Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

Device Description

Bard® Temporary Pacing Electrode Catheters are constructed of insulated electrical wires encased within a woven shaft, which is then coated with various blends of radiopaque polyurethane-based materials. All Temporary Pacing Electrode Catheters are bipolar and include two stainless steel electrodes - one located along the shaft and one at the catheter distal tip. The proximal end of the devices includes the two electrical leads which have shrouded jacks and are used to establish electrical connections with an external pulse generator or monitoring device.

Some products may be packaged with accessories such as a needle / cannula, an ECG adapter, or a balloon inflation syringe. All Bard® Temporary Pacing Catheter devices are packaged with safety adapters, are intended for prescription use only, and are for single use only.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. The Needle / Cannula (Introducer) is not sold separately by C. R. Bard, Inc. and this accessory is only included with certain Bard® Temporary Pacing Electrode Catheter kits. The devices are provided in two different French size / length variants, dependent on size / type of the accompanying Bard® Temporary Pacing Electrode Catheter.

The Needle / Cannula (Introducer) includes a needle and a cannula. The two components of the Introducer are inserted into the vein simultaneously. The needle in then withdrawn, leaving in place the cannula, through which the Bard® Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. The device is intended for prescription use only and is for single use only.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)). It describes the device, its intended use, and comparability to predicate devices. However, this document does not contain acceptance criteria or detailed study results in the format requested.

The text focuses on demonstrating substantial equivalence to a predicate device through:

Comparison of Technological Characteristics: Tables comparing the subject device and the predicate device in terms of design, materials, and dimensions.
Performance Data Summary: A list of various performance tests conducted (e.g., biocompatibility, electrical safety, mechanical tests, functional testing to standards like ISO 10555-1, IEC 60601-1, ISO 80369 series, ISO 11070). The document states that the devices met the requirements of the above standards and performance endpoints.

Therefore, I cannot provide the specific details requested in your prompt (a detailed table of acceptance criteria and reported device performance with numerical values, sample sizes for test sets, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, training set details, or ground truth establishment).

The document explicitly states that the device "met the requirements of the above standards and performance endpoints," implying that the acceptance criteria are defined by these referenced standards and internal specifications, but the specific numerical acceptance criteria and the quantitative results are not disclosed in this summary.

If you have a document that contains the detailed study results and acceptance criteria, please provide it.

Summary

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January 31, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

C. R. Bard, Inc. Caitlin Bowles Senior Regulatory Affairs Specialist 8195 Industrial Blvd. Covington, Georgia 30014

Re: K241334

Trade/Device Name: Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF, DYB Dated: January 3, 2025 Received: January 3, 2025

Dear Caitlin Bowles:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Jessica L.	Digitally signed by Jessica
Batista -S	L. Batista -S
	Date: 2025.01.31 16:58:40
	-05'00'

for

Sara Royce
Assistant Director
Division of Cardiac
Electrophysiology, Diagnostics, and
Monitoring Devices
Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K241334

Device Name

Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer)

Indications for Use (Describe)

Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

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)

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510(k) Summary - K241334

In accordance with 21 CFR §807.92, a 510(k) summary upon which substantial equivalence determination is based is as follows:

Submitter	C. R. Bard, Inc.8195 Industrial BlvdCovington, GA 30014Establishment Registration # - 1018233
Contact Person	Caitlin BowlesSenior Regulatory Affairs SpecialistTelephone Number: 470-205-9024
Date Prepared	December 30, 2024
Subject Devices	Trade Name: Bard® Temporary Pacing Electrode CatheterCommon / Usual Name: Temporary pacemaker electrodeClassification Name: Cardiovascular permanent or temporarypacemaker electrode, 21 CFR §870.3680Product Code: LDFRegulatory Classification: IITrade Name: Needle / Cannula (Introducer)Common / Usual Name: Catheter introducerClassification Name: Catheter introducer, 21 CFR §870.1340Product Code: DYBRegulatory Classification: II
Predicate Devices	Legally marketed device to which substantial equivalence is claimedfor Bard® Temporary Pacing Electrode Catheters:• Primary Predicate: USCI® Special Care Pacing Electrode andUSCI® Bipolar Balloon Pacing Electrode with BH(benzalkonium heparin) Coating – K955712 (C. R. Bard, Inc.)Legally marketed device to which substantial equivalence is claimedfor the Needle / Cannula (Introducer):• Primary Predicate: Prelude Pursuit™ Splittable SheathIntroducer – K172117 (Merit Medical Systems, Inc.)

