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 Description

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

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

AI/ML Overview

The provided text is a 510(k) Premarket Notification summary for a medical device called "Temporary Cardiac Pacing Wire." It describes the device, its intended use, and compares it to a predicate device. This document is a regulatory submission to the FDA, demonstrating substantial equivalence to a legally marketed device rather than proving the device meets a set of acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically for an AI/algorithm-based device. The device in this document is a physical medical device (cardiac pacing wire), and the "performance modification" mentioned refers to testing its compatibility with an MRI environment, not a software algorithm's performance.

To answer your request, if this were an AI/algorithm-based device, the document would need to outline the specific performance metrics (e.g., sensitivity, specificity, accuracy), the thresholds for those metrics (acceptance criteria), and details of a clinical or performance study (e.g., test set size, expert ground truth establishment, MRMC studies) to demonstrate that the algorithm met those criteria.

Based on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, or ground truth establishment for an AI/algorithm. The document focuses on showing substantial equivalence of a physical device with a predicate through design and material comparisons, and non-clinical performance testing related to MRI compatibility.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
Prescription Use (Part 21 CFR 801 Subpart D)
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: (908) 218-2113 Fax: (908) 218-2595 E-mail: Jpappan@its.jnj.com
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.
1. The intracorporeal end of the wire has a section of exposed, uninsulated wire electrode which terminates with an attached stainless steel needle.
1. 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).
1. The extracorporeal end of wire has a straight needle with breakaway tip attached.
1. The wire length is 60 cm.
1. 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 withcolored polyethylene
2	Item 2 –	Uninsulated, multifilament wire (intracorporeal)electrode
3	Item 3 –	Optional wave pre-formed into the uninsulated,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 isintended for use in temporary epicardialcardiac pacing or monitoring and shouldbe removed after temporary pacing hasbeen discontinued	Temporary Cardiac Pacing Wire isintended for use in temporary cardiacpacing or monitoring.
Contraindication	Use of temporary cardiac pacing wires iscontraindicated for permanent cardiacpacing or for monitoring.	When permanent cardiac pacing ormonitoring is required, the use of theTemporary Cardiac Wire iscontraindicated.
MRI SafetyInformationinWarningsSection	MRI INFORMATIONMRMR ConditionalThis Temporary Cardiac Pacing Wire isMR Conditional. A patient with thisdevice can be scanned safely,immediately after placement under thefollowing conditions:Static magnetic field of 1.5-Tesla or3-Tesla onlyMaximum spatial gradient magneticfield of 1000 Gauss/cm(extrapolated).	NA

	Transmit/receive RF head coil only.
	Maximum MR system reported,transmit/receive RF head coilspecific absorption rate (SAR) of 3.2W/kg for 15 minutes of scanning(i.e. per pulse sequence).
	Normal Operating Mode ofoperation for the MR system.
	In non-clinical testing and numericalmodeling, the Temporary CardiacPacing Wire produced a temperature riseof less than 0.5°C at a maximum MRsystem calculated transmit/receive RFhead coil SAR of 3.2-W/kg in 1.5-Tesla/64-MHz and 3-Tesla/128-MHzMR systems.
	Additional MRI Safety InformationDo not perform an MRI procedure ifthe Temporary Cardiac Pacing Wireis damaged or otherwise notfunctioning properly.
	The Temporary Cardiac Pacing wiremust be disconnected from the pulsegenerator prior to entry into the MRsystem room and the ends of theleads should be properly secured toprevent movement.
	The use of a transmit/receive RFbody coil to perform an MRIexamination in a patient with theTemporary Cardiac Pacing Wiremay cause patient injury due toexcessive 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 ispackaged in paperboard envelops, paperfolders and card reels. These are thenpackaged in a poly-Tyvek sterile barrier
U.S.P. requirements	Same	packageTemporary Cardiac Pacing Wire complieswith the requirements of the EuropeanPharmacopoeia for Sterile Non-Absorbablestrands and the United StatesPharmacopoeia U.S.P. Monograph 861,871 and 881 for Non Absorbable SurgicalSutures.

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 ConditionsUsing 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).

Regulation Number and Section

§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.

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