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.

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.

AI/ML Overview

The document provided describes a Special 510(k) Premarket Notification for the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead. This type of submission is for modifications to a manufacturer's own legally marketed device, where the modification does not affect the intended use or fundamental scientific technology. Therefore, the study details provided focus on demonstrating that the modified device remains substantially equivalent to the predicate device, rather than proving performance against specific acceptance criteria for a novel device.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Reported Device Performance
Environmental Conditioning	Meets specified requirements
Visual Verification	Meets specified requirements
Electrical Testing	Meets specified requirements
Mechanical Testing	Meets specified requirements
Sterilization Validation	Processes validated

2. Sample size used for the test set and the data provenance

The document does not specify the sample size used for the described device testing (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing, and Sterilization Validation). It also does not explicitly state the data provenance (e.g., country of origin, retrospective/prospective). These tests are typically performed in a laboratory setting by the manufacturer.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

The concept of "ground truth" and expert adjudication as typically understood in AI/imaging studies does not apply here. This submission is for a physical medical device (a temporary pacing lead), and its performance is evaluated through engineering and laboratory tests, not by human interpretation of data.

4. Adjudication method for the test set

Not applicable. The performance is determined by meeting engineering specifications through objective measurements, not through human adjudication of interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI-assisted diagnostic or interpretative device. It is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-only device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the device testing described, the "ground truth" is established by adherence to predefined engineering specifications and validated test methods for a physical device. This isn't observational data requiring expert consensus or pathology.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a "training set."

9. How the ground truth for the training set was established

Not applicable. This device is not an AI/ML model that requires a "training set" with established ground truth.

Summary of the Study:

The study performed by Medtronic, Inc. was a series of system compatibility tests to demonstrate that the modified Model 6491 Unipolar Pediatric Temporary Pacing Lead is substantially equivalent to its predicate device. The tests included:

Environmental Conditioning: To assess the device's performance under various environmental stresses.
Visual Verification: To ensure the device meets specified visual and aesthetic quality standards.
Electrical Testing: To confirm the electrical characteristics and functionality of the lead (e.g., impedance, pacing threshold).
Mechanical Testing: To evaluate the physical integrity, strength, and durability of the lead components (e.g., tensile strength, flexibility).
Sterilization Validation: To ensure the Ethylene Oxide (ETO) sterilization process effectively sterilizes the device.

The document states that "All system compatibility tests performed have demonstrated that the modified Model 6491 heartwire meets the specified requirements." This indicates that the device successfully passed these engineering and performance tests, supporting its substantial equivalence claim.

Summary

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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

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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

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.

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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.

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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

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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 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

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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):

K012454

Device Name:

Medtronic® Model 6491 Unipolar Pediatric Temporary Pacing Lead

Indications For Use:

(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)

Over-The

Over-The-Counter Use_

Denk Tillh
Division of Cardiovascular & Respiratory Devices
510(k) Number K012454

(Optional Format 1-2-96)

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.