(197 days)
The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.
The provided text describes the MiVi 6F Guide Catheter and its substantial equivalence to predicate devices, focusing on design verification and biocompatibility testing rather than a study proving performance against acceptance criteria in the context of an AI/ML device.
Therefore, many of the requested data points (sample sizes for test and training sets, data provenance, number and qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth for AI/ML models) are Not Applicable (NA) as this is a traditional medical device submission (catheter), not an AI/ML device.
Here's the information that can be extracted and a clear indication of NA for the AI/ML specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Push/Track | Met established criteria | Met established criteria |
| Stent Crossing | Met established criteria | Met established criteria |
| Tip Stiffness | Met established criteria | Met established criteria |
| Torque Response | Met established criteria | Met established criteria |
| Kink Resistance | Met established criteria | Met established criteria |
| Tensile | Met established criteria | Met established criteria |
| Luer Leakage | Met established criteria | Met established criteria |
| Coating Adhesion | Met established criteria | Met established criteria |
| Coating Uniformity | Met established criteria | Met established criteria |
| Coating Thickness | Met established criteria | Met established criteria |
| Surface Integrity | Met established criteria | Met established criteria |
| Radiopacity | Met established criteria | Met established criteria |
| System Introduction | Met established criteria | Met established criteria |
| Device Compatibility | Met established criteria | Met established criteria |
| Packaging (Shipping) | Met established criteria | Met established criteria |
| Cytotoxicity (ISO MEM Elution Assay) | Non-cytotoxic (score '0') | Score '0' at 24, 48, and 72 hours |
| Irritation (Intracutaneous Reactivity Test) | Non-irritating | No abnormal clinical signs/significant dermal reactions |
| Hemolysis (ASTM Direct Contact & Extract) | Non-hemolytic (≤0.2% above control) | Direct: 0.1% above control; Extract: 0.0% above control |
| Thrombosis (4hr Thromboresistance Dogs) | Similar to predicate device | Similar thromboresistance to predicate device |
| Complement Activation (C3a and SC5b-9) | Not an activator and comparable to predicate | C3a: 1.0 (device), 3.2 (predicate); SC5b-9: 0.0 (device), 1.1 (predicate) |
| Pyrogenicity (LAL Limit Test) | Non-pyrogenic (<0.200 EU/device) | <0.005 EU/mL and <0.200 EU/device |
| Sensitization (Guinea Pig Maximization Test) | Non-sensitizing (response '0') | Response '0' for all animals |
| Systemic Toxicity (Acute Systemic Injection Test) | Non-toxic | No clinical signs of toxicity; body weight changes within acceptable parameters |
| Ethylene Oxide Residuals (EO and ECH) | Met ISO 10993-7:2008 requirements | 0.094 mg EO/device and 0.015 mg ECH/device |
| Sterility Assurance Level (SAL) | 10^-6 | Demonstrated 10^-6 |
2. Sample size used for the test set and the data provenance: NA (Traditional device testing, not an AI/ML test set with human data). Performance tests would have involved specific test fixtures, materials, and potentially animal models for biocompatibility.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: NA (Traditional device testing, not an AI/ML test set requiring expert consensus for ground truth). Ground truth for physical properties is based on quantifiable measurements, and for biocompatibility, it's based on standardized biological assay results.
4. Adjudication method for the test set: NA (Traditional device testing).
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: NA (Not an AI/ML device).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: NA (Not an AI/ML device).
7. The type of ground truth used:
For engineering performance tests (Push/Track, Stiffness, etc.): Defined technical specifications and measurement standards (e.g., ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2).
For biocompatibility tests: Standardized biological assay results against established thresholds (e.g., as per EN ISO 10993-1, EN ISO 10993-7).
For packaging and sterilization: Compliance with EN ISO 11607-1 and a demonstrated SAL of 10^-6.
8. The sample size for the training set: NA (Not an AI/ML device).
9. How the ground truth for the training set was established: NA (Not an AI/ML device).
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The MiVi 6F Guide Catheter underwent a comprehensive series of design verification tests and biocompatibility tests to demonstrate its safety and effectiveness and substantial equivalence to legally marketed predicate devices.
Design Verification Testing:
- Tests Conducted: Push/Track, Stent Crossing, Tip Stiffness, Torque Response, Kink Resistance, Tensile, Luer Leakage, Coating Adhesion, Coating Uniformity, Coating Thickness, Surface Integrity, Radiopacity, System Introduction, Device Compatibility.
