MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626

K022238 · Medtronic Vascular · DWS · Oct 9, 2002 · Cardiovascular

Device Facts

• Record ID: K022238
• Device Name: MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626
• Applicant: Medtronic Vascular
• Product Code: DWS · Cardiovascular
• Decision Date: Oct 9, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4500
• Device Class: Class 1

Intended Use

The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

Device Story

Manual surgical instrument; facilitates placement and manipulation of Model 5071 myocardial pacing lead. Components: handle, malleable shaft, lead hub fixation assembly (tongs). Operation: spring-loaded button actuator controls lead grasping/release; thumbwheel provides shaft/lead rotation. Used by clinicians during lead implantation procedures. Benefits: assists in precise lead positioning.

Clinical Evidence

Bench testing only. In vitro studies included visual examination, grabber insertion/removal, grabber rotation, lead fixation/removal, shaft rotation, shaft flexibility, and mechanical testing of tong retention, actuator button, and retainer retention.

Technological Characteristics

Manual surgical instrument; malleable shaft; spring-loaded actuator; thumbwheel rotation mechanism. Single-use. No electronic components or software.

Indications for Use

Indicated for facilitating myocardial pacing lead placement and manipulation of the Model 5071 myocardial pacing lead. No contraindications reported.

Regulatory Classification

Identification

Cardiovascular surgical instruments are surgical instruments that have special features for use in cardiovascular surgery. These devices include, e.g., forceps, retractors, and scissors.

Predicate Devices

• Implant tool currently packaged with the Model 5071 lead

Reference Devices

• Model 5071 myocardial pacing lead

Submission Summary (Full Text)

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

Medtronic Model 10626 Myocardial Implant To

OCT 0 9 2002

# 510(k) SUMMARY

| Date Prepared: | July 10, 2002 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Medtronic, Inc.<br>7000 Central Ave. N.E.<br>Minneapolis, MN 55432 |
| Contact: | Mary Ellen Best<br>Senior Product Regulation Manager<br>Telephone: [phone]<br>Facsimile: [phone]<br>E-mail: [e-mail] |
| Trade / Proprietary Name: | Medtronic Model 10626 Myocardial Implant Tool |
| Common Name: | Myocardial Pacing Lead (Accessory) |
| Device Classification: | I |
| Product Code: | DWS |

#### Device Description

The implant tool consists of a handle, malleable shaft and lead hub fixation assembly (tongs) which grab and release a Model 5071 lead when the springloaded button actuator is depressed and released. The handle assembly includes a rotable, thumbwheel. Rotation of this thumbwheel in a clockwise direction results in equivalent rotation of a lead hub fixation assembly located at the distal end of the tool. Depression of the actuator allows fixation to the Model 5071 lead and also activates the fixation release upon completion of implant. Release of the actuator activates the fixation of the tool to the Model 5071 lead.

#### Indications for Use

The Myocardial Implant Tool is a single use device, intended to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead.

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

### Substantially Equivalent Device

The Model 10626 Myocardial Lead Implant Tool has the same intended use as the implant tool that is currently packaged with the Model 5071 lead. The technological differences between the Model 10626 and the predicate implant tool have been sufficiently evaluated to determine that these technological differences do not diminish the safety or effectiveness of the device.

#### Summary of Studies

Medtronic has thoroughly evaluated the Myocardial Lead Implant Tool. Model 10626 through in vitro testing to assure suitability for its intended used. Testing was performed on tools built according to a documented process and subjected to environmental conditioning.

In vitro testing includes:

- Visual Examination
- Grabber Insertion/Removal
- Grabber Rotation
- Lead Fixation / Removal
- Shaft Rotation
- Shaft Flexibility
- Mechanical testing of tong retention, actuator button, and retainer retention

The Model 10626 meets the requirements of the product specification as defined by Medtronic.

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a bird or eagle in flight, composed of three curved lines. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 0 9 2002

Medtronic, Inc. c/o Mary Ellen Best Principle Regulatory Affairs Specialist Cardiac Rhythm Management 7000 Central Avenue NE Minneapolis, MN 55432

Re: K022238

Trade Name: Model 10626 Myocardial Lead Implant Tool Regulation Number: 21 CFR 870.4500 Regulation Name: Cardiovascular Surgical Instrument Regulatory Class: Class I (one) Product Code: DWS Dated: July 10, 2002 Received: July 11, 2002

#### Dear Ms. Best:

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. Iisting 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.

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

Page 2 -- Ms. Mary Ellen Best

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 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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), 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,

Oalk Ten
Bram D. Zuckerman, M.D.

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

Enclosure

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

510(k) Premarket Notification INDICATIONS FOR USE

## INDICATIONS FOR USE

| 510(k) Number (if known): | N/A |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Model 10626 Myocardial Lead Implant Tool |
| Indications For Use: | The Medtronic Model 10626 Myocardial Implant Tool is used to facilitate myocardial pacing lead placement. It is designed to assist in the placement and manipulation of the Model 5071 myocardial pacing lead. |
| Contraindications: | None |

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="text-decoration: line-through; font-size: 2em;">X</span> </div> |
|------------------------------------------|------------------------------------------------------------------------------------|
|------------------------------------------|------------------------------------------------------------------------------------|

OR

| Over-The-Counter Use | |
|----------------------|--|
|----------------------|--|

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K022238 |

(Optional Format 1-2-96)Production of the