(30 days)
The Headway 21 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 21 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. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.
The provided text describes the 510(k) summary for the Headway 21 Microcatheter. This is a medical device, and the acceptance criteria and study information provided are related to its physical and functional performance, not to an AI or software-based medical device that would have clinical performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested fields (2-9, and the effect size in 5) are not applicable to this type of device and submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance
The Headway 21 Microcatheter performed a series of bench tests to demonstrate its design and functional equivalence to a predicate device. The acceptance criteria for these tests were met if the device "Pass"ed each specified test.
| Bench Testing | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface and physical attributes | Pass | Pass |
| Distal tensile strength | Pass | Pass |
| Hub tensile strength | Pass | Pass |
| Leakage (liquid and air) | Pass | Pass |
| Static and dynamic burst pressure | Pass | Pass |
| Simulated use | Pass | Pass |
| Compatibility with devices | Pass | Pass |
| Flow rate | Pass | Pass |
| Kink resistance | Pass | Pass |
| Catheter flexural fatigue | Pass | Pass |
Study Details Based on the Provided Document:
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A table of acceptance criteria and the reported device performance: See table above.
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Sample size used for the test set and the data provenance: Not explicitly stated for each bench test. These are engineering/device performance tests, not clinical studies with patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical tests would be defined by engineering standards and test methodology, not clinical expert consensus.
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Adjudication method for the test set: Not applicable for these engineering tests. Results are typically determined by predefined pass/fail limits based on engineering specifications.
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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: Not applicable. This is a physical medical device, not an AI or imaging diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
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The type of ground truth used: For bench testing, the "ground truth" is typically established by engineering specifications, validated test methods, and industry standards for medical devices of this type (e.g., tensile strength required for a given material, burst pressure, flow rate thresholds).
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The sample size for the training set: Not applicable. This is a physical medical device, not a machine learning model.
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How the ground truth for the training set was established: Not applicable.
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510(k) Summary
NOV - 5 2009
| Trade Name: | Headway 21 Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 |
| Submitted By: | MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A. |
| Contact: | Naomi Gong |
Predicate Device:
| Number | Description | Clearance Date |
|---|---|---|
| K083343 | Headway 17 Microcatheter | December 4, 2008 |
Device Description:
The Headway 21 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. The outer surface of the Microcatheter is coated with a hydrophilic polymer to increase lubricity. A luer fitting on the Microcatheter hub is used for the attachment of accessories.
Indication For Use:
The Headway 21 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.
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Verification and Test Summary Table
| Bench Testing | Result |
|---|---|
| Surface and physical attributes | Pass |
| Distal tensile strength | Pass |
| Hub tensile strength | Pass |
| Leakage (liquid and air) | Pass |
| Static and dynamic burst pressure | Pass |
| Simulated use | Pass |
| Compatibility with devices | Pass |
| Flow rate | Pass |
| Kink resistance | Pass |
| Catheter flexural fatigue | Pass |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 21 Microcatheter when compared with the predicate device, Headway 17 Microcatheter (K083343).
The devices,
- Have the same intended use,
- Use the same operating principle,
- Incorporate the same basic design,
- Use similar construction and material,
- Are packaged and sterilized using same material and processes.
In summary, the Headway 21 Microcatheter described in this submission is, in our opinion, substantially equivalent to the predicate device.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three tail feathers, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the bird. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring. MD 20993-0002
MicroVention Inc. c/o Ms. Naomi Gong Regulatory Affairs Project Manager 75 Columbia, Suite A Aliso Viejo, CA 92656
NOV - 5 2009
Re: K093160
Trade/Device Name: Headway 21 Microcatheter Common Name: catheter, percutaneous Regulation Number: 21 CFR 870.1250 Regulatory Class: II Product Code: DQY Dated: October 5, 2009 Received: October 6, 2009
Dear Ms. Gong:
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.
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
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Page 2 - Ms. Naomi Gong
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Duna R. bulmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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MicroVention, Inc.
Indications for Use
510(k) Number (if known):_K093/60
Device Name: Headway 21 Microcatheter
Indications For Use:
The Headway 21 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Donna R. Vachines
(Division City, or
(Division Sign-Off Division of Cardiovascular Devi
510(k) Number
Page 1 of 1
§ 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).