(262 days)
The ERA 300 is indicated for use during invasive pacing system procedures in the following activities:
- TEMPORARY EXTERNAL PACING To provide temporary stimulation under DDD, DDI, DOO, VVI, VDD, VOO, AAI, or AOO modalities during implantable pacemaker procedures or physician evaluations.
- LEAD THRESHOLD DETERMINATION To determine in situ lead characteristics of impedance, capture threshold, P/R wave amplitude and P/R wave slew rate. To determine the in vivo retrograde conduction time.
- PACEMAKER FUNCTION TEST To test and analyze the in vitro operation of external or implantable pulse generators. To determine 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 (non-implantable) designed to test the electrical performance of the pulse generator and the pacing lead system at the time of pacemaker implantation and during invasive pacemaker troubleshooting or evaluation procedures. It can also operate as an external programmable pulse generator.
The provided text describes a 510(k) submission for the ERA 300 Dual Chamber Pacing System Analyzer. However, it does not contain a detailed study report with specific acceptance criteria, reported device performance metrics, sample sizes, ground truth establishment methods, or information about expert involvement (like adjudication or MRMC studies).
The document primarily focuses on:
- Device Description: What the ERA 300 is and its functions.
- Substantial Equivalence: Comparing it to already cleared devices (SeaMED Model 3300 and Medtronic Model 5311B).
- Intended Use/Indications for Use: The clinical scenarios for which the device is designed.
- Qualification Testing: A general statement that testing was performed and provided in the submission (referencing "Table III, pages 14-33" which are not included in the provided text). This section mentions "Internal standards and specifications were used when relevant international standards were not available."
- Regulatory Clearance: The FDA letter confirming 510(k) clearance based on substantial equivalence.
Without access to "Table III, pages 14-33" or other detailed performance study documentation, it's impossible to completely fill out the requested table and provide specific answers to many of the questions.
Based on the available information, here's what can be inferred or stated as unknown:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter / Aspect Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| System Checks | Not specified in provided text. | Not specified in provided text. |
| EMC & Circuit Design | Not specified in provided text. | Not specified in provided text. |
| Firmware | Not specified in provided text. | Not specified in provided text. |
| Battery Performance | Not specified in provided text. | Not specified in provided text. |
| Battery Recharger | Not specified in provided text. | Not specified in provided text. |
| Pacemaker Test Cable | Not specified in provided text. | Not specified in provided text. |
| Specific Functions (e.g., Impedance, Capture Threshold, P/R wave amplitude accuracy) | *Not specified in provided text. | |
| Likely based on comparison to predicate devices' performance or internal engineering specifications.* | Not specified in provided text. | |
| Overall Performance | Substantially equivalent to SeaMED Model 3300 and Medtronic Model 5311B. | Determined to be substantially equivalent by FDA (K964190). |
Note: The document states "Qualification testing for the ERA 300 is provided in this submission for the tests described in Table III, pages 14-33." This Table III would contain the specific acceptance criteria and reported performance data. Without it, these fields cannot be filled.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The device tests various electrical parameters. The "test set" would likely refer to the number of individual tests performed on each parameter, or the number of simulated/actual pacemakers/leads used for testing.
- Data Provenance: Not specified. Given it's a 510(k) submission, the testing would have been conducted by the manufacturer (BIOTRONIK GmbH & Co. / BIOTRONIK, Inc.) or its designated testing facilities. "Country of origin" for data collection is not mentioned. "Retrospective or prospective" is not applicable as this is a device performance test, not a clinical study on patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. For a device like a pacing system analyzer, "ground truth" is typically established against calibrated reference equipment, known electrical signals, or by comparison to predicate device measurements, not by human expert consensus or clinical evaluation.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. Device performance for electrical parameters is measured objectively, not adjudicated by human experts.
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
- MRMC Study: No. This device is a pacing system analyzer for objective electrical measurements, not an AI diagnostic tool that assists human readers/interpreters.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance: Yes, in essence. The "qualification testing" described in the document (referencing Table III) would have assessed the device's ability to accurately measure electrical parameters independently. The device's primary function is to perform these measurements standalone.
7. The type of ground truth used
- Type of Ground Truth: Most likely calibrated measurements (e.g., from oscilloscopes, multimeters, signal generators, or other reference testing equipment) and comparison to the established performance of legally marketed predicate devices (SeaMED Model 3300 and Medtronic Model 5311B). For lead characteristics like impedance and capture threshold, known values in test circuits or in animal/human models (under controlled, ethical conditions if applicable) would serve as ground truth, or comparisons to predicate devices in the same setting.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This device is an analyzer for electrical signals, not a machine learning/AI algorithm that requires a "training set" in the conventional sense. Its "training" is in its engineering design and calibration.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable, as there is no "training set" for this type of device.
§ 870.3600 External pacemaker pulse generator.
(a)
Identification. An external pacemaker pulse generator (EPPG) is a prescription device that has a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. This device, which is used outside the body, is used as a temporary substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats in patients following cardiac surgery or a myocardial infarction. The device may have adjustments for impulse strength, duration, R-wave sensitivity, and other pacing variables.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing must validate electromagnetic compatibility (EMC) within a hospital environment.
(2) Electrical bench testing must demonstrate device safety during intended use. This must include testing with the specific power source (
i.e., battery power, AC mains connections, or both).(3) Non-clinical performance testing data must demonstrate the performance characteristics of the device. Testing must include the following:
(i) Testing must demonstrate the accuracy of monitoring functions, alarms, measurement features, therapeutic features, and all adjustable or programmable parameters as identified in labeling;
(ii) Mechanical bench testing of material strength must demonstrate that the device and connection cables will withstand forces or conditions encountered during use;
(iii) Simulated use analysis/testing must demonstrate adequate user interface for adjustable parameters, performance of alarms, display screens, interface with external devices (
e.g. data storage, printing), and indicator(s) functionality under intended use conditions; and(iv) Methods and instructions for cleaning the pulse generator and connection cables must be validated.
(4) Appropriate software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) The labeling must clearly state that these devices are intended for use in a hospital environment and under the supervision of a clinician trained in their use;
(ii) Connector terminals should be clearly, unambiguously marked on the outside of the EPPG device. The markings should identify positive (+) and negative (−) polarities. Dual chamber devices should clearly identify atrial and ventricular terminals;
(iii) The labeling must list all pacing modes available in the device;
(iv) Labeling must include a detailed description of any special capabilities (
e.g., overdrive pacing or automatic mode switching); and(v) Appropriate electromagnetic compatibility information must be included.