LogoFDA 510(k) Search
K Number
K182457
Device Name
Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J
Manufacturer
Brivant Limited (Lake Region Medical)
Date Cleared
2019-04-18

(223 days)

Product Code
DQX
Regulation Number
870.1330
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
Device Description
The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity). The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity. Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long. When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA). Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.
More Information

K123067, K171933

Not Found

No
The device description explicitly states that the guide wire is operated manually, and there is no mention of AI, ML, or any related technologies in the document.

No
The device is described as a guide wire intended to facilitate the delivery of catheter-based devices and provide a pathway, rather than directly treating a condition. Its function is enabling other devices, even if those devices are therapeutic.

No
The device is a guide wire, an interventional device, used to facilitate the delivery of other devices and distinguish vasculature, but not to diagnose conditions itself. While it can "distinguish the vasculature," this is for facilitating intervention, not for making a diagnosis.

No

The device description clearly describes a physical guide wire with specific dimensions, materials (hydrophilic coating), and mechanical properties, indicating it is a hardware device. The principles of operation also describe a manual process, not software execution.

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

Here's why:

  • Intended Use: The intended use clearly describes a device used within the body to facilitate the delivery of other interventional devices during procedures like PTCA and PTA. It's a tool for navigating and supporting procedures within the vascular system.
  • Device Description: The description details a physical guide wire with features for manipulation and compatibility with other devices. It doesn't mention any components or processes related to testing samples of bodily fluids or tissues outside the body.
  • Principles of Operation: The operation is described as "manual by a manual process," which aligns with a physical medical device used in a procedure, not an in vitro diagnostic test.
  • Anatomical Site: The anatomical site is the "Coronary & Peripheral Vasculature," indicating use within the body.
  • Intended User/Care Setting: The intended users are interventional cardiologists and radiologists, who perform procedures on patients, not laboratory personnel performing diagnostic tests on samples.

IVD devices are designed to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device's function is entirely in vivo (within the body).

N/A

Intended Use / Indications for Use

Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.

Product codes

DQX

Device Description

The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).

The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.

Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.

When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).

Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Coronary & Peripheral Vasculature

Indicated Patient Age Range

Adult over the age of 16

Intended User / Care Setting

Interventional Cardiologist, Interventional Radiologist

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 with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". The following bench tests were performed:

  • Tensile Strength
  • Torque Strength
  • Dimensional measurement
  • Torque Response
  • Catheter Compatibility
  • Coating Adherence/Coating Integrity
  • Coating Lubricity and Durability
  • Particulate Testing
  • Tip Flexibility/Stiffness
  • Radiopacity
  • Corrosion Res
  • Flex Resistance Test
  • Guidewire Pull test

The results from these performance evaluations demonstrated that the Hi-Torque Vektor Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).

Biological compatibility of the device has been established through biocompatibility testing carried out in compliance with ISO 10993-1.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K123067, K171933

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.

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1

510K Summary

as required by 21 CFR 807.92

    1. Company Information:
      Contact Person / Official Correspondent: Mr. Tom J Healy Regulatory Affairs and Quality Manager Name: Brivant Limited (Lake Region Medical) Address: Parkmore West Business Park Galway Galway, IRELAND Establishment Registration Number: 3006010712 Tel: 091 385 037 Date prepared: 18 April 2019
    1. Product Trade Name: "Hi-Torque Vektor Guidewire Family" Common/ Usual Name: "Hi-Torque Vektor" Panel: Cardiovascular Class II, 21 CFR 870.1330. Product Code: DQX. Classification Name (per Product Classification): "Catheter guide wire"

3. Predicate Device:

Manufacturer : Abbott Vascular Inc.

Device Name : Hi-Torque Pilot 50 Guidewire 510(k) No : K123067, Class 2, Product Code DQX. Classified per 21 CFR 870.1330

Manufacturer :Asahi Intecc Co. Ltd.
Device Name :Asahi Fielder XT Guidewire
510(k) No :K171933, Class 2, Product Code DQX.
Classified per 21 CFR 870.1330
    1. Description of Device:
      The Hi-Torque Vektor Guide Wire is a 0.014" (0.36 mm) diameter steerable guide wire available in several lengths and has a shapeable distal tip. Refer to the product label for product specifications (e.g. wire length, diameter and length of tip radiopacity).

The Hi-Torque Vektor Guide Wires have a modified proximal end that permits the attachment of the DOC Guide Wire Extension. Refer to the product label for Guide Wire Extension system compatibility. Joining the guide wire extension to the guide wire facilitates the exchange of one interventional device for another, while maintaining guide wire position in the anatomy. After the interventional device exchange has been completed, the extension can be detached and the guide wire can be used in its original capacity.

