(130 days)
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).
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.
The provided text describes a 510(k) premarket notification for Medtronic Streamline Temporary Pacing Leads and Wire. The submission is a "Special 510(K)" which indicates changes to a previously cleared device. The focus of the changes and the study conducted is related to Magnetic Resonance Imaging (MRI) compatibility.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a tabular format with corresponding "reported device performance" in the way one might see for a diagnostic AI device. Instead, the "acceptance criteria" are implied by adherence to established ASTM standards for MRI safety, and the "reported device performance" is the conclusion that the devices are "MR Conditional" under specific conditions.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| RF Heat Assessment (ASTM F2192-19e2) | Passed (tested at 64MHz (1.5T) and 123MHz (3T)) |
| Force and Torques (ASTM F2052-15w) | Passed (tested in a 3.0 T GE Discovery MR750 whole-body MR system) |
| MR Conditional Labeling Requirements | Met, allowing for specific MRI conditions to be listed in the IFU/labeling |
| Image Artifact Assessment | Not tested, as leads are not implanted in head/lower extremity (no risk of artifact affecting relevant scans) |
| Ability to be Scanned Safely under Specific Conditions | Concluded to be MR Conditional under conditions listed below. |
Specific MR Conditions (from IFU - effectively performance details):
| Parameter | Condition/Performance |
|---|---|
| Static Magnetic Field | 1.5T or 3.0T |
| Maximum Spatial Field Gradient | 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 contraindicated) |
| Operating Mode | Normal Operating Mode |
| Maximum Head SAR | 3.2 W/kg |
| Scan Duration | No limit on scan duration |
| Scan Region | Head or lower extremity only |
| MR Image Artifact | No image artifact (within relevant scan regions, as leads are not implanted there) |
| Additional Instructions for Safe Use | Disconnect from pulse generator, insert connector pins into protectors, coil excess lead, tape to skin. MR exams contraindicated for pacing-dependent patients. |
2. Sample size used for the test set and the data provenance
The document specifies "Each Streamline Model" was tested in "two configurations (bundled and extended)". The exact number of individual devices or test samples per model is not provided.
The testing is described as "nonclinical MRI testing" which implies a controlled laboratory environment rather than patient data. Therefore, data provenance is "laboratory setting" and not retrospective or prospective from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the study described is nonclinical testing of physical devices (MRI compatibility) against engineering standards, not a diagnostic assessment where expert ground truth would be established. The "ground truth" here is the physical measurement against an engineering standard.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used for medical image interpretation studies where expert consensus is needed. For nonclinical engineering tests, the results are typically objectively measured against pre-defined thresholds from standards.
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
This information is not provided and is not applicable to the type of device and study presented. The Streamline Temporary Pacing Leads are physical medical devices, not an AI software diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided and is not applicable. The device is a physical pacing lead, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this nonclinical study is the physical measurement against established engineering standards (ASTM F2192-19e2 for RF Heat, and ASTM F2052-15w for Force and Torques).
8. The sample size for the training set
This information is not applicable/provided. The study is nonclinical testing of physical devices, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
This information is not applicable/provided as there is no training set.
§ 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.