(64 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a microcatheter for delivering agents, with no mention of AI or ML capabilities.
Yes
The device is described as being used for the infusion of "therapeutic agents, such as occlusion coils," which indicates a therapeutic purpose.
No
Explanation: The device is a microcatheter intended for the infusion of diagnostic and therapeutic agents, not for diagnosing conditions itself.
No
The device description clearly describes a physical catheter with a lumen, tip, radiopaque markers, coating, and luer fitting. The performance studies also focus on physical and material properties of a hardware device.
Based on the provided information, 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 to diagnose conditions.
- Device Description: The description details a catheter designed for accessing vasculature and delivering agents. This aligns with an interventional medical device, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other typical components of an IVD.
Therefore, the Headway 17 Advanced Microcatheter is an interventional medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Headway 17 Advanced 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 (comma separated list FDA assigned to the subject device)
DOY
Device Description
The Headway 17 Advanced Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semirigid 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 catheters are packaged individually with a variety of preshaped tips.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing: Surface and physical attributes, Tensile strength, Tip shape and retention, Leakage (liquid and air), Static and dynamic burst pressure, Simulated use, Compatibility with devices, Kink resistance, Catheter flexural fatigue, Catheter stiffness, Hydrophilic coating, Particulate measurement analysis, Packaging testing, Insertion tool performance, Flow rate, Hub testing, Corrosion resistance. All met same specifications as predicate or met specification - previously tested on predicate.
Animal Testing: Device performance was evaluated in an acute animal study compared to predicate device. Result: Comparable performance to predicate device.
Biocompatibility Testing (ISO-10993-1): Cytotoxcitiy (ISO 10993-5), Sensitization/Irritation (ISO 10993-10), Hemocompatibility (ISO 10993-4), Systemic Toxicity (ISO 10993-11). All passed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
| Product Name: | Headway 17 Advanced Microcatheter |
|---|---|
| Generic Name: | Percutaneous Catheter |
| Classification: | Class II, 21 CFR 870.1250 |
| Submitted By: | MicroVention, Inc |
| 1311 Valencia Avenue | |
| Tustin, California U.S.A. | |
| 714-247-8000 | |
| AUG 0 6 2010 | |
| Contact: | Naomi Gong |
| Date Prepared: | February 26, 2010 |
Predicate Devices:
| Number | Description | Clearance Date |
|---|---|---|
| K083343 | MicroVention - Headway 17 | |
| Microcatheter | December 4, 2008 | |
| K042568 | Boston Scientific, Excelsior SL-10 | |
| Preshaped Microcatheter | October 15, 2004 |
Device Description:
The Headway 17 Advanced Microcatheter is a single lumen catheter designed to be introduced over a steerable guidewire to access small, tortuous vasculature. The semirigid 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 catheters are packaged individually with a variety of preshaped tips.
Indication For Use:
The Headway 17 Advanced 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
Standards Used for Device Testing:
- ISO 10555-1, Sterile, single-use, intravascular catheters .
- . ISO 10993-1, Biological evaluation of medical devices
Testing Summary:
| Bench Testing | Result |
|---|---|
| Surface and physical attributes | Met same specifications as predicate |
| Tensile strength | Met same specifications as predicate |
| Tip shape and retention | Met same specifications as predicate |
| Leakage (liquid and air) | Met same specifications as predicate |
| Static and dynamic burst pressure | Met same specifications as predicate |
| Simulated use | Met same specifications as predicate |
| Compatibility with devices | Met same specifications as predicate |
| Kink resistance | Met same specifications as predicate |
| Catheter flexural fatigue | Met same specifications as predicate |
| Catheter stiffness | Met same specifications as predicate |
| Hydrophilic coating | Met same specifications as predicate |
| Particulate measurement analysis | Met same specifications as predicate |
| Packaging testing | Met same specifications as predicate |
| Insertion tool performance | Met specification - previously tested on predicate |
| Flow rate | Met specification - previously tested on predicate |
| Hub testing | Met specification - previously tested on predicate |
| Corrosion resistance | Met specification - previously tested on predicate |
| Animal Testing | Result |
| Device performance was evaluated in an acute | |
| animal study compared to predicate device | Comparable performance to predicate device |
| Biocompatibility Testing (ISO-10993-1) | Result |
| Cytotoxcitiy (ISO 10993-5) | Pass |
| Sensitization/Irritation (ISO 10993-10) | Pass |
| Hemocompatibility (ISO 10993-4) | Pass |
| Systemic Toxicity (ISO 10993-11) | Pass |
2
Technological comparison:
.
| Predicate Device (K833434) | 510(k) Subject Device | |
|---|---|---|
| Intended Use | The Headway 17 Advanced | |
| microcatheter is intended for general | ||
| intravascular use, including the | ||
| peripheral, coronary and | ||
| neurovasculature- for the infusion of | ||
| diagnostic and therapeutic agents. | Same | |
| Size | Proximal = 2.4Fr | |
| Distal = 1.9Fr | Proximal = Same | |
| Distal = 1.7 Fr | ||
| Material | Catheter body: polyether block amide, | |
| stainless steel, nylon, PTFE | ||
| Marker band: Pt/Ir | ||
| Hub: nylon | ||
| Strain relief: polyether block amide | ||
| Introducer sheath: polyether block amide | ||
| Shaping mandrel: stainless steel | Same with barium sulfate | |
| incorporated in polyether block | ||
| amide segment | ||
| Distal Shaft Length (Shapeable Length) | 11 cm | Same |
| Proximal ID/OD | ID = .0170" min | |
| OD = .031" | Same | |
| Distal ID/OD | ID = .0170" min | |
| OD = .025" | ID = Same | |
| OD = .022" | ||
| No. of Markers | 2 | Same |
| Coating | Hydrophilic Coating | Same |
| Effective Length | 150 cm | Same |
| Tip Configuration | Straight - Steam Shapeable by physician | |
| prior to use | Same as K042568- Boston | |
| Scientific Excelsior SL-10: | ||
| Preshaped tips -with the option | ||
| of secondary shaping for proper | ||
| adjustment to the anatomy prior | ||
| to use. | ||
| Guidewire compatibility | 0.014 " wires or smaller | Same |
| Method of supply | Sterile and single use | Same |
・
·
:
3
Summary of Substantial Equivalence:
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 17 Advanced Microcatheter when compared with the predicate devices, MicroVention-Headway 17 Microcatheter (K083343) and Boston Scientific-Excelsior SL-10 Preshaped Microcatheter (K042568).
The devices,
- Have the same intended use, 다
- 피 Use the same operating principle,
- 이 Incorporate the same basic design,
- . Use similar construction and material,
- Are sterilized using same methods and processes. ●
In summary, the Headway 17 Advanced Microcatheter as described in this submission is substantially equivalent to the predicate devices
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, with three lines representing the eagle's feathers. The image is in black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 1 7 2010
MicroVention, Inc. c/o Mr. Mark Job Responsible Third Party Official Regulatory Technologies Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K101542
Trade Name: Headway 17 Advanced Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II (two) Product Code: DOY Dated: July 20, 2010 Received: July 21, 2010
Dear Mr. Job:
This letter corrects our substantially equivalent letter of August 6, 2010.
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 Foond, Or to 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.
5
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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" (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/ReportalProblem/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 (240) 276-3150 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
6
MicroVention, Inc.
Indications for Use
K101542 510(k) Number (if known):
"Aug D 6 zono
Device Name: Headway 17 Microcatheter
Indications For Use:
The Headway 17 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)
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