Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead
Device Facts
| Record ID | K190716 |
|---|---|
| Device Name | Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, Streamline 6495 Unipolar Temporary Myocardial Pacing Lead |
| Applicant | Medtronic |
| Product Code | LDF · Cardiovascular |
| Decision Date | Aug 8, 2019 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.3680 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Pediatric |
Intended Use
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended 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 is intended for SINGLE USE ONLY. The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY. The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended 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 is intended for SINGLE USE ONLY. The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended 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 is intended for SINGLE USE ONLY.
Device Story
Streamline temporary pacing leads (Models 6491, 6492, 6494, 6495) are sterile, single-use devices for temporary postsurgical cardiac pacing and sensing. Leads are implanted in myocardial tissue via an atraumatic curved needle; proximal ends exit the chest wall via a chest needle. Models 6491, 6492, and 6495 utilize a blue monofilament coil for fixation; Model 6494 uses stripped wire ends. Model 6495 is bipolar with discrete tip and ring electrodes; others are unipolar. Leads connect to an external pulse generator to deliver pacing therapy. Used in clinical settings by healthcare providers to manage post-surgical cardiac rhythm. No part of the device remains in the body after removal via gentle traction.
Clinical Evidence
Bench testing only. No clinical data was required or provided. Performance was verified through biocompatibility, component qualification, design verification, and shelf-life testing to confirm the modified polyethylene insulation material meets specifications.
Technological Characteristics
Temporary pacing leads featuring insulated multi-filament conductors, myocardial curved needles, and chest needles. Materials include polyethylene (PE) insulation. Bipolar model (6495) includes discrete tip and ring electrodes and coaxial conductor body. Sterilized, single-use. Connectivity via breakaway connector pins to external pulse generators.
Indications for Use
Indicated for temporary postsurgical atrial and ventricular pacing and sensing in patients requiring temporary cardiac pacing for 7 days or less. No specific age or gender restrictions beyond pediatric/general patient population suitability.
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
- Unipolar Pediatric Temporary Pacing Lead (K171253)
- Unipolar Temporary Atrial Pacing Lead (K171253)
- Unipolar Temporary Myocardial Pacing Wire (K140972)
- Bipolar Temporary Myocardial Pacing Lead (K171253)
Related Devices
- K140972 — UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, UNIPOLAR TEMPORARY ATRIAL PACING LEAD, UNIPOLAR TEMPORARY MYOCARDIAL PACING · Medtronic, Inc. · Jun 6, 2014
- K171253 — Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Pacing Lead, Streamline 6495 Bipolar Temporary Myocardial Pacing Lead, Streamline 6500 Unipolar Temporary Myocardial Pacing Lead · Medtronic · May 25, 2017
- K161249 — Streamline 6495 Bipolar Temporary Myocardial Pacing Lead · Medtronic · Aug 19, 2016
- K963898 — MODEL 6495 BIPOLAR TEMPORARY PACING LEAD · Medtronic Vascular · Jul 22, 1997
- K012460 — MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD · Medtronic Vascular · Aug 14, 2001
Submission Summary (Full Text)
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.
August 8, 2019
Medtronic Joven Almazan Regulatory Affairs Specialist 1851 East Deere Ave. Santa Ana, California 92705
Re: K190716
Trade/Device Name: Streamline 6491 Unipolar Pediatric Temporary Pacing Lead, Streamline 6492 Unipolar Temporary Atrial Pacing Lead, Streamline 6494 Unipolar Temporary Myocardial Pacing Wire, 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 9, 2019 Received: July 10, 2019
Dear Joven Almazan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
{1}------------------------------------------------
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Paulsen Implantable Electrophysiology Devices Team Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
### Indications for Use
510(k) Number (if known) K190716
Device Name Streamline Temporary Pacing Leads
Indications for Use (Describe)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended 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 is intended for SINGLE USE ONLY.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and is intended for SINGLE USE ONLY
The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended 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 is intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended 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 is intended for SINGLE USE ONLY.
