(27 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and basic electrical function of temporary pacing leads, with no mention of AI/ML capabilities or data processing beyond basic sensing.
Yes.
The device is intended for temporary post-surgical atrial and ventricular pacing and sensing, which acts as a therapeutic intervention for heart rhythm issues.
No
Explanation: The device is described as a temporary pacing lead designed for "pacing and sensing" to provide electrical stimulation to the heart (pacing). While it does "sense" cardiac activity, its primary intended use is to deliver therapy (pacing), not to diagnose a condition. The information provided focuses on its use for temporary post-surgical pacing rather than diagnosing a disease.
No
The device description clearly details physical components like lead bodies, electrodes, conductors, needles, and connector pins, indicating it is a hardware device. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The described devices are temporary pacing leads designed to be implanted directly into the myocardium (heart muscle) to provide electrical stimulation for pacing and sensing. They are used in vivo (within the living body), not in vitro (in a test tube or laboratory setting).
- Intended Use: The intended use clearly states "temporary post-surgical atrial and ventricular pacing and sensing." This is a therapeutic and monitoring function performed directly on the patient.
- Device Description: The description details the physical components of the leads and how they are implanted and used within the body.
Therefore, these temporary pacing leads fall under the category of implantable medical devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical 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.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical 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 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY
Product codes (comma separated list FDA assigned to the subject device)
LDF
Device Description
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 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 6491 Unipolar Pediatric Temporary Pacing Lead remains in the body.
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 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.
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, 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.
Model 6500 Unipolar Temporary Myocardial Pacing Lead: The Medtronic Model 6500 Unipolar Temporary Myocardial 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 6500 Unipolar Temporary Myocardial Pacing Lead 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 lead remains in the body, except the silicone rubber disc (6) in the case of atrial application.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial and ventricular
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required. The following tests were conducted: Biocompatibility, Junction Strength, Component Qualification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 25, 2017
Medtronic, Inc Debra Taitague Regulatory Affairs Manager 1851 East Deere Ave Santa Ana, California 92705
Re: K171253
Trade/Device Name: 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 Regulation Number: 21 CFR 870.3680 Regulation Name: Cardiovascular Permanent or Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: April 27, 2017 Received: April 28, 2017
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
1
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 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
M.A. Hilleman
for Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171253
Device Name
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
Indications for Use (Describe)
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary post-surgical 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.
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary post-surgical atrial pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for SINGLE USE ONLY.
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is intended for temporary post-surgical 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 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary post-surgical 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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6.0 510(k) Summary
| Date Prepared: | April 27, 2017 |
|---|---|
| Applicant: | Medtronic |
| Medtronic Heart Valves Division | |
| 1851 East Deere Ave | |
| Santa Ana, CA 92705 | |
| Contact Person: | Debra Taitague |
| Regulatory Affairs Specialist | |
| Medtronic | |
| Phone: (234) 248 4186 | |
| Email: debra.a.taitague@medtronic.com | |
| Alternate Contact | |
| Donna Saito | |
| Sr. Regulatory Affairs Manager | |
| Medtronic | |
| Phone: (949) 399 1675 | |
| Email: donna.y.saito@medtronic.com | |
| Trade Name: | 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 | |
| Classification Name: | Temporary Pacing Lead |
| Regulation Number: | 21 CFR 870.3680(a) |
| Product Classification: | Class II |
| Product Code: | LDF |
| Predicate Devices | Model | Product Name |
|---|---|---|
| K140972 | 6491 | Unipolar Pediatric Temporary Pacing Lead |
| K140972 | 6492 | Unipolar Temporary Atrial Pacing Lead |
| K161249 | 6495 | Bipolar Temporary Myocardial Pacing Lead |
| K140972 | 6500 | Unipolar Temporary Myocardial Pacing Lead |
¹ The trademark name Streamline™ mentioned throughout the document represents the temporary pacing lead product family Models; 6491, 6492, 6495, and 6500.
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Device Descriptions 6.1
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. 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 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 parts. 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 wire or catheter with a coiled section and needles at the ends.
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: The image shows a medical device with several labeled components. The components include 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 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 6-3), 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.
Figure 6-3: Model 6465
7
Model 6500 Unipolar Temporary Myocardial Pacing Lead
The Medtronic Model 6500 Unipolar Temporary Myocardial 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 6500 Unipolar Temporary Myocardial Pacing Lead (see Figure 6-4) 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 lead remains in the body, except the silicone rubber disc (6) in the case of atrial application.
Image /page/7/Figure/4 description: This image shows a medical device with several labeled components. The components include 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', a chest needle labeled as '5', and a silicone rubber disc labeled as '6'.
Figure 6-4: Model 6500
8
6.2 Intended Use
There were no changes to the intended use of the devices as related to the change proposed in the Special 510(k) notification. The current Indications for Use statements are noted below:
| Model | Indication for Use |
|---|---|
| 6491 | 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. | |
| 6492 | 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. | |
| 6495 | 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. | |
| 6500 | The Model 6500 Unipolar 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. |
6.3 Contraindications
The following contraindication statement is applicable for all four (4) models presented in this special 510(k) and is not changing.
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 to the Predicate Device
A comparison of the Streamline family of products is being made to the currently marketed predicate devices:
Models 6491, 6492, and 6500 510(k) #K140972 and Model 6495 510(k) # K161249
and indicates the following similarities:
- Same intended use/indications ●
- Same operating principle
- Same fundamental technological characteristics ●
- Same overall design, dimensions, and performance
- All materials are the same except for the minor formulation change and new supplier of the blue monofilament suture.
- Same packaging materials ●
- Same sterilization requirements
9
6.5 Summary of Performance Data
Bench testing was used to verify the performance characteristics of these devices. Clinical testing was not required.
The following tests were conducted
- Biocompatibility ●
- Junction Strength ●
- Component Qualification ●
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.