(130 days)
Not Found
No
The description focuses on the physical components and mechanical function of temporary pacing leads and wires, with no mention of AI or ML capabilities.
Yes
The device is used to treat an irregular heartbeat by providing electrical stimulation to the heart, which is a therapeutic function.
No
The device is described as providing "electrical stimulation to the heart" to "treat an irregular heartbeat," which indicates a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines physical components like lead bodies, electrodes, fixation coils, and needles, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Streamline temporary leads and wires are implanted devices that provide electrical stimulation directly to the heart. They are used to treat an irregular heartbeat by interacting with the heart tissue itself, not by analyzing a sample taken from the body.
- Intended Use: The intended use clearly states that the device "treat an irregular heartbeat... by providing electrical stimulation to the heart." This is a therapeutic intervention, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components of the lead and how it is secured within the myocardium. This aligns with an implanted medical device, not an in vitro diagnostic.
Therefore, the Streamline temporary leads and wires fall under the category of an implanted medical device used for therapeutic purposes, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.
- Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use.
- Model 6492 is intended for atrial use only.
- Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).
Product codes
LDF
Device Description
Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proximal segment. The distal segment has a separate electrode. A polypropylene monofilament (PP) fixation coil (except for model 6494) extends from the distal electrode end and is attached to a small, curved needle. The curved needle creates a channel in the myocardium for embedding the electrode. The PP fixation coil provides a means of securing the electrode in place. The proximal lead body terminates into a chest needle used to penetrate the chest wall, followed by pulling the proximal portion of the lead through the chest. The device is supplied sterile and intended for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart, chest wall
Indicated Patient Age Range
pediatric patient (specifically for Model 6491)
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
RF Heat assessment per ASTMF2192-19e2 at 64MHz (1.5T) and at 123MHz (3T).
Force and Torques in a 3.0 T GE Discovery MR750 whole-body MR system per test method described in ASTM F2052-15w.
Imaging artifact assessment was not tested as it was determined that only the head and lower extremities may be imaged therefore, there is limited to no risk of the lead to cause image artifacts in the scans.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3680 Cardiovascular permanent or temporary pacemaker electrode.
(a)
Temporary pacemaker electrode —(1)Identification. A temporary pacemaker electrode is a device consisting of flexible insulated electrical conductors with one end connected to anexternal 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.(2)
Classification. Class II (performance standards).(b)
Permanent pacemaker electrode —(1)Identification. A permanent pacemaker electrode is 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.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before October 4, 2012, for any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976, or that has, on or before October 4, 2012, been found to be substantially equivalent to any permanent pacemaker electrode device that was in commercial distribution before May 28, 1976. Any other pacemaker repair or replacement material device shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 17, 2025
Medtronic Inc Cynthia Zerfass Principal Regulatory Affairs Specialist 1851 E. Deere Avenue Santa Ana, CA 92705
Re: K242705
Trade/Device Name: Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492) Streamline Unipolar Temporary Myocardial Pacing Wire (6494) Streamline Bipolar Temporary Myocardial Pacing Lead (6495) Streamline Unipolar Temporary Myocardial Pacing Lead (6500) Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent Or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: December 18, 2024 Received: December 18, 2024
Dear Cynthia Zerfass:
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 (the 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 available 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
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory
2
assistance/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,
Digitally signed
Sara M. by Sara M. Royce
-S
Royce -S Date: 2025.01.17
12:53:31 -05'00'
Sara Royce Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
Device Name
Streamline Unipolar Pediatric Temporary Pacing Lead (6491) Streamline Unipolar Temporary Atrial Pacing Lead (6492)
Streamline Unipolar Temporary Myocardial Pacing Wire (6494)
Streamline Bipolar Temporary Myocardial Pacing Lead (6495)
Streamline Unipolar Temporary Myocardial Pacing Lead (6500)
Indications for Use (Describe)
Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.
- · Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use.
- · Model 6492 is intended for atrial use only.
· Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).
Type of Use (Select one or both. as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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
"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."
4
510(k) Summary
| Date Prepared: | January 16, 2025 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Heart Valve Division | |
| 1851 East Deere Ave | |
| Santa Ana, CA 92705 | |
| Establishment Registration Number: 2135394 | |
| Contact: | Cindy Zerfass |
| Principal Regulatory Affairs Specialist | |
| Medtronic Heart Valve Division | |
| Email: cynthia.e.zerfass@medtronic.com | |
| Alternate Contact: | Zach Larsen |
Regulatory Affairs Manager Medtronic Heart Valve Division
Email: zach.s.larsen@medtronic.com
Device Name
| Trade Name | Streamline™ Temporary Pacing Leads and Wire |
|---|---|
| Common Name | Heartwires |
Device Classification
| Classification | |
|---|---|
| Regulation Number | 21 CFR 870.3680 |
| Classification Panel | Cardiovascular |
| Product Code | LDF |
Predicate Device Information
| Model | Description | Predicate 510(k) |
|---|---|---|
| 6491 | Unipolar Pediatric Temporary Pacing Lead | K190716 |
| 6492 | Unipolar Temporary Atrial Pacing Lead | K190716 |
| 6494 | Unipolar Temporary Pacing Wire | K190716 |
| 6495 | Bipolar Temporary Myocardial Pacing Lead | K190716 |
| 6500 | Unipolar Temporary Myocardial Pacing Lead | K171253 |
5
Device Description
Each Streamline temporary pacing lead or wire comprises a lead body with a distal and a proximal segment. The distal segment has a separate electrode. A polypropylene monofilament (PP) fixation coil (except for model 6494) extends from the distal electrode end and is attached to a small, curved needle. The curved needle creates a channel in the myocardium for embedding the electrode. The PP fixation coil provides a means of securing the electrode in place. The proximal lead body terminates into a chest needle used to penetrate the chest wall, followed by pulling the proximal portion of the lead through the chest. The device is supplied sterile and intended for single use only.