Brachial and femoral markers located on the proximal segment of the 0.014" (0.36 mm) Hi-Torque Vektor guide wire aid in gauging guide wire position relative to the guiding catheter

2

tip when using bare wire technique. These Hi-Torque Vektor guide wires are compatible with guiding catheters that are at least 90 cm (brachial) or 100 cm (femoral) long.

When wet, a hydrophilic coating increases the lubricity of the Hi-Torque Vektor guide wire surface. This coating contains highly purified hyaluronic acid (HA).

Principles of Operation: The Hi-Torque Vektor guidewire is operated manually by a manual process.

    1. Indications for Use
      Intended to facilitate the delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature.
    1. Comparison of Technological Characteristics
      The technological characteristics are substantially equivalent to the predicate device. These performance properties include:

  • -Similar length range provided

  • -Same diameter (0.014")

  • -All devices are constructed with a stainless steel core

  • -The proposed 4 models have equivalent tip stiffness characteristics to the predicate devices.

  • -All devices have a hydrophilic coating at the distal tip

  • All devices have a PTFE coating on the guidewire shaft -

  • -All devices are sterilized using ETO gas

    1. Performance Testing (non-clinical)

In vitro bench tests were carried out to demonstrate equivalence with reference to the FDAs guidance document "Coronary and Cerebrovascular Guidewire Guidance, Jan 1995". The following bench tests were performed:

  • -Tensile Strength
  • -Torque Strength
  • -Dimensional measurement
  • -Torque Response
  • -Catheter Compatibility
  • -Coating Adherence/Coating Integrity
  • Coating Lubricity and Durability -
  • -Particulate Testing
  • -Tip Flexibility/Stiffness
  • -Radiopacity

3

  • Corrosion Res ।
  • -Flex Resistance Test
  • Guidewire Pull test -

The results from these performance evaluations demonstrated that the Hi-Torque Vektor Guidewire range met the acceptance criteria defined in the product specification and performed comparably to the predicate device(s).

Biological compatibility of the device has been established through biocompatibility testing carried out in compliance with ISO 10993-1.

See Table 1.0 for comparison with above mentioned predicate devices.

