(70 days)
The Switched Internal Paddles are intended for use with HeartStart defibrillators to defibrillate the heart during open-chest surgical procedures.
The Switched Internal Paddles are used for defibrillation during open-chest (intrathoracic) procedures. These paddles have a shock button located on the right-hand paddle shown in Figure 5-1. This shock button allows the user to deliver a defibrillation shock holding the paddles to discharge the defibrillator remotely. The reusable switched internal paddles are shipped non-sterilized by the health care provider prior to each patient use. These switched internal paddles are accessories to compatible Philips HeartStart Defibrillators as detailed in Table 5-1, and are identified by the M47xxA series model numbers (where "xx" is a variable integer), as listed below in Table 5-1. These paddles can be used on adult and pediatric populations per the indications for use of the compatible defibrillators.
The information provided describes the acceptance criteria and study proving the device meets those criteria for the Philips Switched Internal Paddles.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance (Meets Specifications?) |
|---|---|---|
| System Level Performance | System level device specifications, hardware testing | Test results confirmed Switched Internal Paddles meet specifications. |
| Compliance with IEC 60601-1:2005/(R)2012+A1:2012 | Confirmed compliance. | |
| Compliance with IEC 60601-2-4:2010/AMD1:2018 | Confirmed compliance. | |
| Biocompatibility | Cytotoxicity (ISO 10993-5:2009) | Met acceptance criteria. |
| Sensitization (ISO 10993-10:2010) | Met acceptance criteria. | |
| Irritation or intra-cutaneous reactivity (ISO 10993-10:2010) | Met acceptance criteria. | |
| Acute Systemic Toxicity (ISO 10993-11:2017) | Met acceptance criteria. | |
| Material Mediated Pyrogenicity (ISO 10993-11:2017) | Met acceptance criteria. | |
| Cleaning and Sterilization | Cleaning validation (per narrowed instructions) | Ensured device is as safe and effective as predicate. |
| Sterilization validation (per narrowed instructions) | Ensured device is as safe and effective as predicate. | |
| Compliance with ISO 17665-1:2013 | Confirmed compliance. | |
| Electrical Safety | Compliance with ES60601-1:2005/(R)2012+A1:2012 | Confirmed compliance. |
| Compliance with IEC 60601-2-4:2010 | Confirmed compliance. | |
| Electromagnetic compatibility impact | Modifications did not impact EMC. | |
| Usability | Usability testing for narrowed cleaning/sterilization instructions | Confirmed device is substantially equivalent when used per modified instructions for use. |
| Compliance with ANSI AAMI HE75:2009/(R) 2018 | Confirmed compliance. | |
| Compliance with FDA Guidance for Human Factors & Usability | Confirmed compliance. | |
| Labeling | Labeling verification testing | Test results confirmed compliance. |
2. Sample Size Used for the Test Set and Data Provenance:
- Usability Testing: 15 participants (11 sterile processing technicians and 4 surgical technicians).
- Biocompatibility Testing: "Extra Large Switched Internal Paddles with the largest surface area (Model No. M4741A)" were used to simulate a worst-case scenario. The exact number of units tested is not specified, but it implies a single model for testing.
- Other Bench Testing (Hardware, Electrical Safety, Cleaning/Sterilization Validation, Labeling Verification): The sample sizes for these tests are not explicitly stated in the provided text.
- Data Provenance: Not specified, but likely proprietary internal testing given the nature of the submission for product modifications. It's not explicitly stated as retrospective or prospective, but performance testing is inherently prospective for the modified product. No country of origin is mentioned for the data itself, but the submission is to the U.S. FDA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Usability Testing: The "experts" in this context are the 15 participants in the usability study: 11 sterile processing technicians and 4 surgical technicians. Their qualifications are implied by their roles in a hospital setting (operating room and central processing/sterilization room). No further detail on their specific years of experience or board certification is provided.
- Other Testing: The ground truth for bench tests (biocompatibility, electrical safety, cleaning/sterilization, hardware) is established by adherence to recognized international and national standards (e.g., ISO 10993, IEC 60601, ISO 17665, ANSI AAMI HE75). The "experts" are the engineers and scientists conducting these tests and interpreting results against these standards. Specific numbers or qualifications are not detailed.
4. Adjudication Method for the Test Set:
- Not applicable in the traditional sense for this type of submission. The tests performed are objective measurements against established engineering and biological standards, or observations of user interaction with predefined tasks in usability. There is no mention of a human expert panel adjudicating test results or ground truth in the way it might be done for an AI diagnostic algorithm.
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:
- No MRMC comparative effectiveness study was done. This document describes a K203231 510(k) submission for "Switched Internal Paddles," which is a physical device (defibrillation electrodes) and not an AI diagnostic algorithm or a system requiring human-reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device is a physical medical device (defibrillation paddles). There is no "algorithm only" component or AI involved. The document explicitly states: "The modified Switched Internal Paddles do not use software for its function nor required any software modifications for compatibility with the HeartStart Defibrillators; therefore, software testing is not applicable for this submission."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Ground truth is established by the results of standardized biological tests (e.g., cytotoxicity, sensitization, irritation) against predefined acceptable limits specified in ISO 10993 standards.
- Electrical Safety & Hardware Performance: Ground truth is established by objective measurements verifying compliance with specified engineering requirements and international safety standards (e.g., IEC 60601 series).
- Cleaning & Sterilization Validation: Ground truth is established by verifying the effectiveness of the reprocessing methods through standardized microbiological and chemical tests to ensure sterility and material integrity after reprocessing, as per ISO 17665-1 and other relevant standards.
- Usability: Ground truth is established by observing user interaction with the device following the modified instructions, assessing their ability to safely and effectively use the device, and identifying any potential use errors, against human factors engineering principles (ANSI AAMI HE75) and FDA guidance.
8. The sample size for the training set:
- Not applicable. This device is a physical medical device, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device.
§ 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.