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.

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.

AI/ML Overview

Section 1:

Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied by "Pass")	Reported Device Performance
Surface and physical attributes	Device meets established specifications for surface finish and physical characteristics.	Pass
Distal tensile strength	Device can withstand a specified tensile force at its distal end without failure.	Pass
Hub tensile strength	Device can withstand a specified tensile force at its hub without failure.	Pass
Leakage (liquid and air)	Device exhibits no leakage of liquids or air under specified pressure conditions.	Pass
Static and dynamic burst pressure	Device can withstand specified static and dynamic burst pressures without failure.	Pass
Simulated use	Device performs as intended and remains functional during simulated use conditions.	Pass
Compatibility with devices	Device is compatible with other specified medical devices (e.g., guidewires, infusion pumps).	Pass
Flow rate	Device maintains a specified flow rate for diagnostic and therapeutic agents.	Pass
Kink resistance	Device resists kinking under specified bending conditions.	Pass
Catheter flexural fatigue	Device maintains structural integrity and function after a specified number of flex cycles.	Pass
Torque test	Device exhibits appropriate torquability for navigation within vasculature.	Pass
DMSO compatibility	Device material is compatible with Dimethyl sulfoxide (DMSO) without degradation.	Pass
Cytotoxicity (MEM elution assay, Agarose overlay)	Device extracts do not cause toxic effects on cells.	Pass
Sensitization/Irritation (Guinea pig maximization sensitization, Intracutaneous reactivity)	Device materials do not cause skin sensitization or irritation.	Pass
Hemocompatibility (Hemolysis, Prothrombin time assay, Complement activation C3a and SC5b-9, 4 hour thromboresistance in dogs)	Device exhibits acceptable blood compatibility (low hemolysis, no significant impact on coagulation, minimal complement activation, no significant thrombosis).	Pass
Systemic Toxicity (Systemic toxicity, Rabbit pyrogen test)	Device extracts do not cause systemic toxic effects or pyrogenic reactions.	Pass

Note on Acceptance Criteria: The provided document states "Pass" for each test, implying that the device met the pre-defined acceptance criteria for that specific test. The specific numerical or qualitative thresholds for each criterion are not explicitly stated in this summary.

Section 2:

Sample size used for the test set: Not specified. The document summarizes the results of various bench and biocompatibility tests, but does not provide details on the number of units tested for each criterion.
Data provenance: Not specified. This document pertains to pre-market notification (510(k)) for a medical device and describes laboratory and in-vitro testing. There is no indication of clinical trial data or data from human subjects in this summary. Therefore, the concepts of "country of origin" and "retrospective or prospective" do not directly apply to the reported tests.

Section 3:

Number of experts used to establish the ground truth for the test set: Not applicable. The "ground truth" concept is typically associated with clinical studies or diagnostic artificial intelligence, where expert consensus or pathological findings define the true state. The described tests are primarily engineering and biological performance evaluations. These tests rely on established scientific methods and validated measurement techniques rather than expert interpretation of complex clinical cases.
Qualifications of those experts: Not applicable. (See above explanation).

Section 4:

Adjudication method: Not applicable. The tests described are objective, quantitative or qualitative industrial and laboratory tests. They do not involve interpretation of ambiguous data requiring adjudication for ground truth establishment.

Section 5:

If a multi reader multi case (MRMC) comparative effectiveness study was done: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of diagnostic devices or AI algorithms in clinical settings, often in comparison to human readers. The provided document details the pre-market submission for a physical medical device (microcatheter) and focuses on bench testing and biocompatibility, not diagnostic performance or AI effectiveness.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable. (See above explanation).

Section 6:

If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, a standalone algorithm performance study was not done. This document describes the performance of a physical medical device, not an algorithm.

Section 7:

The type of ground truth used: Not applicable in the traditional sense of clinical diagnostic ground truth (e.g., pathology, outcomes data, expert consensus). For the bench and biocompatibility tests, the "ground truth" or reference standard is derived from:
- Validated test methods and specifications: Standards like ISO 10993 for biocompatibility provide the framework for evaluating the device's interaction with biological systems.
- Engineering specifications and design parameters: For bench tests, the device's design requirements define what constitutes a "pass" result (e.g., specific tensile strength thresholds, flow rates, burst pressures).
- Chemical and material analysis: Compatibility tests (like DMSO compatibility) rely on known material properties and reactions.

Section 8:

The sample size for the training set: Not applicable. This document describes a physical medical device, not an AI algorithm that would require a training set.

Section 9:

How the ground truth for the training set was established: Not applicable. (See above explanation).

Summary

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Killogi 3

Trade Name:	Headway 27 Microcatheter
Generic Name:	Percutaneous Catheter
Classification:	Class II, 21 CFR 870.1250
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, California U.S.A.
Contact:	Naomi Gong
Date:	2011Mar23
Predicate Device:	Headway 21 Microcatheter (K093160)

510(k) Summary

AUG - 5 2011

Device Description:

Indication For Use:

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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".

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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.

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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.

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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

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Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Headway 27 Microcatheter Device Name:

Indications For Use:

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

Page 1 of 1

Regulation Number and Section

§ 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).