MODEL 5071 MYOCARDIAL PACING LEAD

K031274 · Medtronic Vascular · DTB · May 22, 2003 · Cardiovascular

Device Facts

• Record ID: K031274
• Device Name: MODEL 5071 MYOCARDIAL PACING LEAD
• Applicant: Medtronic Vascular
• Product Code: DTB · Cardiovascular
• Decision Date: May 22, 2003
• Decision: ST
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 3
• Attributes: Therapeutic

Intended Use

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.

Device Story

Sutureless, unipolar, myocardial, screw-in lead for ventricular pacing and sensing; secures to myocardium via two clockwise turns; polyester mesh facilitates fibrous ingrowth for fixation; eliminates need for stab wounds or sutures; MP35N nickel alloy conductor; silicone rubber insulation; IS-1 unipolar connector; used in conjunction with permanent pacing systems; implanted by physicians; provides electrical connection between pulse generator and heart tissue.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench test results for lead models 5568, 5024M, and 5524M, and material characterization/biocompatibility testing for MED-4719 insulation.

Technological Characteristics

Unipolar, screw-in myocardial lead; MP35N nickel alloy conductor; silicone rubber insulation; polyester mesh fixation; IS-1 unipolar connector; 100% Ethylene Oxide (EtO) sterilization.

Indications for Use

Indicated for patients requiring permanent ventricular or dual-chamber pacing systems for ventricular pacing and sensing.

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 5071 Lead (K902002, K915736)

Reference Devices

• Model 5568
• Model 5024M
• Model 5524M

Submission Summary (Full Text)

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K031274

Model 5071 Lead

### ATTACHMENT C MAY 22 2003 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] Fax: [phone] E-Mail: tina.benoit(a)medtronic.com

Date Prepared: April 21, 2003

#### Name of Device

| Device Name: | Medtronic® Model 5071 Myocardial Pacing Lead |
|------------------------|----------------------------------------------------------------------------------|
| Device Classification: | Cardiovascular Permanent Pacemaker Electrode<br>Class III, 21 CFR, Part 870.3680 |
| Classification Panel: | Cardiovascular |
| Product Code: | DTB |

#### Predicate Devices

The predicate device for the Model 5071 Lead is the currently market released Model 5071 Lead.

Image /page/0/Picture/12 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized human figure inside a circle. The text "Medtronic" is in a bold, sans-serif font. The word "Confidential" is in a smaller, regular font.

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#### Device Description

The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated. Two leads may be used for bipolar pacing

The lead's screw-in electrode is designed to be secured to the myocardium with two clockwise turns. A polyester mesh allows fibrous ingrowth for additional fixation.

The lead requires no stab wounds or sutures for electrode placement and fixation. Tissue damage from electrode insertion may be compared to the insertion of a 15guage needle.

The lead features a MP35N nickel alloy conductor, silicone rubber insulation, and an IS-1 Unipolar (UNI) lead connector.

#### Packaging

The packaging configuration of the modified Model 5071 Lead has not changed from the market release configuration of the Model 5071 Lead (510(k) Document Control Number K902002, cleared 09/26/90, and K915736, cleared 12/03/92).

#### Intended Use

The Medtronic Model 5071 sutureless. unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are indicated.

#### Technological Characteristics

The technology used with the Model 5071 Lead has is the same technological characteristics as the predicate device.

#### Summary of Studies

Based on the bench test results for lead Models 5568, 5024M, and 5524M and the MED-4719 material characterization and biocompatibility testing, MED-4719 was qualified by similarity as an insulation material in Model 5071.

Image /page/1/Picture/15 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. To the left of the word is a circular graphic with lines and shapes inside. To the right of the word "Medtronic" is the word "Confidential" in a smaller, lighter font.

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### Sterilization Validation

The Model 5071 Lead is sterilized using a 100% Ethylene 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 5071 Lead is supported through this Special 510(k) Premarket Notification.

Tma D Benoit

Tina L. Benoit Regulatory Affairs Specialist Medtronic. Inc.

Image /page/2/Picture/8 description: The image shows the Medtronic logo and the word "Confidential" in black font. The Medtronic logo is on the left side of the image. The word "Confidential" is on the right side of the image. The font is bold and easy to read.

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## INDICATIONS FOR USE

| 510(k) Number (if<br>known): | K031274 |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medtronic† Model 5071 Myocardial Pacing Lead |
| Indications For Use: | The Medtronic Model 5071 sutureless, unipolar,<br>myocardial, screw-in lead is designed for ventricular<br>pacing and sensing. The lead has application where<br>permanent ventricular or dual-chamber pacing systems are<br>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)

Image /page/3/Picture/9 description: The image shows the Medtronic logo with the word "Confidential" next to it. The Medtronic logo consists of a stylized image on the left and the word "Medtronic" in bold, black letters. The word "Confidential" is in a smaller font size and is located to the right of the Medtronic logo. The image is likely a header or footer from a document.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 22 2003

Medtronic, Inc. c/o Ms. Tina L. Benoit Regulatory Affairs Specialist 7000 Central Avenue NE Minneapolis, MN 55432-3576

Re: K031274

Trade Name: Model 5071 Myocardial Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Pacemaker leads Regulatory Class: Class III (three) Product Code: DTB Dated: April 17, 2003 Received: April 23, 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 L. 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]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Bram D. Zuckerman, M.D.
Director

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 (if known): | K031274 |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Medtronic® Model 5071 Myocardial Pacing Lead |
| Indications For Use: | The Medtronic Model 5071 sutureless, unipolar, myocardial, screw-in lead is designed for ventricular pacing and sensing. The lead has application where permanent ventricular or dual-chamber pacing systems are 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 1-2-95) Delbert Th

51

Confidential

12