(198 days)
The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intraarterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, V medication, epidural medication, blood and blood products.
The Sapphire pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.
The pump is intended to be used by both licensed health care professionals in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical ground transportation.
The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.
The enhanced Sapphire Infusion Pump with and without the WiFi capability is the result of modifications to the FDA cleared Sapphire Infusion pump (K123049). The modifications are the addition of WiFi to allow the pump to communicate wirelessly with compatible systems and additional Software enhancements. There are no changes to the basic infusion pump technology.
The Q Core Sapphire infusion pump is a single-channel, volumetric infusion pump that is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. It is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, epidural medication, blood and blood products and includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural. The pump has alarms for occlusions, air in the line, administration set installment issues, and internal battery issues. The Pump includes software and is powered by an external power source or by an internal battery. It is intended to be used by both licensed health care professionals in the clinical environment, and home users in an ambulatory environment. The Sapphire pump is designed to follow the patient through the various care areas, and is suitable for use in the different settings.
The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single- use and single-patient use only. Components from the previously cleared administration sets were used to make sets with new configurations, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. These new configurations are substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics.
Here's a breakdown of the acceptance criteria and study information for the Q Core Medical Sapphire Infusion Pump, based on the provided text:
Important Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical trial report with specific acceptance criteria and performance metrics for a novel AI algorithm. Therefore, the information that can be extracted will primarily relate to engineering and software validation, not necessarily a human-in-the-loop AI effectiveness study as might be expected for an AI-powered diagnostic device.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for an infusion pump with WiFi enhancements, the "acceptance criteria" discussed are primarily related to safety, performance against established standards, and equivalence to a predicate device, rather than diagnostic accuracy metrics typically seen in AI studies.
| Acceptance Criteria / Test Performed | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety per IEC 60601-1 | Device underwent testing to demonstrate compliance. Implies successful compliance with the standard for electrical safety in medical electrical equipment. |
| EMC testing per IEC 60601-1-2 | Device underwent testing to demonstrate compliance. Implies successful compliance with the standard for electromagnetic compatibility in medical electrical equipment. |
| Software Verification and Validation (per FDA Guidance May 11, 2005) | Device underwent testing to demonstrate safety and performance as intended. Implies that the software meets the specified functional, performance, and safety requirements. |
| Human Factors Testing | Device underwent testing. Implies that the device's design is user-friendly and minimizes use errors. |
| FCC Testing | Device underwent testing. Implies compliance with Federal Communications Commission regulations for electromagnetic interference, especially relevant for the new WiFi functionality. |
| Administration Set Shelf Life Testing | Administration sets underwent testing. Implies that the sets maintain their integrity and functionality over their specified shelf life. |
| Substantial Equivalence to Predicate Sapphire Infusion Pump (K123049) | Determined to be substantially equivalent with respect to: - Indications for use |
- Basic infusion pump hardware/mechanism
- Delivery modes
- Safety features
(Modifications: addition of WiFi, additional software enhancements. No changes to basic infusion pump technology.) |
| Substantial Equivalence to Plum A+® Infusion System with Hospira MedNet™ Software (K042081) | Determined to be substantially equivalent with respect to the WiFi function (both have WiFi function). |
| Substantial Equivalence of New Q Core Administration Sets to those cleared under K123049 | Determined to be substantially equivalent with respect to: - Dedicated use with Q Core pumps - Indicated for intravenous infusion
- Prescription use
- Standard, conventional components
- Same material characteristics (biocompatible, non-DEHP, latex-free)
- Same free flow protection (cassette with AFFV)
- Sterile, non-pyrogenic, single patient/use
- Intended for hospital or home use |
2. Sample Size Used for the Test Set and the Data Provenance
This document does not specify a "test set" in the context of an AI algorithm's performance on clinical data samples. The testing described is primarily engineering and software validation. Therefore, details like data provenance or sample size for a clinical test set are not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as the document describes validation for an infusion pump, not an AI diagnostic or prognostic device requiring expert-established ground truth from clinical data.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
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
This information is not applicable as the document describes validation for an infusion pump, not an AI-powered diagnostic product that would typically involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
While the pump contains software and the new functionality is WiFi to communicate wirelessly, the document describes the entire device (hardware and software) as the subject of the submission. It's not a standalone AI algorithm in the typical sense. The "Software Verification and Validation" constitutes testing of the algorithm/software within the device, but it's not described as a separate "standalone" performance study on clinical data.
7. The Type of Ground Truth Used
For the software and engineering validation tests listed:
- Electrical Safety, EMC, FCC Testing, Shelf Life: Ground truth is established by the specified international standards (IEC 60601-1, IEC 60601-1-2) or internal quality control specifications for the administration sets.
- Software Verification and Validation: Ground truth is established by the device's functional and performance requirements specifications, as well as the FDA Guidance for medical device software.
- Human Factors Testing: Ground truth relates to usability standards and the ability of users to operate the device safely and effectively, typically assessed through user studies.
There is no mention of "expert consensus, pathology, or outcomes data" as ground truth in this submission, as it's not a diagnostic device.
8. The Sample Size for the Training Set
This information is not applicable. The device described is an infusion pump with software, not a machine learning model that undergoes "training" on a dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above.
§ 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).