(21 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a microcatheter, with no mention of AI or ML capabilities.
Yes
The intended use states that the device is for the infusion of "therapeutic agents, such as occlusion coils."
Yes
The device is intended for the infusion of diagnostic agents, such as contrast media, which are used to aid in diagnosis.
No
The device description clearly describes a physical catheter with a lumen, guidewire introduction, radiopaque markers, hydrophilic coating, and a luer fitting. This is a hardware medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "general intravascular use... for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils." This describes a device used within the body for delivering substances or devices, not for testing samples outside the body.
- Device Description: The description details a catheter designed to be introduced into blood vessels. This is consistent with an in-vivo (within the living organism) device, not an in-vitro (in glass, or outside the living organism) diagnostic.
- Lack of IVD Characteristics: An IVD would typically involve analyzing biological samples (blood, urine, tissue, etc.) to provide information about a patient's health status. This device does not perform any such analysis.
The Headway Microcatheter is an invasive medical device used for delivering substances or other devices within the vascular system.
N/A
Intended Use / 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.
Product codes
DQY
Device Description
The Headway 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: Separation Force, Unscrewing Torque, Ease of Assembly, Resistance to Overriding, Stress Cracking, Durability/Lubricity of Hydrophilic Coating – Tip Shape and Tip Retention, Simulated Use, Compatibility with Embolic Agents, Dynamic Burst Pressure, Radio-Detectability, Flow Rate, kink Resistance, Catheter Stiffness, Package Integrity, Catheter Flexural Fatigue, Catheter Particle Measurement, Biocompatibility. All met established criteria.
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).
0
| 510(k) Summary | ||
|---|---|---|
| Trade Name: | Headway 17 Microcatheter | |
| Generic Name: | Percutaneous Catheter | |
| Classification: | Class II, 21 CFR 870.1250 | DEC 04 2008 |
| Submitted By: | MicroVention, Inc. | |
| 75 Columbia | ||
| Aliso Viejo, California U.S.A. | ||
| Contact: | Florin Truuvert |
Predicate Device:
| Number | Description | Predicate For | Clearance Date |
|---|---|---|---|
| K013789 | Boston Scientific | ||
| Excelsior SL-10 | |||
| Microcatheter. | Headway 17 | ||
| Microcatheter. | Dec 06, 2001 |
Device Description
The Headway 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 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 |
|---|---|
| Separation Force | Met established criteria |
| Unscrewing Torque | Met established criteria |
| Ease of Assembly | Met established criteria |
| Resistance to Overriding | Met established criteria |
| Stress Cracking | Met established criteria |
| Durability/Lubricity of Hydrophilic Coating – | Met established criteria |
| Tip Shape and Tip Retention | Met established criteria |
| Simulated Use | Met established criteria |
| Compatibility with Embolic Agents | Met established criteria |
| Dynamic Burst Pressure | Met established criteria |
| Radio-Detectability | Met established criteria |
| Flow Rate | Met established criteria |
| kink Resistance | Met established criteria |
| Catheter Stiffness | Met established criteria |
| Package Integrity | Met established criteria |
| Catheter Flexural Fatigue | Met established criteria |
| Catheter Particle Measurement | Met established criteria |
| Biocompatibility | Met established criteria |
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 17 Microcatheter compared with the predicate device Boson Scientific Excelsior SL-10(K013789).
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 processes. .
In summary, the Headway 17 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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 0 4 2008
Microvention, Inc. c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Re:
Headway 17 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: December 2, 2008 Received: December 2, 2008
Dear Mr. Job:
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 such 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.
3
Page 2 - Mr. Mark Job
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); good manufacturing practice requirements as set forth in 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.
This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industr/support/index.html.
Sincerely vours.
vma R. vhmer
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
510(k) Number (if known): 《083343
Device Name: Headway 17 Microcatheter
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.
Prescription Use × AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
ina D. La Hines
(Division Sich-Off) Division of Cardrovascular Devices
Page 1 of
510(k) Number_K083343