The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial 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 Medtronic Model 6492 Unipolar Temporary Atrial 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. No part of the lead remains in the body.

AI/ML Overview

This document describes a Special 510(k) Premarket Notification for the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead. This type of submission is for modifications to a legally marketed device where the modifications do not affect the intended use or alter the fundamental scientific technology. Therefore, the submission focuses on demonstrating that the modified device maintains substantial equivalence to the predicate device through specific testing. It does not contain an "acceptance criteria" table in the traditional sense for a new device's performance, but rather a "summary of studies" showing that the modified device still meets all specified requirements.

Here's an analysis of the provided text in relation to your request:

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

The document does not present a formal table of "acceptance criteria" and "reported device performance" as would be seen for a new device's clinical efficacy study. Instead, it states that "All system compatibility tests performed have demonstrated that the modified Model 6492 heartwire meets the specified requirements." This implies that the acceptance criteria are inherent in the "specified requirements" for each test.

Acceptance Criteria	Reported Device Performance
Environmental Conditioning: Meets specified requirements.	Demonstrated that the modified Model 6492 heartwire meets the specified requirements.
Visual Verification: Meets specified requirements.	Demonstrated that the modified Model 6492 heartwire meets the specified requirements.
Electrical Testing: Meets specified requirements.	Demonstrated that the modified Model 6492 heartwire meets the specified requirements.
Mechanical Testing: Meets specified requirements.	Demonstrated that the modified Model 6492 heartwire meets the specified requirements.
Sterilization Validation: Achieves required sterility assurance level (SAL) through 100% Ethylene Oxide (ETO) process.	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)

The document does not specify the sample size for the "system compatibility testing" (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing) or for the Sterilization Validation. It also does not mention the data provenance (country of origin, retrospective/prospective). This is common for Special 510(k) submissions focusing on engineering and bench testing rather than clinical trials.

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)

Not applicable. This device submission relies on engineering and bench testing, not expert-derived ground truth from human observations or interpretations.

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

Not applicable. This submission concerns physical device testing, not assessment of human interpretation or diagnostic accuracy.

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/software device and no MRMC study was conducted.

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

Not applicable. This is not an AI/software device. The testing described (Environmental Conditioning, Visual Verification, Electrical Testing, Mechanical Testing, Sterilization Validation) represents the "standalone" performance of the physical device in meeting its engineering specifications.

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

For the engineering and sterilization tests, the "ground truth" is defined by the specified requirements and validated test methods. For example, in electrical testing, the ground truth would be the expected electrical parameters as per the device's design specifications. For sterility, the ground truth is a validated Sterility Assurance Level (SAL).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary

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K01 2458 p. 1/3

AUG 1 4 2001 MEDTRONIC CONFIDENTIA

Special 510(k) Premarket Notification Model 6492 Unipolar Temporary Atrial Pacing Lead Attachment D: 510(k) Summary of Substantial 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 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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01 2458 p.2/3

MEDTRONIC CONFIDENTIAL

Special 510(k) Premarket Notification Model 6492 Unipolar Temporary Atrial Pacing Lead Attachment D: 510(k) Summary of Substantial Equivalence

Predicate Devices

The predicate device for the Model 6492 Unipolar Temporary Atrial Pacing Lead is the currently market released Model 6492 Unipolar Temporary Atrial Pacing Lead.

Device Description

Packaging

The sterile packaging for the Model 6492 Unipolar Temporary Atrial 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 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary atrial 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 6492 Unipolar Temporary Atrial Pacing Lead has is the same technological characteristics as the predicate device.

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K012458 p.3/3

MEDTRONIC CONFIDENTIAL

Special 510(k) Premarket Notification Special Temporary Atrial Pacing Lead

Summary of Studies

Medtronic, Inc. performed system compatibility testing to support that the Model Medironic, Inc. Performed system ocing 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 6492 heartwire meets the specified requirements.

Sterilization Validation

The Model 6492 Unipolar Temporary Atrial 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 I firough data 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 6492 Unipolar Temporary Atrial Pacing Lead is supported through this Special 510(k) Premarket Notification.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned inside a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper half of the circle.

Public Health Service

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: K012458

RoT2150
Trade Name: Model 6492 Unipolar Temporary Atrial 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 we have teviewed your becaon b r (x) xe is substantially equivalent (for the indications for use above and we nave determined an arketed predicate devices marketed in interstate commerce stated in the enclosation to legally manage of the Medical Device Amendments, or to devices that phor to May 20, 1978, and exardance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Free. "The general smanufacturing 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 (1 remancer ripproval), 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 mspoctions, the Four and 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 I his lotter will and n your ding of substantial equivalence of your device to a legally marketed nouticate 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 don't open 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, (301) 59 + 10 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 mormation on your responsive this 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,

Don't Tell
Lee James E. Dillard III

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 6492 Unipolar Temporary Atrial Pacing Lead Indications for Use

INDICATIONS FOR USE

K012458

510(k) Number (if known):

Device Name:

Medtronic® Model 6492 Unipolar Temporary Atrial 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-Counter Use__________________________________________________________________________________________________________________________________________________________

Division of Cardiovascular & Respiratory Devices
510(k) Number K012453

(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.