Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,

Q: Who is the manufacturer of Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,?

C.R. Bard, Inc. filed the 510(k) submission for Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter, (K241334).

Q: What is the FDA product code for Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,?

LDF. It is classified under 21 CFR 870.3680 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,?

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

Q: Who can help prepare an FDA 510(k) submission like Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,?

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.

K241334 · C.R. Bard, Inc. · LDF · Jan 31, 2025 · Cardiovascular

Device Facts

Record ID	K241334
Device Name	Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 4Fr. (006221P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 115 cm, 5Fr. (006225P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 6Fr. (006241P); Semi-Floating Temporary Pacing Electrode Catheter, Bipolar, Stainless Steel Electrodes, 125 cm, 7Fr. (006242P); NBIH Temporary Pacing Electrode Catheter,
Applicant	C.R. Bard, Inc.
Product Code	LDF · Cardiovascular
Decision Date	Jan 31, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.3680
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Bard® Temporary Pacing Electrode Catheters transmit electrical signals between an external pulse generator and the heart; used for temporary cardiac pacing or monitoring. Catheters feature bipolar stainless steel electrodes; woven shaft coated with radiopaque polyurethane. Needle/Cannula (Introducer) facilitates percutaneous venous access; components inserted simultaneously; needle withdrawn to leave cannula for catheter advancement. Used in professional healthcare facilities; operated by clinicians. Output is electrical signal transmission; enables cardiac pacing or monitoring. Benefits include temporary management of cardiac rhythm or diagnostic monitoring. Single-use; prescription-only.

Clinical Evidence

Bench testing only. No clinical trials performed. Evidence includes biocompatibility (ISO 10993-1), electrical safety/EMC (IEC 60601-1, IEC 60601-1-2), and mechanical performance testing (ISO 10555-1, ISO 11070, ISO 80369). Specific tests: radio-detectability (ASTM F640), tensile force, leakage, balloon reliability, and electrical continuity.

Technological Characteristics

Catheters: Stainless steel electrodes, gold-plated brass pins, polyurethane shaft, polypropylene overmolding. Balloon variants: natural rubber latex, polyethylene/polycarbonate stopcock, polyester tie thread. Introducer: FEP catheter with barium sulfate, stainless steel needle, polypropylene hub. Sterilization: Ethylene oxide. Standards: ISO 10993-1, ISO 10555-1, IEC 60601-1, ISO 80369-1/7/20, ISO 11070, ASTM F640.

Indications for Use

Indicated for patients requiring temporary cardiac pacing or monitoring via transvenous electrode catheter placement. The introducer is indicated for facilitating the introduction of these catheters into the venous vasculature.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external 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. Permanent pacemaker electrode: 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.

Predicate Devices

USCI® Special Care Pacing Electrode and USCI® Bipolar Balloon Pacing Electrode with BH (benzalkonium heparin) Coating (K955712)
Prelude Pursuit™ Splittable Sheath Introducer (K172117)

Related Devices

K251186 — Bard® Temporary Pacing Electrode Catheter Needle / Cannula (Introducer) · C.R. Bard, Inc. · May 15, 2025
K955712 — USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING · C.R. Bard, Inc. · Oct 11, 1996
K160260 — Tempo Temporary Pacing Lead · Biotrace Medical, Inc. · Oct 25, 2016
K152633 — Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe · Edwards Lifesciences, LLC · Oct 15, 2015
K963073 — HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET · Harmac Medical Products, Inc. · Aug 14, 1997

Submission Summary (Full Text)