| Type of Use (Select one or both, as applicable) | <span> <span style="padding-right: 20px;"> <b>[X]</b> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[PRAStaff@fda.hhs.gov](mailto:PRAStaff@fda.hhs.gov)
*"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."*
{3}------------------------------------------------
# 510(k) Summary
| Date Prepared: | April 12, 2019 |
|-------------------|----------------------------------------------------------------------------------------------------------------------------|
| Applicant: | Medtronic<br>Medtronic Heart Valves Division<br>1851 East Deere Ave<br>Santa Ana, CA 92705 |
| Contact Person: | Joven Almazan<br>Regulatory Affairs Specialist<br>Medtronic<br>Phone: (234) 248 4186<br>Email: joven.almazan@medtronic.com |
| Alternate Contact | Donna Saito<br>Sr. Regulatory Affairs Manager<br>Medtronic<br>Phone: (949) 399 1675<br>Email: donna.y.saito@medtronic.com |
| Trade Name: | Streamline™1 Temporary Pacing Leads |
|-------------------------|-------------------------------------|
| Classification Name: | Temporary Pacing Lead |
| Regulation Number: | 21 CFR 870.3680(a) |
| Product Classification: | Class II |
| Product Code: | LDF |
| Predicate Devices | Model | Product Name |
|-------------------|-------|-------------------------------------------|
| K171253 | 6491 | Unipolar Pediatric Temporary Pacing Lead |
| K171253 | 6492 | Unipolar Temporary Atrial Pacing Lead |
| K140972 | 6494 | Unipolar Temporary Myocardial Pacing Wire |
| K171253 | 6495 | Bipolar Temporary Myocardial Pacing Lead |
The trademark name Streamline™ mentioned throughout the document represents the temporary pacing lead 1 product family Models; 6491, 6492, 6494, and 6495.
{4}------------------------------------------------
#### 6.1 Device Descriptions
### Model 6491 Unipolar Pediatric Temporary Pacing Lead
The Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for use in both the atrium and the ventricle. The unipolar lead is comprised of a lead body with the distal and proximal segment.
The Model 6491 Unipolar Pediatric Temporary Pacing Lead (see Figure 6-1) consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together. A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. A curved atraumatic chest needle (5) at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall. To remove the pacing lead, gentle traction should be applied.
No part of the Medtronic Model 6491 Unipolar Pediatric Temporary Pacing Lead remains in the body.
Image /page/4/Figure/5 description: This image shows a diagram of a medical device with several labeled components. The diagram includes labels for the electrode (1), insulated multi-filament conductor (2), blue monofilament coil (3), curved needle (4), and chest needle (5). The device appears to be a type of catheter or probe used in medical procedures.
Figure 6-1: Model 6491
{5}------------------------------------------------
## Model 6492 Unipolar Temporary Atrial Pacing Lead
The Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for use in the atrium. The unipolar lead is comprised of a lead body with distal and proximal segments.
The Model 6492 Unipolar Temporary Atrial Pacing Lead (see Figure 6-2) consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together. A blue monofilament (3) proximally coiled for fixation of the lead is attached to the electrode and terminates distally 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. To remove the pacing lead, gentle traction should be applied.
No part of the Medtronic Model 6492 Unipolar Temporary Atrial Pacing Lead remains in the body.
Image /page/5/Figure/4 description: This image shows a medical device with several labeled parts. The device includes an electrode labeled as '1', an insulated multi-filament conductor labeled as '2', and a blue monofilament coil labeled as '3'. Additionally, there is a curved needle labeled as '4' and a chest needle labeled as '5'.
Figure 6-2: Model 6492
{6}------------------------------------------------
### Model 6494 Unipolar Temporary Myocardial Pacing Wire
The Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for use in both the atrium and the ventricle. The two leads are comprised of a lead body with distal and proximal segment.
