(334 days)
The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.
The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.
The provided text focuses on the 510(k) summary for the HighPak-12 Smart Battery, a rechargeable lithium battery intended for use in the LifePak-12 defibrillator. It primarily discusses the device's description, materials, and testing in the context of establishing substantial equivalence to predicate devices. However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific performance metrics requested.
Based on the provided information, I can extract the following:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states "Product testing was conducted to evaluate conformance to product specification." However, it does not provide a specific table of acceptance criteria with numerical targets or the detailed reported device performance against such targets.
It mentions the following testing categories:
- Electromagnetic Compatibility (EMC)
- Charging
- Discharging
- Proper fit and operation in the LifePak-12 Defibrillator
The statement "The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life" suggests a performance improvement in terms of amp-hours, but no specific acceptance criterion or quantitative measurement for "longer life" is given.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for testing (e.g., number of batteries tested).
It also does not mention data provenance (e.g., country of origin of the data, retrospective or prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not applicable to a battery performance test. Ground truth established by experts is typically relevant for diagnostic or image interpretation devices.
4. Adjudication Method for the Test Set:
This information is not applicable to a battery performance test, as there would be no subjective interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not applicable to a battery performance test. MRMC studies are used to evaluate human reader performance, often with AI assistance, for diagnostic tasks.
6. Standalone Performance Study (Algorithm Only):
This information is not applicable to a battery, which is a hardware component and not an algorithm. The testing described (EMC, charging, discharging, fit/operation) evaluates the physical device's performance.
7. Type of Ground Truth Used:
For the testing mentioned (EMC, charging, discharging, proper fit and operation), the "ground truth" would be the engineering specifications and functional requirements of the battery and the LifePak-12 defibrillator. For instance, for "charging," the ground truth would be that the battery charges successfully and within expected parameters according to its design and the defibrillator's charging mechanism. For "fit and operation," the ground truth would be seamless physical integration and successful power delivery to the defibrillator.
8. Sample Size for the Training Set:
This information is not applicable. Battery performance testing does not typically involve a "training set" in the context of machine learning or AI algorithms. The testing is for verifying hardware performance.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated above.
In summary, the provided K062331 document for the HighPak-12 Smart Battery outlines its intended use, design similarity to predicate devices, and general categories of testing performed (EMC, charging, discharging, fit/operation). However, it does not detail specific acceptance criteria with numerical values, sample sizes for testing, or information relevant to AI/algorithm performance studies, as these are not relevant for the type of device being described.
§ 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.