(29 days)
The temporary pacemaker is used with a cardiac pacing lead system for temporary single or dual chamber pacing in a clinical environment by trained personnel. The temporary pacemaker can be used where short-term demand (synchronous) or asynchronous pacing is indicated for therapeutic, prophylactic or diagnostic purposes. The temporary pacemaker 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 cardiac pacing include, but are not limited to, the following:
- Complete heart block
- Sinus bradycardia
- Sick sinus syndrome
- Bradycardia with congestive heart failure
- Atrial and/or ventricular arrhythmias
- Cardiac arrest
- Support, management, and evaluation of a patient prior to permanent pacemaker Implantation
- Support during permanent pacemaker replacement
- Cardiac complications during invasive or surgical procedures
- Support following cardiac surgery
- Acute myocardial infarction complicated by heart block
- Atrial tachyarrhythmias that require high-rate burst pacing for treatment
The Model 5392 EPG is a battery-powered, dual chamber, temporary pacemaker designed primarily for temporary antibradycardia pacing therapy. The 53922 EPG cover accessory is an optional disposable protective cover to reduce accidental activation of the controls of the 5392 EPG.
The provided document is a 510(k) premarket notification for the Medtronic Model 5392 External Pulse Generator (EPG). This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a de novo study of a novel device's performance against specific acceptance criteria for a new clinical application.
Therefore, the requested information about acceptance criteria and a study proving a device meets them, particularly in the context of an AI/human comparative effectiveness study, ground truth establishment, and training/test set details, is not fully applicable or directly provided in this document. This submission is for a minor modification to an already cleared device.
However, I can extract the relevant information from the document regarding the modifications and the qualification that addresses those changes.
Here's an analysis based on the provided text, addressing what can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a table of acceptance criteria for the entire device or specific performance metrics in a clinical sense. Instead, it refers to acceptance criteria for the qualification of manufacturing process changes.
| Acceptance Criteria (for manufacturing process changes) | Reported Device Performance (regarding process changes) |
|---|---|
| Specified acceptance criteria for manufacturing process qualification | Results met the specified acceptance criteria. |
| Did not raise new safety or performance issues. | No new safety or performance issues were raised. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "devices manufactured with the updated cables and new routing" were evaluated. This likely refers to a manufacturing batch or a specific number of units undergoing testing related to the physical changes.
- Data Provenance: Not explicitly stated, but implicitly derived from an internal manufacturing qualification process by Medtronic, Inc. This would be considered retrospective in the sense that it's an internal validation of manufacturing changes, not new clinical data collection.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Number of Experts & Qualifications: Not applicable/not specified. The "ground truth" here is compliance with manufacturing specifications and ensuring the physical changes do not introduce new safety or performance issues. This would typically be assessed by engineering and quality assurance personnel against established internal standards, rather than clinical experts establishing a medical "ground truth."
4. Adjudication Method for the Test Set:
- Adjudication Method: Not applicable/not specified. The evaluation involved "qualification of the manufacturing process," which implies adherence to predefined manufacturing and quality control standards, rather than a subjective adjudication process by multiple individuals.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically for evaluating diagnostic imaging devices or AI algorithms used in clinical decision-making, often comparing human performance with and without AI assistance. The Medtronic Model 5392 EPG is a temporary pacemaker, and this submission is for a minor modification to its manufacturing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Performance Study: No. This device is not an AI algorithm. Its performance is inherent to its electromechanical function as a pacemaker, not a software algorithm providing independent analysis.
7. The Type of Ground Truth Used:
- Type of Ground Truth: The "ground truth" related to this submission is primarily adherence to engineering specifications, manufacturing quality standards, and safety requirements for the physical changes (cable routing and length). It's about ensuring the modified device functions as intended and meets established design and quality parameters, not a clinical ground truth like pathology or patient outcomes.
8. The Sample Size for the Training Set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the Ground Truth for the Training Set was Established:
- Ground Truth for Training Set Establishment: Not applicable. As there is no training set mentioned, this question is not relevant.
Summary of the K162550 Submission:
This 510(k) submission is for minor modifications to the Medtronic Model 5392 External Pulse Generator (EPG). The modifications are specifically related to the "routing and length of three internal cables." The purpose of the submission is to demonstrate that these minor changes do not alter the device's fundamental safety or effectiveness and that it remains substantially equivalent to the previously cleared version (K150246).
The "study" referenced is a qualification of the manufacturing process, which included "new fixtures." The key finding is that this qualification "met the specified acceptance criteria and did not raise new safety or performance issues," leading to the conclusion of substantial equivalence. This is a common type of submission for non-significant device changes and not a clinical performance study.
§ 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.