MODEL 4951M MYOCARDIAL UNIPOLAR LEAD

K031210 · Metronic, Inc. · DTB · May 16, 2003 · Cardiovascular

Device Facts

• Record ID: K031210
• Device Name: MODEL 4951M MYOCARDIAL UNIPOLAR LEAD
• Applicant: Metronic, Inc.
• Product Code: DTB · Cardiovascular
• Decision Date: May 16, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

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 Story

Medtronic Model 4951M is an epicardial, unipolar pacing lead designed for atrial or ventricular sensing and pacing. The lead features a platinized electrode with a barbed tip for myocardial fixation, a polyurethane base pad with suture holes, and a polyester mesh for fibrous ingrowth. It utilizes an MP35N nickel alloy conductor and IS-1 unipolar connector. The device is implanted by a physician to provide electrical connection between the heart tissue and an implantable pulse generator. It functions as a passive component of a pacing system to deliver therapeutic electrical pulses to the heart and transmit cardiac signals to the pulse generator. Two leads may be used for bipolar pacing configurations.

Clinical Evidence

Bench testing only. Evidence includes material characterization and biocompatibility testing for the MED-4719 strain relief material, qualified by similarity to Model 4073 lead testing.

Technological Characteristics

Epicardial unipolar lead; platinized electrode; MP35N nickel alloy conductor; polyurethane insulation; polyester mesh for fixation; IS-1 unipolar connector. Sterilization: 100% Ethylene Oxide (EtO).

Indications for Use

Indicated for patients requiring pacing and sensing in the atrium or ventricle as part of an implantable atrial, ventricular, or dual-chamber pacing system.

Regulatory Classification

Identification

Temporary pacemaker electrode: A device consisting of flexible insulated electrical conductors with one end connected to an external 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. Permanent pacemaker electrode: 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.

Predicate Devices

• Model 4951M Lead (K894040)
• Model 4951M Lead (K913288)

Reference Devices

• Model 4073 Lead

Submission Summary (Full Text)

{0}------------------------------------------------

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: [phone] [phone] Fax: E-Mail: [e-mail]

Date Prepared: April 15, 2003

### Name of Device

| Device Name: | Medtronic® Model 4951M Myocardial, Unipolar<br>Lead |
|-----------------------|----------------------------------------------------------------------------------|
| Device Classification | Cardiovascular Permanent Pacemaker Electrode<br>Class 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.

{1}------------------------------------------------

## Predicate Devices

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

### Device Description

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. Two leads may be used for bipolar pacing.

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.

#### Intended Use

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.

#### 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.

{2}------------------------------------------------

### 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.

{3}------------------------------------------------

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

{4}------------------------------------------------

#### 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 [phone]. 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 [phone] or [phone] 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

{5}------------------------------------------------

# INDICATIONS FOR USE

| 510(k) Number (if<br>known): | K031210 |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medtronic® Model 4951M Myocardial, Unipolar Lead |
| Indications For Use: | The Medtronic Model 4951M Myocardial, IS-1 Unipolar<br>Lead is designed for pacing and sensing in either the<br>atrium or ventricle. The lead has application where an<br>implantable atrial, ventricular or dual-chamber pacing<br>system 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)

OR

Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Kacatur

510(k)