(13 days)
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No
The document describes a simple pacing wire with no mention of AI/ML capabilities or related performance metrics.
Yes.
The device is designed for temporary atrial and ventricular pacing and sensing, which falls under therapeutic use by providing electrical stimulation to regulate heart rhythm.
No
The device is described as a temporary myocardial pacing wire used for pacing and sensing, not for diagnosing conditions. Its primary function is to deliver electrical impulses to the heart or sense electrical activity, which is a therapeutic or monitoring function, not a diagnostic one.
No
The device description clearly details a physical wire with electrodes and needles, indicating it is a hardware device, not software-only. The performance studies also focus on physical and electrical testing of the hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside the body (in vitro).
- Device Function: The Model 6494 Unipolar Temporary Myocardial Pacing Wire is a device that is inserted into the body (in vivo) to directly interact with the heart for temporary pacing and sensing. It does not analyze specimens taken from the body.
The description clearly indicates it's a device for direct intervention within the body, not for laboratory testing of samples.
N/A
Intended Use / Indications for Use
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
Product codes (comma separated list FDA assigned to the subject device)
74 LDF
Device Description
The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi-filament wire. One end of this wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Myocardial (heart)
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)
Medtronic, Inc. performed system compatibility testing to support that the Model 6494 Unipolar Temporary Myocardial Pacing Wire is equivalent to the predicate device. Device testing included:
- Environmental Conditioning .
- Visual Verification .
- Dimensional Testing .
- Electrical Testing .
- Mechanical Testing .
All system compatibility tests performed have demonstrated that the modified Model 6494 heartwire meets the specified requirements.
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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K012459 p. 1/3
MEDTRONIC CONFIDENTIAL
Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence
AUG 1 4 2001
ATTACHMENT D 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE
Submitter
Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432
Contact: Tina Benoit, Associate Product Regulation Manager Telephone: (763) 514-4112 Fax: (763) 514-6424 E-Mail: tina.benoit@medtronic.com
Date Prepared: July 31, 2001
Name of Device
Trade Name: Temporary Pacemaker Electrode, 74 LDF Common Name: Temporary Pacing Lead Classification: Class II
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K012459 p.2/3
MEDTRONIC CONFIDENTIAL
Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence
Predicate Devices
The predicate device for the Model 6494 Unipolar Temporary Myocardial Pacing I ne products as the currently market released Model 6494 Unipolar Temporary Myocardial Pacing Wire.
Device Description
The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi-filament wire. One end of this wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied. No part of the wire remains in the body.
Packaging
The sterile packaging for the Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of a double pouch configuration. The inner pouch (or package liner) and outer pouch materials are transparent Tyvek - polyester/polyethylene laminate. The pouches are heat-sealed.
Intended Use
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The device is supplied sterile and intended for single use only.
Technological Characteristics
The technology used with the Model 6494 Unipolar Temporary Myocardial Pacing Wire has is the same technological characteristics as the predicate device.
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K012459 p. 3
MEDTRONIC CONFIDENTIAL
Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Attachment D: 510(k) Summary of Substantial Equivalence
Summary of Studies
Medtronic, Inc. performed system compatibility testing to support that the Model 6494 Unipolar Temporary Myocardial Pacing Wire is equivalent to the predicate device. Device testing included:
- Environmental Conditioning .
- Visual Verification .
- Dimensional Testing .
- Electrical Testing .
- Mechanical Testing .
All system compatibility tests performed have demonstrated that the modified Model 6494 heartwire meets the specified requirements.
Sterilization Validation
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is sterilized using a 100% Ethylene Oxide (EtO) sterilization process. Processes appropriate for sterilizing the devices were validated.
Conclusion
Through data and information presented, numerous similarities support a determination of substantial equivalence and show the device modifications do not affect the intended use of the device or alter the fundamental scientific technology of the device. Market clearance of the Model 6494 Unipolar Temporary Myocardial Pacing Wire is supported through this Special 510(k) Premarket Notification.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
AUG 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Tina L. Benoit Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576
Re: K012459
Trade Name: Model 6494 Unipolar Temporary Myocardial Pacing Wire Regulation Number: 21 CFR 870.3680 Regulatory Class: Class II (two) Product Code: 74 LDF Dated: July 31, 2001 Received: August 1, 2001
Dear Ms. Benoit:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this
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Page 2 - Ms. Tina L. Benoit
response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and 11 you declies specific as in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, (Jease contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small micrifacturers 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,
Douk Tith
ames E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Indications for Use
INDICATIONS FOR USE
510(k) Number (if known):
NA
Device Name:
Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire
Indications For Use:
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
DaVatell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012451
(Optional Format 1-2-96)