Search Results

The Sapphire Infusion pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products.

The Sapphire Infusion pump includes the following infusion modes for all intended uses: Continuous, Intermittent, TPN, PCA, Multi-step, and Epidural.

It is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home. The pump is intended to be used by both licensed health care professionals and by lay users.

The Sapphire and the administration sets are indicated for use by both adult and pediatric populations.

The dedicated Q Core administration sets for the Sapphire pump are intended for single-use only.

The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The SapphireInfusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial, perineural and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV medication, perineural medication, epidural medication, blood and blood products. The Sapphire Infusion 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 and lay users. The pump is intended to be used in the following environments of use: clinical, ambulatory, pre-hospital medical air and ground transportation and home use.

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

The pump software includes the following infusion modes, but any one can be disabled: Continuous, Intermittent, TPN (Total Parenteral Nutrition), PCA (Patient Controlled Analgesia), Multi-Step and Epidural.

The Sapphire Infusion Pump offers an optional preprogrammed drug library which can be programmed using an additional software program "Drug library editor". The preprogrammed range limits are associated with certain drugs and/or certain modes and/or certain care areas.

Sapphire Infusion Pump accessories include the mini cradle with IPS, PCA lock boxes (100, 250, and 500ml), PCA/PCEA bolus handle, battery charger, battery case for extra battery source, administrations sets, a backpack, multi-pump mounting bracket, and an AC adapter.

Updates included in this submission:

• 1. Addition of a new administration route Perineural Adding an administration route, Perineural, to the indications for use of the device. This update did not require any modification to the pump technology or design.
• 2. Additional updates (catchup changes) that did not change the basic functionality or technological characteristics of the pump or the administration sets
  • . Software (SW) - e.g., minor enhancements, back to spec corrections, cybersecurity enhancements including implementation of digital code signing, reorganization of alarm priorities and audio and visual alarm characteristics, addition of low battery alarm at 10 minutes, addition of air-in-line alarm off option.
  • Pump cradle (accessory) added ●
  • Administration sets, including sets with NRFit connectors. ●

This document is a 510(k) Summary for the Sapphire Infusion Pump and Sapphire administration sets. It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

Here's an analysis of the provided text to extract the requested information about acceptance criteria and the supporting study:

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

The document details various technological characteristics and their performance parameters, comparing the subject device to the predicate device. For many characteristics, the performance is stated as "Same," indicating it meets the established performance of the predicate. Where there are updates or new features, the testing confirms that safety and effectiveness are maintained.

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

The document does not specify sample sizes or data provenance for the individual bench tests or performance testing. It states that "Accuracy testing under anticipated environments of use and routes" was performed, and administration sets performance testing was done per ISO 80369-6:2016, but without details on sample size. Similarly, human factors studies were conducted with the "intended user population, use environment and use scenarios," but specific numbers are not provided. The testing is bench testing and human factors testing, not clinical studies involving patient data.

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 section is Not Applicable as the document discusses testing of a medical device (infusion pump and administration sets) for performance and safety characteristics, not a diagnostic algorithm where expert ground truth is typically required for image or data interpretation. The ground truth for performance testing is established by engineering specifications, regulatory standards (e.g., IEC, ISO), and risk analysis.

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

This section is Not Applicable. Adjudication methods like 2+1 or 3+1 refer to a consensus process among experts for establishing ground truth in diagnostic studies, which is not relevant to the performance and safety testing described for an infusion pump.

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 section is Not Applicable. The document describes a medical device (infusion pump) and its administration sets, not an AI-assisted diagnostic or treatment planning system. Therefore, MRMC studies or human reader improvement with AI are not relevant here.

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

This section is Not Applicable. The product is a physical device (infusion pump) with embedded software, not a standalone algorithm without human interaction. Performance testing was done on the device itself and its accessories.

