(13 days)
Not Found
Not Found
No
The description focuses on the physical components and function of a temporary pacing lead, with no mention of AI or ML capabilities.
Yes
The device is described as a "Temporary Pacing Lead" used for "atrial and ventricular pacing and sensing," which implies it is used to manage or treat a medical condition related to heart rhythm.
No
The device is a temporary pacing lead, which delivers electrical pulses to stimulate the heart, rather than diagnosing a condition.
No
The device description clearly details physical components like an electrode, conductor, monofilament coil, and needles, 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 atrial and ventricular pacing and sensing." This describes a therapeutic and diagnostic function performed in vivo (within the body), not in vitro (outside the body) on biological specimens.
- Device Description: The description details a physical lead designed to be implanted in myocardial tissue for electrical pacing and sensing. This is consistent with an implantable medical device, not a device used for testing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (blood, urine, tissue, etc.), reagents, or laboratory procedures, which are hallmarks of IVD devices.
Therefore, the Model 6491 Unipolar Pediatric Temporary Pacing Lead is a medical device used for temporary cardiac pacing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Model 6491 Unipolar Pediatric Temporary Pacing Lead 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
74 LDF
Device Description
The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Medtronic, Inc. performed system compatibility testing to support that the Model 6491 Unipolar Pediatric Temporary Pacing Lead is equivalent to the predicate device. Device testing included:
- Environmental Conditioning .
- Visual Verification .
- Electrical Testing .
- Mechanical Testing .
All system compatibility tests performed have demonstrated that the modified Model 6491 heartwire meets the specified requirements.
Key Metrics
Not Found
Predicate Device(s)
The predicate device for the Model 6491 Unipolar Pediatric Temporary Pacing I he production as not the market released Model 6491 Unipolar Pediatric Temporary Pacing Lead.
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.
0
K012454 p. 1/3
medtronic confidential
Special 510(k) Premarket Notifi Model 6491 Umpolar Fediatho Tempstantial Equivalence
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 tina.benoit@medtronic.com E-Mail:
Date Prepared: July 31, 2001
Name of Device
Trade Name: Temporary Pacemaker Electrode, 74 LDF Common Name: Temporary Pacing Lead Classification: Class II
1
KOI2454 p.2/3
MEDTRONIC CONFIDENTIAL
Special 510(k) Premarket Notification Model 6491 Unipolar Pediatric Temporary Pacing Lead MOdel 646 Pormary of Substantial Equivalence
Predicate Devices
The predicate device for the Model 6491 Unipolar Pediatric Temporary Pacing I he production as not the market released Model 6491 Unipolar Pediatric Temporary Pacing Lead.
Device Description
The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied.
Packaging
The sterile packaging for the Model 6491 Unipolar Pediatric Temporary Pacing Lead 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 6491 Unipolar Pediatric Temporary Pacing Lead 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 6491 Unipolar Pediatric Temporary Pacing Lead is the same technological characteristics as the predicate device.
2
K012454 p.3/3
Special 510(k) Premarket Notificatio Model 6491 Unipolar Pediatric Temporary Pacing Lead Attachment D: 510(k) Summary of Substantial Equivalence
Summary of Studies
Medtronic, Inc. performed system compatibility testing to support that the Model 6491 Unipolar Pediatric Temporary Pacing Lead is equivalent to the predicate device. Device testing included:
- Environmental Conditioning .
- Visual Verification .
- Electrical Testing .
- Mechanical Testing .
All system compatibility tests performed have demonstrated that the modified Model 6491 heartwire meets the specified requirements.
Sterilization Validation
The Model 6491 Unipolar Pediatric Temporary Pacing Lead 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 6491 Unipolar Pediatric Temporary Pacing Lead is supported through this Special 510(k) Premarket Notification.
3
Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines suggesting movement or connection.
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: K012454
Trade Name: Model 6491 Unipolar Pediatric Temporary Pacing Lead 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 ( fecting 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
4
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 additionally 809.10 for 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, please 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 Manufacturers 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,
James E. Dillard III
Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
MEDTRONIC CONFIDENTIAL
Special 510(k) Premarket Notification Model 6491 Unipolar Pediatric Temporary Pacing Lead Indications for Use
INDICATIONS FOR USE
510(k) Number (if known):
NA
Device Name:
Medtronic® Model 6491 Unipolar Pediatric Temporary Pacing Lead
Indications For Use:
The Model 6491 Unipolar Pediatric Temporary Pacing Lead 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
Over-The-Counter Use_
4
Denk Tillh
Division of Cardiovascular & Respiratory Devices
510(k) Number K012454
(Optional Format 1-2-96)