(108 days)
Not Found
Not Found
No
The device description and performance studies focus on the physical components and biocompatibility of a temporary pacing lead, with no mention of AI or ML capabilities.
Yes
The device is used for temporary postsurgical atrial and ventricular pacing, which is a therapeutic intervention to regulate heart rhythm.
No
Explanation: The device is described as a temporary myocardial pacing lead, designed for pacing and sensing, not for diagnosing conditions. While it "senses," its primary function isn't diagnostic interpretation but rather collecting data for pacing.
No
The device description clearly outlines physical components like electrodes, conductors, needles, and a lead body, indicating it is a hardware device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Description: The Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is a device that is implanted directly into the myocardial tissue (heart muscle) for temporary pacing and sensing. This is an in vivo (within the living body) application.
- Intended Use: The intended use is for temporary pacing and sensing within the heart, not for testing samples taken from the body.
Therefore, based on the provided information, the Streamline 6495 Bipolar Temporary Myocardial Pacing Lead is a medical device used in vivo, not an in vitro diagnostic device.
N/A
Intended Use / Indications 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.
Product codes
LDF
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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
myocardial tissue, chest wall
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
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 Proposed: Polyolefin | Biocompatibility Manufacturability | Passed Passed |
Key Metrics
Not Found
Predicate Device(s)
Streamline 6495 Bipolar Temporary Myocardial Pacing Lead
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
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
1
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 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
2
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)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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7.0 510(k) Summary
| Date Prepared: | May 02, 2016 |
|---|---|
| Applicant: | Medtronic |
| Medtronic Heart Valve Division | |
| 1851 East Deere Ave | |
| Santa Ana, CA 92705 | |
| Contact Person: | Debra Taitague |
| Regulatory Affairs Specialist | |
| Medtronic | |
| Phone: (234) 248 4186 | |
| Fax: (949) 553 8983 | |
| Email: debra.a.taitague@medtronic.com | |
| Alternate Contact | |
| Donna Saito | |
| Sr. Regulatory Affairs Manager | |
| Medtronic | |
| Phone: (949) 399 1675 | |
| Fax: (949) 553 8983 | |
| Email: donna.y.saito@medtronic.com | |
| Trade Name: | Streamline 6495 Bipolar Temporary Myocardial Pacing |
| Lead Electrode | |
| Classification Name: | Temporary Pacing Lead |
| Regulation Number: | 21 CFR 870.3680(a) |
| Product Classification: | Class II |
| Product Code: | LDF |
| Name of Predicate | |
| 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.
4
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
5
- 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.