Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

K161249 · Medtronic · LDF · Aug 19, 2016 · Cardiovascular

Device Facts

• Record ID: K161249
• Device Name: Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
• Applicant: Medtronic
• Product Code: LDF · Cardiovascular
• Decision Date: Aug 19, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.3680
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary postsurgical 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 Story

The Streamline 6495 is a bipolar temporary myocardial pacing lead used for postsurgical cardiac pacing and sensing. The device consists of a coaxial conductor lead body with a distal ring electrode and a tip electrode, each crimped to a conductor and terminating in an atraumatic myocardial curved needle. A blue monofilament coil provides myocardial fixation. An atraumatic chest needle at the proximal end allows the lead to exit the chest wall, terminating in two breakaway connector pins. The device is used in a clinical setting by healthcare professionals. It is designed for short-term use (≤ 7 days); upon completion of therapy, the lead is removed via gentle traction, leaving no residual material in the body. The device facilitates temporary pacing to support cardiac function post-surgery.

Clinical Evidence

Bench testing only. Verification and validation testing for the shrink band material change included biocompatibility and manufacturability assessments, all of which passed.

Technological Characteristics

Bipolar temporary myocardial pacing lead; coaxial conductor lead body; distal ring and tip electrodes; myocardial curved needle; chest needle; breakaway connector pins; blue monofilament fixation coil. Materials include polyolefin shrink band. Sterile, single-use device.

Indications for Use

Indicated for temporary postsurgical atrial and ventricular pacing and sensing in patients requiring temporary cardiac pacing for 7 days or less.

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

• Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 19, 2016

Medtronic Debra Taitague Regulatory Affairs Specialist 1801 East Deere Ave Santa Ana, California 92705

Re: K161249

Trade/Device Name: Streamline 6495 Bipolar Temporary Myocardial Pacing Lead Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: July 20, 2016 Received: July 21, 2016

Dear Debra Taitague:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

M.G. Willemann

for

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 (if known) K161249

#### Device Name

Streamline 6495 Bipolar Temporary Myocardial Pacing Lead

Indications for Use (Describe)

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary postsurgical 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.

Type of Use (Select one or both, as applicable)

| <label> <input checked="checked" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) </label> |
|----------------------------------------------------------------------------------------------------------------|
| <label> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </label> |

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# 7.0 510(k) Summary

| Date Prepared: | May 02, 2016 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic<br>Medtronic Heart Valve Division<br>1851 East Deere Ave<br>Santa Ana, CA 92705 |
| Contact Person: | Debra Taitague<br>Regulatory Affairs Specialist<br>Medtronic<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br>Alternate Contact<br>Donna Saito<br>Sr. Regulatory Affairs Manager<br>Medtronic<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Trade Name: | Streamline 6495 Bipolar Temporary Myocardial Pacing<br>Lead Electrode |
| Classification Name: | Temporary Pacing Lead |
| Regulation Number: | 21 CFR 870.3680(a) |
| Product Classification: | Class II |
| Product Code: | LDF |
| Name of Predicate<br>Device | Streamline 6495 Bipolar Temporary Myocardial Pacing Lead |

## Device Description

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead (see Figure 1) which contains a distal, discrete, ring electrode (1), a discrete, tip electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto a conductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.

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Terminated on the back of the chest needle are two breakaway connector pins (6). To remove the pacing lead, gentle traction should be applied. No part of the lead remains in the body.

Image /page/4/Figure/1 description: The image shows a medical device with several labeled components. The components include a ring electrode labeled as 1, a tip electrode labeled as 2, and a coaxial conductor lead body labeled as 3. Additionally, there is a curved needle labeled as 4, a chest needle labeled as 5, and breakaway connector pins labeled as 6.

Figure 1: Model 6465

### Indication for Use

The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary postsurgical 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.

## Contraindications

There are no known general contraindications to temporary postsurgical pacing. The particular medical condition and anatomy of the patient, however, may dictate the lead system and implantation procedure to be used.

# Comparison to Predicate Device

A comparison of the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is being made to the current marketed predicate device: the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead and listed below indicates the following similarities:

- Intended Use: The intended use is the same as the predicate
- Performance: The performance is substantially equivalent to the predicate device.
- Principles of Operation and Technology: The principles of operation are the same as the o predicate device.
- . Design: The overall design is the same as the predicate features

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- o Materials: The material types used are the same as the predicate
# Description of Change

The purpose of this Premarket notification submission is to notify FDA of the proposed material change made to the formulation of the shrink band material. The current supplier, Vesta Thermoplastic Division informed Medtronic that their raw material supplier will no longer provide them with the raw material resins.

# Summary of Testing

Testing has demonstrated that the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is substantially equivalent to the predicate. Presented in Table 7-1 are the tests conducted:

Table 7-1: Tests conducted

| Component | Base Material Change | Verification Validation | Results |
|-------------|----------------------|-------------------------|---------|
| Shrink Band | Current: Polyolefin | Biocompatibility | Passed |
| | Proposed: Polyolefin | Manufacturability | Passed |

# Conclusion

The data included in this submission is sufficient in providing reasonable assurance of the safety and effectiveness of the device and the Streamline 6495 Bipolar Temporary Myocardial Pacing lead is substantially equivalent to the legally marketed predicate device, the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead.