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.

AI/ML Overview

The provided document describes the predicate device comparison and performance testing for the "Hi-Torque Vektor Guidewire Family" to demonstrate substantial equivalence to its predicate devices, rather than a study proving the device meets general acceptance criteria in the context of AI/ML performance evaluation. The document is for a traditional medical device (a guidewire) and not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML performance (e.g., sample size for test set, expert qualifications for ground truth, MRMC study, effect size of AI assistance, standalone performance, training set size) are not applicable or extractable from this document.

However, I can extract information related to the acceptance criteria and performance of the device based on the provided text, focusing on the bench testing conducted to demonstrate equivalence.

Here's a summary of the applicable information:

1. A table of acceptance criteria and the reported device performance

The document states that "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)."

The acceptance criteria themselves (e.g., specific values for tensile strength, torque strength) are not explicitly detailed in the provided text. Instead, the performance is reported in relation to the predicate devices and internal product specifications. The table below outlines the tested parameters and the reported performance relative to the predicate devices.

Acceptance Criteria (Bench Test Type)	Reported Device Performance (Hi-Torque Vektor)
Material & Biocompatibility	Stainless Steel Core: Same as predicatesPlatinum Tungsten Alloy: Same as predicates (Pilot 50 and Fielder XT use Platinum Tungsten Coil, which is considered equivalent for this purpose)Solder: Same as predicatesPolyurethane: Same as predicatesPTFE Coating: Same as predicatesHydrophilic Coating: Same as predicatesBiocompatibility: Established through testing in compliance with ISO 10993-1.
Sterilization Status	Supplied Sterile (same as predicates)
Packaging	Tyvek, heat sealed to a film of PET/PE Sterile Packaging (same as assumed for predicates)
Overall Design & Construction	PTFE coated stainless steel core wire with tapered distal grind section, radiopaque platinum/tungsten coil soldered at distal tip, coil and core distal section encapsulated in a tungsten doped polyurethane jacket, hydrophilic coating applied to polyurethane jacket. (Similar to predicates, with minor difference in polyurethane jacket doping).
Core Design	Core to Tip (same as predicates)
Guidewire Length	195cm, 300cm (similar range to predicates 190cm, 300cm)
Guidewire Nominal Diameter	0.014" (same as predicates)
PTFE Coating Diameter	0.014" maximum (same as predicates)
Polymer Jacket Length	22cm (different from Pilot 50 (29cm) and Fielder XT (16cm), but acceptable within the context of substantial equivalence)
Polymer Jacket Diameter	0.014" maximum (same as predicates)
Tensile Strength	Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Torque Strength	Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Dimensional measurement	Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Torque Response	Equivalent torque response to Pilot 50 and Fielder XT.
Catheter Compatibility	Equivalent compatibility characteristics to Hi-Torque Pilot 50 and Fielder XT.
Coating Adherence/Coating Integrity	Equivalent coating adherence/integrity characteristics to Hi-Torque Pilot 50 and Fielder XT when tested using this test method.
Coating Lubricity and Durability	Lubricity: Demonstrated higher lubricity pinch forces than Hi-Torque Pilot 50; Demonstrated lower lubricity pinch forces than Fielder XT. (This indicates performance falls between the two predicates, which is acceptable for equivalence).Durability: Demonstrated superior hydrophilic coating durability to both Hi-Torque Pilot 50 and Fielder XT.
Particulate Testing (Particulate Residue)	Equivalent particulate residue to Hi-Torque Pilot 50 and Fielder XT - all parts meet the specification.
Tip Flexibility/Stiffness	The proposed 4 models have equivalent tip stiffness characteristics to the predicate devices. Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Radiopacity	Radiopaque platinum/tungsten coil (same as predicates). Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Corrosion Resistance	Equivalent corrosion resistance properties to Hi-Torque Pilot 50 and Fielder XT.
Flex Resistance Test (Bending Durability)	Equivalent bending durability properties to Hi-Torque Pilot 50 and Fielder XT.
Guidewire Pull test	Met product specifications and performed comparably to predicate devices (specific values not provided in this document).
Kink Resistance	Equivalent (body) / Superior (tip) kink resistance to Hi-Torque Pilot 50; Equivalent kink resistance to Fielder XT (body & tip).
Extension Capability	Has extension capability and is compatible with the Abbott DOC extension system (identical to Hi-Torque Pilot 50). Demonstrated improved performance compared to Hi-Torque Pilot 50.
Tip Shapeability	Shapeable Tip (same as predicates)
Pre-Formed 'J' Tips Offered	Offered with a straight tip and an additional pre-formed J tip (same as Hi-Torque Pilot 50; Fielder XT is straight tip only).
Shaft Depth Markings	Has shaft depth markings/indicators (same as Hi-Torque Pilot; Fielder XT does not).
Proximal Wire Identifier	Has a proximal wire identifier (Hi-Torque Pilot 50 and Fielder XT do not).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document describes in vitro bench tests. No specific sample sizes for each test are provided, nor is information on data provenance in terms of country of origin or retrospective/prospective nature, as these are not relevant for bench testing of a physical device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. Ground truth for these physical performance tests (e.g., tensile strength, lubricity) is established by standardized test methods and instrumentation, not by expert consensus or clinical assessment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable, as ground truth is based on objective physical measurements and established test methods, not subjective assessment requiring adjudication.

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 question is not applicable. The device is a guidewire, a physical medical device, not an AI/ML-powered diagnostic or assistive tool. "Human readers" and "AI assistance" are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable, as the device is a guidewire and does not involve algorithms or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The ground truth for the performance evaluations (bench tests) is based on the results generated by standardized in vitro test methods and comparison to predefined product specifications and the performance of "legally marketed predicate devices."

8. The sample size for the training set

This question is not applicable, as the device does not involve machine learning or a training set.

9. How the ground truth for the training set was established

This question is not applicable, as the device does not involve machine learning or a training set.

Summary

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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).

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

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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

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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.

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Table 1.0: Predicate Comparison Table

	EquivalenceCategory	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 expectedClass III)
US Classification	Clinical	II	II	II
Classification Name	Clinical	Catheter Guide Wire	Catheter Guide Wire	Catheter Guide Wire
FDA ClassificationProduct Code	Clinical	DQX	DQX	DQX
Indications for Use	Clinical	Intended to facilitate thedelivery of catheter-basedinterventional devices duringpercutaneous transluminalcoronary angioplasty (PTCA)and percutaneoustransluminal angioplasty(PTA). This guide wire may beused with compatible stentdevices during therapeuticprocedures. The guide wiremay be used to reach andcross a target lesion, provide apathway within the vesselstructure, facilitate thesubstitution of one diagnosticor interventional device foranother, and to distinguish thevasculature.	Intended to facilitate thedelivery 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 & PeripheralVasculature	Coronary & PeripheralVasculature	Coronary & PeripheralVasculature
Operating Principle	Clinical	Device is hand held andoperated by manual method.User will hold, rotate, pushand pull the wire to steer itthrough the vasculature	Device is hand held andoperated by manualmethod. User will hold,rotate, push and pull thewire to steer it throughthe vasculature	Device is hand held andoperated by manualmethod. User will hold,rotate, push and pull thewire to steer it throughthe vasculature
Single patientdevice	Clinical	Yes	Yes	Yes
Single use orreusable	Clinical	Single Use	Single Use	Single Use
Medical userqualification	Clinical	Interventional Cardiologist,Interventional Radiologist	InterventionalCardiologist,Interventional Radiologist	InterventionalCardiologist,Interventional Radiologist
DeploymentMethod	Clinical	Guidewire insertion shall bevia femoral / radial access andintroduced to the body via anintroducer/ sheath / guidecatheter/ etc. The guidewireis then directed to the targetlocation by manualmanipulation	Guidewire insertion shallbe via femoral / radialaccess and introduced tothe body via anintroducer/ sheath /guide catheter/ etc. Theguidewire is thendirected to the targetlocation by manualmanipulation	Guidewire insertion shallbe via femoral / radialaccess and introduced tothe body via anintroducer/ sheath /guide catheter/ etc. Theguidewire is then directedto the target location bymanual manipulation
