(134 days)
Not Found
No
The description focuses on the physical characteristics and intended use of a microcatheter, with no mention of AI or ML capabilities.
No.
The device is used to infuse therapeutic agents, but it is not a therapeutic device itself. Its primary function is delivery.
No
The device is a microcatheter intended for the infusion of diagnostic and therapeutic agents, not for performing the diagnostic assessment itself. It facilitates diagnostics by delivering agents, but is not a diagnostic device.
No
The device description clearly describes a physical catheter with a lumen, guidewire introduction, flexible tip, radiopaque markers, hydrophilic coating, and a luer fitting. These are all hardware components.
Based on the provided information, the Headway 27 Microcatheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's 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 for accessing vasculature and delivering agents, consistent with an in-vivo (within the living organism) application.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Headway 27 Microcatheter's function is entirely different.
N/A
Intended Use / Indications for Use
The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature 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)
DQY
Device Description
The Headway 27 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 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, Distal tensile strength, Hub tensile strength, Leakage (liquid and air), Static and dynamic burst pressure, Simulated use, Compatibility with devices, Flow rate, Kink resistance, Catheter flexural fatigue, Torque test, DMSO compatibility - All Passed.
Biocompatibility: Cytotoxcitiy (ISO 10993-5) - MEM elution assay, Agarose overlay; Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization, Intracutaneous reactivity; Hemocompatibility (ISO 10993-4) - Hemolysis, Prothrombin time assay, Complement activation C3a and SC5b-9, 4 hour thromboresistance in dogs; Systemic Toxicity (ISO 10993-11) - Systemic toxicity, Rabbit pyrogen test - 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.
Headway 21 Microcatheter (K093160)
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
Killogi 3
| Trade Name: | Headway 27 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 |
| Date: | 2011Mar23 |
| Predicate Device: | Headway 21 Microcatheter (K093160) |
510(k) Summary
AUG - 5 2011
Device Description:
The Headway 27 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 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
1
| 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 |
| Torque test | Pass |
| DMSO compatibility | Pass |
Verification and Test Summary Table
| Biocompatibility | Result |
|---|---|
| Cytotoxcitiy (ISO 10993-5) |
- MEM elution assay
- Agarose overlay | Pass |
| Sensitization/Irritation (ISO 10993-10) - Guinea pig maximization sensitization
- Intracutaneous reactivity | Pass |
| Hemocompatibility (ISO 10993-4) - Hemolysis
- Prothrombin time assay
- Complement activation C3a and SC5b-9
- 4 hour thromboresistance in dogs | Pass |
| Systemic Toxicity (ISO 10993-11) - Systemic toxicity
- Rabbit pyrogen test | Pass |
Technological Comparison
The Headway 27 utilizes the same fundamental technology, basic design, operating principle and intended use as the predicate device with the exception of the outer and inner diameter dimensions. The inner diameter was increased to 0.027" from 0.021" and the outer diameter was increased to 0.037" from 0.030".
2
Summary of Substantial Equivalence
The data presented in this submission demonstrates the technological similarity and equivalency of the Headway 27 Microcatheter when compared with the predicate device, Headway 21 Microcatheter (K093160).
The devices,
- Have the same intended use, 트
- . Use the same operating principle,
- Incorporate the same basic design, .
- Use similar construction and material, 트
- 트 Are packaged and sterilized using same material and processes.
In summary, the Headway 27 Microcatheter described in this submission is, in our opinion, substantially equivalent to the predicate device.
3
Image /page/3/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 an abstract image of an eagle.
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 1311 Valencia Avenue Tustin, CA 92780
Re: K110813
Trade/Device Name: Headway 27 Microcatheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II Product Code: DQY Dated: July 20, 2011 Received: July 21, 2011
AUG - 5 2011
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. Please noté: 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.
4
Page 2 - Ms. Naomi Gong
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 (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
5
Indications for Use
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Headway 27 Microcatheter Device Name:
Indications For Use:
The Headway 27 Microcatheter is intended for general intravascular use, including the peripheral, coronary and neurovasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
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)
Cardiovascular Devices
510(k) Number K110813
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