Temporary Cardiac Pacing Wire

K173923 · ETHICON, Inc. · LDF · Aug 2, 2018 · Cardiovascular

Device Facts

• Record ID: K173923
• Device Name: Temporary Cardiac Pacing Wire
• Applicant: ETHICON, Inc.
• Product Code: LDF · Cardiovascular
• Decision Date: Aug 2, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

Device Story

Temporary Cardiac Pacing Wire is a sterile, single-use epicardial electrode used for temporary cardiac pacing or monitoring. The device consists of an insulated multifilament stainless steel conductor coated with polyethylene, featuring an exposed uninsulated intracorporeal electrode (straight or pre-formed wave) with a stainless steel needle, and an extracorporeal end with a breakaway needle. It is used in clinical settings by healthcare professionals. The device is placed epicardially to provide electrical pacing signals to the heart. It is MR Conditional, allowing scanning under specific conditions (1.5T or 3T, specific SAR limits). The device must be disconnected from the pulse generator before entering the MRI environment. It provides a temporary electrical pathway for cardiac management and is removed once pacing is no longer required.

Clinical Evidence

Bench testing only. No clinical data provided. Performance was verified through non-clinical MRI heating tests and numerical modeling at 1.5-Tesla/64-MHz and 3-Tesla/128-MHz, demonstrating a temperature rise of less than 0.5°C at a maximum SAR of 3.2 W/kg.

Technological Characteristics

Materials: 316L stainless steel conductor, polyethylene coating. Form factor: 60 cm length, various diameters (0 to 2-0). Principle: Passive epicardial electrode for electrical pacing. Connectivity: None (passive). Sterilization: Gamma irradiation. MR Conditional: 1.5T/3T, max spatial gradient 1000 Gauss/cm, transmit/receive RF head coil only, max SAR 3.2 W/kg.

Indications for Use

Indicated for temporary epicardial cardiac pacing or monitoring in patients requiring short-term pacing support. Contraindicated for permanent cardiac pacing or monitoring.

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

• Temporary Cardiac Pacing Wire (K980503)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 2, 2018

Ethicon, Inc. Joice Pappan Regulatory Affairs Specialist II P.O. Box 151 Route 22 West Somerville, New Jersey 08876-0151

Re: K173923

Trade/Device Name: Temporary Cardiac Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: July 2, 2018 Received: July 3, 2018

Dear Joice Pappan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You mav, 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 avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

M.A. Hillemann

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K173923

Device Name

Temporary Cardiac Pacing Wire

Indications for Use (Describe)

Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| <div> <span> <svg class="bi bi-check-square-fill" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2zm10.03 4.97a.75.75 0 0 0-1.08.022L7.477 9.417 5.384 7.323a.75.75 0 0 0-1.06 1.06L6.97 11.03a.75.75 0 0 0 1.079-.02l3.992-4.99a.75.75 0 0 0-.01-1.05z" fill-rule="evenodd"></path> </svg> </span>Prescription Use (Part 21 CFR 801 Subpart D) </div> | |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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100597244 | Rev. 1 Temporary Cardiac Pacing Wire

Image /page/3/Picture/3 description: The image shows the word "ETHICON" in large, red, serif font. Below the word "ETHICON" is the phrase "PART OF THE Johnson & Johnson FAMILY OF COMPANIES" in a smaller, gray font. The words "Johnson & Johnson" are in a cursive font. The image is a logo for Ethicon, a company that is part of the Johnson & Johnson family of companies.

510(k) Summa

Submitter: ETHICON Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151

- Contact Person: Joice Pappan Senior Regulatory Affairs Program Lead ETHICON, Inc. a Johnson & Johnson company Ph: [phone] Fax: [phone] E-mail: [e-mail]
Date Prepared: December 22, 2017

Device Trade Name: Temporary Cardiac Pacing Wire

Device Common Name: Electrode, Pacemaker, Temporary

Class: II

Classification Name: Cardiovascular permanent or temporary pacemaker electrode 21 CFR 870.3680

## Product Code: LDF

## Predicate Devices:

| Device | Company | Product Code | 510(k) Number | Predicate for: |
|-------------------------------|---------------|--------------|---------------|-------------------------------------------------------------------------------------------------|
| Temporary Cardiac Pacing Wire | ETHICON, Inc. | OMD | K980503 | Fundamental Scientific Technology, Design, Materials, Construction, Performance Characteristics |

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### Device Description:

The Temporary Cardiac Pacing Wire is a sterile single-use product. Temporary cardiac pacing wires consist of the following configurations and optional accessories:

- 1. The monopolar leads consist of one insulated multifilament stainless steel conductor coated with colored polyethylene.
- 2. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
- 3. The exposed, uninsulated section of the intracorporeal end of the wire is either straight or has one or more multiple pre-formed curves (pre-formed wave).
- 4. The extracorporeal end of wire has a straight needle with breakaway tip attached.
- 5. The wire length is 60 cm.
- 6. Wires range in multiple diameters from 0 to 2-0, depending on the product code.

| | The lead consists of: | |
|---|-----------------------|---------------------------------------------------------------------------|
| 1 | Item 1 – | Insulated multifilament conductor coated with<br>colored polyethylene |
| 2 | Item 2 – | Uninsulated, multifilament wire (intracorporeal)<br>electrode |
| 3 | Item 3 – | Optional wave pre-formed into the uninsulated,<br>intracorporeal wire end |
| 4 | Item 4 – | Intracorporeal curved needle |
| 5 | Item 5 – | Extracorporeal straight breakaway needle |

### Indications for Use:

Temporary Cardiac Pacing Wire is intended for use in temporary epicardial cardiac pacing or monitoring and should be removed after temporary pacing has been discontinued.

