(142 days)
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.
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 and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. A curved atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.
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 and an insulated multi-filament conductor which are crimped together. A blue monofilament proximally coiled for fixation of the lead is attached to the electrode and terminates distally in an atraumatic myocardial curved needle. A blue monofilament coil provides fixation while the lead is implanted in myocardial tissue. An atraumatic chest needle at the proximal end of the conductor wire permits exiting the pacing lead through the chest wall.
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 consists of two insulated multi-filament wire. At one end of each wire has been stripped to have an electrode surface. This surface area can partly or completely be used as an electrode. The stripped end terminates distally in an atraumatic myocardial curved needle. An atraumatic chest needle at the proximal end of the conductor wire permits running the pacing wire to exit through the chest wall.
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, a discrete, tip electrode, and a coaxial conductor lead body. Each discrete electrode is crimped onto a conductor and terminates in an atraumatic myocardial curved needle. 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 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, which provide an attachment to an external pulse generator.
This document describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads (Models 6491, 6492, 6494, and 6495). The submission primarily addresses a minor formulation change to the base polyethylene (PE) material used for the insulation coating of the pacing wires.
Here's an analysis of the provided text in relation to your request about acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" alongside specific numerical "reported device performance" values for each criterion. Instead, it states that the devices successfully passed the acceptance criteria for various tests. The acceptance criteria are "pre-established specifications," but these specifications are not detailed.
| Acceptance Criterion (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Successfully passed pre-established specifications. |
| Component Qualification | Successfully passed pre-established specifications. |
| Design Verification | Successfully passed pre-established specifications. |
| Shelf Life | Successfully passed pre-established specifications. |
| PE base material qualification | The new PE formulation is considered qualified for its intended use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the precise sample sizes used for each of the bench tests (Biocompatibility, Component Qualification, Design Verification, Shelf Life). It only states that "Bench testing was used to verify the performance characteristics."
The data provenance (country of origin, retrospective/prospective) is not mentioned. Given that this is bench testing for a medical device, it's typically conducted in a controlled laboratory environment.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to the information provided. The study described is bench testing, not a clinical study involving diagnostic interpretation or "ground truth" established by medical experts in the traditional sense (e.g., radiologists, pathologists). The "ground truth" for bench testing would be the engineering and material science standards and specifications that the device is required to meet, established by Medtronic's internal R&D and quality teams, and aligned with regulatory requirements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple human readers interpret data, and discrepancies need to be resolved. Bench testing involves objective measurements against predefined specifications, not subjective interpretation.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required." This submission is for a material change in a physical medical device (pacing leads), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (pacing leads) and does not involve an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
As mentioned in point 3, the concept of "ground truth" as typically used in AI/diagnostic studies is not directly applicable here. For bench testing of a physical medical device, the "ground truth" is defined by the technical specifications, industry standards, and regulatory requirements that the device must meet. This involves objective measurements and adherence to predefined engineering and material science parameters.
8. The sample size for the training set
This question is not applicable. There is no AI or machine learning component to this device, and therefore no "training set" in the context of AI development.
9. How the ground truth for the training set was established
This question is not applicable, as there is no training set for this device.
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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.
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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
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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) | [X] Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
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510(k) Summary
| Date Prepared: | April 12, 2019 |
|---|---|
| Applicant: | MedtronicMedtronic Heart Valves Division1851 East Deere AveSanta Ana, CA 92705 |
| Contact Person: | Joven AlmazanRegulatory Affairs SpecialistMedtronicPhone: (234) 248 4186Email: joven.almazan@medtronic.com |
| Alternate Contact | Donna SaitoSr. Regulatory Affairs ManagerMedtronicPhone: (949) 399 1675Email: 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.
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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
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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
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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
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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.
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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 postsurgicalatrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. Thedevice is supplied sterile and is intended for SINGLE USE ONLY. |
| 6492 | The Model 6492 Unipolar Temporary Atrial Pacing Lead is intended for temporary postsurgicalatrial pacing and sensing for a contemplated implant duration of 7 days or less. The device issupplied sterile and is intended for SINGLE USE ONLY. |
| 6494 | The Model 6494 Unipolar Temporary Myocardial Pacing wire is intended for temporarypostsurgical atrial and ventricular pacing and sensing for a contemplated implant duration of 7 daysor 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 postsurgicalatrial and ventricular pacing and sensing for a contemplated implant duration of 7 days or less. Thedevice 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
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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.
§ 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.