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The Q Core Sapphire infusion pump is intended for the controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV 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-patient use and single-use only.

The Q Core Sapphire infusion pump the result of modifications to the FDA cleared AP 34 Infusion pump (K082182). The modifications were changes to the user interface and additional functions that include new delivery modes and the Drug Library feature. There are no changes to the basic infusion pump technology. Like its predicates, the Sapphire 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 alams 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 in pre-hospital medical ground transportation.

The dedicated Q Core Administration Sets for the Sapphire infusion pump are provided sterile and are for single-patient use and single use only.

This document, K123049, is a 510(k) summary for the Q Core Sapphire Infusion Pump System. It details the device description, indications for use, technological characteristics, and pre-clinical testing performed to establish substantial equivalence to predicate devices. The document does not contain acceptance criteria for specific performance metrics or detailed study results that "prove the device meets the acceptance criteria" in the way one might expect for a diagnostic or AI-driven device with defined sensitivity/specificity targets.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices through a series of pre-clinical tests and comparisons of technical characteristics.

Here’s a breakdown of the information based on your request, highlighting what is (and isn't) present in this 510(k) summary:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria with reported performance values in terms of specific sensitivity, specificity, accuracy, or similar quantitative metrics for a diagnostic claim. The "performance" is demonstrated through compliance with recognized standards and comparison to predicate devices, rather than a direct measurement against a predefined criterion table.

The preclinical testing section lists the types of tests performed and the standards they adhere to. These standards implicitly contain acceptance criteria that the device must meet, but the specific numerical results of these tests (e.g., how accurate the pump was in terms of percentage deviation) are not included in this summary.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the 510(k) summary. The document describes the types of preclinical tests performed (e.g., electrical safety, pump accuracy), but does not detail sample sizes for these tests or the provenance of any data used. This is typical for submissions focused on mechanical/electronic device performance and compliance with a standard, rather than clinical efficacy studies.

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)

This information is not applicable and therefore not provided. This 510(k) summary is for an infusion pump, which is a hardware device for drug delivery, not a diagnostic device that requires expert adjudication for ground truth (e.g., medical imaging analysis). The performance evaluation relies on engineering tests against established standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and therefore not provided. As explained above, this is not a diagnostic device involving expert consensus.

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 and therefore not provided. An infusion pump does not involve human readers interpreting data, nor does it incorporate AI in a way that would lead to an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable and therefore not provided. The device is a physical pump, not an algorithm, so a standalone algorithm performance study is irrelevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the tests mentioned (e.g., pump accuracy, electrical safety) would be established by the specifications and criteria outlined in the respective IEC and ISO standards. For example, for pump accuracy, the ground truth would be the expected flow rate vs. the measured flow rate within acceptable deviations defined by IEC 60601-2-24. This is a technical specification compliance model, not a clinical "ground truth" derived from patient data or expert consensus.

8. The sample size for the training set

This information is not applicable and therefore not provided. The Q Core Sapphire Infusion Pump is not an AI/ML-driven device that utilizes a training set in the conventional sense.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided, as there is no training set for this type of device.

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