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Device Description

Bard® Temporary Pacing Electrode Catheters:

Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Needle / Cannula (Introducer):

Indications for Use

Bard® Temporary Pacing Electrode Catheters:

Bard® Temporary Pacing Catheters are designed to transmit an electrical signal from an external pulse generator to the heart or from the heart to a monitoring device.

Needle / Cannula (Introducer):

The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.

The Bard® Temporary Pacing Electrode Catheters and predicate device (primary predicate, K955712) feature the same intended use: transmitting a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.

The indications for use are specifically for introduction of Bard® Temporary Pacing Electrode Catheter pacing leads.

The subject device and primary predicate (K172117) are introducers and feature the same intended use: facilitating placing a catheter through the skin into a vein.

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Comparison of Technological Characteristics

Bard® Temporary Pacing Electrode Catheters:

Comparisons of the Bard® Temporary Pacing Electrode Catheters without balloons (subject), Bard® Temporary Pacing Electrode Catheters with balloons (subject), and the predicate device are provided in Table 1.

Table 1. Comparison of the Subject (Bard® Temporary Pacing Electrode Catheters without balloons) and Predicate (USCI® Special Care Pacing Electrode and USCI® Bipolar Balloon Pacing Electrode with Benzalkonium-heparin (BH) Coating) Devices

