K Number

Device Name

HYDRAVIEW GUIDEWIRE

Manufacturer

BRIVANT LIMITED

Date Cleared

2014-09-04

(59 days)

Product Code

DQX DOX

Regulation Number

870.1330

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.

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K083094, K103377

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical properties and mechanical performance of a guidewire, with no mention of AI/ML or data processing.

Therapeutic

No
The device is a guidewire used to facilitate the placement of other interventional devices and leads, not to provide therapy itself.

Diagnostic

This device is a guidewire used to facilitate the placement of other interventional devices, not to diagnose a condition.

SaMD (Software as a Medical Device)

The device description clearly states it is a physical guidewire made of stainless steel with a PTFE coating, designed for insertion into the vasculature. It is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is to "facilitate the selective placement of interventional devices with compatible guidewire lumen and compatible coronary venous leads" within the coronary and peripheral vasculature. This describes a device used in vivo (within the body) for a procedural purpose, not for testing samples in vitro (outside the body) to diagnose a condition.
Device Description: The description details a physical guidewire used for navigation and support during medical procedures. This aligns with an in vivo device.
Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostic testing.

Therefore, the HydraView Polymer Guidewires are an interventional medical device used during procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DOX, DQX

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

coronary and peripheral vasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

In vitro bench tests were carried out to demonstrate equivalence of the modified design to the predicate marketed devices i.e Streamer and Charter with reference to the FDAs guidance 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 HydraView design is substantially equivalent to the predicate Streamer Guidewire and that the materials of construction are identical to the predicate Charter Guidewire.

The changes made to the device do not raise any new questions regarding safety and effectiveness. Biological Safety of the device has been established through successful use of the same materials and manufacturing process in current 510(k) approved Lake Region Medical products.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K083094, K103377

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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

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

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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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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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 Preparation
Date	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 of
Technological
Characteristics	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

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 Hydraview
Guidewire design does not introduce any new issues of safety and effectiveness such
that the proposed Hydraview Guidewire is considered substantially equivalent to the
predicate devices. |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing
(non-clinical) | In vitro bench tests were carried out to demonstrate equivalence of the modified design
to the predicate marketed devices i.e Streamer and Charter with reference to the FDAs
guidance 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 HydraView
design is substantially equivalent to the predicate Streamer Guidewire and that the
materials of construction are identical to the predicate Charter Guidewire

The changes made to the device do not raise any new questions regarding safety and
effectiveness. |
| | Biological Safety of the device has been established through successful use of the same
materials and manufacturing process in current 510(k) approved Lake Region Medical
products. |
| Conclusions | Based on safety and performance testing, technological characteristics and the
indications for use for the device, the HydraView Guidewire has been demonstrated to
be appropriate for its intended use and is considered to be substantially equivalent to
the predicate devices. |