Verification | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires were | ||
| dimensionally evaluated. | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for visual | ||
| inspection and dimensional | ||
| verification. | ||
| Particulate | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires were | ||
| evaluated per USP . | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for | ||
| particulate counts and sizes. | ||
| Friction Force | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires were | ||
| evaluated for friction force. | The Mirage™ and X-pedion™ | |
| Hydrophilic Guidewires met the | ||
| acceptance criteria for friction | ||
| force. |
8
| 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. | ||
| 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. | ||
| 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. |
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.