(205 days)
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.
The provided text describes the MicroVention, Inc. Headway 27 Microcatheter and its substantial equivalence to a predicate device (Headway 27 Microcatheter, K110813). The document primarily focuses on bench testing and biocompatibility testing to demonstrate this equivalence.
Here's an analysis of the acceptance criteria and study data based on your request:
1. Table of Acceptance Criteria and Reported Device Performance:
| Bench Testing Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface Contamination | • Liquid on surface• Particulate on external surface• Surface defects/sharp edges | • Free from uncured hydrophilic coating.• No surface particulate > .02 mm² per tappi chart• Free from surface defect/no sharp edges• Embedded particulate acceptable if OD is in specification• Free from damage |
| Dimensional Attributes | • Catheter effective length• Catheter lumen• Catheter outer diameter• Length of distal OD (2.2Fr section) | • 150 ± 2 cm• .027" (0.69 mm)• nominal .040"/.034-.028" (1.0/.86-.71 mm)• ≥ 6cm |
| Force at Break | Device shall not break during use | ≥ 1.12 lbs (5.0 N) for outer diameters from .030" to .045" (.76 to 1.1 mm) |
| Freedom from Leakage (Liquid) | (low pressure - long duration)Device shall not leak fluids | No liquid leaking from hub and catheter shaft at 46 psi (317.2 kPa) for 30 second duration |
| Freedom from Leakage (Air) | (high pressure - short time)Device shall not leak fluids | No liquid leaking from hub and catheter shaft at 300 psi/2068 kPa (rated burst pressure) for 10 second duration |
| Burst Pressure of Catheter | Air shall not leak into device | No air leaking into syringe for 15 seconds |
| Dynamic Burst Pressure | Microcatheter will not burst statically below rated burst pressure. | Microcatheter: will not burst below 300 psi (2068 kPa) |
| Durability and Lubricity of Hydrophilic Coating | Verification that hydrophilic coating does not delaminate during use | Rated 3 or higher (simulated use) |
| Tip Shape and Tip Retention | Not explicitly stated, but implied to retain original shape sufficiently | Tip retain better than 55% of its original shape |
| Simulated Use | Not explicitly stated, but implied to perform acceptably in tested categories | Rated 3 or higher in tested categories |
| Compatibility with Agents | Not explicitly stated, but implied to perform acceptably with applicable agents | Rated 3 or higher in tested applicable categories |
| Flow Rate | Reference data | N/A (Reference data, not performance against a specific criterion for this submission) |
| Kink Resistance | Not explicitly stated, but implied to be comparable to competitors | Equivalent to or better kink resistance than competitive |
| Catheter Stiffness | Document stiffness using Tinius Olsen - reference data only | N/A (Reference data, not performance against a specific criterion for this submission) |
| Catheter Flexural Fatigue | The catheter must have acceptable results per the following conditions:- Flexural fatigue: simulated use, tip shaping testing- Hoop stress fatigue: flow rate, dynamic burst, liquid leakage | Passed |
| Catheter Particle Testing | Per USP <788> - less than 25 particles greater than 10 microns and less than 3 particles greater than 25 micron | Passed |
| Dead Space | Reference data | N/A (Reference data, not performance against a specific criterion for this submission) |
| Torque Test | 50 rotations without catheter breakage or equivalent to competitive product catheters. | Passed |
| DMSO Test | Functional performance and chemical stability | Passed |
| Biocompatibility (Cytotoxicity MEM Elution) | Cell culture tested with test article exhibited slight reactivity (Grade 1) | Non-toxic |
| Biocompatibility (Cytotoxicity Cell Culture Agar Overlay) | Grade 2: zone limited to under specimen | Non-toxic |
| Biocompatibility (Sensitization Guinea Pig Maximization Test) | Grade 0: No visible change | Non-irritant |
| Biocompatibility (Irritation Intracutaneous Reactivity Evaluation Test) | Comparative between control and test article <1.0 | Non-irritant |
| Biocompatibility (Hemocompatibility Rabbit Blood Direct Contact) | Implied acceptable hemolysis level | 0.1% hemolysis (Non-hemolytic) |
| Biocompatibility (Hemocompatibility Unactivated Partial Thromboplastin Time Assay) | Implied normal clotting range adherence | Test article = 12.6 seconds (Normal PT clotting range = 10-14 seconds) (No effect on coagulation) |
| Biocompatibility (Hemocompatibility Complement Activation Assay) | Implied acceptable C3a and SC5b-9 levels | C3a = 17.7%SC5b-9= 1.6 % (No effect on complement activation) |
| Biocompatibility (Hemocompatibility Thrombogenicity Study in Dogs) | Implied acceptable thrombogenicity compared to control | Minimal to moderate thrombus formation, clotting ability was not compromised (Similar thromboresistance compared to control) |
| Biocompatibility (Systemic Toxicity Systemic Injection Test) | No decrease in body weight of >10%. No reaction found. | Non-toxic effects |
| Biocompatibility (Systemic Toxicity Rabbit Pyrogen Test) | Temperature increases was 0.0℃ from baseline. | Non-pyrogenic |
2. Sample size used for the test set and the data provenance:
The document describes general bench testing and biocompatibility testing. It does not specify the sample sizes (number of units tested) for each individual bench test or the biocompatibility studies.
The data provenance is not explicitly stated as retrospective or prospective, nor does it mention the country of origin of the data. Given the context of a 510(k) submission, this data would typically be generated by the manufacturer (MicroVention, Inc., USA) as part of their device development and validation process, likely in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided in the document. The studies performed are primarily physical and chemical bench tests, and in vitro and in vivo biocompatibility tests, which do not typically involve human expert interpretation for "ground truth" establishment in the way, for example, a diagnostic image review would. For "rated 3 or higher," "passed," etc., these would be based on predefined objective criteria in test protocols, not subjective expert consensus.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided in the document. Adjudication methods are typically used in studies involving human interpretation or decision-making, such as clinical trials or diagnostic accuracy studies, to resolve discrepancies among multiple reviewers. The tests described are objective, physical, chemical, and biological assessments.
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:
This is not applicable and not provided. The device in question is a microcatheter, a physical medical device used for intravascular delivery. It is not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the sense of an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable and not provided for the same reasons as point 5. The device is a physical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the bench tests are the pre-defined engineering specifications and performance criteria for the physical properties of the catheter (e.g., length, diameter, burst pressure, kink resistance, force at break). For the biocompatibility tests, the "ground truth" is established by standardized ISO 10993 biological evaluation test methods which define acceptable biological responses (e.g., non-toxic, non-irritant, non-hemolytic).
8. The sample size for the training set:
There is no mention of a "training set." This concept is relevant to machine learning or AI algorithms. The Headway 27 Microcatheter is a physical medical device, and its development and testing involve traditional engineering and biological validation, not machine learning model training.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is placed to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 26, 2015
MicroVention, Inc. Ms. Cynthia Valenzuela Sr. International Regulatory Affairs 1311 Valencia Avenue Tustin, California 92780
Re: K142449 Trade/Device Name: Headway 27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: January 19, 2015 Received: February 27, 2015
Dear Ms. Valenzuela,
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
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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
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Indications for Use
510(k) Number (if known) K142449
Device Name Headway 27 Microcatheter
Indications for Use (Describe)
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Type of Use (Select one or both, as applicable)
| Research Use (Part 21 CFR 312) or Screening Purposes |
|---|
| Compassionate Use (21 CFR 312.310) |
Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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1.3. 510(k) Summary
| Trade Name: | Headway 27 Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 (DQY), 21CFR 870.1200 (DQO) |
| Submitted By: | MicroVention, Inc.1311 Valencia AvenueTustin, California U.S.A. |
| Contact: | Cynthia Valenzuela (714) 247 8053 or (949) 413-0071 |
| Date: | 2014 AUG 06 |
| Predicate Device: | Headway 27 Microcatheter (K110813) |
510(k) Summary
Device Description:
The Headway 27 Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate advancement through vessels. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. An introducer sheath and shaping mandrel are also provided.
Indications For Use:
The Headway Microcatheter is intended for general intravascular use, including the peripheral, coronary and neuro vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
| Headway 27 (predicate) | Headway 27 (proposed) | |
|---|---|---|
| Intended Use | The Headway microcatheter is intendedfor general intravascular use, including theperipheral, coronary and neurovasculature-for the infusion of diagnostic andtherapeutic agents. | Same |
| Material | Same | |
| Catheter BodyOuter layer of polyurethane elastomer(Polyblend and Pellethane), polyether blockamide (Pebax) and polyamide (Grilamid); innerlayer of stainless steel braid/coil, PTFE andpolyolefin elastomer | ||
| MarkerPlatinum/Iridium | ||
| HubNylon | ||
| Strain ReliefPebax | ||
| IntroducerPebax | ||
| Shaping Mandrel | Stainless steel |
Technological Comparison:
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| Proximal ID/OD | ID = .027" minOD = .040" | ID = .0278" minOD = .040" |
|---|---|---|
| Distal ID/OD | ID = .027" minOD = .034" | ID = .027" minOD = .035" |
| Effective Length | 150 cm | 156 cm |
| Coating | Hydrophilic coating(Hydak® - same) | Same |
| Tip Configuration | Straight - Steam Shapeable by physicianprior to use | Same |
| Guidewire Compatibility | 0.018" wires or smaller | 0.014"/0.016"/0.018"/0.021" |
