(28 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is used to deliver therapeutic agents, but it is not itself a therapeutic device. It is a delivery system.
Yes
The device is intended for the infusion of "diagnostic materials such as contrast media," which are used to aid in diagnosis.
No
The device description clearly describes a physical catheter with a lumen, shaft, luer adapter, radiopaque marker, and coating, indicating it is a hardware 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 that the device is for the "controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media" within the peripheral and neuro vasculature. This is a therapeutic and diagnostic procedure performed directly on the patient's body, not on a sample taken from the patient.
- Device Description: The description details a catheter designed for insertion into blood vessels for delivery of substances. This aligns with an in-vivo (within the living body) procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing information about a patient's health status based on such analysis. IVDs are designed to be used in vitro (outside the living body) to examine specimens.
Therefore, the Marathon™ Flow Directed Micro Catheter is a medical device used for in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
Product codes (comma separated list FDA assigned to the subject device)
KRA, QJP
Device Description
The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and neuro vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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)
The following non-clinical bench testing was performed to evaluate the performance of the Marathon™ Flow Directed Micro Catheter. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
Bench Testing Summaries:
- Dimension- Useable Length: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for useable length.
- Dynamic Burst: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for dynamic burst.
- Static Burst: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for static burst.
- Static Burst Post Plug & Push: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for static burst, post plug and push.
- Hub Tensile: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub tensile.
- Hub Tensile Post Plug & Push Conditioning: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub tensile post plug and push.
- Deadspace: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for deadspace.
- Visual Inspection: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for visual inspection.
- Standard Luer Hub Requirements: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for standard luer hub requirements.
- Hub Air Leak: The Marathon™ Flow Directed Micro Catheter met the acceptance criteria for hub air leak.
Biocompatibility data was leveraged per ISO 10993-1 from the React™ 71 Catheter (K182101). While biocompatibility testing was not required, hemocompatibility and cytotoxicity were performed and passed required acceptance criteria.
- 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 test article was non-cytotoxic. Conclusion: The Marathon™ Flow Directed Micro Catheter is considered non-cytotoxic.
- Hemocompatibility: The test article showed no evidence of color and was free of particulates. The test article met the test requirements and was non-hemolytic. Conclusion: The Marathon™ Flow Directed Micro Catheter is considered non-hemolytic.
No animal testing was conducted.
No clinical testing was conducted.
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
§ 870.1210 Continuous flush catheter.
(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).
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.
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Elizabeth Campion Regulatory Affairs Specialist 9775 Toledo Way Irvine, California 92618
September 14, 2020
Re: K202318
Trade/Device Name: Marathon Flow Directed Micro Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: Class II Product Code: KRA, QJP Dated: August 12, 2020 Received: August 17, 2020
Dear Elizabeth Campion:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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,
Naira Muradyan, Ph.D. Assistant 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) K202318
Device Name Marathon™ Flow Directed Micro Catheter
Indications for Use (Describe)
The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
| 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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| K202318 | |
|---|---|
| --------- | -- |
510(k) Summary [21 CFR 807.92]
| 510(k) Owner: | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
9775 Toledo Way
Irvine, CA 92618
Establishment Registration: 2029214 |
|-----------------|--------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Elizabeth Campion
Regulatory Affairs Specialist
Telephone: (949) 701-7710
Email: elizabeth.c.campion@medtronic.com |
| Date Summary Prepared: | September 8, 2020 |
|---|---|
| Trade Name of Device: | Marathon TM Flow Directed Micro Catheter |
| Common Name of Device: | Vascular Microcatheter |
| Review Panel: | Neurology |
| Product Code: | KRA, QJP |
| Regulation Number: | 21 CFR 870.1210 |
| Regulation Name: | Continuous Flush Catheter |
| Device Classification | Class II |
| Predicate Device: | Marathon TM Flow Directed Micro Catheter |
| 510(K)s: K093750 |
Predicate Device
Marathon™ Flow Directed Micro Catheter (K093750)
Reference Device
Riptide Aspiration System (React™ 71 Catheter) (K182101)
Device Description
The Marathon™ Flow Directed Micro Catheters are single-lumen, endhole catheters designed for the sub selective infusion of physician-specified therapeutic agents such as embolization materials and diagnostic materials such as contrast media in tortuous, distal vessels. The catheter has a semi-rigid proximal shaft and a highly flexible distal shaft to facilitate the advancement of the catheter in the anatomy. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a radiopaque marker at the distal end to facilitate fluoroscopic visualization. The outer surfaces of the catheter are coated to increase lubricity. Microcatheter may be used with stylet, guidewire or introducer sheath to increase the rigidity of the distal section during introduction into the guiding catheter.
Indications for Use Statement
The Marathon™ Flow Directed Micro Catheter is intended to access the peripheral and neuro vasculature for the controlled selective infusion of physician-specified therapeutic agents such as embolization materials and of diagnostic materials such as contrast media.