	Subject Device:	Predicate Device (K955712):
Design / TechnologicalCharacteristic	Bard® Temporary Pacing ElectrodeCatheters without balloonsBard® Temporary Pacing ElectrodeCatheters with balloons	USCI® Special Care PacingElectrodeUSCI® Bipolar Balloon PacingElectrode
FDA Clearance Number	Subject of this submission	K955712
FDA Product Code	LDF (Electrode, Pacemaker,Temporary)	LDF (Electrode, Pacemaker,Temporary)
Labeling Characteristics
Indications for Use	Bard® Temporary Pacing Cathetersare designed to transmit an electricalsignal from an external pulse generatorto the heart or from the heart to amonitoring device.	The USCI® Pacing Electrodes areused to transmit a pacing electricalstimulus from the pulse generator tothe heart and/or transmit an electricalstimulus from the heart to a recordingdevice.
Recommendedmaximum duration fortemporary pacing	The intended lifetime of use for Bard®Temporary Pacing Catheters is up to11 days.Note: Real-world clinical evidence forthe subject device has demonstratedsubstantial equivalence up to this 11day maximum duration.	Per labeling: N/A – Not stated onlabeling.Note: the predicate submissionincluded discussion on duration of use,and the duration of the subject devicefalls within the same timeframe asduration of use for the predicatedevice.
General Characteristics
Sterilization Method	Ethylene oxideNote: OEM product codes 108154Pand 106173P are sterilized by thepurchaser before marketing	Ethylene oxide
Single Use Only	Yes	Yes
Non-pyrogenic	Yes	Yes
Design / TechnologicalCharacteristic	Subject Device:Bard® Temporary Pacing ElectrodeCatheters without balloons	Predicate Device (K955712):USCI® Special Care PacingElectrode
	Bard® Temporary Pacing ElectrodeCatheters with balloons	USCI® Bipolar Balloon PacingElectrode
Materials
Electrodes	Stainless steel	Stainless steel
Electrical Tail Pins /Jacks	Gold plated brass	Tin plated brass
Electrical Tail Pins / JackOvermolding	Polypropylene	N/A
Shaft	Polyurethane	Polyurethane
Coating	N/A – No coating	Benzalkonium Heparin (BH)
Bifurcate	Black Polyethylene	Black Polyethylene
Balloon (variants withballoon only)	Natural rubber latex	Natural rubber latex
Stopcock (variants withballoon only)	Polyethylene and polycarbonate	Polyethylene and polycarbonate
Balloon Tie Thread(variants with balloononly)	Polyester	Polyester
Dimensions / Specifications
Balloon Feature(variants with balloononly)	Yes – 1.5 mL volume	Yes – 1.5 mL volume
Distal Configuration	Variants without balloon: CurvedVariants with balloon: Straight or RightHeart Curve	Variants without balloon: CurvedVariants with balloon: Straight or RightHeart Curve
Distal Tip Type	Variants without balloon: Standardmaterial used for shaft distal tip (non-patient contacting) or Soft distal tipmaterial used for shaft distal tip (non-patient contacting)	Variants without balloon: Standardmaterial used for shaft distal tip (non-patient contacting)
	Subject Device:	Predicate Device (K955712):
Design / TechnologicalCharacteristic	Bard® Temporary Pacing ElectrodeCatheters without balloons	USCI® Special Care PacingElectrode
	Bard® Temporary Pacing ElectrodeCatheters with balloons	USCI® Bipolar Balloon PacingElectrode
	Variants with balloon: Standardmaterial used for shaft distal tip (non-patient contacting)	Variants with balloon: Standardmaterial used for shaft distal tip (non-patient contacting)
French Sizes	Variants without balloon: 4 - 7 French	Variants without balloon: 4 - 5 French
	Variants with balloon: 4 – 5 French(Straight tip); 5 French (Right HeartCurve)	Variants with balloon: 4 – 5 French(Straight tip); 5 French (Right HeartCurve)
Lengths (Overall)	Variants without balloon: 100cm,125cm, 132cm	Variants without balloon: 132cm
	Variants with balloon: 126cm	Variants with balloon: 126cm
Lengths (Usable)	Variants without balloon: 83cm,108cm, 115cm	Variants without balloon: 115cm
	Variants with balloon: 110cm	Variants with balloon: 110cm
Electrodes (Number andspacing)	Bipolar (2 electrodes)	Bipolar (2 electrodes)
	Variants without balloon: 1st electrodeat distal tip with 2nd electrode 1cmproximal or 1st electrode at distal tipwith 2nd electrode 2.5cm proximal	Variants without balloon: 1st electrodeat distal tip, 2nd electrode 1cm proximal
	Variants with balloon: 1st electrode atdistal tip with 2nd electrode 1cmproximal	Variants with balloon: 1st electrode atdistal tip with 2nd electrode 1cmproximal
Radiopaque	Yes	Yes
Accessories	Introducer (Needle / Cannula)(Included with certain models only) –also subject to this submission	Introducer (Needle / Cannula)
		ECG Adapter
	Safety Lead Adapter (Included with allmodels)
	ECG Adapter (Included with certainmodels only)
	Ballon Inflation Syringe (Included withall models with balloons)
Design / TechnologicalCharacteristic	Subject Device:Bard® Temporary Pacing ElectrodeCatheters without balloonsBard® Temporary Pacing ElectrodeCatheters with balloons	Predicate Device (K955712):USCI® Special Care PacingElectrodeUSCI® Bipolar Balloon PacingElectrode
Introducer Compatibility	Via a Needle Cannula Introducer (orpercutaneous introducer sheath - notsold or provided by C. R. Bard, Inc.).One of two introducer variants may beprovided with some products based onthe French size of the Bard®Temporary Pacing Electrode Catheter.	Via a Needle Cannula, Hemaquet™Sterile-lock Introducer, or USCIPercutaneous Catheter IntroducerPer IFU (variants without balloon):French size designation of theintroducer reflects the maximum outerdiameter of a catheter or temporarytransvenous pacing lead that theintroducer sheath will accept.Per IFU (variants with balloon):Introducer French size provided isdependent on the balloon electrodeFrench size

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Needle / Cannula (Introducer):

A comparison of the Needle / Cannula (Introducer) to the primary predicate (K172117) is provided in Table 2.

Table 2. Comparison of the Subject (Introducer (Needle / Cannula) Used with Bard® Temporary Pacing Electrode Catheters and Primary Predicate (Prelude Pursuit™ Splittable Sheath Introducer)

