CHARTER GUIDEWIRE by BRIVANT, LTD.

The Charter™ Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or 0.018" diameter stainless steel core wire, one end of which is reduced in diameter over a 43cm approx. segment in a progressive fashion through a centreless grinding operation. The profile of this reduced section affords the product a reduced area of stiffness and can be varied to produce various levels of support.

The distal part of the reduced section is covered with a 3cm, 0.010" platinum tungsten spring coil. This provides greater visibility on x-ray equipment. A 39cm approx. length of black / grey Estane 88A radiopaque heat shrink polymer tubing is applied over the tapered distal end of the wire and ground to form a constant outer diameter, OD, equivalent in diameter to the main core body.

Coatings are placed on the device to improve the lubricity and ease in its advancement through the guide catheter and the blood vessel

AI/ML Overview

The provided text describes a 510(k) application for the Charter™ Guidewire. This is a medical device, not an AI/ML powered device, therefore the criteria for AI/ML powered devices cannot be fully satisfied by the provided information.

However, I can extract the acceptance criteria and the study type conducted based on the available text.

Here's a breakdown of the requested information based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Functional/Mechanical	Tensile Strength	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Torque Strength	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Outer Diameter measurement	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Torque Response	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Catheter Compatibility	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Coating Adherence/Coating Integrity	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Tip Stiffness	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
	Particulate Residue	"The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device."
Overall Equivalence	Demonstration of substantial equivalence to predicate devices, ensuring no new issues of safety and effectiveness, and appropriateness for intended use. Comparability to existing devices in the range. Meeting requirements for intended use.	"Based on safety and performance testing, technological characteristics and the indications for use for the device, the proposed new Charter™ Guidewire models has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the original [predicate device]."

Study Information (Based on a medical device, not an AI/ML framework):

Sample size used for the test set and the data provenance:
- The study involved in vitro bench testing.
- The sample size for these tests is indicated as "n" (which is not a specific number but typically implies a sufficient number for statistical validity in bench testing).
- The documentation does not specify provenance like country of origin for the "data" as it pertains to physical device testing, not patient data. It is a prospective bench test conducted by the manufacturer to assess device properties.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of device and study. "Ground truth" in the context of AI/ML or diagnostic studies refers to a verified diagnosis or outcome. For a physical medical device like a guidewire, the "ground truth" is established by direct measurement and adherence to engineering specifications and performance standards through well-defined bench test methodologies.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable. Adjudication refers to resolving disagreements between human readers or between an AI and human readers in diagnostic tasks. The bench tests described are objective measurements against defined acceptance criteria.
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. This type of study is relevant for diagnostic devices (especially those involving image interpretation by human readers, often assisted by AI). The Charter™ Guidewire is a physical interventional device, not a diagnostic one.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This refers to AI algorithm performance. The Charter™ Guidewire is a physical device, and its "performance" is measured by its physical and mechanical properties described in the bench tests, not by an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on pre-defined product specifications and industry standards for guidewire performance, as outlined in the "In vitro bench testing" section, specifically referencing the "FDAs guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'". The device's performance is measured against these objective, quantifiable criteria.
The sample size for the training set:
- This is not applicable. There is no "training set" in the context of a physical medical device's performance testing. Training sets are used to develop and train AI/ML models.
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.

Summary

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K122856 page 1 of 2

ОСТ

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Charter 510(k) Application

510(k) Summary as required by 21 CFR 807.92(c)

Device Name	Charter™ Guidewire
Submitters	Brivant Ltd,
name/contact	Parkmore West Business Park,
details	Galway,
	Ireland

	Contact Details:
	Kenneth Walsh
	Senior QA/RA Supervisor
	Tel: +353 91 385391
	Fax: +353 91 766598
Summary	31st August 2012
Preparation Date
Device Name &	Trade Name:	Charter™ Guidewire
Classification	Common Name:	Guidewire
	Classification Name:	Catheter, Guidewire
	Device Classification:	Class II, 21 CFR §870.1330
	Product Code:	DQX
Intended Use	Intended Use:
	The Charter™ Guidewires are intended for use in the coronary and peripheral
	vasculature.

	Contraindications:
	The Charter™ Guidewire is not intended for use in the cerebral vasculature.
	Patients judged not acceptable for percutaneous intervention (PCI)
Device Description	The Charter™ Guidewire is a disposable medical device designed for single use
	only. It consists of a PTFE coated 140cm, 180cm, or 300cm 0.014", 0.016" or
	0.018" diameter stainless steel core wire, one end of which is reduced in
	diameter over a 43cm approx. segment in a progressive fashion through a
	centreless grinding operation. The profile of this reduced section affords the
	product a reduced area of stiffness and can be varied to produce various levelsof support.

	The distal part of the reduced section is covered with a 3cm, 0.010" platinumtungsten spring coil. This provides greater visibility on x-ray equipment. A 39cmapprox. length of black / grey Estane 88A radiopaque heat shrink polymer tubing


	is applied over the tapered distal end of the wire and ground to form a constant
	outer diameter, OD, equivalent in diameter to the main core body.
	Coatings are placed on the device to improve the lubricity and ease in itsadvancement through the guide catheter and the blood vessel

Predicate Devices		Manufacturer	510k	Date
	Charter Guidewire		K103377	18th May 2011
Principle of	The Charter™ Guidewire is operated manually by a manual process

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Charter 510(k) Application Operation The Charter™ wire has the following differences from the originally approved Comparison of Technological devices. Introduction of a 0.016" diameter range. Characteristics Introduction of a "soft" version tip providing models with greater distal flexibility. Introduction of 300cm length models. In vitro bench testing was performed to support a determination of substantial equivalence (refer to performance testing below) between the new Charter™ Guidewires models and the existing. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use and performs comparably to the existing devices in the range. The introduction of these new models raise no new issues of safety and effectiveness such that the proposed new Charter™ Guidewire models are considered substantially equivalent to the predicate devices. In vitro bench tests were carried out to demonstrate equivalence with reference Performance Testing (nonto the FDAs guidance document "Coronary and Cerebrovascular Guidewire clinical) Guidance, Jan 1995". The following bench tests were performed: . Tensile Strength Torque Strength Outer Diameter measurement Torque Response Catheter Compatibility Coating Adherence/Coating Integrity Tip Stiffness Particulate Residue The results from these performance evaluations demonstrated that the Charter™ Guidewire met the acceptance criteria defined in the product specification and performed comparably to the predicate device. Conclusions Based on safety and performance testing, technological characteristics and the indications for use for the device, the proposed new Charter™ Guidewire models has been demonstrated to be appropriate for its intended use and is considered

to be substantially equivalent to the original

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

OCT 17 2012

Brivant Ltd. Lake Region Medical International Research & Development Centre c/o Kenneth Walsh Parkmore West Business Park Galway Ireland

Re: K122856

Trade/Device Name: Charter Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX

Dear Mr. Walsh:

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

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Page 2 - Mr. Kenneth Walsh

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.

Tu A. Sillel

$\mathscr{R}$

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 Statement

510{k) Number (if known):

Device Name:

CHARTER™ GUIDEWIRE

and peripheral vasculature.

K122856

Indications for Use:

Contraindications:

The Charter Guidewire is not intended.for use in the cerebral vasculature. Patients judged not acceptable for percutaneous intervention (PCI).

Charter™ Guidewires are intended for use in the coronary

MZKilleh

iovascular Devices

510(k) Number K112286

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.