(214 days)
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Not Found
No
The summary describes a physical pacing wire and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as a "Temporary Bipolar Myocardial Pacing Wire" which "functions as a temporary implant for the transmission of electrical heart pacing signals," indicating it is used to treat or manage a physiological condition (heart rhythm).
No
The device transmits electrical pacing signals, which is a therapeutic function, not a diagnostic one. It does not analyze patient data or provide information about a disease or condition.
No
The device description clearly states it is a "Temporary Bipolar Myocardial Pacing Wire," which is a physical, implantable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use of this device is to be placed directly in contact with the native myocardium (heart muscle) following cardiac surgery. It transmits electrical signals to the heart, not from a specimen taken from the body.
- IVDs are used to provide information about a physiological state, health, or disease. While this pacing wire is used in a medical context related to heart function, its primary function is therapeutic (pacing the heart), not diagnostic (analyzing a specimen to diagnose a condition).
The device description and intended use clearly indicate it's a temporary implant for electrical pacing, which is a therapeutic intervention, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed. The wire may be used on either the atrium or ventricle.
Product codes
LDF
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
atrium or ventricle (myocardium)
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 2 2004
European Custom Manufacturing B.V. c/o Mr. Maarten Kanters QA Manager Oost-Om 54 P.O. Box 53 NL-5420 AB Gemert Netherlands
Re: K033858
Trade Name: Temporary Bipolar Myocardial Pacing Wire Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: II (two) Product Code: LDF Dated: May 25, 2004 Received: June 28, 2004
Dear Mr. Kanters:
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 may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Mr. Maarten Kanters
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4648. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
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 Statement
K033858 510(K) Number:
Temporary Bipolar Myocardial Pacing Wire Device Name:
Indications for use: The Temporary Bipolar Myocardial Pacing Wire functions as a temporary implant for the transmission of electrical heart pacing signals. The heart wire is placed following cardiac surgery to be in direct contact with the native myocardium while the natural heart is surgically exposed.
The wire may be used on either the atrium or ventricle.
Sincerely,
Maarten Kanters
QA Manger European Custom Manufacturing BV
Division Sion-C n of Cardiovascular Devices
510(k) Number /