(266 days)
Not Found
No
The summary describes a physical medical device (catheter and introducer) for transmitting electrical signals and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The performance studies focus on physical and electrical properties, not algorithmic performance.
Yes
The device is designed to transmit electrical signals from an external pulse generator to the heart to pace it, which is a therapeutic function.
No
The device is designed to transmit electrical signals for pacing or monitoring, but it does not independently analyze or interpret physiological signals to establish a diagnosis.
No
The device description clearly details physical components such as insulated electrical wires, woven shafts, electrodes, leads, and accessories like needles and cannulas, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to transmit electrical signals to or from the heart for pacing or monitoring. This is a direct interaction with the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical catheter and introducer designed for insertion into the venous vasculature and placement within the heart.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples (blood, urine, tissue, etc.) outside of the body. IVDs are specifically designed for testing these types of samples to provide information about a person's health status.
The device described is a medical device used for direct intervention and monitoring within the patient's circulatory system and heart, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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 Needle / Cannula (Introducer) is intended for the introduction of Bard® Temporary Pacing Electrode Catheters into the venous vasculature.
Product codes
LDF, DYB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, venous vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Professional healthcare facility
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bard® Temporary Pacing Electrode Catheters:
- 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.
- Performance Testing: Certain endpoints of the following standards have been deemed relevant: ISO 10555-1:2013 [AMD 2017], IEC 60601-1:2020, IEC 60601-1-2:2020, ISO 80369-1:2018, ISO 80369-7:2021, ISO 80369-20:2015. 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
- Functional testing of small-bore connectors
- 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.
Needle / Cannula (Introducer):
- 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.
- 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: ISO 11070:2014, ISO 80369-1:2018, ISO 80369-7:2021, ISO 80369-20:2015. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 |
| Introducer needle length | Variant I - 9.3 cm
Variant II - 7.5 cm | 7 cm |
| Predicate only: Dilator
length (for reference) | | Dilator: 7.59" or 19.3 cm (13cm
introducer) and 12.34" or 31.3 cm (25
cm introducer) |
10
l
11
- = 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. -
- Performance Testing
Certain endpoints (as applicable) of the following standards have been deemed relevant to Bard® Temporary Pacing Electrode Catheter performance:
- Performance Testing
-
. 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
12
- . 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.
13
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.
-
- 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:
- Performance Testing
-
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.