(85 days)
The External Power Source (EPS) System is designed to provide an alternative source of power for the following Deltec Pumps: CADD-1 , CADD-PCA , CADD-PLUS*, CADD-TPN*, and CADD-Prizm™ ambulatory infusion pumps.
The External Power Source (EPS) System is comprised of a rechargeable power pack, AC adaptor, battery adaptor, notched battery door, and replacement battery pack for the power pack. The EPS System was developed as an alternate power source to 9 volt batteries for various CADD pumps Deltec manufactures. The EPS System is designed for use with CADD-1 pump, CADD-PLUS pump, CADD-PCA (Models 5800 and 5800R) pumps, and the CADD-Prizm™ pump. An alternate rechargeable power pack with replaceable nickel-metal hydride (NiNH) batteries has been developed and the subject of this 510(k) Notification.
This submission is for a battery pack, not an AI/ML device. Therefore, the requested information regarding acceptance criteria, study design for AI/ML performance, and related metrics is not applicable. The provided text describes a 510(k) premarket notification for an "External Power Source (EPS) System, Alternate Power Pack (nickel-metal hydride)" and focuses on demonstrating its equivalence to an existing nickel-cadmium battery pack and its functional performance as a power source.
Here's an analysis of the provided information, noting the aspects that are applicable and those that are not for an AI/ML device:
1. A table of acceptance criteria and the reported device performance
- Applicable Information: The document doesn't explicitly state "acceptance criteria" in a tabled format as one would for an AI/ML device (e.g., target specificity, sensitivity). Instead, it relies on a comparison table of features and functional testing against a guidance document.
- Reported Device Performance:
- Battery Chemistry: nickel-metal hydride
- Rechargeable Power Pack: YES
- Replaceable Battery Pack: YES
- Low Battery Alarm: YES
- Ready Indicator Lights: YES (this is a difference from the predicate, which had "NO")
- Operating Temperature: 2°C to 40°C
- Weight: ≈570 g
- Functional Testing Outcome: "Based upon the testing that was conducted, the power pack with NiMH batteries performed as intended and within specification." (This broadly states it met the functional requirements).
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable (AI/ML context): This device is a hardware component (battery pack). There is no "test set" in the sense of a dataset for AI/ML evaluation. The evaluation involved functional testing of the actual battery pack hardware.
- Applicable (Hardware context): The document does not specify the number of units tested for functional performance. Data provenance isn't relevant for this type of hardware testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: No "ground truth" establishment by experts is described for a battery pack in the context of diagnostic accuracy. Functional testing for a battery would involve engineering and performance specifications, not expert consensus on interpretations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are relevant for resolving discrepancies in expert interpretations in clinical or imaging studies, which is not the nature of this device's evaluation.
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: MRMC studies are for evaluating the impact of an AI system on human reader performance, typically in diagnostic imaging. This device is a power supply and has no interaction with human diagnostic interpretation or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This refers to the performance of an AI algorithm alone. The device is a battery pack, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable (AI/ML context): The concept of "ground truth" for a battery pack's functional testing would relate to engineering specifications and physical measurements (e.g., voltage output, charge retention, temperature stability).
8. The sample size for the training set
- Not Applicable: There is no "training set" for an AI/ML model for this device.
9. How the ground truth for the training set was established
- Not Applicable: As there is no training set, this question is not relevant.
Summary specific to this K960957:
The submission describes a functional performance study of a hardware device (battery pack). The "acceptance criteria" for this device are implicitly tied to:
- Equivalence to Predicate Device: Matching key features and performance characteristics of the previously cleared NiCad battery pack (Table 1).
- Compliance with Guidance: Performing "in accordance with the Rechargeable Battery Preliminary Guidance for Data to be Submitted to the Food and Drug Administration in Support of Premarket Notification Applications (January 1994)."
- Performance as Intended: The general statement that "the power pack with NiMH batteries performed as intended and within specification."
No AI/ML-specific study design or performance metrics are present or relevant in this 510(k) summary.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).