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510(k) Data Aggregation
(412 days)
Sapphire Infusion Pump, Sapphire administration sets
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:
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- 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.
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- 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.
| Acceptance Criteria (Technological Characteristic) | Reported Device Performance | Comments / Supporting Information |
|---|---|---|
| Real-time display | Same | NA |
| Microcomputer controlled pump | Same | NA |
| Internal clock | Same | NA |
| Administration Set | Same | NA |
| Air-in-line sensor | Same | NA |
| Occlusion sensor | Same | NA |
| Temperature Sensor | Same | NA |
| Number of Channels | 1 | NA |
| History Log | Yes | NA |
| Battery/Low, Depleted | Same, with the addition of a low battery alarm at 10 minutes. | No effect on the pump safety or effectiveness. The new alarm was verified and validated as part of Software V&V and meets IEC 60601-1-8 requirements. |
| Pump in stop mode (unattended) | Same | (see Note #1 below, though Note 1 refers to the battery alarm. This likely refers to a previous note not fully captured, or implies it maintains parity with predicate). |
| High pressure (Upstream/Downstream Occlusion) | Upstream -0.4bar, Downstream 1.2 bar | NA (Same as predicate) |
| Pump Fault | Same | NA |
| Low volume in medication reservoir | Same | NA |
| Cassette detachment /misplaced/door open | Same | NA |
| Air-in-line | Same | NA |
| Flow Error | Same | NA |
| Key stuck | Same | NA |
| End-of-Infusion | Same | NA |
| Programmable End-of-Infusion alarm | Same | NA |
| High Internal Temperature | Same | NA |
| Delivery Mode | Same | NA |
| Infusion Options | Same | NA |
| Security and/or Lock Levels | Same | NA |
| Demand Dose Lockout | Same | NA |
| Delivery Limit | Yes, with option to disable by technician | No effect on the pump safety or effectiveness (see discussion # Note 2 below for details on why this doesn't raise new questions). |
| Air Detection | Yes, with option to disable by technician | No effect on the pump safety or effectiveness (see discussion # Note 2 below for details on why this doesn't raise new questions). This modification was implemented after risk analysis and review of similar cleared devices; verified and validated via SW V&V and Human Factors tests. |
| Piggy back/Secondary | Same | NA |
| Delayed Start | Same | NA |
| Flow rate accuracy | Ave: 2.5% (-3.6% at 5-15°C to +3.5% at 30-40°C) | Same as predicate. |
| Minimum Continuous Delivery Rate | 0.1 mL/hr | Same |
| Maximum Continuous Delivery Rate | 999 mL/hr | Same |
| Minimum Intermittent Delivery Rate | 0.1 mL/hr | Same |
| Maximum Intermittent Delivery Rate | 999 mL/hr | Same |
| Minimum PCA Delivery Rate | 0 mL/hr | Same |
| Maximum PCA Delivery Rate | 99.9 mL/hr | Same |
| Minimum TPN Delivery Rate | 0.1 mL/hr | Same |
| Maximum TPN Delivery Rate | 600 mL/hr | Same |
| Minimum Epi Delivery Rate | 0.1 mL/hr | Same |
| Maximum Epi Delivery rate | 200 mL/hr | Same |
| Patient Demand Dose | Yes | Same |
| Bolus Accuracy | Ave: 2.5% (-7.5% to 7.5% at 0.1mL/h) | Same as predicate. |
| Maximum Patient Demand Dose | 20 mL | Same |
| Clinician Bolus | Yes | Same |
| Maximum Clinician Bolus | 30 mL | Same |
| Maximum Epidural Hourly Volume | 60 mL/hr | Same |
| Maximum Boluses per Hour | 60 per hour / 60 per 4 hours | Same |
| KVO | Yes | Same |
| KVO Rate | 0 - 20 mL/hr or the actual rate, whichever is lower | Same |
| Reservoir volume | 0.1 to 9999 mL | Same |
| Dose lockout time | Yes | Same |
| Dose per Hour Limit | Yes | Same |
| Delivery Limit | Yes | Same |
| Programmable Maximum Delivery Rate (Continuous Rate and Bolus) | Yes | Same |
| Administration sets (Q Core supplied) | Same | NA |
| AC adapter | Same | NA |
| Remote Dose Cord | Same | NA |
| Reservoir enclosure (Lockbox) | Same (100, 250, 500) | NA |
| Pole mount (Mini Cradle) with embedded power supply | (New accessory) | Does not raise different questions of safety or effectiveness. Tested for performance with the pump to meet Electrical Safety (IEC 60601-1) and EMC (IEC 60601-1-2 and IEC 61000). |
| Pump Pouch | Same | NA |
| Multi-pump mounting bracket | Same | NA |
| Battery case | Same | NA |
| Electrical Safety | Compliant with IEC 60601-1 | Same as predicate. |
| Electromagnetic compatibility | Compliant with IEC 60601-1-2 | Same as predicate. |
| Pump Size | 143 x 96 x 49 mm (5.63 x 3.78 x 1.93 inches) HxWxD | Same |
| Pump Weight | 518 g (18.27 oz.), including battery | Same |
| Power Sources | Rechargeable Li-Ion Battery 7.4V/1960 mAh; AC adapter Input: 100-240 AC; 50-60 Hz | Same |
| Operating Environment (Temperature) | +5°C to 40°C (41°F to 104°F) | Same |
| Operating Environment (Relative Humidity) | 15% to 95% | Same |
| Storage Environment (Temperature) | - 40°C to + 70°C (-40°F to 158°F). | Same |
| Storage Environment (Relative Humidity) | 15% to 95% | Same |
| Administration Sets (NRFit connector) | Added NRFit connectors | Verification and validation of the connectors concluded that this modification does not alter their safety and effectiveness (ISO 80369-6:2016 compliant). |
| Administration Sets (Sleeve removal) | Sleeve removed | Verification and Validation of the sets performance concluded that this modification did not alter their safety and effectiveness. |
| Administration Sets (Length and priming update) | Length: Up to 300 cm (from 280 cm); Priming volume: Up to 30 ml (from 20 ml) | Verification and Validation of the sets performance concluded that this modification has no implication on the safety and effectiveness. |
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.
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