- Standards Followed: ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1, ISO 594-2, and FDA guidance for PTCA catheters.
- Results: All performance tests "Met established criteria."
Shelf Life and Packaging Verification:
- Tests Conducted: Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing.
- Standards Followed: EN ISO 11607-1.
- Results: Devices met established criteria, ensuring packaging integrity and sterility maintenance.
Biocompatibility Testing:
- Category: Externally Communicating, Circulating Blood, Limited Exposure (≤24 hours) as per EN ISO 10993-1:2009.
- Tests Conducted: Cytotoxicity (ISO MEM Elution Assay), Irritation/Intracutaneous Reactivity (ISO Intracutaneous Reactivity Test), Hemolysis (ASTM Direct Contact and Extract Methods), Thrombosis (Four Hour Thromboresistance Evaluation in Dogs), Complement Activation (C3a and SC5b-9), Pyrogenicity (Limulus Amebocyte Lysate (LAL) Limit Test), Sensitization (ISO Guinea Pig Maximization Test), Systemic Toxicity (Acute Systemic Injection Test).
- Ethylene Oxide Residuals: Compliance with EN ISO 10993-7:2008 for EO and ECH residuals was confirmed. A Sterility Assurance Level (SAL) of 10^-6 was demonstrated.
- Results: All biocompatibility tests passed, concluding the device to be biocompatible for its intended use and substantially equivalent to the predicate device from a biocompatibility perspective. The thrombosis and complement activation tests specifically showed comparable or superior results to the predicate device.
Conclusion:
The "Not Applicable" for clinical performance data indicates that the extensive non-clinical testing (design verification, shelf life, packaging, and biocompatibility) was deemed sufficient by the FDA to demonstrate the device's safety and effectiveness and its substantial equivalence to predicate devices, without the need for clinical studies. The collective results of these studies demonstrated that the MiVi 6F Guide Catheter meets all established acceptance criteria, supporting its market clearance.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 18, 2014
MiVi Neuroscience, LLC Ms. Michelle Straight VP of Quality & Regulatory 10900 73td Avenue North, Suite 150 Maple Grove, MN 55369
Re: K140557 Trade/Device Name: MiVi 6F Guide Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 14, 2014 Received: August 15, 2014
Dear Ms. Straight,
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
{1}------------------------------------------------
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Carlos L. Pena -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K140557
Device Name MiVi 6F Guide Catheter
Indications for Use (Describe)
The MiVi 6F Guide Catheter is indicated for use in facilitating the insertion and guidance of microcathers into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Carlos L. Pena -S
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}------------------------------------------------
Image /page/3/Picture/0 description: The image is a logo for MIVI Neuroscience. The logo features the word "MIVI" in large, bold, teal letters, with the word "NEUROSCIENCE" in smaller letters underneath. To the right of the text is a teal silhouette of a human head, with the brain and blood vessels visible. The entire logo is enclosed in a rounded teal rectangle.
10900 73rd Ave. North, Suite 150 Maple Grove, MN 55369
510(k) SUMMARY: K140557
Date Prepared: 3-Mar-2014
Submitter's Name / Contact Person
Manufacturer
MiVi Neuroscience, LLC 10900 73rd Ave N, Suite 150 Maple Grove, MN 55369
Contact Person
Michelle Straight Vice President of RA/QA Phone: 612-940-7240 Fax: 763-577-1044 Email: mstraight@mivi.neuro.com
General Information
| Trade Name | MiVi 6F Guide Catheter |
|---|---|
| Common / Usual Name | Guide Catheter |
| Classification Name | Percutaneous Catheter (21 CFR 870.1250, Product Code DQY) |
| Regulatory Classification | |
| Class | II |
| Panel | Neurodiagnostic and Neurotherapeutic Device (NNDB) Division of Neurological and Physical Medicine Devices (DNPMD) |
| Predicate Device(s) | Stryker Concentric ® Medical, Inc. K110483 Modified HD Guide Catheter Stryker Concentric ® Distal Access Catheters Models 90120, 90121, 90130, 90131, 90160, 90161 and 90162 |
Device Description
The MiVi 6F Guide Catheter consists of a single lumen, braided, variable stiffness shaft designed for use in facilitating the insertion and guidance microcatheters into a selected blood vessel in the peripheral, coronary or neurovascular system. A radiopaque marker is included on the distal end for angiographic visualization. The catheter shaft has a hydrophilic coating to reduce friction during use. A luer hub on the proximal end allows attachments for flushing, insertion of catheters and aspiration. It is used in junction with a rotating hemostatic valve with side-arm adapter for flushing, catheter insertion and aspiration. The MiVi 6F Guide Catheter has a straight distal tip and is available in a 110 cm length and 6F diameter.