## Summarv of Technological Characteristics and Performance Testing:

Temporary Cardiac Pacing Wire is identical to the Temporary Cardiac Pacing Wire with wave (K980503) marketed device. The principle of operation and fundamental scientific technology of the modified device are equivalent to the predicate device. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device.

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The performance modification was accomplished via testing in the MRI environment and updating the labeling per FDA guidance "Establishing Safety and compatibility of Passive implants in the Magnetic Resonance (MR) environment" dated December 11, 2014. Additionally, the change proposed in this premarket notification, modifies the indications for use statement which reinforces that the device is for short-term, temporary pacing only, as stated by the product name. The labeling (Instructions for Use) have also been modified to add clarity for the use of the device.

A comparison between the proposed and the predicate device is given in Table 1 below.

| | Proposed Device | Predicate Device |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Temporary Cardiac Pacing Wire | Temporary Cardiac Pacing Wire |
| 510(k) Number | TBD | K980503 |
| Product Code | Same | LDF |
| Regulation | Same | 21 CFR 870.3680 |
| Absorbable | Same | No |
| Intended Use | Temporary Cardiac Pacing Wire is<br>intended for use in temporary epicardial<br>cardiac pacing or monitoring and should<br>be removed after temporary pacing has<br>been discontinued | Temporary Cardiac Pacing Wire is<br>intended for use in temporary cardiac<br>pacing or monitoring. |
| Contraindication | Use of temporary cardiac pacing wires is<br>contraindicated for permanent cardiac<br>pacing or for monitoring. | When permanent cardiac pacing or<br>monitoring is required, the use of the<br>Temporary Cardiac Wire is<br>contraindicated. |
| MRI Safety<br>Information<br>in<br>Warnings<br>Section | MRI INFORMATION<br><br>MR<br><br>MR Conditional<br>This Temporary Cardiac Pacing Wire is<br>MR Conditional. A patient with this<br>device can be scanned safely,<br>immediately after placement under the<br>following conditions:<br>Static magnetic field of 1.5-Tesla or<br>3-Tesla onlyMaximum spatial gradient magnetic<br>field of 1000 Gauss/cm<br>(extrapolated). | NA |
| | | |
| | Transmit/receive RF head coil only. | |
| | Maximum MR system reported,<br>transmit/receive RF head coil<br>specific absorption rate (SAR) of 3.2<br>W/kg for 15 minutes of scanning<br>(i.e. per pulse sequence). | |
| | Normal Operating Mode of<br>operation for the MR system. | |
| | In non-clinical testing and numerical<br>modeling, the Temporary Cardiac<br>Pacing Wire produced a temperature rise<br>of less than 0.5°C at a maximum MR<br>system calculated transmit/receive RF<br>head coil SAR of 3.2-W/kg in 1.5-<br>Tesla/64-MHz and 3-Tesla/128-MHz<br>MR systems. | |
| | Additional MRI Safety Information<br>Do not perform an MRI procedure if<br>the Temporary Cardiac Pacing Wire<br>is damaged or otherwise not<br>functioning properly. | |
| | The Temporary Cardiac Pacing wire<br>must be disconnected from the pulse<br>generator prior to entry into the MR<br>system room and the ends of the<br>leads should be properly secured to<br>prevent movement. | |
| | The use of a transmit/receive RF<br>body coil to perform an MRI<br>examination in a patient with the<br>Temporary Cardiac Pacing Wire<br>may cause patient injury due to<br>excessive MRI-induced heating. | |
| Color | Same | Dyed and Undyed |
| Material | Same | 316L Stainless Steel |
| Composition | Same | |
| Sterilization | Same | Sterilized by Gamma Irradiation |
| Packaging | Same | Temporary Cardiac Pacing Wire is<br>packaged in paperboard envelops, paper<br>folders and card reels. These are then<br>packaged in a poly-Tyvek sterile barrier |
| U.S.P. requirements | Same | package<br>Temporary Cardiac Pacing Wire complies<br>with the requirements of the European<br>Pharmacopoeia for Sterile Non-Absorbable<br>strands and the United States<br>Pharmacopoeia U.S.P. Monograph 861,<br>871 and 881 for Non Absorbable Surgical<br>Sutures. |

Table 1: Device Comparison Table

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The following tests were completed for the Temporary Cardiac Pacing Wire

| Design Verification |
|------------------------------------------------------------------------------------------------------------------|
| MRI-related heating, 1.5-Tesla/64-MHz. Heating test |
| MRI-related heating, 3-Tesla/128-MHz. Heating test |
| Evaluation of Ethicon Temporal Pacing Wires Heating under MRI Conditions<br>Using RF Coils at 64-MHz and 128 MHz |

#### Summary of Substantial Equivalence Comparison:

Temporary Cardiac Pacing Wire is identical to the existing Temporary Cardiac Pacing Wire "with wave" (K980503) marketed device except for the following changes: (1) performance modification to test the MRI Environment, (2) modifications to the labeling (instructions for use, contraindication statements, and general updates). There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed device. The clarifications to the labeling and indications for use statement were made to add clarity for users.

#### Conclusion:

Based on the similarities to the predicate device identified in this submission, except for proposed modification to clarify the labeling (instructions for use), adding the MRI warning information, revision of the Indication statement and the Contraindication statement, updating the Warnings, Precautions and Interactions sections, the devices have the same fundamental technology, and the same principle of operation. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. Temporary Cardiac Pacing Wire is considered to be substantially equivalent to the predicate device (K980503).