{0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ 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 {3}------------------------------------------------ # 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) | | |------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</div> | # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 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 Blvd Covington, GA 30014 Establishment Registration # - 1018233 | |-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Caitlin Bowles Senior Regulatory Affairs Specialist Telephone Number: 470-205-9024 | | Date Prepared | December 30, 2024 | | Subject Devices | Trade Name: Bard® Temporary Pacing Electrode Catheter Common / Usual Name: Temporary pacemaker electrode Classification Name: Cardiovascular permanent or temporary pacemaker electrode, 21 CFR §870.3680 Product Code: LDF Regulatory Classification: II Trade Name: Needle / Cannula (Introducer) Common / Usual Name: Catheter introducer Classification Name: Catheter introducer, 21 CFR §870.1340 Product Code: DYB Regulatory Classification: II | | Predicate Devices | Legally marketed device to which substantial equivalence is claimed for Bard® Temporary Pacing Electrode Catheters: • Primary Predicate: USCI® Special Care Pacing Electrode and USCI® Bipolar Balloon Pacing Electrode with BH (benzalkonium heparin) Coating – K955712 (C. R. Bard, Inc.) Legally marketed device to which substantial equivalence is claimed for the Needle / Cannula (Introducer): • Primary Predicate: Prelude Pursuit™ Splittable Sheath Introducer – K172117 (Merit Medical Systems, Inc.) | {5}------------------------------------------------ ### 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. 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. #### Needle / Cannula (Introducer): 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. # 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. {6}------------------------------------------------ # 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 / Technological Characteristic | Bard® Temporary Pacing Electrode Catheters without balloons Bard® Temporary Pacing Electrode Catheters with balloons | USCI® Special Care Pacing Electrode USCI® Bipolar Balloon Pacing Electrode | | 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 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 USCI® Pacing Electrodes are used to transmit a pacing electrical stimulus from the pulse generator to the heart and/or transmit an electrical stimulus from the heart to a recording device. | | Recommended maximum duration for temporary pacing | The intended lifetime of use for Bard® Temporary Pacing Catheters is up to 11 days. Note: Real-world clinical evidence for the subject device has demonstrated substantial equivalence up to this 11 day maximum duration. | Per labeling: N/A – Not stated on labeling. Note: the predicate submission included discussion on duration of use, and the duration of the subject device falls within the same timeframe as duration of use for the predicate device. | | General Characteristics | | | | Sterilization Method | Ethylene oxide Note: OEM product codes 108154P and 106173P are sterilized by the purchaser before marketing | Ethylene oxide | | Single Use Only | Yes | Yes | | Non-pyrogenic | Yes | Yes | | Design / Technological Characteristic | Subject Device: Bard® Temporary Pacing Electrode Catheters without balloons | Predicate Device (K955712): USCI® Special Care Pacing Electrode | | | Bard® Temporary Pacing Electrode Catheters with balloons | USCI® Bipolar Balloon Pacing Electrode | | Materials | | | | Electrodes | Stainless steel | Stainless steel | | Electrical Tail Pins / Jacks | Gold plated brass | Tin plated brass | | Electrical Tail Pins / Jack Overmolding | Polypropylene | N/A | | Shaft | Polyurethane | Polyurethane | | Coating | N/A – No coating | Benzalkonium Heparin (BH) | | Bifurcate | Black Polyethylene | Black Polyethylene | | Balloon (variants with balloon only) | Natural rubber latex | Natural rubber latex | | Stopcock (variants with balloon only) | Polyethylene and polycarbonate | Polyethylene and polycarbonate | | Balloon Tie Thread (variants with balloon only) | Polyester | Polyester | | Dimensions / Specifications | | | | Balloon Feature (variants with balloon only) | Yes – 1.5 mL volume | Yes – 1.5 mL volume | | Distal Configuration | Variants without balloon: Curved Variants with balloon: Straight or Right Heart Curve | Variants without balloon: Curved Variants with balloon: Straight or Right Heart Curve | | Distal Tip Type | Variants without balloon: Standard material used for shaft distal tip (non- patient contacting) or Soft distal tip material used for shaft distal tip (non- patient contacting) | Variants without balloon: Standard material used for shaft distal tip (non- patient contacting) | | | Subject Device: | Predicate Device (K955712): | | Design / Technological Characteristic | Bard® Temporary Pacing Electrode Catheters without balloons | USCI® Special Care Pacing Electrode | | | Bard® Temporary Pacing Electrode Catheters with balloons | USCI® Bipolar Balloon Pacing Electrode | | | Variants with balloon: Standard material used for shaft distal tip (non- patient contacting) | Variants with balloon: Standard material 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 Heart Curve) | Variants with balloon: 4 – 5 French (Straight tip); 5 French (Right Heart Curve) | | 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 and spacing) | Bipolar (2 electrodes) | Bipolar (2 electrodes) | | | Variants without balloon: 1st electrode at distal tip with 2nd electrode 1cm proximal or 1st electrode at distal tip with 2nd electrode 2.5cm proximal | Variants without balloon: 1st electrode at distal tip, 2nd electrode 1cm proximal | | | Variants with balloon: 1st electrode at distal tip with 2nd electrode 1cm proximal | Variants with balloon: 1st electrode at distal tip with 2nd electrode 1cm proximal | | 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 all models) | | | | ECG Adapter (Included with certain models only) | | | | Ballon Inflation Syringe (Included with all models with balloons) | | | Design / Technological Characteristic | Subject Device: Bard® Temporary Pacing Electrode Catheters without balloons Bard® Temporary Pacing Electrode Catheters with balloons | Predicate Device (K955712): USCI® Special Care Pacing Electrode USCI® Bipolar Balloon Pacing Electrode | | Introducer Compatibility | Via a Needle Cannula Introducer (or percutaneous introducer sheath - not sold or provided by C. R. Bard, Inc.). One of two introducer variants may be provided with some products based on the French size of the Bard® Temporary Pacing Electrode Catheter. | Via a Needle Cannula, Hemaquet™ Sterile-lock Introducer, or USCI Percutaneous Catheter Introducer Per IFU (variants without balloon): French size designation of the introducer reflects the maximum outer diameter of a catheter or temporary transvenous pacing lead that the introducer sheath will accept. Per IFU (variants with balloon): Introducer French size provided is dependent on the balloon electrode French size | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ # 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 / Technological Characteristic | Subject Device: Introducer (Needle / Cannula) | Primary Predicate Device (K172117): Prelude Pursuit™ Splittable Sheath Introducer | |---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA Clearance Number | Subject of this submission | K172117 | | FDA Product Code | DYB (Introducer, Catheter) | DYB (Introducer, Catheter) | | Indications for Use | The Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature. | The introduction of various types of pacing/defibrillator leads and catheters into the venous vasculature. | | Design / Technological Characteristic | Subject Device: Introducer (Needle / Cannula) | Primary Predicate Device (K172117): Prelude Pursuit™ Splittable Sheath Introducer | | General Characteristics | | | | Principles of Operation | "Over the needle" operation mechanism. The introducer catheter tubing is positioned with a glove fit over the needle tubing, and the needle protrudes from the end of the cannula tubing to create initial access. The two components of the Introducer are inserted into the vein simultaneously. The needle is then withdrawn, leaving in place the cannula, through which the Temporary Pacing Electrode Catheter can be advanced through the vessel and into the desired placement location. | Introducer needle is inserted into the vessel. Guidewire is inserted through the needle into the vessel and needle is removed, leaving the guidewire in place. The dilator / introducer sheath assembly is advanced over the guidewire and into the vessel. Once the assembly is fully introduced into the venous system, the guidewire and dilator are retracted, leaving the introducer sheath in position, through which the catheter / pacing lead can be advanced 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, Syringe or Introducer sheath, Dilator | | Compatibility | Introduction of Bard® Temporary Pacing Electrode Catheters | Introduction of various types of pacing/defibrillator leads and catheters | | Materials | | | | Introducer catheter | Fluorinated Ethylene Propylene (FEP) with Barium Sulfate with high density polyethylene hub | Polymers - formulation undisclosed | | Introducer needle | Stainless steel needle with polypropylene hub | Stainless steel needle with polymer hub | | Design / Technological Characteristic | Subject Device: Introducer (Needle / Cannula) | Primary Predicate Device (K172117): Prelude Pursuit™ Splittable Sheath Introducer | | Dimensions / Specifications | | | | Introducer catheter inner diameter (minimum) | Variant I - 5.3 French Variant II - 6.5 French | 5 – 16 French | | Introducer catheter length | Variant I - 6.7 to 8.3 cm Variant II - 5.1 to 5.7 cm | 13 & 25 cm | | Introducer needle outer diameter | Variant I - 16G Variant II - 14G | 18G…