Patient Population	Clinical	Age: Adult over the age of 16Weight: No average	Age: Adult over the ageof 16Weight: No average	Age: Adult over the age of16Weight: No average
Clinical Condition	Clinical	Cardiac and PeripheralVascular Disease	Cardiac and PeripheralVascular Disease	Cardiac and PeripheralVascular Disease
		Other co-morbidity conditionsmay apply such as diabetes,hypertension, hyperlipidemia,atherosclerosis, CHF, andPrevious MI.	Other co-morbidityconditions may applysuch as diabetes,hypertension,hyperlipidemia,atherosclerosis, CHF, andPrevious MI.	Other co-morbidityconditions may applysuch as diabetes,hypertension,hyperlipidemia,atherosclerosis, CHF, andPrevious MI.
Materials andBiocompatibility	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 ofPET/PE Sterile Packaging	Tyvek, heat sealed to afilm of PET/PE SterilePackaging(unknown but assumed)	Tyvek, heat sealed to afilm of PET/PE SterilePackaging(unknown but assumed)
Overall Design &	Technical	PTFE coated stainless steel	PTFE coated stainless	PTFE coated stainless
Construction		core wire with a tapered distalgrind section to impartflexibility. Radiopaqueplatinum/tungsten coilsoldered at the distal tip. Coiland core distal section areencapsulated in a tungstendoped polyurethane jacket.Hydrophilic coating applied tothe polyurethane jacket	steel core wire with atapered distal grindsection to impartflexibility. Radiopaqueplatinum/tungsten coilsoldered at the distal tip.Coil and core distalsection are encapsulatedin a polyurethane jacket.Hydrophilic coatingapplied to thepolyurethane jacket	steel core wire with atapered distal grindsection to impartflexibility. Radiopaqueplatinum/tungsten coilsoldered at the distal tip.Coil and core distalsection are encapsulatedin a polyurethane jacket.Hydrophilic coatingapplied to thepolyurethane jacket
Core Design	Technical	Core to Tip	Core to Tip	Core to Tip
Guidewire Length	Technical	195cm, 300cm	190cm, 300cm	190cm, 300cm
Guidewire NominalDiameter	Technical	0.014"	0.014"	0.014"
PTFE CoatingDiameter	Technical	0.014" maximum	0.014" maximum	0.014" maximum
Polymer JacketLength	Technical	22cm	29cm	16cm
Polymer JacketDiameter	Technical	0.014" maximum	0.014" maximum	0.014" maximum
Torque Response	Technical	Equivalent torque response toPilot 50 and Fielder XT	Equivalent torqueresponse to Hi-TorqueVektor	Equivalent torqueresponse to Hi-TorqueVektor
Hydrophilic CoatingLubricity	Technical	The Hi-Torque Vektordemonstrated higher lubricitypinch forces than the Hi-Torque Pilot 50 when testedusing this test method.The Hi-Torque Vektordemonstrated lower lubricitypinch forces than the FielderXT when tested using this testmethod.	The Hi-Torque Pilot 50demonstrated lowerlubricity pinch forces thanthe Hi-Torque Vektorwhen tested using thistest method.	The Fielder XTdemonstrated higherlubricity pinch forces thanthe Hi-Torque Vektorwhen tested using thistest method.
Hydrophilic CoatingDurability	Technical	The Hi-Torque Vektordemonstrated superiorhydrophilic coating durability	The Hi-Torque Pilot 50demonstrated inferiorhydrophilic coatingdurability to the Hi-Torque Vektor	The Fielder XTdemonstrated inferiorhydrophilic coatingdurability to the Hi-Torque Vektor
		to the Hi-Torque Pilot 50 whentested using this test method.	Torque Vektor whentested using this testmethod.	Torque Vektor whentested using this testmethod.
