(128 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and its intended use and performance testing, with no mention of AI or ML.
Yes
The device is described as being used for the infusion of "therapeutic agents, such as embolization materials," in both peripheral/coronary and neurovascular contexts, indicating its role in delivering treatments.
No
The device is a microcatheter used for the infusion of diagnostic and therapeutic agents; it is not described as performing any diagnostic function itself.
No
The device description clearly indicates it is a physical catheter with a lumen, guidewire compatibility, markers, coating, and a luer fitting, all of which are hardware components.
Based on the provided information, the Headway Duo Microcatheter is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for intravascular use to infuse diagnostic and therapeutic agents directly into the body's vasculature (peripheral, coronary, and neurovascular).
- Device Description: The description details a physical catheter designed for insertion into blood vessels.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information about a person's health. This device does not perform any such analysis on specimens.
The Headway Duo Microcatheter is a medical device used in vivo (within the living body) for delivering substances.
N/A
Intended Use / Indications for Use
The Headway Duo Microcatheter is intended for general intravascular use, including the periphera and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
The Headway Duo Microcatheter is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.
Product codes
DQO
Device Description
The Headway Duo Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximalsection transitions to a flexible distal tip to facilitate advancement through vessels. Dual racionali markers at the distal end facilitate fluoroscopic visualization. The outer surface f 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and coronary vasculature, neurovasculature
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)
Bench Testing:
- Surface and physical attributes: Pass
- Distal tensile strength: Pass
- Hub tensile strength: Pass
- Hub test (ISO 594-2): 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
- Radio-detectability: Pass
- Catheter flexural fatigue: Pass
- Torque test: Pass
- Particulate test: Pass
- DMSO compatibility: Pass
Biocompatibility (ISO 10993-5, ISO 10993-10, ISO 10993-4, ISO 10993-11):
- Cytotoxcitiy (ISO 10993-5):
- MEM elution assay: Pass
- Agarose overlay: Result not specified
- Sensitization/Irritation (ISO 10993-10):
- Guinea pig maximization sensitization: Pass
- Intracutaneous reactivity: Result not specified
- Hemocompatibility (ISO 10993-4):
- Hemolysis: Result not specified
- Prothrombin time assay: Pass
- Complement activation C3a and SC5b-9: Result not specified
- 4 hour thromboresistance in dogs: Result not specified
- Systemic Toxicity (ISO 10993-11):
- Systemic toxicity: Pass
- Rabbit pyrogen test: Result not specified
Compatibility: The Headway Duo has been verified to be compatible for use with embolization materials, such as occlusion coils, liquid embolic devices (such as Onyx® and Trufill® liquid embolic systems), and PVA particles.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Headway 17 Microcatheter (K083343)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
K120917
P. 1 of 2
| 510(k) Summary | |
|---|---|
| Trade Name: | Headway Duo Microcatheter |
| Generic Name: | Diagnostic Intravascular Catheter |
| Classification: | Class II, 21 CFR 870.1200, DQO |
| AUG 2 2012 | |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| Contact: | Naomi Gong |
| Date: | 2012Mar23 |
| Predicate Device: | Headway 17 Microcatheter (K083343) |
Device Description:
The Headway Duo Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semi-rigid proximalsection transitions to a flexible distal tip to facilitate advancement through vessels. Dual racionali markers at the distal end facilitate fluoroscopic visualization. The outer surface f 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 Duo Microcatheter is intended for general intravascular use, including the peripheral and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
The Headway Duo Microcatheter is intended for neurovascular use, for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use the in neurovasculature and are compatible with the inner diameter of the Head way Dvo Microcatheter.
Verification and Test Summary :
| Bench Testing | Result |
|---|---|
| Surface and physical attributes | Pass |
| Distal tensile strength | Pass |
| Hub tensile strength | Pass |
| Hub test (ISO 594-2) | Pass |
| Leakage (liquid and air) | Pass |
| Static and dynamic burst pressure | Pass |
| Simulated use | Pass |
| Compatibility with devices | Pass |
1
| Flow rate | Pass |
|---|---|
| Kink resistance | Pass |
| Radio-detectability | Pass |
| Catheter flexural fatigue | Pass |
| Torque test | Pass |
| Particulate test | Pass |
| DMSO compatibility | Pass |
| Biocompatibility | Result |
| Cytotoxcitiy (ISO 10993-5) | |
| - MEM elution assay | Pass |
| - Agarose overlay | |
| Sensitization/Irritation (ISO 10993-10) | |
| - Guinea pig maximization sensitization | Pass |
| - Intracutaneous reactivity | |
| Hemocompatibility (ISO 10993-4) | |
| - Hemolysis | |
| - Prothrombin time assay | Pass |
| - Complement activation C3a and SC5b-9 | |
| - 4 hour thromboresistance in dogs | |
| Systemic Toxicity (ISO 10993-11) | |
| - Systemic toxicity | Pass |
| - Rabbit pyrogen test |
The Headway Duo has been verified to be compatible for use with embolization materials, such as occlusion coils, liquid embolic devices (such as Onyx® and Trufill® liquid embolic systems), and PVA particles.
Technological Comparison:
The Headway Duo utilizes the same fundamental technology, operating principle and intended use as the predicate device. The microcatheter length has been extended up to 157 and 168 cm.
Summarv of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway Duo Microcatheter when compared with the predicate device, Headway 17 Microcatheter (K083343).
The devices.
- 트 Have the same intended use,
- Use the same operating principle,
- Incorporate the same basic design,
- Are packaged and sterilized using same material and processes.
In summary, the Headway Duo Microcatheter described in this submission is substantially equivalent to the predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with its wings spread, facing to the right.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
2 2012 AUG
MicroVention, Inc c/o Ms. Naomi Gong Regulatory Affairs Project Manager 1311 Valencia Avenue Tustin, CA 92780
Re: K120917
Trade/Device Name: Headway Duo Microcatheter . Regulation Number: 21 CFR 870.1200 · Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: July 3, 2012 Received: July 5, 2012
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. Iisting 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
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three bars representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The logo is printed in black and white.
Page 2 - Ms. Naomi Gong
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609
or any Federal statutes and regulations administered by other Federal agencies!!!!#o&rimaND 2099-0002 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/CDRH/CDRHOffices/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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
K120917 510(k) Number (if known):
Headway Duo Microcatheter Device Name:
Indications For Use:
The Headway Duo Microcatheter is intended for general intravascular use, including the periphera and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as embolization materials.
The Headway Duo Microcatheter is intended for neurovascular use for the infusion of diagnostic agents, such as contrast media, and therapeutic agents that have been cleared or approved for use in the neurovasculature and are compatible with the inner diameter of the Headway Duo Microcatheter.
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)
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(Division Sign Off
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