The Model 6500 Unipolar Temporary Myocardial 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 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally attached to the conductor wire permits exiting the pacing lead through the chest wall. The electrode terminates distally in an atraumatic myocardial curved needle. 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. All components of the lead remain in the body, except the silicone rubber disc in case of atrial application.

AI/ML Overview

This Medtronic document (K012452) describes a Special 510(k) Premarket Notification for the Model 6500 Unipolar Temporary Myocardial Pacing Lead. This filing focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel performance against acceptance criteria with a new type of study.

Here's an analysis of the provided information in the context of your request:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a table of specific acceptance criteria (e.g., target accuracy, sensitivity, specificity) and corresponding performance metrics for a diagnostic or AI device. Instead, it details various engineering and compatibility tests designed to show the new device performs equivalently to the predicate device.

Here's a summary of the "acceptance criteria" and "reported performance" as inferred from the document:

Acceptance Criteria Category	Specific Tests Performed by Device	Reported Performance
System Compatibility	Environmental Conditioning	Meets specified requirements
	Visual Verification	Meets specified requirements
	Dimensional Testing	Meets specified requirements
	Electrical Testing	Meets specified requirements
	Mechanical Testing	Meets specified requirements
Sterilization	Ethylene Oxide (ETO) Sterilization Process Validation	Processes appropriate for sterilizing the devices were validated.

2. Sample Size Used for the Test Set and Data Provenance

This document does not describe a clinical "test set" in the context of evaluating a diagnostic algorithm's performance on patient data. The "tests" mentioned are device engineering and compatibility tests.

Sample Size for Test Set: Not applicable in the context of diagnostic performance on patient data. The sample size for the engineering tests is not explicitly stated (e.g., "how many leads were subjected to dimensional testing?").
Data Provenance: Not applicable in the context of patient data. The tests were performed internally by Medtronic, Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable as the submission does not involve establishing ground truth for a diagnostic test using expert review of patient data. The "ground truth" for the engineering tests would be the established specifications and expected performance benchmarks for the device components.

4. Adjudication Method for the Test Set

This information is not applicable as there is no human-in-the-loop diagnostic review or ground truth adjudication process described for a test set of patient data.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. This type of study is typically used to evaluate the impact of an AI algorithm on human reader performance (e.g., radiologists interpreting images). The Model 6500 is a physical medical device (a pacing lead), not an AI diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study for an algorithm was not done. The "device" in question is a physical pacing lead, not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the studies described relates to engineering specifications and performance standards for a medical device. It's essentially engineering specifications and established performance benchmarks for properties like electrical conductivity, mechanical strength, dimensions, and visual integrity, as well as validated sterilization procedures. It is not expert consensus, pathology, or outcomes data in the context of diagnostic interpretation.

8. The Sample Size for the Training Set

This information is not applicable. The Model 6500 is a physical medical device, not an AI model that requires a training set of data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for an AI model.

In summary:

This document is a Special 510(k) for a physical medical device. It focuses on demonstrating substantial equivalence to a predicate device through engineering and compatibility testing, rather than evaluating the clinical performance of a diagnostic algorithm or AI system. Therefore, many of the requested items related to AI/diagnostic study design are not present in this type of regulatory submission.

Summary

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MEDTRONIC CONFIDENTIAL AUG 1 4 2001

Special 510(k) Premarke Model 6500 Unipolar Temporary Myocardial Pacing Lead loder 6500 Unipolar Teliffordi y Myobatantial Equivalence

KOL2452

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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Predicate Devices

The predicate device for the Model 6500 Unipolar Temporary Myocardial Pacing
Parties of the Model 6500 Unicolar Temporary The predicate device for the Model 6500 Unipslar Temporary Myocardial Pacing Lead.

Device Description

The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an The Model 0500 Unipolar Temperary They conductor which are crimped together. electrode and an insulated multi-inament concession of the lead is attached to the A blue monomanent proximally ocheardumatic myocardial curved needle. A
t electrode and terminates distally in an atraumatic myocardial in museum electrode and terminates distanty in an active the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire tissue. An alraumatic chest neceite at the probably of oremove the pacing lead, permits exiting the pacing icad through the enains in the body, except the silicone rubber disc in case of atrial application.

Packaging

The sterile packaging for the Model 6500 Unipolar Temporary Myocardial Pacing I he sterife packaging for the Model Coop Configuration. The inner pouch (or package liner) Lead consists of a dodoic pouch connigation. Tyvek - polyester/polyethylene laminate. The pouches are heat-sealed.

Intended Use

The is designed for temporary atrial and ventricular pacing and sensing for a The is designed for temporary attrails release. The device is supplied sterile and intended for single use only.

Technological Characteristics

The technology used with the Model 6500 Unipolar Temporary Myocardial The technology asoc with the Moderial characteristics as the predicate device.

Summary of Studies

Medtronic, Inc. performed system compatibility testing to support that the Model 6500 Unipolar Temporary Myocardial Pacing Lead is equivalent to the predicate device. Device testing included:

Environmental Conditioning

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Special 510 Model 6500 Unipolar Temporary Myocardia loder 6500 Umpolar Temporary ikyo ostantial Equivalence

Visual Verification .
Dimensional Testing .
Electrical Testing .
Mechanical Testing .

All system compatibility tests performed have demonstrated that the modified Model 6500 heartwire meets the specified requirements.

Sterilization Validation

The Model 6500 Unipolar Temporary Myocardial Pacing Lead is sterilized using a The Model 0300 Oxide (ETO) sterilization process. Processes appropriate for sterilizing the devices were validated.

Conclusion

Through data and information presented, numerous similarities support a I hrough data and micrination proseence, 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 6500 Unipolar Temporary Myocardial Pacing Lead is supported through this Special 510(k) Premarket Notification.

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Image /page/3/Picture/1 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 an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 4 2001

Ms. Tina L. Benoit Medtronic, Inc. Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K012452

Trade Name: Model 6500 Unipolar Temporary Myocardial 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 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 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,

Dore K. Miller

James E. Dillard II Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

KO12452 NA

Device Name:

Medtronic® Model 6500 Unipolar Temporary-Myocardial Pacing Lead

Indications For Use:

The Model 6500 Unipolar Temporary Myocardial Pacing I he Model 0500 Omporary atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. schsing for a concemplated in 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) 1 Over-The-Counter Use__ OR Prescription Use (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Deak Teth

Division of Cardiovascular & Respiratory Devices
510(k) Number K012452

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.