The Model 6494 Unipolar Temporary Myocardial Pacing Wire (see Figure 6-3) consists of two insulated multi-filament wire (1). At one end of each wire has been stripped to have an electrode surface (2). This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle (3). An atraumatic chest needle (4) at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall. To remove the pacing wire, gentle traction should be applied.
No part of the Medtronic Model 6494 Unipolar Temporary Myocardial Pacing Wire remains in the body.
Image /page/6/Figure/4 description: This image shows a diagram of a medical device with several labeled components. The diagram includes an insulated multi-filament wire labeled as '1', an electrode surface labeled as '2', and a curved needle labeled as '3'. Additionally, there is a chest needle labeled as '4', indicating the device's potential use in chest-related medical procedures.
Figure 6-3: Model 6494
{7}------------------------------------------------
### Model 6495 Bipolar Temporary Myocardial Pacing Lead
The Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for use in both the atrium and the ventricle. The bipolar lead is comprised of a lead body with distal and proximal segments which includes the integrated bifurcated proximal lead connection.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multifilament lead (see Figure 6-4), 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). The curved needle is used to create a channel in the myocardium for embedding the electrodes. 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. Terminated on the back of the chest needle are two breakaway connector pins (6), which provide an attachment to an external pulse generator.
No part of the Medtronic Model 6495 Bipolar Temporary Myocardial Pacing Lead remains in the body.
Image /page/7/Figure/4 description: This image shows a diagram of the Model 6465, with labels pointing to different parts. The parts labeled are: Ring Electrode (1), Tip Electrode (2), Coaxial Conductor Lead Body (3), Curved Needle (4), Chest Needle (5), and Breakaway Connector Pins (6). The diagram shows the different components of the Model 6465 and how they are connected.
{8}------------------------------------------------
### 6.2 Intended Use
There were no changes to the intended use of the devices as related to the change proposed in the Traditional 510(k) notification. The current Indications for Use statements are noted below:
| Model | Indications for Use |
|-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6491 | The Model 6491 Unipolar Pediatric Temporary Pacing Lead is intended for temporary postsurgical<br>atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The<br>device is supplied sterile and is intended for SINGLE USE ONLY. |
| 6492 | The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgical<br>atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is<br>supplied sterile and is intended for SINGLE USE ONLY. |
| 6494 | The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporary<br>postsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days<br>or less. The device is supplied sterile and is intended for SINGLE USE ONLY. |
| 6495 | The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary postsurgical<br>atrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. The<br>device is supplied sterile and is intended for SINGLE USE ONLY. |
#### 6.3 Contraindications
The following contraindication statement is not changing and is applicable for all four (4) models presented in this Traditional 510(k).
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.
### 6.4 Comparison of the Predicate Device
A comparison of the Streamline family of products is being made to the currently marketed predicate devices:
Models 6491, 6492, 6495 510(k) # K171253 and 6494 510(k) #K140972 and indicate the following similarities:
- Same intended use/indications ●
- Same operating principle ●
- Same fundamental technological characteristics ●
- Same overall design, dimensions, and performance ●
- o All materials are the same except for the minor formulation change of the base polyethylene (PE) material used for the insulation coating of the wire; The insulated wire comes in three different colors (yellow, purple, and blue) and no changes are being made to the supplier, chemical compositions or to the concentrations of these colorants.
- Same packaging materials ●
- Same sterilization requirements
{9}------------------------------------------------
#### Summary of Performance Data 6.5
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required.
The following tests were conducted and the change to the PE base material successfully passed the acceptance criteria of the pre-established specifications. The new PE formulation is considered qualified for its intended use.
- Biocompatibility
- Component Qualification ●
- Design Verification ●
- Shelf Life ●
#### 6.6 Conclusion
In summary, the information included in this submission demonstrates that the changes made to the Streamline family of products are substantially equivalent to the legally marketed predicate versions.
