(56 days)
Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP This battery will be shipped to biomedical equipment technicians and or customers who request a replacement battery for the particular device(s) listed above
Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Medfusion 2001 & 2010 replacement battery pack:
Based on the provided FDA 510(k) letter (K012259), the primary "study" performed is a demonstration of substantial equivalence to a legally marketed predicate device. This is a regulatory pathway for low-to-moderate risk medical devices and does not typically involve the detailed performance studies common for novel devices or AI/ML-driven software.
Therefore, many of the requested categories (like sample size for test sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance, training sets) are not applicable in the context of this 510(k) submission for a replacement battery pack, as it is a component demonstrating substantial equivalence rather than a novel diagnostic or therapeutic device.
The "acceptance criteria" here are largely implicit in the FDA's decision about substantial equivalence, meaning the new device performs as safely and effectively as a predicate device without raising new questions of safety or effectiveness. For a battery pack, this mainly revolves around physical specifications, electrical compatibility, and safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred from Substantial Equivalence) | Reported Device Performance (Inferred from Submission) |
|---|---|
| Functional Equivalence: Compatible with Medfusion 2001 & 2010 Infusion Pumps. | "Replacement battery pack for MEDFUSION, INC. 2001 & 2010 INFUSION PUMP." |
| Safety: Does not introduce new safety concerns compared to the original battery. | (Implicit in 510(k) clearance) |
| Performance: Provides equivalent power and duration as the original battery. | (Implicit in 510(k) clearance) |
| Material/Design Equivalence: Similar materials and design to the original battery. | (Implicit in 510(k) clearance) |
Note: The letter explicitly states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This is the core "acceptance criteria" and "performance" in this context. The detailed technical specifications that support this substantial equivalence are not contained within this letter.
2. Sample size used for the test set and the data provenance
- Not Applicable. The provided document is an FDA clearance letter for a 510(k) submission based on substantial equivalence for a replacement battery pack. This pathway typically does not involve clinical "test sets" in the way a diagnostic AI/ML device would. The "tests" performed would be engineering bench tests for compatibility, electrical performance, and safety, comparing the new battery to the original or predicate battery. The details of these tests (sample sizes, specific data provenance) are not included in this summary letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, the concept of "ground truth" and expert adjudication for a battery pack's performance is not relevant in the way it is for diagnostic algorithms. Engineering and safety testing typically relies on validated measurement instruments and standards.
4. Adjudication method for the test set
- Not Applicable. See points 2 and 3.
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 replacement battery pack, not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm.
7. The type of ground truth used
- Not Applicable. For a battery pack, "ground truth" would be established by objective physical and electrical measurements against predefined specifications and existing predicate device performance, not expert consensus or pathology.
8. The sample size for the training set
- Not Applicable. This device does not involve a "training set" as it is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).