The HydraView Polymer Guidewires are intended for use in the coronary and peripheral vasculature to facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads.

Device Description

The HydraView Guidewire is a disposable medical device designed for single use only. It consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of which is reduced in diameter over a 30cm 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 is varied to produce 3 unique levels of support; ES, DS and EDS.

AI/ML Overview

The provided text is a 510(k) summary for the HydraView Polymer Guidewire and contains information about its equivalence to predicate devices based on non-clinical performance testing. It is not a study proving a device meets acceptance criteria related to an AI algorithm or diagnostic performance. Therefore, I cannot extract the specific information requested in your prompt regarding AI performance, human readers, ground truth establishment, or sample sizes for AI training/test sets.

However, I can extract information related to the non-clinical performance testing for the HydraView Polymer Guidewire, which serves as the "study" in this context to demonstrate substantial equivalence to its predicate devices.

Here's an interpretation of the available information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that in-vitro bench tests were carried out to demonstrate equivalence. While explicit acceptance criteria and specific numerical reported performance values are not detailed in this summary, the following table lists the tests performed, implying that the acceptance criterion for each was "comparable to predicate devices" or "conformance to requirements for intended use." The reported performance is that the device met these implied criteria.

Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Verification (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Tensile Strength (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Torque strength (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Torque response/Torqueability (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Coating adherence/Integrity (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Catheter/Lead compatibility (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Tip Stiffness (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Biocompatibility testing (passed and comparable to predicate)	Materials are identical to predicate Charter Guidewire and successful use in other 510(k) approved products. Safety established.
Radiopacity testing (comparable to predicate)	Demonstrated equivalence to predicate and conformance to requirements.
Particulate Testing (comparable to predicate, within limits)	Demonstrated equivalence to predicate and conformance to requirements.

2. Sample Size Used for the Test Set and Data Provenance

This document describes bench testing of a medical device, not an AI algorithm. Therefore, "test set" and "data provenance" in the context of clinical data are not applicable. The evaluations were in-vitro (bench tests). The sample sizes for each specific bench test (e.g., number of guidewires tested for tensile strength) are not provided in this summary.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is for AI algorithm validation, which is not described here. For mechanical device testing, "ground truth" is typically established by engineering specifications, validated test methods, and comparison against established predicate device performance. Experts would be involved in designing and executing the tests and interpreting the engineering data, but their "number" and "qualifications" in the sense of clinical ground truth establishment are not relevant or provided.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This is for clinical data adjudication in AI studies and is not applicable to the bench testing described.

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 is for AI algorithm clinical studies and is not applicable to the bench testing described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This is for AI algorithm performance and is not applicable to the bench testing described.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

Engineering Specifications and Performance Standards: The tests were conducted "with reference to the FDA's guidance document 'Coronary and Cerebrovascular Guidewire Guidance, Jan 1995'."
Predicate Device Performance: The primary comparison for demonstrating substantial equivalence was against the performance of the Streamer Guidewire and Charter Guidewire (predicate devices). This means the established, safe, and effective performance of the predicate devices served as the benchmark.

8. The Sample Size for the Training Set

This is for AI algorithms and is not applicable to the bench testing described.

9. How the Ground Truth for the Training Set Was Established

This is for AI algorithms and is not applicable to the bench testing described.

Summary

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Image /page/0/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the circle is an emblem featuring a stylized human figure with three faces in profile, stacked on top of each other.

Public Health Service

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

September 4, 2014

Brivant Limited % Kenneth Walsh Regulatory Affairs Group Leader Parkmore West Business Park Galway, Ireland

Re: K141831

Trade/Device Name: HydraView Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DOX Dated: July 4, 2014 Received: July 7, 2014

Dear Kenneth 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 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

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Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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,

M. A. Hilleman

for
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)

K141831

Device Name HydraView Polymer Guidewire

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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Image /page/3/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized graphic to the left of the words "Lake Region" in a bold, serif font. Below "Lake Region" is the word "Medical" with a registered trademark symbol.

Product: HydraView Guidewire Submission Type: Special 510(k) Submission Date: July 04, 2014

510(k) Summary

Device Name	HydraView Polymer Guidewire
Submitters name	Brivant Limited,
	Parkmore West Business Park
	Galway,
	Ireland
Application	Kenneth Walsh
Correspondent	Regulatory Affairs Group Leader
	Lake Region Medical Limited
	Tel: +353 91 385037
	Fax: +353 91 766598
Summary PreparationDate	4th July 2014
Device Name &Classification	Trade Name:	HydraView Polymer Guidewire
	Common Name:	Guidewire
	Classification Name:	Catheter, Guidewire
	Device Classification:	Class II, 21 CFR §870.1330
	Product Code:	DQX
Intended Use	Intended Use:
	The HydraView Polymer Guidewires are intended for use in the coronary and peripheral
	vasculature to facilitate the selective placement of interventional devices with
	compatible guidewire lumen and compatible coronary venous leads.
	Contraindications:
	The HydraView Polymer Guidewires are not intended for use in the cerebral vasculature.
	Patients judged not acceptable for percutaneous intervention.
Device Description	The HydraView Guidewire is a disposable medical device designed for single use only. It
	consists of a PTFE coated 190cm, 0.014" diameter stainless steel core wire, one end of
	which is reduced in diameter over a 30cm 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 is varied to produce 3 unique levels of support;
	ES, DS and EDS.
Predicate Devices		Device/Manufacturer	510k	Date
	Streamer Guidewire/ Brivant Limited		K083094	7th July 2009
	Charter Guidewire/ Brivant Limited		K103377	18th May 2011
Principle of Operation	The HydraView guidewire is operated manually by a manual process
Comparison ofTechnologicalCharacteristics	This HydraView Guidewire has the following differences from the primary predicate
	device:
	- Change in the polymer material at the distal tip of the device.
	- Minor dimensional changes to the tip profile.
	- Minor change to indications for use statement
	No other changes are proposed to the device.
	In vitro bench testing data is available to support a determination of substantial
	equivalence between the Hydraview Guidewire models and the predicate (refer to
	performance testing below).
	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

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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a stylized symbol resembling interconnected circles on the left, followed by the words "Lake Region" in a bold, serif font. Below "Lake Region" is the word "Medical" in a smaller font, with the registered trademark symbol next to it. A thin black line runs horizontally beneath the logo.

	use and performs comparably to the existing devices in the range. The HydraviewGuidewire design does not introduce any new issues of safety and effectiveness suchthat the proposed Hydraview Guidewire is considered substantially equivalent to thepredicate devices.
Performance Testing(non-clinical)	In vitro bench tests were carried out to demonstrate equivalence of the modified designto the predicate marketed devices i.e Streamer and Charter with reference to the FDAsguidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995".
	The following bench tests were performed:- Dimensional Verification- Tensile Strength- Torque strength- Torque response/Torqueability- Coating adherence/Integrity- Catheter/Lead compatibility- Tip Stiffness- Biocompatibility testing- Radiopacity testing- Particulate Testing
	The results from these performance evaluations demonstrate the proposed HydraViewdesign is substantially equivalent to the predicate Streamer Guidewire and that thematerials of construction are identical to the predicate Charter GuidewireThe changes made to the device do not raise any new questions regarding safety andeffectiveness.
	Biological Safety of the device has been established through successful use of the samematerials and manufacturing process in current 510(k) approved Lake Region Medicalproducts.
Conclusions	Based on safety and performance testing, technological characteristics and theindications for use for the device, the HydraView Guidewire has been demonstrated tobe appropriate for its intended use and is considered to be substantially equivalent tothe predicate devices.

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.