Principle of Operation
Arrhythmias can occur following cardiac surgery. When a patient's not in sinus rhythm, cardiac output is not optimal, putting the patient's life at risk.
All temporary pacing leads are intended for temporary atrial and/or ventricular pacing and sensing for a contemplated implant duration of 7 days or fewer. They are designed to pace and sense the heart during and after cardiac surgery compatible with Medtronic's external pacing systems (EPG).
Description of Change
This Special 510(K) aims to notify the FDA of the language related to the Magnetic Resonance Imaging (MRI) condition added to the IFU. All models of the Streamline family products were tested in a nonclinical environment and deemed MR Conditional. Other changes were made to the IFU, which entailed rewording the Indication for Use, Contraindications, and Warnings, with no change to the intent.
Indication for Use
Streamline temporary leads and wires treat an irregular heartbeat during or after cardiac surgery by providing electrical stimulation to the heart.
- Models 6491, 6494, 6495, and 6500 are intended for atrial and ventricular use. ●
- Model 6492 is intended for atrial use only. .
- . Model 6491 and Model 6492 have smaller chest fixation coils and are appropriate for use in thin heart tissue and, in the case of Model 6491, a smaller chest cavity (for example, in a pediatric patient).
Contraindications
There are no known general contraindications to temporary postsurgical pacing. The cardiac surgeon determines the pacing system to be used on the patient medical condition and anatomy
Comparison to Predicate Devices
Streamline Temporary Pacing Leads and wire have the following similarities to the predicate devices that have received FDA clearance: K190716 and K171253.
- . Same intended use/indications for all devices in scope
- The same finished device operating principle for all devices in scope
- All Models are packaged using the same materials and sterilized via EtO.
6
Summary of Testing
Each Streamline Model was tested in two configurations bundled and extended and assessed as follows:
- RF Heat assessment per ASTMF2192-19e2 at 64MHz (1.5T) and at 123MHz (3T) .
- . Force and Torques in a 3.0 T GE Discovery MR750 whole-body MR system per test method described in ASTM F2052-15w
- Imaging artifact assessment was not tested as it was determined that only the head ● and lower extremities may be imaged therefore, there is limited to no risk of the lead to cause image artifacts in the scans.
Conclusion
The nonclinical MRI testing and calculations support that the Streamline family of products is MR Conditional and can be scanned safely under the following conditions:
The following table is included in the IFU.
Magnetic Resonance Imaging (MRI) safety information
Image /page/6/Picture/9 description: The image shows a black triangle with the letters "MR" in bold black font inside of it. The triangle is equilateral and the letters are centered within the triangle. The image is simple and the contrast between the black triangle and the white background makes it easy to see.
A patient with a Medtronic Streamline pacing lead or wire may be safely scanned under the following conditions. Failure to follow these conditions may result in injury to the patient.
| Name /Identification of the device | 6491, 6492, 6494, 6495, 6500 |
|---|---|
| Nominal value(s) of static magnetic field [T] | 1.5T or 3.0T |
| Maximum spatial field gradient [T/m] | 20 T/m |
| RF excitation | Circularly polarized or multichannel |
| RF transmit coil type | RF head transmit coil or lower extremity transmit coil. RF body transmit coil is contraindicated. |
| Operating Mode | Normal Operating Mode |
| Maximum head SAR | 3.2 W/kg |
| Scan duration | There is no limit on scan duration. |
| Scan region | Head or lower extremity only |
| MR Image artifact | The Streamline pacing leads are not implanted in the head or lower extremity and therefore will not produce an image artifact. |
| Additional instructions or information essential for safe use in the MR environment | Before an MR exam, disconnect the connector pin from the pulse generator. The pulse generator is unsafe in a MR environment. MR exams are contraindicated for patients who remain dependent on pacing. |
| When a patient undergoes an MR scan, the connector pins must be inserted into the pin protectors (Chapter 6, step 6c), with the excess lead coiled. The pin protectors and the coiled lead must be taped to an area of the patient's skin (Chapter 6, step 7), such as to the patient's chest. | |
| If information about a specific parameter is not included, there are no conditions associated with the parameter. |