4

Table 1.0: Predicate Comparison Table

| | Equivalence
Category | Hi-Torque Vektor
(Proposed Device) | Hi-Torque Pilot 50
(Primary Predicate) | Fielder XT
(Secondary Predicate) |
|-----------------------------------------------------|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | N/A | Lake Region Medical | Abbott Vascular | Asahi Intecc |
| EU Classification | Clinical | III | III | III
(unknown but expected
Class III) |
| US Classification | Clinical | II | II | II |
| Classification Name | Clinical | Catheter Guide Wire | Catheter Guide Wire | Catheter Guide Wire |
| FDA Classification
Product Code | Clinical | DQX | DQX | DQX |
| Indications for Use | Clinical | Intended to facilitate the
delivery of catheter-based
interventional devices during
percutaneous transluminal
coronary angioplasty (PTCA)
and percutaneous
transluminal angioplasty
(PTA). This guide wire may be
used with compatible stent
devices during therapeutic
procedures. The guide wire
may be used to reach and
cross a target lesion, provide a
pathway within the vessel
structure, facilitate the
substitution of one diagnostic
or interventional device for
another, and to distinguish the
vasculature. | Intended to facilitate the
delivery of catheter-based interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). This guide wire may be used with compatible stent devices during therapeutic procedures. The guide wire may be used to reach and cross a target lesion, provide a pathway within the vessel structure, facilitate the substitution of one diagnostic or interventional device for another, and to distinguish the vasculature. This guide wire may also be used to cross or assist in crossing de novo chronic total coronary occlusions (CTO) | ASAHI PTCA Guide Wires are intended to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA), including use in crossing or assisting in crossing de novo coronary chronic total occlusions (CTO). |
| Contraindications | Clinical | Not intended for use in the cerebral vasculature or with atherectomy devices | Not intended for use in the cerebral vasculature or with atherectomy devices | The ASAHI PTCA Guide Wires are not to be used in the neurovasculature. |
| Anatomical sites | Clinical | Coronary & Peripheral
Vasculature | Coronary & Peripheral
Vasculature | Coronary & Peripheral
Vasculature |
| Operating Principle | Clinical | Device is hand held and
operated by manual method.
User will hold, rotate, push
and pull the wire to steer it
through the vasculature | Device is hand held and
operated by manual
method. User will hold,
rotate, push and pull the
wire to steer it through
the vasculature | Device is hand held and
operated by manual
method. User will hold,
rotate, push and pull the
wire to steer it through
the vasculature |
| Single patient
device | Clinical | Yes | Yes | Yes |
| Single use or
reusable | Clinical | Single Use | Single Use | Single Use |
| Medical user
qualification | Clinical | Interventional Cardiologist,
Interventional Radiologist | Interventional
Cardiologist,
Interventional Radiologist | Interventional
Cardiologist,
Interventional Radiologist |
| Deployment
Method | Clinical | Guidewire insertion shall be
via femoral / radial access and
introduced to the body via an
introducer/ sheath / guide
catheter/ etc. The guidewire
is then directed to the target
location by manual
manipulation | Guidewire insertion shall
be via femoral / radial
access and introduced to
the body via an
introducer/ sheath /
guide catheter/ etc. The
guidewire is then
directed to the target
location by manual
manipulation | Guidewire insertion shall
be via femoral / radial
access and introduced to
the body via an
introducer/ sheath /
guide catheter/ etc. The
guidewire is then directed
to the target location by
manual manipulation |
| Patient Population | Clinical | Age: Adult over the age of 16
Weight: No average | Age: Adult over the age
of 16
Weight: No average | Age: Adult over the age of
16
Weight: No average |
| Clinical Condition | Clinical | Cardiac and Peripheral
Vascular Disease | Cardiac and Peripheral
Vascular Disease | Cardiac and Peripheral
Vascular Disease |
| | | Other co-morbidity conditions
may apply such as diabetes,
hypertension, hyperlipidemia,
atherosclerosis, CHF, and
Previous MI. | Other co-morbidity
conditions may apply
such as diabetes,
hypertension,
hyperlipidemia,
atherosclerosis, CHF, and
Previous MI. | Other co-morbidity
conditions may apply
such as diabetes,
hypertension,
hyperlipidemia,
atherosclerosis, CHF, and
Previous MI. |
| Materials and
Biocompatibility | Biological | Stainless Steel Core | Stainless Steel Core | Stainless Steel Core |
| | | Platinum Tungsten Alloy | Platinum Tungsten Coil | Platinum Tungsten Coil |
| | | Solder | Solder | Solder |
| | | Polyurethane | Polyurethane | Polyurethane |
| | | PTFE Coating | PTFE Coating | PTFE Coating |
| | | Hydrophilic Coating - | Hydrophilic Coating - | Hydrophilic Coating - |
| Sterilization Status | Technical | Supplied Sterile | Supplied Sterile | Supplied Sterile |
| Packaging | Technical | Tyvek, heat sealed to a film of
PET/PE Sterile Packaging | Tyvek, heat sealed to a
film of PET/PE Sterile
Packaging
(unknown but assumed) | Tyvek, heat sealed to a
film of PET/PE Sterile
Packaging
(unknown but assumed) |
| Overall Design & | Technical | PTFE coated stainless steel | PTFE coated stainless | PTFE coated stainless |
| Construction | | core wire with a tapered distal
grind section to impart
flexibility. Radiopaque
platinum/tungsten coil
soldered at the distal tip. Coil
and core distal section are
encapsulated in a tungsten
doped polyurethane jacket.
Hydrophilic coating applied to
the polyurethane jacket | steel core wire with a
tapered distal grind
section to impart
flexibility. Radiopaque
platinum/tungsten coil
soldered at the distal tip.
Coil and core distal
section are encapsulated
in a polyurethane jacket.
Hydrophilic coating
applied to the
polyurethane jacket | steel core wire with a
tapered distal grind
section to impart
flexibility. Radiopaque
platinum/tungsten coil
soldered at the distal tip.
Coil and core distal
section are encapsulated
in a polyurethane jacket.
Hydrophilic coating
applied to the
polyurethane jacket |
| Core Design | Technical | Core to Tip | Core to Tip | Core to Tip |
| Guidewire Length | Technical | 195cm, 300cm | 190cm, 300cm | 190cm, 300cm |
| Guidewire Nominal
Diameter | Technical | 0.014" | 0.014" | 0.014" |
| PTFE Coating
Diameter | Technical | 0.014" maximum | 0.014" maximum | 0.014" maximum |
| Polymer Jacket
Length | Technical | 22cm | 29cm | 16cm |
| Polymer Jacket
Diameter | Technical | 0.014" maximum | 0.014" maximum | 0.014" maximum |
| Torque Response | Technical | Equivalent torque response to
Pilot 50 and Fielder XT | Equivalent torque
response to Hi-Torque
Vektor | Equivalent torque
response to Hi-Torque
Vektor |
| Hydrophilic Coating
Lubricity | Technical | The Hi-Torque Vektor
demonstrated higher lubricity
pinch forces than the Hi-
Torque Pilot 50 when tested
using this test method.

