Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

Q: Who is the manufacturer of Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

Brivant Limited (Lake Region Medical) filed the 510(k) submission for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J (K182457).

Q: What is the FDA product code for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

DQX. It is classified under 21 CFR 870.1330 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

Hi-Torque Pilot 50 Guidewire (K123067); Asahi Fielder XT Guidewire (K171933).

Q: Who can help prepare an FDA 510(k) submission like Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K182457 · Brivant Limited (Lake Region Medical) · DQX · Apr 18, 2019 · Cardiovascular

Device Facts

Record ID	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
Applicant	Brivant Limited (Lake Region Medical)
Product Code	DQX · Cardiovascular
Decision Date	Apr 18, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1330
Device Class	Class 2

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.

Device Story

Hi-Torque Vektor is a 0.014" steerable guidewire used by interventional cardiologists/radiologists to navigate coronary and peripheral vasculature. Device features stainless steel core, shapeable distal tip, and hydrophilic coating (hyaluronic acid) for lubricity. Proximal end allows attachment of DOC Guide Wire Extension for device exchange. Brachial/femoral markers aid positioning. Operated manually; physician pushes, rotates, and pulls wire to steer through vessels. Facilitates delivery of interventional devices (e.g., stents, balloon catheters) to target lesions. Benefits include improved trackability and device exchange capability while maintaining access.

Clinical Evidence

Bench testing only. Evaluations included tensile strength, torque strength/response, dimensional measurement, catheter compatibility, coating adherence/integrity, lubricity/durability, particulate testing, tip flexibility/stiffness, radiopacity, corrosion resistance, and flex resistance. Results met all product specifications and demonstrated performance comparable to predicate devices.

Technological Characteristics

0.014" diameter steerable guidewire; stainless steel core; platinum/tungsten alloy radiopaque coil; polyurethane jacket; PTFE shaft coating; hydrophilic hyaluronic acid distal coating. Supplied sterile (ETO). Manual operation. Compatible with DOC extension system.

Indications for Use

Indicated for adults over 16 with cardiac or peripheral vascular disease (e.g., diabetes, hypertension, hyperlipidemia, atherosclerosis, CHF, previous MI) requiring PTCA or PTA procedures. Contraindicated for use in cerebral vasculature or with atherectomy devices.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Hi-Torque Pilot 50 Guidewire (K123067)
Asahi Fielder XT Guidewire (K171933)

Submission Summary (Full Text)

{0}------------------------------------------------ # Please wait... If this message is not eventually replaced by the proper contents of the document, your PDF viewer may not be able to display this type of document. You can upgrade to the latest version of Adobe Reader for Windows®, Mac, or Linux® by visiting http://www.adobe.com/go/reader_download. For more assistance with Adobe Reader visit http://www.adobe.com/go/acrreader. Windows is either a registered trademark of Microsoft Corporation in the United States and/or other countries. Mac is a trademark of Apple Inc., registered in the United States and other countries. Linux is the registered trademark of Linus Torvalds in the U.S. and other countries. {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 - 2. 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 | - 4. 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. - 5. 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. - 6. 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 - 7. 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…

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Hi-Torque Vektor, .014, 195cm, Str, Hi-Torque Vektor, .014, 195cm, J, Hi-Torque Vektor, .014, 300cm, Str, Hi-Torque Vektor, .014, 300cm, J

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Special Controls

Predicate Devices

Submission Summary (Full Text)

Panel 1

Section Matches

Product Code Matches

Special Control Matches

My Alerts

Create Alert

Search Filters

Agent Token

Connected apps