(35 days)
The ERA 300 is intended for use during invasive pacemaker procedures in the following activities: . Temporary External Pacing Provides temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations. . Lead Threshold Determination Determines in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. Determines the in vivo retrograde conduction time. . Pacemaker Function Test Tests and analyzes the in vitro operation of external or implantable pulse generators. Determines the following parameters: pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.
The ERA 300 is a portable, dual chamber pacing system analyzer designed to test the electrical performance of the pulse generator and the pacing lead system or operate as a temporary external pulse generator at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. The ERA 300 utilizes a touch-proof configuration to help prevent hazardous connection between patients and electrical power sources.
The provided document is a 510(k) Premarket Notification for a modification to the BIOTRONIK ERA 300 Pacing System Analyzer (PSA). The modification concerns the additional battery supplier for the device, not the device's main functionalities or its performance in diagnostic tasks. Therefore, the information typically requested in your prompt regarding acceptance criteria, study design for performance evaluation, sample sizes, ground truth establishment, expert roles, and comparative effectiveness studies is not directly applicable to this specific 510(k) submission.
The 510(k) essentially states that a new battery supplier (pbq) has been identified because the previous supplier (Panasonic) will no longer manufacture the existing 8 Volt battery. The key point for this regulatory submission is that the newly sourced battery meets the same internal specifications as the original one, thus ensuring that the core device's performance remains unchanged.
However, I can extract information related to the device's general description, intended use, and the regulatory aspect of the modification.
Here's an interpretation based on the provided document, addressing your points where possible, and explicitly stating when the information is not present or relevant to this specific submission:
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) about a battery supplier change, the acceptance criteria are that the new battery meets the existing internal specifications for the ERA 300 PSA. The "device performance" refers to the new battery performing indistinguishably from the old one, thereby maintaining the ERA 300's established performance.
| Acceptance Criteria (for the new battery) | Reported Device Performance (with the new battery) |
|---|---|
| Meets the same internal BIOTRONIK specifications | "manufactured battery meets the same internal BIOTRONIK specifications" |
| Including purchasing specifications | (Inferred as met by "same internal BIOTRONIK specifications") |
| Including incoming inspection specifications | (Inferred as met by "same internal BIOTRONIK specifications") |
| Including performance specifications | (Inferred as met by "same internal BIOTRONIK specifications") |
Note: The document does not detail the specific performance specifications (e.g., battery life, voltage output range, charge time) as these are presumed to be the same as established for the original battery and are internal BIOTRONIK specifications. The crucial aspect is equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. This submission is for a battery supplier change, not a performance study comparing the ERA 300's diagnostic capabilities. The "test set" here would refer to the new battery being tested against specifications, not a clinical data set. The document does not specify the number of batteries tested.
- Data Provenance: Not applicable. No clinical or observational data are described. The testing described relates to internal product specifications for the battery.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. There is no "ground truth" in the diagnostic sense for this battery modification. The "truth" is whether the new battery meets the specifications. Biotronik's internal engineers and quality control personnel would be responsible for verifying this, but their number and specific qualifications (beyond being competent in product testing) are not detailed in this regulatory summary.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" (e.g., 2+1, 3+1 consensus) in the medical imaging or diagnostic sense for this type of component change. The assessment is against pre-defined engineering and performance specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This type of study is completely irrelevant to a 510(k) for an additional battery supplier. An MRMC study would be used to evaluate the diagnostic accuracy of a system, potentially comparing human readers' performance with and without AI assistance on a given task (e.g., interpreting medical images). This document is not about such a system or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This submission is for a medical device (Pacing System Analyzer), not an algorithm or AI. Standalone performance studies are typically for AI/CAD systems.
7. The Type of Ground Truth Used
The "ground truth" in this context is the pre-established internal BIOTRONIK specifications for the 8 Volt battery used in the ERA 300 PSA. The new battery needed to demonstrate that it met these specifications. This is a technical specification truth, not a clinical ground truth like pathology, expert consensus, or outcomes data.
8. The Sample Size for the Training Set
Not applicable. There is no AI/algorithm being trained.
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no AI/algorithm being trained.
Summary regarding the device's overall performance (as described in the document, but not the focus of this specific 510(k)):
The ERA 300 Pacing System Analyzer is broadly characterized by its functionalities, which include:
- Temporary External Pacing: Provides temporary stimulation under various modalities (DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO).
- Lead Threshold Determination: Determines in situ lead characteristics (impedance, capture threshold, P/R wave amplitude, P/R wave slew rate) and in vivo retrograde conduction time.
- Pacemaker Function Test: Tests and analyzes in vitro operation of pulse generators to determine parameters such as pulse amplitude and width, sensitivity, refractory period, A/V delay, and rate/interval.
The original ERA 300 Pacing System Analyzer (K964190, cleared 07-10-97 and K033613, cleared on 12-08-03) would have had performance studies and acceptance criteria related to these functionalities. This 510(k) for the battery change relies on the substantial equivalence principle, meaning the change (new battery) does not alter the fundamental safety or effectiveness parameters that were established for the predicate device.
§ 870.3720 Pacemaker electrode function tester.
(a)
Identification. A pacemaker electrode function tester is a device which is connected to an implanted pacemaker lead that supplies an accurately calibrated, variable pacing pulse for measuring the patient's pacing threshold and intracardiac R-wave potential.(b)
Classification. Class II (performance standards).