| Accessories | Introducer sheath and shaping mandrel | Same |
| Method of Supply | Sterile and single use | Same |
| Sterilization Method | Ethylene Oxide | Same |
| Packaging Configuration | Catheter placed into a HDPE dispenser tube.Dispenser tube, introducer and shaping mandrelplaced on a polyethylene packaging card that isinserted into a Tyvek® pouch. Pouch and IFUplaced in bleached sulfate carton box. | Same |
Technological Comparison (conti.):
Verification and Test Summary:
| Bench Testing | Acceptance Criteria | Result | |
|---|---|---|---|
| Surface Contamination | • Liquid on surface• Particulate on externalsurface• Surface defects/sharpedges | • Free from uncuredhydrophilic coating.• No surfaceparticulate > .02 mm²per tappi chart• Free from surfacedefect/no sharp edges• Embedded particulateacceptable if OD is inspecification• Free from damage | Passed |
| Dimensional Attributes | • Catheter effectivelength• Catheter lumen• Catheter outerdiameter• Length of distal OD(2.2Fr section) | • 150 ± 2 cm• .027" (0.69 mm)• nominal .040"/.034-.028" (1.0/.86--.71mm)• ≥ 6cm | Passed |
| Force at break | Device shall not breakduring use | ≥ 1.12 lbs (5.0 N) forouter diameters from.030" to .045" (.76 to1.1 mm) | Passed |
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| Bench Testing | Acceptance Criteria | Result | |
|---|---|---|---|
| Freedom from Leakage(Liquid) | (low pressure - longduration)Device shall not leakfluids | No liquid leaking fromhub and catheter shaft at46 psi (317.2 kPa) for30 second duration | Passed |
| Freedom from Leakage(air) | (high pressure - shorttime)Device shall not leakfluids | No liquid leaking fromhub and catheter shaft at300 psi/2068 kPa (ratedburst pressure) for 10second duration | Passed |
| Burst Pressure of Catheter | Air shall not leak intodevice | No air leaking intosyringe for 15 seconds | Passed |
| Dynamic Burst Pressure | Microcatheter will notburst statically belowrated burst pressure. | Microcatheter: will notburst below 300 psi(2068 kPa) | Passed |
| Durability and Lubricity of Hydrophilic Coating-Verification that hydrophilic coating does not delaminateduring use | Rated 3 or higher(simulated use) | Passed | |
| Tip Shape and Tip Retention | Tip retain better than55% of its originalshape | Passed | |
| Simulated Use | Rated 3 or higher intested categories | Passed | |
| Compatibility with agents | Rated 3 or higher intested applicablecategories | Passed | |
| Flow Rate | Reference data | N/A | |
| Kink Resistance | Equivalent to or betterkink resistance thancompetitive | Passed | |
| Catheter Stiffness | Document stiffnessusing Tinius Olsen -reference data only | N/A | |
| Catheter Flexural Fatigue | The catheter must haveacceptable results perthe followingconditions:- Flexural fatigue:simulated use, tipshaping testing- Hoop stress fatigue:flow rate, dynamicburst, liquid leakage, | Passed |
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| Bench Testing | Acceptance Criteria | Result |
|---|---|---|
| Catheter Particle Testing | Per USP <788> - lessthan 25 particles greaterthan 10 microns and lessthan 3 particles greaterthan 25 micron | Passed |
| Dead Space | Reference data | N/A |
| Torque Test | 50 rotations withoutcatheter breakage orequivalent tocompetitive productcatheters. | Passed |
| DMSO Test | Functional performanceand chemical stability | Passed |
| Biocompatibility | Results | Conclusion |
|---|---|---|
| Cvtotoxicity ISO 10993-5MEM Elution Test | Cell culture tested with test articleexhibited slight reactivity (Grade 1) | Non-toxic |
| Cytotoxicity ISO 10993-5Cell Culture Agar Overlay | Grade 2: zone limited to underspecimen | Non-toxic |
| Sensitization ISO 10993-10Guinea Pig Maximization Test | Grade 0: No visible change | Non-irritant |
| Irritation ISO 10993-10Intracutaneous Reactivity EvaluationTest | Comparative between control and testarticle <1.0 | Non-irritant |
| Hemocompatibility - Rabbit BloodDirect Contact (ISO10993-4) | 0.1% hemolysis | Non-hemolytic |
| Hemocompatibility - UnactivatedPartial Thromboplastin Time AssayDirect Contact (ISO10993-4) | Test article = 12.6 seconds(Normal PT clotting range = 10-14seconds) | No effect on coagulation |
| Hemocompatibility - ComplementActivation Assay (ISO10993-4) | C3a = 17.7%SC5b-9= 1.6 % | No effect oncomplement activation |
| Hemocompatibility -Thrombogenicity Study in Dogs(ISO10993-4) | Minimal to moderate thrombusformation, clotting ability was notcompromised | Similarthromboresistancecompared to control |
| Systemic toxicity - Systemic InjectionTest(ISO10993-11) | No decrease in body weight of >10%.No reaction found. | Non-toxic effects |
| Systemic toxicity - Rabbit PyrogenTest (ISO10993-11) | Temperature increases was 0.0℃ frombaseline. | Non-pyrogenic |
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Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 27 Microcatheter when compared with the predicate device, Headway 27 Microcatheter (K110813).
The devices,
- " Have the same intended use,
- Use the same operating principle,
- Incorporate the same basic design,
- . Are packaged and sterilized using same methods.
In summary, the Headway 27 Microcatheter described in this submission was found to have a safety and effectiveness profile that is similar to the predicate devices.
§ 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).