(60 days)
The Steelex Electrode Set is intended for use in temporary cardiac pacing or monitoring.
The Steelex Electrode Set comprises a stainless steel 316L braided wire (ASTM-F138), with a plastic isolating cover (Polyethylene). One end of the wire is armed with a stainless steel 420 (ASTM-F899) ½ circle or 3% circle round-bodied needle and the other end is armed with a stainless steel (ASTM-F899) straight needle (break-off). The straight break-off needle also serves as the connection to the generator. The needle sizes for Steelex Electrode Set are available in the USP sizes 302, 420 or 420F, 0, 1-0, 2-0 and 3-0.
The provided text is a 510(k) summary for the Steelex Electrode Set. It describes the device, its indications for use, and its substantial equivalence to predicate devices. However, it explicitly states that "No performance standards have been promulgated under Section 514 of the Food. Drug and Cosmetic Act for these devices." This means there are no formal acceptance criteria or a study proving the device meets them in the traditional sense of a clinical performance study with specific metrics.
Instead, the FDA's decision to clear this device via 510(k) is based on substantial equivalence to already approved predicate devices. This regulatory pathway means the new device is considered as safe and effective as a legally marketed device if it has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics and the information submitted to FDA does not raise new questions of safety and effectiveness and demonstrates that the device is at least as safe and effective as the legally marketed device.
Therefore, for this particular submission, the answers to your questions will reflect this regulatory approach rather than a traditional performance study.
Here's the information based on the provided text, while noting the absence of a specific performance study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (Implied by Substantial Equivalence) |
|---|---|
| Safe and effective for temporary cardiac pacing or monitoring | Considered as safe and effective as the predicate devices: Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503)Medtronic; Model 6494 Unipolar Temporary Myocardial Pacing Wire (K012459) |
| Same intended use as predicate devices | Intended for use in temporary cardiac pacing or monitoring, identical to the common use of predicate devices. |
| Similar technological characteristics to predicate devices | Comprises stainless steel 316L braided wire (ASTM-F138) with plastic isolating cover (Polyethylene); armed with stainless steel 420 (ASTM-F899) needles (½ circle or 3/8 circle round-bodied and straight break-off). Needle sizes include USP sizes 3-0, 2-0, 1-0, 0, 4-20, 4-20F, 3-0. This falls within the typical design of temporary pacing electrodes. |
| Does not raise new questions of safety or effectiveness | No new questions of safety or effectiveness were raised, allowing clearance based on equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No specific "test set" was used for a performance study as described. The determination of substantial equivalence relies on comparing the device's design, materials, and intended use against already cleared predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No specific ground truth was established by experts for a test set in the context of a performance study. The FDA's review panel (Cardiovascular) and Office of Device Evaluation (ODE) experts assess the submitted documentation for substantial equivalence to predicates.
4. Adjudication Method for the Test Set
Not applicable. No test set adjudication method is mentioned as there was no performance study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
Not applicable. This device is a temporary pacing electrode, not an AI-assisted diagnostic or assistive device. Therefore, no MRMC study or assessment of AI assistance for human readers was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness profile of the predicate devices (Ethicon, Inc.; Temporary Cardiac Pacing Wire (K980503) and Medtronic; Model 6494 Unipolar Temporary Myocardial pacing Wire (K012459)) as established through their prior FDA clearances. The new device is deemed safe and effective because it is substantially equivalent to these already approved devices.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.