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.

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.

AI/ML Overview

The provided document describes the MicroVention Headway 17 Advanced Microcatheter and its substantial equivalence to predicate devices, not a study evaluating acceptance criteria for an AI/ML device. Therefore, the questions related to AI/ML device performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment cannot be answered from the provided text.

The document focuses on demonstrating that the Headway 17 Advanced Microcatheter is substantially equivalent to existing devices based on various bench, animal, and biocompatibility tests. The "acceptance criteria" here are implicitly related to meeting the performance and safety specifications demonstrated by the predicate devices and relevant industry standards.

Here's the information that can be extracted or inferred from the provided text, structured to best match your request, while acknowledging the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

For a device like the Headway 17 Advanced Microcatheter (a physical medical device, not an AI/ML system), "acceptance criteria" are typically defined by regulatory standards (like ISO 10555-1 and ISO 10993-1) and by demonstrating performance comparable to existing, legally marketed predicate devices. The study performed is a series of bench tests, animal studies, and biocompatibility tests to prove this.

Acceptance Criteria Category (Implied)	Specific Tests Performed	Reported Device Performance
Physical and Mechanical Performance	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
Biocompatibility	Cytotoxicity (ISO 10993-5)	Pass
	Sensitization/Irritation (ISO 10993-10)	Pass
	Hemocompatibility (ISO 10993-4)	Pass
	Systemic Toxicity (ISO 10993-11)	Pass
Clinical Performance (pre-market)	Acute animal study compared to predicate device	Comparable performance to predicate device

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not explicitly stated for each bench test. For the "acute animal study," the exact number of animals is not provided.
Data Provenance: Not explicitly stated, but MicroVention, Inc. is located in Tustin, California, U.S.A. The studies are pre-market evaluations, which are inherently prospective for the specific purpose of device clearance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to a physical device submission of this nature. "Ground truth" in this context would be defined by validated testing methodologies and compliance with established standards, not expert consensus on interpretations of data a human would use.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable. The performance is measured against engineering specifications and predicate device performance, not through expert adjudication of an AI/ML output.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as the device is a physical microcatheter, not an AI-based system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable as the device is a physical microcatheter, not an AI-based system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests: Engineering specifications and compliance with international standards (ISO 10555-1, ISO 10993-1) serve as the "ground truth" for performance.
For the animal study: "Comparable performance to predicate device" implies that the predicate device's established safety and efficacy in an animal model served as the ground truth reference. Biocompatibility tests use Pass/Fail criteria defined by the ISO 10993 series.

8. The sample size for the training set

This question is not applicable as the device is a physical microcatheter and does not involve AI/ML training.

9. How the ground truth for the training set was established

This question is not applicable as the device is a physical microcatheter and does not involve AI/ML training.

Summary

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510(k) Summary

Product Name:	Headway 17 Advanced Microcatheter
Generic Name:	Percutaneous Catheter
Classification:	Class II, 21 CFR 870.1250
Submitted By:	MicroVention, Inc1311 Valencia AvenueTustin, 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 17Microcatheter	December 4, 2008
K042568	Boston Scientific, Excelsior SL-10Preshaped Microcatheter	October 15, 2004

Device Description:

Indication For Use:

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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 acuteanimal 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

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Technological comparison:

	Predicate Device (K833434)	510(k) Subject Device
Intended Use	The Headway 17 Advancedmicrocatheter is intended for generalintravascular use, including theperipheral, coronary andneurovasculature- for the infusion ofdiagnostic and therapeutic agents.	Same
Size	Proximal = 2.4FrDistal = 1.9Fr	Proximal = SameDistal = 1.7 Fr
Material	Catheter body: polyether block amide,stainless steel, nylon, PTFEMarker band: Pt/IrHub: nylonStrain relief: polyether block amideIntroducer sheath: polyether block amideShaping mandrel: stainless steel	Same with barium sulfateincorporated in polyether blockamide segment
Distal Shaft Length (Shapeable Length)	11 cm	Same
Proximal ID/OD	ID = .0170" minOD = .031"	Same
Distal ID/OD	ID = .0170" minOD = .025"	ID = SameOD = .022"
No. of Markers	2	Same
Coating	Hydrophilic Coating	Same
Effective Length	150 cm	Same
Tip Configuration	Straight - Steam Shapeable by physicianprior to use	Same as K042568- BostonScientific Excelsior SL-10:Preshaped tips -with the optionof secondary shaping for properadjustment to the anatomy priorto use.
Guidewire compatibility	0.014 " wires or smaller	Same
Method of supply	Sterile and single use	Same

・

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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

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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.

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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

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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)

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).