		The Hi-Torque Vektordemonstrated superiorhydrophilic coating durabilityto the Fielder XT when testedusing this test method.
Device / CatheterCompatibility	Technical	Equivalent compatibilitycharacteristics to Hi-TorquePilot 50 and Fielder XT	Equivalent compatibilitycharacteristics to Hi-Torque Vektor	Equivalent compatibilitycharacteristics to Hi-Torque Vektor
Coating Adherence/ Integrity	Technical	Equivalent coating adherence/ integrity characteristics toHi-Torque Pilot 50 and FielderXT when tested using this testmethod	Equivalent coatingadherence / integritycharacteristics to Hi-Torque Vektor	Equivalent coatingadherence / integritycharacteristics to Hi-Torque Vektor
Kink Resistance	Technical	Equivalent (body) / Superior(tip) kink resistance to Hi-Torque Pilot 50Equivalent kink resistance toFielder XT (body & tip)	Equivalent (body) /Inferior (tip) kinkresistance to Hi-TorqueVektor	Equivalent (body & tip)kink resistance to Hi-Torque Vektor
Particulate Residue	Technical	Equivalent particulate residueto Hi-Torque Pilot 50 andFielder XT - all parts meet thespecification	Equivalent particulateresidue to Hi-TorqueVektor - all parts meetthe specification	Equivalent particulateresidue to Hi-TorqueVektor - all parts meetthe specification
Radiopacity	Technical	Radiopaqueplatinum/tungsten coil	Radiopaqueplatinum/tungsten coil	Radiopaqueplatinum/tungsten coil
CorrosionResistance	Technical	Equivalent corrosionresistance properties to Hi-Torque Pilot 50 and Fielder XT	Equivalent corrosionresistance properties toHi-Torque Vektor	Equivalent corrosionresistance properties toHi-Torque Vektor
ISO Flex ResistanceTest (BendingDurability)	Technical	Equivalent bending durabilityproperties to Hi-Torque Pilot50 and Fielder XT	Equivalent bendingdurability properties toHi-Torque Vektor	Equivalent bendingdurability properties toHi-Torque Vektor
ExtensionCapability	Technical	The Hi-Torque Vektor hasextension capability and iscompatible with the AbbottDOC extension system(identical to Hi-Torque Pilot50).Hi-Torque Vektor hasdemonstrated improvedperformance compared to Hi-Torque Pilot 50	The Hi-Torque Pilot hasextension capability andis compatible with theAbbott DOC extensionsystem (identical to Hi-Torque Vektor).Hi-Torque Vektor hasdemonstrated improvedperformance comparedto Hi-Torque Pilot 50	The Fielder XT hasextension capability (withAsahi extension system)
Tip Shapeability	Technical	Shapeable Tip	Shapeable Tip	Shapeable Tip
Pre-Formed 'J' TipsOffered	Technical	The Hi-Torque Vektor isoffered with a straight tip andan additional pre-formed J tip	The Hi-Torque Pilot 50 isoffered with a straight tipand an additional pre-formed J tip	The Fielder XT is offeredin straight tip only
Shaft DepthMarkings	Technical	The Hi-Torque Vektor hasshaft depth markings /indicators	The Hi-Torque Pilot hasshaft depth markings /indicators	The Fielder XT does nothave shaft markings /indicators
Proximal WireIdentifier	Technical	The Hi-Torque Vektor has aproximal wire identifier	The Hi-Torque Pilot 50does not have a proximalwire identifier	The Fielder XT does nothave a proximal wireidentifier

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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.

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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

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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

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.