The Medtronic Model 4951M Myocardial, IS-1 Unipolar Lead is designed for pacing and sensing in either the atrium or ventricle. The lead has application where an implantable atrial, ventricular or dual-chamber pacing system is indicated.

Device Description

The lead features a platinized electrode that can be secured to the heart by gently pushing the barbed tip into the epicardium and securing it in myocardial tissue. Suture holes in the polyurethane base pad are provided for greater security. A polyester mesh allows for fibrous ingrowth for additional fixation. The lead also features an MP35N nickel alloy conductor, polyurethane insulation, and an IS-1 Unipolar (UNI) lead connector.

AI/ML Overview

This document is a 510(k) summary for a medical device lead, which assesses its substantial equivalence to a predicate device. It doesn't contain information about machine learning algorithms, AI performance, or studies with acceptance criteria comparing device performance against specific metrics using expert-derived ground truth.

Therefore, most of the requested information cannot be extracted from the provided text. The document focuses on regulatory approval based on similarity to an existing device, rather than a performance study involving AI or complex statistical analysis against defined acceptance criteria.

Here's a breakdown of what can be inferred or stated as unavailable based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on showing the modified device's characteristics are substantially equivalent to a previously cleared predicate device, rather than setting and meeting specific performance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no described test set of data (in the context of AI/ML) is mentioned. The "Summary of Studies" refers to bench tests and material characterization, not performance on a data set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there is no mention of a test set requiring expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there is no mention of a test set.
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 document pertains to a physical medical device (a lead), not an AI-assisted diagnostic or interpretative system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document pertains to a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The document describes bench testing and material characterization for a physical device, not an AI/ML algorithm requiring ground truth annotation.
8. The sample size for the training set: Not applicable. No training set for an algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable. No training set or ground truth for a training set is mentioned.

What the document does describe in terms of "studies" and "equivalence":

Summary of Studies: "Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M."
- This indicates that bench testing and material characterization were performed. However, specific acceptance criteria or performance numbers from these tests are not provided in this summary. The "qualification by similarity" implies that the new material performed equivalently to a previously validated material, but the details of that equivalence are not here.
Predicate Device: The predicate device is "the currently market released Model 4951M Lead." This means the current submission is for a modified version of an already approved device.
Technological Characteristics: "The technology used with the Model 4951M Lead has is the same technological characteristics as the predicate device."
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."

In essence, this is a regulatory document focused on demonstrating that minor modifications to an existing device do not change its fundamental nature or intended use, thereby justifying approval via the Special 510(k) pathway. It does not provide the kind of performance data with acceptance criteria that would be found in a study for an AI/ML device.

Summary

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K031210

Special 510(k) Premarket Notification Attachment C: 510(k) Summary of Substantial Equivalence Model 4951M Lead

MAY 1 6 2003

ATTACHMENT C 510(K) SUMMARY OF SUBSTANTIAL EQUIVALENCE

Submitter

Medtronic, Inc. 7000 Central Avenue N.E. Minneapolis, MN 55432

Contact: Tina Benoit, Regulatory Affairs Specialist Telephone: (763) 514-4112 (763) 514-6424 Fax: E-Mail: tina.benoit@medtronic.com

Date Prepared: April 15, 2003

Name of Device

Device Name:	Medtronic® Model 4951M Myocardial, UnipolarLead
Device Classification	Cardiovascular Permanent Pacemaker ElectrodeClass III, 21 CFR, Part 870.3680
Classification Panel	Cardiovascular
Product Code:	DTB

Image /page/0/Picture/11 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" in bold, black letters. To the right of the word "Medtronic" is the word "Confidential" in a smaller, non-bold font.

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Predicate Devices

The predicate device for the Model 4951M Lead is the currently market released Model 4951M Lead.

Device Description

Intended Use

Technological Characteristics

The technology used with the Model 4951M Lead has is the same technological characteristics as the predicate device.

Summary of Studies

Based on the bench test results for lead Model 4073 and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as a strain relief material in Model 4951M.

Image /page/1/Picture/13 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image of a person inside of a circle. The word "Medtronic" is written in a bold, sans-serif font.

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Packaging

The packaging configuration of the modified Model 4951M Myocardial Unipolar Lead has not changed from the market released configuration of the Model 4951 M Myocardial Unipolar Lead (510(k) Document Control Number K894040, cleared 07/14/89, and K913288, cleared 10/17/91).

Sterilization Validation

The Model 4951M Lead is sterilized using a 100% Ethylenc Oxide (EtO) sterilization process.

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 4951M Lead is supported through this Special 510(k) Premarket Notification.

Image /page/2/Picture/8 description: The image shows the Medtronic logo and the word "Confidential" to the right of the logo. The Medtronic logo consists of a stylized human figure inside a circle with radiating lines. The word "Medtronic" is in a bold, sans-serif font. The word "Confidential" is in a smaller, lighter font.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

Food and Druci Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 6 2003

Medtronic, Inc. c/o Ms. Tina Benoit Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432

Re: K031210

Trade Name: Medtronic® Model 4951M Myocardial, Unipolar Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular permanent or temporary pacemaker electrode Regulatory Class: Class III (three) Product Code: DTB Dated: April 16, 2003 Received: April 17, 2003

Dear Ms. Benoit:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Tina Benoit

or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,

N. Oelletuh

Bram D. Zuckerman, M.D Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (ifknown):	K031210
Device Name:	Medtronic® Model 4951M Myocardial, Unipolar Lead
Indications For Use:	The Medtronic Model 4951M Myocardial, IS-1 UnipolarLead is designed for pacing and sensing in either theatrium or ventricle. The lead has application where animplantable atrial, ventricular or dual-chamber pacingsystem is indicated.

(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_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Kacatur

510(k)

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.