(51 days)
The Streamline 1 Temporary Pacing Leads are indicated for temporary atrial, or atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The devices are supplied sterile and intended for single use only.
Model 6491 Unipolar Pediatric Temporary Pacing Lead: The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary 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.
Model 6492 Unipolar Temporary Atrial Pacing Lead: The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary 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.
Model 6494 Unipolar Temporary Myocardial Pacing Wire: The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary 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.
Model 6495 Bipolar Temporary Myocardial Pacing Lead: The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary 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.
Model 6500 Unipolar Temporary Myocardial Pacing Lead: The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
Model 6491: The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 1). 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.
Model 6492: The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 2). 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.
Model 6494: The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi- filament wire (1) (see Figure 3). One end of this 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 wire remains in the body.
Model 6495: The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi- filament lead (see Figure 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). 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.
Model 6500: The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode (1) and an insulated multi-filament conductor (2) which are crimped together (see Figure 5). 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 case of atrial application.
This document is a 510(k) summary for Medtronic's Streamline™ Temporary Pacing Leads. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the modifications to the Streamline™ Temporary Pacing Leads "do not affect the intended use of the devices or alter the fundamental scientific technology of the devices." This suggests that the substantial equivalence claim is based on the known performance characteristics of the predicate devices and the minor nature of the changes (pin protector, sterile barrier, packaging, and shelf-life reduction).
Therefore, based on the provided text, I cannot provide the requested information about:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
- If a standalone performance (algorithm only) was done
- The type of ground truth used
- The sample size for the training set
- How the ground truth for the training set was established
This document is a regulatory submission demonstrating substantial equivalence, not a clinical or performance study report with detailed performance metrics against acceptance criteria.
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JUN 0 6 2014
510(k) Summary 2
l. Applicant Information
| Date Prepared: | June 05, 2014 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Address: | 710 Medtronic Parkway, NEMinneapolis, MN 55432 |
| Contact Person: | Debra TaitagueRegulatory Affairs SpecialistMedtronic, Inc.Phone: (234) 248 4186Fax: (949) 553 8983Email: debra.a.taitague@medtronic.com |
| Alternate Contact | Donna SaitoSr. Regulatory Affairs ManagerMedtronic, Inc.Phone: (949) -399-1675Fax: (949) 553 8983Email: donna.y.saito@medtronic.com |
ll. Device Name and Classification
| Trade Name: | Temporary Pacemaker Electrode |
|---|---|
| Common Name: | Temporary Pacing Lead |
| EstablishmentRegistration Number | 2025587 |
| ProductClassification: | Class II 21 CFR 870.3680(a) |
| Product Code: | LDF |
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| Predicate Devices | Model | Product Name |
|---|---|---|
| K012454 | 6491 | Unipolar Pediatric Temporary Pacing Lead |
| K012458 | 6492 | Unipolar Temporary Atrial Pacing Lead |
| K012459 | 6494 | Unipolar Temporary Myocardial Pacing Wire |
| K012460 | 6495 | Bipolar Temporary Myocardial Pacing Lead |
| K012452 | 6500 | Unipolar Temporary Myocardial Pacing Lead |
111. Indications for Use and Device Description
The Streamline 1 Temporary Pacing Leads are indicated for temporary atrial, or atrial and ventricular pacing and sensing for a contemplated implant duration of 7 day or less. The devices are supplied sterile and intended for single use only. The following are the specific device descriptions for each Streamline™ Temporary Pacing Lead model.
| Model | Device Description |
|---|---|
| 6491 | The Model 6491 Unipolar Pediatric Temporary Pacing Lead consists of an electrode (1) and aninsulated multi-filament conductor (2) which are crimped together (see Figure 1). A bluemonofilament (3) proximally coiled for fixation of the lead is attached to the electrode andterminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coilprovides 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 chestwall. To remove the pacing lead, gentle traction should be applied. No part of the lead remainsin the body. |
| 6492 | The Model 6492 Unipolar Temporary Atrial Pacing Lead consists of an electrode (1) and aninsulated multi-filament conductor (2) which are crimped together (see Figure 2). A bluemonofilament (3) proximally coiled for fixation of the lead is attached to the electrode andterminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coilprovides 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 chestwall. To remove the pacing lead, gentle traction should be applied. No part of the lead remainsin the body. |
| 6494 | The Model 6494 Unipolar Temporary Myocardial Pacing Wire consists of an insulated multi-filament wire (1) (see Figure 3). One end of this wire has been stripped to have an electrodesurface (2). This surface area can partly or completely be used as an electrode. The strippedend terminates distally in an atraumatic myocardial curved needle (3). An atraumatic chestneedle (4) at the proximal end of the conductor wire permits running the pacing wire to exitthrough the chest wall. To remove the pacing wire, gentle traction should be applied. No part ofthe wire remains in the body. |
| 6495 | The Model 6495 Bipolar Temporary Myocardial Pacing Lead consists of an insulated multi-filament lead (see Figure 4) which contains a distal, discrete, ring electrode (1), a discrete, tip |
1 The trademark name Streamline™ mentioned throughout the document represents the heartwire product family Models; 6491, 6492, 6494, 6495, and 6500.
