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.

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.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Model 6494 Unipolar Temporary Myocardial Pacing Wire) and primarily focuses on proving substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study in the context of AI/machine learning device performance, as implied by the detailed questions.

Instead, the document details physical and functional testing to ensure the modified device meets specified requirements and is equivalent to an existing device.

Here's an analysis based on the provided text, addressing the questions as much as possible, acknowledging where the requested information is not applicable or unavailable:

1. A table of acceptance criteria and the reported device performance

The document states that Medtronic, Inc. performed "system compatibility testing to support that the Model 6494 Unipolar Temporary Myocardial Pacing Wire is equivalent to the predicate device." It then lists the types of tests done and a general conclusion. Specific acceptance criteria and quantitative performance metrics are not provided.

Acceptance Criteria Category	Reported Device Performance
Environmental Conditioning	"Meets the specified requirements"
Visual Verification	"Meets the specified requirements"
Dimensional Testing	"Meets the specified requirements"
Electrical Testing	"Meets the specified requirements"
Mechanical Testing	"Meets the specified requirements"
Sterilization Validation	"Processes appropriate for sterilizing the devices were validated"

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "system compatibility testing" and "device testing" but doesn't specify sample sizes for these tests. There's no mention of a "test set" in the context of data for an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to this type of device submission. The device is a physical medical instrument (pacing wire), not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to this type of device submission. Adjudication methods are typically used in clinical studies or for establishing ground truth in AI/ML performance evaluations, neither of which is described here.

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

This is not applicable. The device is a temporary myocardial pacing wire, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

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

This is not applicable. The "ground truth" for this device's performance would be against established engineering specifications and international standards for electrical, mechanical, and material properties of such medical devices, rather than clinical outcomes or expert consensus on data interpretation. The document broadly states "meets the specified requirements."

8. The sample size for the training set

This is not applicable. The device is a physical instrument, not an AI/ML model that requires a training set.

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

This is not applicable. As there is no AI/ML training set, there's no ground truth to establish for it in this context.

Summary

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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

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.

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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

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Special 510(k) Premarket Notification Model 6494 Unipolar Temporary Myocardial Pacing Wire Indications for Use

INDICATIONS FOR USE

510(k) Number (if known):

K012459

Device Name:

Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire

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-Counter Use_

DaVatell
Division of Cardiovascular & Respiratory Devices
510(k) Number K012451

(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.