Design / TechnologicalCharacteristic	Subject Device: Introducer (Needle /Cannula)	Primary Predicate Device (K172117):Prelude Pursuit™ Splittable SheathIntroducer
FDA Clearance Number	Subject of this submission	K172117
FDA Product Code	DYB (Introducer, Catheter)	DYB (Introducer, Catheter)
Indications for Use	The Needle / Cannula (Introducer) isintended for the introduction of Bard®Temporary Pacing Electrode Cathetersinto the venous vasculature.	The introduction of various types ofpacing/defibrillator leads and cathetersinto the venous vasculature.
Design / TechnologicalCharacteristic	Subject Device: Introducer (Needle /Cannula)	Primary Predicate Device (K172117):Prelude Pursuit™ Splittable SheathIntroducer
General Characteristics
Principles of Operation	"Over the needle" operationmechanism. The introducer cathetertubing is positioned with a glove fitover the needle tubing, and the needleprotrudes from the end of the cannulatubing to create initial access. The twocomponents of the Introducer areinserted into the vein simultaneously.The needle is then withdrawn, leavingin place the cannula, through which theTemporary Pacing Electrode Cathetercan be advanced through the vesseland into the desired placementlocation.	Introducer needle is inserted into thevessel. Guidewire is inserted throughthe needle into the vessel and needleis removed, leaving the guidewire inplace. The dilator / introducer sheathassembly is advanced over theguidewire and into the vessel. Oncethe assembly is fully introduced intothe venous system, the guidewire anddilator are retracted, leaving theintroducer sheath in position, throughwhich the catheter / pacing lead can beadvanced into position.*
Sterilization Method	Ethylene oxide	Ethylene oxide
Single Use Only	Yes	Yes
Device Specific Characteristics
Splittable Sheath	No	Yes
Accessories /Components	Introducer catheter, Introducer needle,Needle guard (Removed prior to use)	Introducer sheath, Dilator, Guidewire,Introducer needle, SyringeorIntroducer sheath, Dilator
Compatibility	Introduction of Bard® TemporaryPacing Electrode Catheters	Introduction of various types ofpacing/defibrillator leads and catheters
Materials
Introducer catheter	Fluorinated Ethylene Propylene (FEP)with Barium Sulfate with high densitypolyethylene hub	Polymers - formulation undisclosed
Introducer needle	Stainless steel needle withpolypropylene hub	Stainless steel needle with polymerhub
Design / TechnologicalCharacteristic	Subject Device: Introducer (Needle /Cannula)	Primary Predicate Device (K172117):Prelude Pursuit™ Splittable SheathIntroducer
Dimensions / Specifications
Introducer catheter innerdiameter (minimum)	Variant I - 5.3 FrenchVariant II - 6.5 French	5 – 16 French
Introducer catheterlength	Variant I - 6.7 to 8.3 cmVariant II - 5.1 to 5.7 cm	13 & 25 cm
Introducer needle outerdiameter	Variant I - 16GVariant II - 14G	18G
Introducer needle length	Variant I - 9.3 cmVariant II - 7.5 cm	7 cm
Predicate only: Dilatorlength (for reference)		Dilator: 7.59" or 19.3 cm (13cmintroducer) and 12.34" or 31.3 cm (25cm introducer)

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= Information extracted from current IFU for Prelude Prestige™ [Pursuit] devices via firm's website (https://www.merit.com/product/prestige-splittable-sheath-introducer/#documents education) on 16 April 2024.

Performance Data Summary

Bard® Temporary Pacing Electrode Catheters:

Biocompatibility Testing 1.
Biocompatibility testing on the subject devices was carried out in alignment with the requirements for an External Communicating - Circulating Blood contacting device with prolonged contact duration per ISO 10993-1:2018. The subject device was determined to be biocompatible for its intended use.
1. Performance Testing
  Certain endpoints (as applicable) of the following standards have been deemed relevant to Bard® Temporary Pacing Electrode Catheter performance:
. ISO 10555-1:2013 [AMD 2017] - Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements
. IEC 60601-1:2020 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC 60601-1-2:2020 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests

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. ISO 80369-1:2018 - Small-bore connectors for liguids and gases in healthcare applications - Part 1: General requirements
. ISO 80369-7:2021 - Small-bore connectors for liguids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
. ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

To demonstrate intended device performance, as well as to support the substantial equivalence of the subject Bard® Temporary Pacing Electrode Catheters to the technological and performance characteristics were evaluated by completion of the below testing endpoints:

