(204 days)
The Solo Pace Control external pulse generator is used with a cardiac pacing lead system for temporary single chamber pacing in a clinical environment by trained personnel. The external pulse generator can be used where short-term demand pacing is indicated for therapeutic purposes. The external pulse generator must be used in an environment where the patient is monitored continuously to ensure that it is operating properly and delivering appropriate therapy to the patient. Specific indications for temporary pacing include, but are not limited to:
- · Complete heart block
- · Sinus bradycardia
- Sick sinus syndrome
- · Bradycardia with congestive heart failure
- · Cardiac complications during invasive or surgical procedures
- · Support, management, and evaluation of a patient before permanent pacemaker implantation
- · Support during permanent pacemaker replacement
- · Interventional cardiology procedures where pacing is required
The Solo Pace EPG is an AC main powered with battery backup, single chamber, temporary pacemaker designed primarily for interventional cardiology procedures that require controlled pacing. It is a nonsterile component intended to be used outside the sterile field to provide temporary atrial or ventricular pacing as needed during a variety of interventional cardiac procedures. The Solo Pace EPG is bed mountable. It provides assistive operational workflow stages including: (1) pacing capture check; (2) rapid pacing; (3) control pacing; and (4) back-up pacing, which can be set by the physician based upon their preference. The Solo Pace EPG may also be operated in a manual mode, without any assistive modes. The Solo Pace EPG is configured to require the physician to make all clinical decisions (e.g., the presence or absence of contact with pace-able tissue, the presence or absence of 1:1 capture, appropriate conditions for rapid pacing.)
The provided document is a 510(k) premarket notification letter from the FDA to Solo Pace, Inc. regarding their device, Solo Pace Control. It states that the device is substantially equivalent to legally marketed predicate devices.
However, the document does not contain any information about:
- Specific acceptance criteria and reported device performance in a table format. It mentions "performance testing was performed in accordance with recognized international and domestic standards and FDA guidance documents," and "The results of the above performance testing met the specified acceptance criteria." However, it does not detail what those criteria were or the specific performance results.
- Sample sizes used for a test set.
- Data provenance (e.g., country of origin, retrospective or prospective).
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
- Standalone algorithm performance.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The document primarily focuses on regulatory aspects, such as the device's classification, indications for use, comparison to a predicate device, and a high-level summary of performance testing categories (e.g., electrical safety, EMC, software verification, cybersecurity). It confirms that testing was done and met acceptance criteria, but it does not provide the granular detail required to answer your specific questions about the study design, ground truth establishment, or specific performance metrics.
Therefore, based solely on the provided text, I cannot describe the acceptance criteria and the study that proves the device meets the acceptance criteria in the requested detail. The document confirms that such studies were performed and met criteria, but it does not include the specifics of those studies.
§ 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.