(84 days)
Weck Cardiac Pacing Wires are intended for use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients.
Weck cardiac pacing wires consist of a small curved stainless steel needle attached to fluoropolymer coated stainless steel braided wire which is attached on the opposite end to a Keith or Milner breakaway needle (see picture below). The wire is bare at the distal end to allow conduction of pacing signals to the heart. This is a standard temporary epicardial pacing wire design.
There are three design variations included in this submission that are offered as a convenience to the user:
- Color coding White and orange color coding of the insulation allows the user to differentiate between atrial and ventricular wires after chest closure.
- Heart needle Three heart needle sizes are intended to allow for variations in physiology between patients. Another variation has no curved heart needle for surgeons who prefer to suture the wire to the epicardium rather than implanting it.
- Retention feature A "wing" version wire is formed by peeling back the insulation in three places, 120° apart, for a distance of 1/2" near the curved heart needle. The "wing" is intended as a convenience feature to provide a suture-free method of securing the electrode to the heart.
The provided text describes a 510(k) summary for Weck Cardiac Pacing Wires, which aims to demonstrate substantial equivalence to predicate devices rather than conducting a full de novo study with strict acceptance criteria and performance evaluations as might be found for a novel device. Therefore, much of the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial or algorithm performance study is not explicitly detailed.
However, based on the document, we can infer the "acceptance criteria" as ensuring the device performs equivalently to predicate devices on key functional attributes. The "study" refers to the engineering and bench testing performed to confirm these characteristics.
Here's a breakdown of the requested information based on the provided text, with explanations where information is not explicitly stated or is inferred from the regulatory context:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from reported evaluations) | Reported Device Performance |
|---|---|
| Biocompatibility according to FDA G95-1 / ISO 10993-1 requirements | Confirmed biocompatibility. |
| Electrical continuity | Confirmed to be equivalent and perform acceptably. |
| Strength of the needle swages and ability to withstand tensile forces during use | Confirmed to be equivalent and perform acceptably. |
| Corrosion resistance | Confirmed to be equivalent and perform acceptably. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Heart needle insertion force | Confirmed to be equivalent and perform acceptably. ---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Extraction force | Confirmed to be equivalent and perform acceptably. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
| Fatigue resistance | Confirmed to be equivalent and perform acceptably. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Compatibility with pacemakers | Confirmed to be equivalent and perform acceptably. |
| Lead pacing impedance | Confirmed to be equivalent and perform acceptably. |
| Lead sensing impedance | Confirmed to be equivalent and perform acceptably. |
| Substantial equivalence to predicate devices (Weck's preamendment Temporary Cardiac Electrodes, Ethicon TPW 32 and TPW 92 pacing wires, and Medtronic Model 6500 and 6491 temporary pacing wires) for stated intended use in temporary cardiac pacing following cardiac surgery in adult and pediatric patients. | The FDA reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for 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 sample sizes for "test sets" in terms of patient data or clinical trials. The "testing" refers to bench and engineering evaluations. The provenance of this engineering testing data (e.g., country of origin, retrospective/prospective) is not provided.
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 information is not applicable and not provided. The "ground truth" for this type of device (a medical wire) would be based on established engineering standards and material science, not expert consensus on interpretations of images or patient data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable and not provided. Adjudication methods are typically used in clinical trials or studies where there is subjective assessment by multiple reviewers. This submission focuses on objective engineering and performance characteristics.
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
Not applicable. This is not an AI-assisted diagnostic device, nor is it a device where "human readers" would be involved in interpreting its output. No MRMC study was conducted or mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance evaluations (electrical continuity, strength, corrosion resistance, etc.) would be established against engineering specifications, material standards, and industry-accepted benchmarks for temporary cardiac pacing wires, based on the performance of the predicate devices. This is implied by the statement "Weck evaluated each characteristic of the wires important to proper functioning and confirmed that each of the wires is equivalent and performs acceptably."
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.