(30 days)
Not Found
No
The summary describes a physical medical device (microcatheter) and its mechanical properties and intended use for delivering agents. There is no mention of software, algorithms, image processing, or terms related to AI/ML.
No.
The device is used to deliver diagnostic and therapeutic agents, but it is not itself a therapeutic device. Its function is delivery, not therapy.
No
The device is described as being used for the "infusion of diagnostic agents, such as contrast media," but it is not itself performing a diagnostic function. It is a tool for delivering agents that aid in diagnosis.
No
The device description clearly describes a physical catheter with a lumen, tip, markers, coating, and hub, indicating it is a hardware device, not software only.
Based on the provided information, the Headway 21 Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Headway 21 Intended Use: The intended use of the Headway 21 Microcatheter is for intravascular use to infuse diagnostic and therapeutic agents directly into the body's vasculature. This is an in vivo procedure (performed within a living organism), not an in vitro procedure (performed outside the body).
- Device Description: The description details a catheter designed for insertion into blood vessels, further supporting its in vivo nature.
Therefore, the Headway 21 Microcatheter is a medical device used for procedures within the body, not for testing samples outside the body.
N/A
Intended Use / 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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral, coronary and neuro vasculature
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
Bench Testing: 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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, Inc |
| 1311 Valencia Avenue | |
| Tustin, 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.
1
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.
2
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
3
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
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