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| Model | Device Description |
|---|---|
| electrode (2); and a coaxial conductor lead body (3). Each discrete electrode is crimped onto aconductor and terminates in an atraumatic, myocardial curved needle (4). A blue monofilamentcoil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chestneedle (5) at the proximal end of the conductor wire permits exiting the pacing lead through thechest 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 inthe body. | |
| 6500 | The Model 6500 Unipolar Temporary Myocardial Pacing Lead consists of an electrode (1) andan insulated multi-filament conductor (2) which are crimped together (see Figure 5). A bluemonofilament (3) proximally coiled for fixation of the lead is attached to the electrode andterminates distally in an atraumatic myocardial curved needle (4). A blue monofilament coilprovides 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 chestwall. To remove the pacing lead, gentle traction should be applied. No part of the lead remainsin the body, except the silicone rubber disc (6) in case of atrial application. |
Comparison to Predicate Devices IV.
A comparison of the modified product to the current marketed predicate products indicates the following similarities:
- Same intended use .
- Same technological characteristics .
- . Same operating principle
- Same design features .
- Same base materials .
The differences between the modified products to the current marketed predicate devices are as follows:
- The pin protector is visually different and manufactured with a ridged material
- Aseptic presentation of the device; instead of a double pouch sterile barrier there . is only a single pouch sterile barrier
ﺎ
- Shrink wrap will be removed and the shelf carton opening mechanism was . changed
- Shelf Life reduction from 4 years to 2 years .
V. Conclusion
Based upon the available testing, the modifications to the Streamline™ Temporary Pacing Leads do not affect the intended use of the devices or alter the fundamental scientific technology of the devices.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.
Public Health Service
ood and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2014
Medtronic, Inc. % Debra Taitague Regulatory Affairs Specialist 1851 East Deere Ave. Santa Ana, California 92705
Re: K140972
Trade/Device Name: Streamline 11 Heartwires Temporary Pacing Leads Regulation Number: 21 CFR 870.3680(a) Regulation Name: Temporary Pacemaker Electrode Regulatory Class: Class II Product Code: LDF Dated: May 6, 2014 Received: May 8, 2014
Dear Ms. 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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Page 2 - Debra Taitague
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/ResqurcesforYou/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/ReportalProblem/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 yours,
Image /page/4/Picture/8 description: The image shows a logo with the letters FDA. The letters are stylized and overlapping. The logo is black and white and appears to be a vectorized image.
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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The following are the Indications for Use for each model of Streamline™ Temporary Pacing Leads:
- 6491
- · 6492
- 6494
- 6495
- · 6500
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510(k) Number (if known): K140972
Device Name: Model 6491 Unipolar Pediatric Temporary Pacing Lead
Indications for Use:
The Model 6491 Unipolar Pediatric Temporary Pacing Lead is designed for temporary 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.
Prescription Use _ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
AND/OR
Image /page/6/Picture/9 description: The image shows a signature and a date stamp. The date on the stamp reads "2014.06.06" and the time is "12:56:36 -04'00'". The signature is illegible, but appears to be written in cursive. The stamp is circular and has a decorative border.
Page __ of __
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510(k) Number (if known): K140972
Device Name: Model 6492 Unipolar Temporary Atrial Pacing Lead
Indications for Use:
The Model 6492 Unipolar Temporary Atrial Pacing Lead is designed for temporary 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.
Prescription Use _ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/7/Picture/11 description: The image shows a date and time stamp. The date is June 6, 2014, and the time is 14:13:48. The time zone is -04'00. There is also a signature to the left of the date and time stamp.
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510(k) Number (if known): K140972
Device Name: Model 6494 Unipolar Temporary Myocardial Pacing Wire
Indications for Use:
The Model 6494 Unipolar Temporary Myocardial Pacing Wire is designed for temporary 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.
Prescription Use _ × (Part 21 CFR 801 Subpart D) Over-The-Counter Use 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page of of
Date:
2014.06.06
14:14:13+04'00'
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510(k) Number (if known): K140972
Device Name: Model 6495 Bipolar Temporary Myocardial Pacing Lead
Indications for Use:
The Model 6495 Bipolar Temporary Myocardial Pacing Lead is designed for temporary 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.
Prescription Use × (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Image /page/9/Picture/9 description: The image shows the text "Concurrence of CDRH, Office of Device Evaluation (ODE)" at the top. Below this text is a stamp that includes the word "Date:" and the date "2014.06.06". The stamp also includes the time "14:14:36".
Page of of
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510(k) Number (if known): K140972
Device Name: Model 6500 Unipolar Temporary Myocardial Pacing Lead
Indications for Use:
The Model 6500 Unipolar Temporary Myocardial Pacing Lead is designed for temporary pacing and sensing for a contemplated implant duration of 7 days or less. The device is supplied sterile and intended for single use only.
Prescription Use __ × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Image /page/10/Picture/11 description: The image shows a stamp with the letters "FDA" in a circular pattern. Next to the stamp, the word "Date:" is written, followed by the date "2014.06.06" and the time "14:15:00". The time zone "-04'00" is written below the time.
§ 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.