The ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.

Device Description

The Vadiswire ZigiWire Mode2 and ZigiWire Mode3 Guidewire Systems are sterile guidewire systems designed to facilitate the placement of diagnostic catheters and sheaths in the peripheral vasculature. The individual guidewires used in the ZigiWire Systems consist of exchange length peripheral guidewires cleared under AdvanceCath (TechDevice) Corporation's 510(k) K053251. TechDevice Corporation manufactures the guidewires used in the ZigiWire Systems for Vadiswire, which are individually the same as several of the guidewires previously cleared under K053251.

The ZigiWire Systems consist of two models: one (ZigiWire Mode3) incorporates three individual exchange length peripheral guidewires, and the second (ZigiWire Mode2) incorporating two individual exchange length peripheral guidewires. The individual guidewires used in the system range from 0.014 - 0.022 inches in diameter and are standard Teflon-coated, stainless steel guidewires with flexible radiopaque tips. Each ZigiWire System is provided with the individual guidewires in an all straight tip shape, or with all guidewires in the J-tip shape. The ZigiWire Systems are also provided with accessories which are intended to assist in inserting the guidewires into diagnostic catheters. These accessories consist of a wire introducer, which loosely holds the individual guidewires and helps to guide them into the hub of a catheter, a handle to separate the wires prior to use, and wire torquers for each wire. The handle incorporates a side port to enable flushing the introducer with the guidewires in place.

AI/ML Overview

The provided text is a 510(k) summary for the ZigiWire Mode2 and Mode3 Guidewire Systems. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria in the context of a new, novel product with performance claims evaluated against a clinical study with ground truth. Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or cannot be extracted from this document, as it focuses on bench testing for equivalence rather than clinical performance or AI algorithm validation.

Here's a breakdown of what can and cannot be extracted:

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

Acceptance Criteria (Bench Tests for Equivalence)	Reported Device Performance
Bond Testing	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Aseptic Removal from Pouch	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Wire Removal from Handle	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Wire Handle Hold and Release of Guidewire	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Introducer Flushing	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Manual Tip Forming	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Wire Placement in Simulated Use	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Catheter Compatibility	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Steerability	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Deliverability of Guiding Catheter or Sheath	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Guidewire Removal	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.
Tip Flexibility	Results demonstrated comparable technological and performance characteristics to predicate devices and supported safety and effectiveness.

Note: The document states that the results "demonstrate that the technological and performance characteristics of the subject ZigiWire Guidewire Systems are comparable to the predicate devices, support the safety and effectiveness of the devices that are the subject of this 510(k), and ensure the subject devices can perform in a manner equivalent to the predicate devices with the identical intended use." It does not provide specific numerical acceptance thresholds or detailed performance metrics for each test, as it's a summary tailored for substantial equivalence.

Regarding the other requested information (2-9), these are generally applicable to studies for novel performance claims, particularly for AI/CADe devices, and are largely not found in a 510(k) summary for a guidewire system:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of bench testing. The "test set" consisted of the guidewire systems themselves undergoing the listed physical tests. Data provenance in this context isn't about clinical data.
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): Not applicable. "Ground truth" in the AI/clinical study sense is not established by experts for physical performance of a guidewire system. The "truth" is determined by the physical properties and behavior of the device during the specified bench tests.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are relevant for clinical studies where expert consensus might establish ground truth for image interpretation or disease diagnosis.
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: Not applicable. This refers to AI-assisted diagnostic or interpretative devices, not a guidewire.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This refers to AI algorithms.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "truth" is based on the physical outcomes of the bench tests (e.g., bond strength, successful wire removal, steerability).
The sample size for the training set: Not applicable. There is no "training set" for physical guidewire testing.
How the ground truth for the training set was established: Not applicable.

In summary, this document describes a traditional 510(k) submission for a medical device (guidewire) based on established predicate devices and bench testing to demonstrate substantial equivalence, rather than a clinical study evaluating a novel diagnostic or therapeutic claim with specific performance acceptance criteria against "ground truth" as might be seen for an AI/CADe device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2014

Vadiswire Corporation Mr. Edward Wulfman President 339 Kirkland Way #G Kirkland, WA, 98033

Re: K141218

Trade/Device Name: ZigiWire Mode2 Guidewire System, ZigiWire Mode3 Guidewire System Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Class: Class II Product Code: DQX Dated: November 20, 2014 Received: November 24, 2014

Dear Mr. Wulfman:

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 note: 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.

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

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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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kenneth J. Cavanaugh -S

for

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141218

Device Name

ZigiWire Mode2 Guidewire System ZigiWire Mode3 Guidewire System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services (301) 443-6740 EF

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510(k) SUMMARY

General Information:

Date of Summary Preparation:	May 09, 2014
Name and Address of Manufacturer:	Vadiswire Corporation339 Kirkland Way #GKirkland, WA 98033
Contact Person:	Edward (Ted) WulfmanPresidentPhone: 425-985-1570Fax: 425-889-9201
Device Trade Names:	ZigiWire Mode2 Guidewire SystemZigiWire Mode3 Guidewire System
Common Name:	Wire, Guide, Catheter
Regulation Number:	21 CFR 870.1330
Regulation Name:	Catheter guidewire
Regulatory Class:	Class II
Classification Panel:	Cardiovascular
Product Code:	DOX

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Performance Standards: Performance Standards do not currently exist for these devices. None are established under Section 514.

Device Description: The Vadiswire ZigiWire Mode2 and ZigiWire Mode3 Guidewire Systems are sterile guidewire systems designed to facilitate the placement of diagnostic catheters and sheaths in the peripheral vasculature. The individual guidewires used in the ZigiWire Systems consist of exchange length peripheral guidewires cleared under AdvanceCath (TechDevice) Corporation's 510(k) K053251. TechDevice Corporation manufactures the guidewires used in the ZigiWire Systems for Vadiswire, which are individually the same as several of the guidewires previously cleared under K053251.

Indications for Use: The ZigiWire Guidewire Systems facilitate placement and exchange of catheters and other instruments in the peripheral vasculature. The ZigiWire Guidewire Systems are not intended for use in the coronary arteries or neurovasculature.

Predicate Devices: Vadiswire Corporation cites the following devices as the predicate devices for the substantial equivalence basis.

Predicate Devices	Predicate 510(k)
AdvanceCath (TechDevice) Guidewire	K053251
Amplatz Super Stiff Guidewire	K942382

Testing Summary: To demonstrate substantial equivalence of the subject ZigiWire Guidewire Systems to the predicate devices, the technological and performance characteristics were evaluated by completion of the following testing:

Bond Testing
Aseptic Removal from Pouch
Wire Removal from Handle ●
o Wire Handle Hold and Release of Guidewire
Introducer Flushing
Manual Tip Forming ●
o Wire Placement in Simulated Use
Catheter Compatibility
o Steerability

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Deliverability of Guiding Catheter or Sheath
o Guidewire Removal
Tip Flexibility

The results from these tests:

demonstrate that the technological and performance characteristics of the subject o ZigiWire Guidewire Systems are comparable to the predicate devices,
support the safety and effectiveness of the devices that are the subject of this 510(k), and
o ensure the subject devices can perform in a manner equivalent to the predicate devices with the identical intended use.

Conclusion (Statement of Equivalence): The data and information presented within this submission (including in vitro bench testing) and the similarities between the subject and predicate devices support a determination of substantial equivalence, and therefore market clearance of the subject ZigiWire Guidewire Systems through this 510(k) Premarket Notification.

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.