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

The ground truth for the performance and safety testing of the Sapphire Infusion Pump and administration sets is based on several factors:

• Regulatory Standards: Compliance with established international standards such as IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (Alarms), IEC 62133-2 (Battery Safety), ISO 10993-11 (Biocompatibility), ISO 80369-6 (Administration sets performance, specifically for NRFit connectors), ASTM F2503-13 (MR Safety).
• FDA Guidance Documents: Compliance with FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Guidance for Industry, FDA Reviewers and Compliance on Off-the-Shelf Software Use in Medical Devices, Infusion Pumps Total Product Life Cycle, Applying Human Factors and Usability Engineering to Medical Devices, Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, and Reprocessing Medical Devices in Health Care Settings.
• Predicate Device Performance: The primary ground truth for many characteristics is the established safety and effectiveness of the previously cleared Sapphire Infusion Pump (K161667) and administration sets (K141389, K123049). The subject device demonstrates "Same" performance for a majority of parameters.
• Risk Analysis and Verification/Validation: For any new features or modifications (e.g., perineural route, 10-minute low battery alarm, option to disable air detection, mini cradle with IPS, NRFit connectors, sleeve removal, length/priming volume changes), the ground truth is established through internal risk analyses and subsequent verification and validation testing to confirm they do not introduce new questions of safety or effectiveness and meet their design requirements.

8. The sample size for the training set

This section is Not Applicable. The Sapphire Infusion Pump is a hardware device with controlling software, not an AI/ML model that undergoes a training phase with a specific dataset.

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

This section is Not Applicable for the same reasons as point 8.

Ask a specific question about this device

The dedicated Q Core administration sets for the Sapphire pump are intended for single-patient use and single-use only.

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 a set with new configuration, all within the parameters (e.g. length, diameters, materials) of the sets cleared with the Sapphire Infusion Pump. This new configuration is substantially equivalent to the administration sets that were cleared under K123049, having identical indications for use and technological characteristics. In addition, this set includes a pressure activated back check valve ("PAV") that has the same cracking pressure as the back check valve that was cleared with administration sets under K031749 (Bodyguard Infusion System). The PAV valve has been added to make it consistent with other sets on the market.

The provided text is a 510(k) summary for the Q Core Administration Set, indicating device clearance based on substantial equivalence to predicate devices. It describes the device, its intended use, and pre-clinical testing performed. However, it does not contain the specific acceptance criteria or the detailed results of a study designed to prove the device meets those criteria, as typically presented in a scientific publication.

The document states that "Preclinical testing included in the submission to demonstrate that the new administration set is safe and performs as intended involved the following: Visual tests, Dimensional testing, Physical requirements, Flow accuracy." It then concludes that the new administration set "is substantially equivalent... with respect to the indications for use, technological characteristics and materials."

Therefore, based only on the provided text, I cannot complete the table or answer the specific questions about acceptance criteria and a study demonstrating compliance. The document is a regulatory approval letter and summary, not a detailed scientific study report.

However, I can extract the information that is present and indicate what is missing based on your request:

1. Table of acceptance criteria and the reported device performance

• Indications for Use
• Technological Characteristics
• Materials
• Cracking pressure of the back check valve | - Passed Visual tests
• Passed Dimensional testing
• Passed Physical requirements
• Passed Flow accuracy

Conclusion: The new administration set is "substantially equivalent" to predicate devices K123049 (primary predicate) and K031749 (for back check valve cracking pressure). |

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

• Sample size used for the test set: Not specified in the provided document. The document only mentions "Preclinical testing" but does not detail the number of units tested for Visual, Dimensional, Physical, or Flow accuracy.
• Data provenance: Not specified. The document indicates Q Core Medical Ltd. is located in Netanya, ISRAEL, but does not state where the testing was conducted or the origin of the data.
• Retrospective or prospective: Not specified.

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 not present in the document. The testing described (Visual, Dimensional, Physical, Flow accuracy) for an administration set does not typically involve expert review for "ground truth" establishment in the manner of medical image analysis or clinical diagnosis. These are engineering and performance tests against specifications.

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

• Not applicable/Not specified. Adjudication methods like "2+1" are typically used in clinical studies or expert reviews to resolve discrepancies, which isn't described for the preclinical engineering tests mentioned.

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 document describes a medical device (infusion administration set) that does not involve "human readers" or "AI assistance" in its direct function. It is a physical medical component, not a diagnostic or AI-powered system.

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

• Not applicable. This is not an algorithm-based device.

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

• For the preclinical testing mentioned (Visual, Dimensional, Physical, Flow accuracy), the "ground truth" would be the engineering specifications and performance standards for the device, and compliance with these standards (or equivalence to predicate device performance) would be the measure. No expert consensus, pathology, or outcomes data is mentioned as ground truth for these tests.

8. The sample size for the training set

• Not applicable. This device does not use a "training set" in the context of machine learning or AI development.

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

• Not applicable. This device does not use a "training set."

Ask a specific question about this device