{4}------------------------------------------------
Intended Use / Indications
The MiVi 6F Guide Catheter is indicated for: use in facilitating the insertion and guidance of microcatheters into a selected blood vessel in the peripheral, coronary and neuro vascular systems. It may also be used as a diagnostic angiographic catheter.
Principle of Operation
The device will be utilized to endovascularly insert and guide microcatheters under fluoroscopy so that the microcatheters can deliver contrast agents or other devices during diagnostic and/or therapeutic procedures for patients with arterial disease or damage.
Accessories
There are no accessories to the MiVi 6F Guide Catheters.
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Feature | MiVi 6F GuideCatheter | Stryker Concentric®Medical, Inc. K110483Modified HD GuideCatheterStryker ConcentricREF 90170 and 90171 | Stryker Concentric®Distal Access CathetersREF 90120, 90121,90130, 90131, 90160,90161 and 90162 |
| Classification | II, DQY | II, DQY | II, DQY |
| Indications forUse | The MiVi 6F GuideCatheter is indicatedfor use in facilitatingthe insertion andguidance ofmicrocatheters into aselected blood vesselin the peripheral,coronary and neurovascular systems. | The Modified HD GuideCatheter is indicated forfacilitating the insertionand guidance of anocclusion catheter,infusion catheter orother appropriatemicrocatheter into aselected blood vessel inthe peripheral, coronaryand neuro vascularsystems. It may also beused as a diagnosticangiographic catheter. | The Distal AccessCatheter is indicated foruse in facilitating theinsertion and guidance ofan occlusion catheter,infusion catheter or otherappropriatemicrocatheter into aselected blood vessel inthe peripheral, coronaryand neuro vascularsystems. It may also beused as a diagnosticangiographic catheter. |
| ShaftMaterialsMaterials, Packaging and Sterilization | PTFE lined PEBAXwith stainless steelbraid | PTFE lined polymerwith stainless steel braid | PTFE lined polymerwith stainless steel braid |
| Proximal End | Hub with female luer | Hub with female luer | Hub with female luer |
| Configuration | conical fitting | conical fitting | conical fitting |
| Packaging | Catheter attached to anSBS packaging cardinside PET/PE/Tyvekpouch, inside SBS box | Catheter attached to SBSpackaging card insidecarton | Catheter attached to SBSpackaging card insidecarton |
| Sterilization | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |
Comparison to Predicate Devices:
{5}------------------------------------------------
| Subject Device | Predicate Device | Predicate Device | |
|---|---|---|---|
| Feature | MiVi 6F GuideCatheter | Stryker Concentric®Medical, Inc. K110483Modified HD GuideCatheterStryker ConcentricREF 90170 and 90171 | Stryker Concentric®Distal Access CathetersREF 90120, 90121,90130, 90131, 90160,90161 and 90162 |
| Dimensions | |||
| EffectiveLength | 107.3 cm | 105 cm120 cm | 115 cm to 136 cm |
| Outer Diameter | 6F | 6.3F | 3.9F to 5.2F |
| Inner Diameter | Distal: .054"Proximal: .064" | .070" | .038" to .057" |
| Tip Shape | Straight | Straight | Straight |
Design verification testing of the MiVi 6F Guide Catheter consisted of:
| Performance Test | Result |
|---|---|
| Push/Track | Met established criteria |
| Stent Crossing | Met established criteria |
| Tip Stiffness | Met established criteria |
| Torque Response | Met established criteria |
| Kink Resistance | Met established criteria |
| Tensile | Met established criteria |
| Luer Leakage | Met established criteria |
| Coating Adhesion | Met established criteria |
| Coating Uniformity | Met established criteria |
| Coating Thickness | Met established criteria |
| Surface Integrity | Met established criteria |
| Radiopacity | Met established criteria |
| System Introduction | Met established criteria |
| Device Compatibility | Met established criteria |
Testing was conducted in accordance with ISO 10555-1:2013, ISO 10555-3:2013, AAMI TIR42:2010, ISO 594-1 and ISO 594-2 standards and FDA guidance: FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters September 8, 2010.
Shelf Life Testing (Product and Packaging) and Distribution Shipping Challenge Conditioning and Testing were performed and the devices met established criteria.
