(264 days)
The Sterilizable Internal Defibrillation Paddles are intended for use with LIFEPAK defibrillators to internally detect ECG rhythm and provide defibrillation or synchronized cardioversion directly to the surgically exposed heart within a sterile use environment.
Defibrillation is indicated for the termination of certain potentially fatal arrhythmias, such as ventricular fibrillation and symptomatic ventricular tachycardia.
Synchronized cardioversion is indicated for the treatment of atrial fibrillation, atrial flutter, paroxysmal supraventricular tachycardia, supraventricular tachycardia, and in relatively stable patients, ventricular tachycardia.
The Sterilizable Internal Defibrillation Paddles is an accessory designed to be used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. The Sterilizable Internal Defibrillation Paddles are intended for use by highly-trained medical professionals to internally detect electrocardiogram (ECG) rhythm and deliver internal defibrillation and synchronized cardioversion therapy directly to the surgically exposed heart. This accessory consists of metal paddle electrodes, and molded plastic handles with discharge control (located on the right handle) which connects directly to the defibrillator.
The Sterilizable Internal Defibrillation Paddles accessory requires sterilization before initial use and after each use, per the Sterilizable Internal Defibrillation Paddles Instructions for Use.
The provided text describes a 510(k) premarket notification for Sterilizable Internal Defibrillation Paddles. It's important to clarify that this document is for a medical device (hardware), not an AI/ML algorithm. Therefore, many of the typical questions for AI/ML device acceptance criteria and study design (like ground truth, expert adjudication, MRMC studies, training/test set sizes) are not directly applicable in the same way.
Instead, the acceptance criteria for such a device typically revolve around demonstrating substantial equivalence to a predicate device, as well as meeting established safety and performance standards through design verification and validation.
However, I will extract the information that is comparable or relevant to your questions, and specify where the requested information is not applicable for this type of device.
Acceptance Criteria and Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to the predicate device and meeting design specifications related to safety and performance.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | The device's intended use (internally detect ECG rhythm, defibrillation/synchronized cardioversion directly to surgically exposed heart in a sterile environment) must be equivalent to the predicate device. | The "Indications for Use" and "Intended Use" are stated to be equivalent to the predicate device. The device is used with biphasic LIFEPAK defibrillator/monitors during open heart cardiac surgery. |
| Functional Equivalence | Features and functional characteristics must be equivalent to the predicate device, despite material/design changes (integrated handle-electrode assembly, improved durability/resistance to cleaning/sterilization). | The "features, and functional characteristics of the proposed Sterilizable Internal Defibrillation Paddles are equivalent to the predicate device." The changes (integrated assembly, material for durability/sterilization) "have not raised any new issues when compared to the existing predicate devices." |
| Design Verification | All established design specifications (including those related to electrical performance, mechanical integrity, material properties, and sterilization efficacy) must be met. | "Design Verification Testing" was completed to "demonstrate that the proposed Sterilizable Internal Defibrillation Paddles meet the safety and performance requirements established in the design specifications." |
| Biocompatibility | The materials in contact with human tissue must be biocompatible. -------------------- | "Biocompatibility Testing" was completed to demonstrate safety. |
| Electrical Safety & EMC | The device must meet electrical safety standards and electromagnetic compatibility requirements. -------------------- | "Electrical Safety and Electromagnetic Compatibility Testing" was completed. |
| Design Validation | The device must perform effectively and safely under simulated use conditions and, where applicable, in animal models, consistent with its intended clinical application. -------------------- | "Design Validation Testing" was completed, described as including "Animal Testing" and "Simulated Use Testing." |
| No New Safety/Efficacy Issues | There must be no new questions of safety or effectiveness raised by the device compared to the predicate. -------------------- | The submission concludes that the information "demonstrates that the Sterilizable Internal Defibrillation Paddles are substantially equivalent to the predicate Internal Defibrillation Handles and Electrodes with respect to performance," implying no new safety or efficacy issues. |
Non-Applicable / General Information for Hardware Devices
The following questions are primarily relevant to AI/ML software performance studies and are not directly applicable to this hardware device's 510(k) submission as described.
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a hardware device in the context of AI/ML test sets. Performance testing for hardware involves laboratory, animal, and simulated use testing, not "test sets" of data in the AI/ML sense. Data sources for such tests are internal (e.g., test benches, animal studies).
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI/ML test set is not a concept used for this type of hardware device's testing.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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 a hardware device, not an AI assistance tool for human readers.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an accessory to a defibrillator and requires a highly-trained medical professional for use. It is a human-operated device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. The "ground truth" for a hardware device means meeting its engineering and safety specifications, and performing its intended function.
- 8. The sample size for the training set: Not applicable for hardware.
- 9. How the ground truth for the training set was established: Not applicable for hardware.
Summary of Device-Specific Study Information (Performance Data)
The submission highlights that no human clinical studies were submitted as part of this 510(k) Premarket Notification. This is typical for devices seeking substantial equivalence where predicate device experience or non-clinical data is deemed sufficient.
The performance data that supports the acceptance criteria for this hardware device includes:
- Design Verification Testing: To ensure the device meets established design specifications.
- Biocompatibility Testing: To ensure materials are safe for biological contact.
- Electrical Safety and Electromagnetic Compatibility Testing: To ensure the device operates safely within electrical and electromagnetic parameters.
- Design Validation Testing: Which encompassed:
- Animal Testing: To evaluate performance in a living biological system.
- Simulated Use Testing: To assess performance under conditions mimicking clinical use.
§ 870.5300 DC-defibrillator (including paddles).
(a)
Low-energy DC-defibrillator —(1)Identification. A low-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of a maximum of 360 joules of energy used for defibrillating (restoring normal heart rhythm) the atria or ventricles of the heart or to terminate other cardiac arrhythmias. This generic type of device includes low energy defibrillators with a maximum electrical output of less than 360 joules of energy that are used in pediatric defibrillation or in cardiac surgery. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class II (performance standards).(b)
High-energy DC-defibrillator —(1)Identification. A high-energy DC-defibrillator is a device that delivers into a 50 ohm test load an electrical shock of greater than 360 joules of energy used for defibrillating the atria or ventricles of the heart or to terminate other cardiac arrhythmias. The device may either synchronize the shock with the proper phase of the electrocardiogram or may operate asynchronously. The device delivers the electrical shock through paddles placed either directly across the heart or on the surface of the body.(2)
Classification. Class III (premarket approval).(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a DC-defibrillator (including paddles) described in paragraph (b)(1) of this section that was in commercial distribution before May 28, 1976. Any other DC-defibrillator (including paddles) described in paragraph (b)(1) of this section shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.