(219 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and MRI compatibility of a temporary cardiac pacing wire, with no mention of AI or ML.
Yes
The device is intended for "temporary epicardial cardiac pacing or monitoring," which involves applying electrical impulses to stimulate the heart, thereby restoring or regulating its rhythm. This direct intervention to influence a physiological function of the body qualifies it as a therapeutic device.
Yes
The "Intended Use / Indications for Use" states that the device is intended for "temporary epicardial cardiac pacing or monitoring." Monitoring is a diagnostic function.
No
The device description clearly outlines physical components like wires, needles, and insulation, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary epicardial cardiac pacing or monitoring." This is a direct intervention on the patient's body for therapeutic or monitoring purposes.
- Device Description: The description details a physical wire designed to be placed within the body (epicardial cardiac) for electrical pacing or monitoring.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a physiological state, disease, or congenital abnormality.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens. This device is clearly intended for in vivo (within the living body) use.
N/A
Intended Use / 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.
Product codes
LDF
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.
The lead consists of:
- Item 1 – Insulated multifilament conductor coated with colored polyethylene
- Item 2 – Uninsulated, multifilament wire (intracorporeal) electrode
- Item 3 – Optional wave pre-formed into the uninsulated, intracorporeal wire end
- Item 4 – Intracorporeal curved needle
- Item 5 – Extracorporeal straight breakaway needle
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
epicardial cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The following tests were completed for the Temporary Cardiac Pacing Wire:
- 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 Using RF Coils at 64-MHz and 128 MHz
Key Results: In non-clinical testing and numerical modeling, the Temporary Cardiac Pacing Wire produced a temperature rise of less than 0.5°C at a maximum MR system calculated transmit/receive RF head coil SAR of 3.2-W/kg in 1.5-Tesla/64-MHz and 3-Tesla/128-MHz MR systems.
Key Metrics
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.
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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
1
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
2
Indications for Use
510(k) Number (if known)
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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3
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 |
4
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.
| The lead consists of: | ||
|---|---|---|
| 1 | Item 1 – | Insulated multifilament conductor coated with |
| colored 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.
5
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 | |
| intended for use in temporary epicardial | ||
| cardiac pacing or monitoring and should | ||
| be removed after temporary pacing has | ||
| been discontinued | Temporary Cardiac Pacing Wire is | |
| intended for use in temporary cardiac | ||
| pacing or monitoring. | ||
| Contraindication | Use of temporary cardiac pacing wires is | |
| contraindicated for permanent cardiac | ||
| pacing or for monitoring. | When permanent cardiac pacing or | |
| monitoring is required, the use of the | ||
| Temporary Cardiac Wire is | ||
| contraindicated. | ||
| MRI Safety | ||
| Information | ||
| in | ||
| Warnings | ||
| Section | MRI INFORMATION |
MR
MR Conditional
This Temporary Cardiac Pacing Wire is
MR Conditional. A patient with this
device can be scanned safely,
immediately after placement under the
following conditions:
Static magnetic field of 1.5-Tesla or
3-Tesla onlyMaximum spatial gradient magnetic
field of 1000 Gauss/cm
(extrapolated). | NA |
| | | |
| | Transmit/receive RF head coil only. | |
| | Maximum MR system reported,
transmit/receive RF head coil
specific absorption rate (SAR) of 3.2
W/kg for 15 minutes of scanning
(i.e. per pulse sequence). | |
| | Normal Operating Mode of
operation for the MR system. | |
| | In non-clinical testing and numerical
modeling, the Temporary Cardiac
Pacing Wire produced a temperature rise
of less than 0.5°C at a maximum MR
system calculated transmit/receive RF
head coil SAR of 3.2-W/kg in 1.5-
Tesla/64-MHz and 3-Tesla/128-MHz
MR systems. | |
| | Additional MRI Safety Information
Do not perform an MRI procedure if
the Temporary Cardiac Pacing Wire
is damaged or otherwise not
functioning properly. | |
| | The Temporary Cardiac Pacing wire
must be disconnected from the pulse
generator prior to entry into the MR
system room and the ends of the
leads should be properly secured to
prevent movement. | |
| | The use of a transmit/receive RF
body coil to perform an MRI
examination in a patient with the
Temporary Cardiac Pacing Wire
may cause patient injury due to
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
packaged in paperboard envelops, paper
folders and card reels. These are then
packaged in a poly-Tyvek sterile barrier |
| U.S.P. requirements | Same | package
Temporary Cardiac Pacing Wire complies
with the requirements of the European
Pharmacopoeia for Sterile Non-Absorbable
strands and the United States
Pharmacopoeia U.S.P. Monograph 861,
871 and 881 for Non Absorbable Surgical
Sutures. |
Table 1: Device Comparison Table
6
7
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 |
| 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).