Packaging Verification Testing complies with EN ISO 11607-1 and assessed the ability of finished packages to withstand the effects of anticipated hazards of the distribution environment on essential packaging characteristics and the ability of packaging to protect the device and to maintain sterility (sterile barrier testing).
Biocompatibility testing was conducted in accordance with EN ISO 10993-1. MiVi 6F Guide Catheters have been classified according to EN ISO 10993-1:2009, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing as follows:
{6}------------------------------------------------
Category: Externally Communicating Contact type: Circulating blood Contact Duration: Limited exposure (≤24 hours)
Based on this classification, tests relevant to the device described within this premarket notification were selected and conducted in accordance with EN ISO 10993-1 and its applicable sub-parts.
The MiVi 6F Guide Catheter devices meet ethylene Oxide (EO) and ethylene chlorohydrin (ECH) residuals specified in EN ISO 10993-7:2008, Biological Evaluation of Medical Devices -Part 7: Ethylene Oxide Sterilization Residuals. A sterility assurance level (SAL) of 10-6 will be demonstrated.
Testing showed the device, including its packaging, to be biocompatible for its intended use as an externally communicating, circulating blood contacting device as classified under EN ISO 10993-1:2009. The MiVi 6F Guide Catheter successfully passed all of the following biocompatibility tests and was found to be safe and effective and substantially equivalent to the predicate device from a biocompatibility perspective.
| Test | Results | Conclusions |
|---|---|---|
| Cytotoxicity - ISO MEM ElutionAssay | The test article scored '0' at 24, 48, and 72 hours and isconsidered non-cytotoxic | Not cytotoxic |
| Irritation or IntracutaneousReactivity - ISO IntracutaneousReactivity Test | Animals in the study showed noabnormal clinical signs, nosignificant dermal reactions at theinjection and control sites at the24, 48, and 72 hour observationperiod. | Non-irritating |
| HemocompatibilityHemolysis - ASTM HemolysisDirect Contact and ExtractMethods | The test article had a blankcorrected hemolytic index of0.1% above the control in thedirect contact test. The testarticle had a blank correctedhemolytic index of 0.0 % abovethe control in the extract test. | Non-hemolytic |
| HemocompatibilityThrombosis - Four HourThromboresistance Evaluation inDogs | The combined analysis of APTT,platelet counts, device weights,and clinical observationsindicated that the animal'sclotting abilities were notcompromised after implantationof the devices. The test articlehad similar thromboresistanceresults to the predicate device sowas found to be substantiallyequivalent to it. | Similarthromboresistancecharacteristics as controlStryker ConcentricGuide CatheterPredicate Device. |
{7}------------------------------------------------
| Test | Results | Conclusions |
|---|---|---|
| HemocompatibilityComplement Activation -Complement Activation C3a andSC5b-9) | The test article concentrations ofC3a was 1.0 and the predicatedevice was 3.2 and SC5b-9 was0.0 and the predicate device was1.1 so the test article was notfound to be an activator ofcomplements. The test articleresults were also comparable tothe predicate device so was foundto be substantially equivalent toit. | Comparable to StrykerConcentric GuideCatheter predicatedevice for complementactivation. Not anactivator |
| Pyrogenicity - LimulusAmebocyte Lysate (LAL) LimitTest | Both test articles contained<0.005 EU/mL and <0.200EU/device | Non-pyrogenic |
| Sensitization - ISO Guinea PigMaximization Test | None of the animals challengedwith the test article extracts wereobserved with a sensitizationresponse greater than '0'. | Non-sensitizing |
| Systemic Toxicity (Acute) - ISOAcute Systemic Injection Test | No clinical signs consistent withtoxicity were observed and bodyweight changes were withinacceptable parameters over thecourse of the study. | Non-toxic |
| Ethylene Oxide Residuals -Ethylene Oxide and EthyleneChlorohydrin | The 6F MiVi Guide Catheter had.094 mg EO/device and .015 mgECH/device so met both the EOand ECH requirements | Met the ISO 10993-7:2008/ requirementsfor EO residuals. |
Summary of Clinical Performance Data
Not applicable as no clinical data was needed to demonstrate substantial equivalence to the predicate devices.
Conclusion
MiVi Neurosciences has determined its 6F Guide Catheter to be substantially equivalent to the current legally marketed predicate devices because of the following:
-
- Intended use and indications for use are the same as for the predicate devices.
-
- There is no difference in the fundamental scientific technology or the devices.
-
- The risk assessments and successful verification testing including testing to EN ISO 10555-1 and EN ISO 10555-3, raise no new questions of safety and effectiveness.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).