4
Technical Comparison with Predicate Device:
A comparison of the Marathon™ Flow Directed Micro Catheter to the predicate device is provided in the table below:
| Table 1: Technical Comparison with Predicate Device | ||
|---|---|---|
| Attribute | Predicate: Marathon™ Flow Directed Micro | |
| Catheter (K093750) | Subject: Marathon™ Flow | |
| Directed Micro Catheter | ||
| Indication for Use (IFU) | ||
| Statement | The Marathon™ Flow Directed Micro Catheter is | |
| intended to access the peripheral and neuro | ||
| vasculature for the controlled selective infusion of | ||
| physician-specified therapeutic agents such as | ||
| embolization materials and of diagnostic materials | ||
| such as contrast media. | Same | |
| Proximal Tubing | Grilamid and Pebax with stainless steel helical coil | Same |
| Proximal Tubing | Adhesive, UV Cure | N/A |
| Proximal Tubing and hub | Adhesive, Loctite | Dymax UV Adhesive |
| Outer Strain Relief Adhesive | Adhesive, Loctite | Same |
| Strain Relief | Inner: Elvax | |
| Outer: Dynaflex | Same | |
| Inner lining | PTFE | Same |
| Outer Coating | Proprietary Hyaluronic acid, acrylic resin binder | Same |
| Hub | Polypropylene | Trogamid |
| Marker Bands | Platinum-Iridium Alloy | Same |
| Usable Length | $165±2.5$ cm | Same |
| Proximal Section OD (hub) | 2.7 F | Same |
| Distal Section OD (at tip) | 1.3 F | Same |
| Distal Section ID (at tip) | .13" | Same |
| Carton | Natural, PTFE Tubing | Same |
| Pouch | High-Density Polyethylene (HDPE) | Same |
| Shelf Life | 3 Year | 1 Year |
| Sterilization | Ethylene Oxide (EO) | Same |
| Use | Single-Use | Same |
Biocompatibility
Biocompatibility data was leveraged per ISO 10993-1 from the React™ 71 Catheter (K182101), as the modified hub has the same nature and duration of contact, has similar geometry, and is identical in formulation, processing, and sterilization. Additionally, no other chemicals were added, and the Dymax UV adhesive is non-patient contacting. While biocompatibility testing was not required, hemocompatibility and cytotoxicity were performed and passed required acceptance criteria. See Table 2 for test summary.
| Test Category | Summary of Results | Conclusion |
|---|---|---|
| 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 test article was non-cytotoxic. | The Marathon™ Flow Directed Micro | |
| Catheter is considered non-cytotoxic. |
5
| Table 2: Summary of Biocompatibility Testing | ||
|---|---|---|
| Test Category | Summary of Results | Conclusion |
| Hemocompatibility | The test article showed no evidence of color and | |
| was free of particulates. The test article met the | ||
| test requirements and was non-hemolytic. | The Marathon™ Flow Directed Micro | |
| Catheter is considered non- | ||
| hemolytic. |
Performance Data- Bench
The following non-clinical bench testing was performed to evaluate the performance of the Marathon™ Flow Directed Micro Catheter. The successful results of the testing demonstrated that the changes do not raise new questions of safety and effectiveness, supporting the substantial equivalence to the predicate device.
| Table 3: Summary of Performance Data- Bench | ||
|---|---|---|
| Bench Testing | Test Method Summary | Summary of Results |
| Dimension- | ||
| Useable Length | Dimension- Useable Length: | |
| MarathonTM Flow Directed Micro Catheter | ||
| should measure 165 ± 2.5cm. | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for useable length. | ||
| Dynamic Burst | Dynamic Burst: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2014/A1:2017 Annex G | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for dynamic burst. | ||
| Static Burst | Static Burst: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2014/A1:2017 Annex F | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for static burst. | ||
| Static Burst Post | ||
| Plug & Push | Static Burst Post Plug & Push: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2014/A1:2017 Annex F | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for static burst, | ||
| post plug and push. | ||
| Hub Tensile | Hub Tensile: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2013/A1:2017 Annex B | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for hub tensile. | ||
| Hub Tensile Post | ||
| Plug & Push | Hub Tensile Post Plug & Push Conditioning: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2014/A1:2017 Annex F | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for hub tensile | ||
| post plug and push. | ||
| Deadspace | Deadspace: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter deadspace should be ≤ 0.27 3 and ≥ | ||
| 0.23 ml, without Syringe adapter | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for deadspace. | ||
| Visual Inspection | Visual Inspection: | |
| The MarathonTM Flow Directed Micro | ||
| Catheter Hub should be clear and free from | ||
| defects and crazing | The MarathonTM Flow Directed Micro Catheter | |
| met the acceptance criteria for visual | ||
| inspection. |
6
| Table 3: Summary of Performance Data- Bench | ||
|---|---|---|
| Bench Testing | Test Method Summary | Summary of Results |
| Standard Luer | ||
| Hub | ||
| Requirements | Standard Luer Hub Requirements: | |
| The Marathon™ Flow Directed Micro | ||
| Catheter was evaluated per ISO 80369- | ||
| 7:2016 and ISO 80369-20:2015 | The Marathon™ Flow Directed Micro Catheter | |
| met the acceptance criteria for standard luer | ||
| hub requirements. | ||
| Hub Air Leak | Hub Air Leak: | |
| The Marathon™ Flow Directed Micro | ||
| Catheter was evaluated per ISO 10555-1 | ||
| 2014/A1:2017 Annex D | The Marathon™ Flow Directed Micro Catheter | |
| met the acceptance criteria for hub air leak. |
Performance Data- Animal:
No animal testing was conducted as there is no change to the Indication for Use (IFU) Statement for the Marathon™ Flow Directed Micro Catheter in comparison to the legally marketed predicate device. The differences in technological characteristics do not raise new questions of safety and effectiveness as demonstrated through non-clinical bench testing using well-established acceptable scientific methods.
Performance Data – Clinical:
No clinical testing was conducted as there is no change to the Indication for Use (IFU) Statement for the Marathon™ Flow Directed Micro Catheter in comparison to the legally marketed predicate device. The differences in technological characteristics do not raise new 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 Marathon™ Flow Directed Micro Catheter in comparison to the legally marketed predicate device. In addition, the differences in technological characteristics do not raise new 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 the proposal of substantial equivalence for the Marathon™ Flow Directed Micro Catheter.