. Radio-detectability (ASTM F640)
Surface inspection
Corrosion Resistance
. Freedom from Leakage (Bard® Temporary Pacing Electrode Catheters with balloons only)
. Peak Tensile Force
. Electrical safety and electromagnetic compatibility as applicable to a Type CF applied part when used with an external pulse generator as a system in the professional healthcare facility intended use environment
Female luer lock on stopcock component of Bard® Temporary Pacing Electrode Catheters with balloons only:
- Dimensional requirements of small-bore connectors o
- Functional testing of small-bore connectors O
Ability of balloon to be inflated with balloon inflation syringe (Bard® Temporary Pacing Electrode ● Catheters with balloons only)
. Bard® Temporary Pacing Electrode Catheter functionality with the Needle / Cannula (Introducer) accessory
System Verification / Interoperability
. Lifetime of Use / Duration of Pacing - Electrical functionality after exposure to simulated use conditions
Electrical continuity and insulation resistance
Balloon inflated diameter
. Balloon leak resistance
. Balloon reliability: leak resistance after worst-case number of inflation cycles, mechanical inflation / deflation cycling to failure, and cumulative air injection to failure.

The subject Bard® Temporary Pacing Electrode Catheter devices met the requirements of the above standards and performance endpoints, and were substantially equivalent to the predicate device for other performance testing completed.

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Needle / Cannula (Introducer):

1. Biocompatibility Testing

Biocompatibility testing on the subject devices was carried out in alignment with the requirements for an External Communicating - Circulating Blood contacting device with prolonged contact duration per ISO 10993-1:2018. The subject device was determined to be biocompatible for its intended use.

1. Performance Testing
  As with the predicate device, the subject devices have also undergone various types of functionality testing per ISO 11070 to demonstrate no impact to device performance. Certain endpoints (as applicable) of the following standards have been deemed relevant to Needle/Cannula (Introducer) performance:
ISO 11070:2014 Sterile single-use intravascular introducers, dilators and guidewires .
. ISO 80369-1:2018 - Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements
. ISO 80369-7:2021 - Small-bore connectors for liguids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
. ISO 80369-20:2015 - Small-bore connectors for liquids and gases in healthcare applications - Part 20: Common test methods

To demonstrate intended device performance, as well as to support the substantial equivalence of the subject Needle/Cannula (Introducer) to the predicate device, the technological and performance characteristics were evaluated by completion of the below testing endpoints:

Surface inspection of Introducer Needle and Introducer catheter
. Corrosion Resistance of Introducer needle
. Needle Point inspection
. Strength of Union of Needle Tube and Needle Hub
Tip of Introducer Needle and Introducer catheter
. Peak Tensile Force of Introducer catheter
. Dimensional requirements of small-bore connectors
Functional testing of small-bore connectors
. Needle / Cannula (Introducer) functionality with Bard® Temporary Pacing Electrode Catheters
System Verification / Interoperability
. Lifetime of Use - Introducer functionality after exposure to simulated use conditions

The subject Introducer (Needle / Cannula) used with Bard® Temporary Pacing Electrode Catheter devices met the requirements of the above standards and performance endpoints, and were substantially equivalent to the predicate device for performance testing completed.

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Conclusion

Bard® Temporary Pacing Electrode Catheters:

The subject Bard® Temporary Pacing Electrode Catheters are substantially equivalent to the legally marketed predicate device as demonstrated by the same indications for use and similar / equivalent design features as the predicate device, USCI® Special Care Pacing Electrode and USCI® Bipolar Balloon Pacing Electrode with Benzalkonium-heparin (BH) Coating (K955712). The subject device is substantially equivalent to the legally marketed predicate device, and nonclinical test data / real-world clinical evidence demonstrate that the subject device is substantially equivalent and that any differences in technological characteristics do not raise different questions of safety and effectiveness.

Needle / Cannula (Introducer):

The subject Needle / Cannula (Introducer) is substantially equivalent to the legally marketed predicate device as demonstrated by the same indications for use and similar / equivalent design features as the primary predicate device Prelude Pursuit™ Splittable Sheath Introducer (K172117). The subject device is substantially equivalent to the legally marketed predicate device, and nonclinical test data demonstrates that the subject device is substantially equivalent and that any differences in technological characteristics do not raise different questions of safety and effectiveness.

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to an implantable pacemaker pulse generator and the other end applied to the heart. The device is used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or to transmit the electrical signal of the heart to the pulse generator.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.