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.

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.

AI/ML Overview

The provided text describes the 510(k) submission for the Headway 17 Microcatheter, focusing on its substantial equivalence to a predicate device rather than detailing studies with acceptance criteria based on performance metrics like accuracy, sensitivity, or specificity for an AI/device.

Therefore, the information presented does not include the typical elements one would expect when describing the acceptance criteria and a study proving device performance for an AI-powered medical device in the way your prompt requests.

However, I can extract the relevant information from the provided document as it pertains to acceptance criteria for a non-AI medical device (microcatheter) and the study (bench testing) that demonstrated it met those criteria.

Here's the breakdown based on the provided text, structured to align with your request where applicable, but noting the absence of AI-specific elements:

1. A table of acceptance criteria and the reported device performance

For the Headway 17 Microcatheter, the "acceptance criteria" are implied by the "Result" column stating "Met established criteria." The specific quantitative or qualitative criteria for each test are not detailed in this summary but are understood to have been pre-defined and satisfied.

Bench Testing (Acceptance Criteria Category)	Reported Device Performance (Met Criteria)
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

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

Sample Size for Test Set: Not specified in the provided 510(k) summary. These types of bench tests typically use a predefined number of device units or components, but the exact quantity is not disclosed here.
Data Provenance: The study is "Bench Testing," implying it was conducted in a laboratory setting by the manufacturer (MicroVention, Inc., based in Aliso Viejo, California, U.S.A.). It is prospective in the sense that the tests were performed on newly manufactured devices to demonstrate compliance for regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable for these types of bench tests. The "ground truth" for mechanical properties, material compatibility, or physical performance in bench tests is typically established through direct measurement, established engineering principles, and validated test methods, rather than expert consensus on medical images or patient data.

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

This concept is not applicable to the bench testing described. Adjudication methods are relevant for studies requiring experts to resolve discrepancies in interpretation, particularly in diagnostic contexts.

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

No, an MRMC comparative effectiveness study was not done or described. This type of study is specific to evaluating AI's impact on human performance in diagnostic tasks and is not relevant for a microcatheter's physical and mechanical performance evaluation via bench testing.

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 or described. The device is a physical microcatheter, not an AI algorithm.

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

The "ground truth" for these bench tests is derived from objective measurements against pre-defined engineering and performance specifications. Examples include:
- Measurement of forces (e.g., separation force).
- Observation of material integrity (e.g., stress cracking).
- Measurement of fluid flow rates.
- Evaluation of biological response in biocompatibility tests.
- Demonstration of compatibility with other agents (e.g., embolic agents).
- Fluoroscopic visualization for radio-detectability.
- Established limits for catheter stiffness and kink resistance.

8. The sample size for the training set

Not applicable. There is no "training set" as this is a physical medical device, not an AI/machine learning model.

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

Not applicable. As there is no training set, this question is not relevant.

In summary, the provided document details the regulatory submission for a physical microcatheter, focusing on its substantial equivalence to a predicate device through bench testing. The evaluation criteria are based on engineering and material performance standards rather than AI-specific metrics.

Summary

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	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 ColumbiaAliso Viejo, California U.S.A.
Contact:	Florin Truuvert

Predicate Device:

Number	Description	Predicate For	Clearance Date
K013789	Boston ScientificExcelsior SL-10Microcatheter.	Headway 17Microcatheter.	Dec 06, 2001

Device Description

Indication For Use

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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.

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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:

K083343

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.

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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); 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

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Indications for Use

510(k) Number (if known): 《083343

Device Name: Headway 17 Microcatheter

Indications For Use:

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

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).