The Hi-Torque Vektor
demonstrated lower lubricity
pinch forces than the Fielder
XT when tested using this test
method. | The Hi-Torque Pilot 50
demonstrated lower
lubricity pinch forces than
the Hi-Torque Vektor
when tested using this
test method. | The Fielder XT
demonstrated higher
lubricity pinch forces than
the Hi-Torque Vektor
when tested using this
test method. |
| Hydrophilic Coating
Durability | Technical | The Hi-Torque Vektor
demonstrated superior
hydrophilic coating durability | The Hi-Torque Pilot 50
demonstrated inferior
hydrophilic coating
durability to the Hi-Torque Vektor | The Fielder XT
demonstrated inferior
hydrophilic coating
durability to the Hi-Torque Vektor |
| | | to the Hi-Torque Pilot 50 when
tested using this test method. | Torque Vektor when
tested using this test
method. | Torque Vektor when
tested using this test
method. |
| | | The Hi-Torque Vektor
demonstrated superior
hydrophilic coating durability
to the Fielder XT when tested
using this test method. | | |
| Device / Catheter
Compatibility | Technical | Equivalent compatibility
characteristics to Hi-Torque
Pilot 50 and Fielder XT | Equivalent compatibility
characteristics to Hi-
Torque Vektor | Equivalent compatibility
characteristics to Hi-
Torque Vektor |
| Coating Adherence
/ Integrity | Technical | Equivalent coating adherence
/ integrity characteristics to
Hi-Torque Pilot 50 and Fielder
XT when tested using this test
method | Equivalent coating
adherence / integrity
characteristics to Hi-
Torque Vektor | Equivalent coating
adherence / integrity
characteristics to Hi-
Torque Vektor |
| Kink Resistance | Technical | Equivalent (body) / Superior
(tip) kink resistance to Hi-
Torque Pilot 50
Equivalent kink resistance to
Fielder XT (body & tip) | Equivalent (body) /
Inferior (tip) kink
resistance to Hi-Torque
Vektor | Equivalent (body & tip)
kink resistance to Hi-
Torque Vektor |
| Particulate Residue | Technical | Equivalent particulate residue
to Hi-Torque Pilot 50 and
Fielder XT - all parts meet the
specification | Equivalent particulate
residue to Hi-Torque
Vektor - all parts meet
the specification | Equivalent particulate
residue to Hi-Torque
Vektor - all parts meet
the specification |
| Radiopacity | Technical | Radiopaque
platinum/tungsten coil | Radiopaque
platinum/tungsten coil | Radiopaque
platinum/tungsten coil |
| Corrosion
Resistance | Technical | Equivalent corrosion
resistance properties to Hi-
Torque Pilot 50 and Fielder XT | Equivalent corrosion
resistance properties to
Hi-Torque Vektor | Equivalent corrosion
resistance properties to
Hi-Torque Vektor |
| ISO Flex Resistance
Test (Bending
Durability) | Technical | Equivalent bending durability
properties to Hi-Torque Pilot
50 and Fielder XT | Equivalent bending
durability properties to
Hi-Torque Vektor | Equivalent bending
durability properties to
Hi-Torque Vektor |
| Extension
Capability | Technical | The Hi-Torque Vektor has
extension capability and is
compatible with the Abbott
DOC extension system
(identical to Hi-Torque Pilot
50).
Hi-Torque Vektor has
demonstrated improved
performance compared to Hi-
Torque Pilot 50 | The Hi-Torque Pilot has
extension capability and
is compatible with the
Abbott DOC extension
system (identical to Hi-
Torque Vektor).
Hi-Torque Vektor has
demonstrated improved
performance compared
to Hi-Torque Pilot 50 | The Fielder XT has
extension capability (with
Asahi extension system) |
| Tip Shapeability | Technical | Shapeable Tip | Shapeable Tip | Shapeable Tip |
| Pre-Formed 'J' Tips
Offered | Technical | The Hi-Torque Vektor is
offered with a straight tip and
an additional pre-formed J tip | The Hi-Torque Pilot 50 is
offered with a straight tip
and an additional pre-
formed J tip | The Fielder XT is offered
in straight tip only |
| Shaft Depth
Markings | Technical | The Hi-Torque Vektor has
shaft depth markings /
indicators | The Hi-Torque Pilot has
shaft depth markings /
indicators | The Fielder XT does not
have shaft markings /
indicators |
| Proximal Wire
Identifier | Technical | The Hi-Torque Vektor has a
proximal wire identifier | The Hi-Torque Pilot 50
does not have a proximal
wire identifier | The Fielder XT does not
have a proximal wire
identifier |

5

6

7

8

9

8. Conclusion

Based on performance testing, technological characteristics and the indications for use for the device, the Hi-Torque Vektor Guidewire has been demonstrated to be appropriate for its intended use and is considered to be substantially equivalent to the predicate devices.

10

Image /page/10/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 18, 2019

Brivant Limited (Lake Region Medical) Tom Healy Regulatory Affairs and Quality Manager Parkmore West Business Park Galway, H91 CK22 Ireland

Re: K182457

Trade/Device Name: Hi-Torque Vektor Guidewire Family Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DQX Dated: March 7, 2019 Received: March 19, 2019

Dear Tom Healy:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

11

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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

Enclosure