(284 days)
The Q Core Sapphire Infusion Pump is intended for 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 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 in a clinical environment, and home users in an ambulatory environment and in pre-hospital medical air and ground transportation.
The dedicated Q Core administration sets for the Sapphire Infusion Pump are intent use and singleuse only.
The Q Core Sapphire Infusion Pump is a single-channel, volumetric infusion pump. The Sapphire Infusion Pump is intended for controlled delivery through intravascular, subcutaneous, intra-arterial and epidural routes. The pump is designed to deliver fluids such as Normal Saline, Total Parenteral Nutrition (TPN), lipids, IV 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 in the clinical environment, and home users in an ambulatory environment. The Sapphire Infusion 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 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.
The Q Core Sapphire Infusion Pump includes Wiff functionality that is compatible with MedNet. The WiFi feature can be turned on or off, via an authorized Technician. As such, the Sapphire Infusion Pump is available with and without the WiFi functionality.
Sapphire Infusion Pump accessories include the mini cradle, 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.
The modifications are the expansion of the pre-hospital medical transport environment to include another means of medical transport (air), an additional cleaning and disinfection agent, additional Software enhancements and additional accessories.
The provided text describes a 510(k) premarket notification for the Sapphire Infusion Pump (K161667). This submission is for modifications to a previously cleared device (K141389). Therefore, the study focuses on demonstrating substantial equivalence rather than a new device meeting specific acceptance criteria in a comparative effectiveness study.
Here's an analysis of the acceptance criteria and study information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in the traditional sense of a clinical trial or performance study for a novel device. Instead, it details that the modified device maintains substantial equivalence to its predicate device. The acceptance criteria are implicitly that the modified device's performance, especially for the new features/environments, should be comparable to or meet the safety and effectiveness standards of the predicate device and relevant industry standards.
The table in the document (pages 5-6) is a comparison between the Predicate Device (K141389) and the Subject Device (K161667), highlighting similarities and differences. The "Reported Device Performance" for the subject device is implied to be "Same" as the predicate for most attributes, or "Supported by literature and/or bench testing/validation" for differences.
Here's a restructured table based on the information provided, focusing on changes and how they meet criteria (implicitly, the criteria are "equivalent to predicate" or "validated"):
| Acceptance Criteria (Implied) | Reported Device Performance (K161667) |
|---|---|
| Indications for Use: Expanded to include medical air transport. | Validated through testing for the additional environment. Does not alter original indications or intended use. |
| Max Clinician Bolus: New maximum of 30 mL. | Supported by literature and reference device (K111275 CADD®-Solis VIP). |
| Max Epidural Hourly Volume: New maximum of 60 mL. | Supported by literature references. |
| Additional Lockbox Size (250mL): Introduction of new size. | No new risks introduced. |
| Multi-pump mounting bracket: New accessory. | Validated through bench testing. |
| Battery case: New accessory. | Validated through bench testing. |
| New Cleaning and Disinfection Agent: Compatibility and effectiveness. | Validated through a cleaning and disinfection validation protocol. |
| Software Enhancements: Functionality remains robust. | Validated through software validation and verification testing; changes to user interface validated through human factors testing. No basic functionality changes. |
| Electrical Safety: Compliance with standards. | Compliant with IEC 60601-1 and IEC 60601-1-12 (Same as predicate). |
| Electromagnetic Compatibility: Compliance with standards. | Compliant with IEC 60601-1-2 (Same as predicate). |
| Basic Functionality/Performance (e.g., accuracy, modes, alarms, mechanical specs): Remain equivalent to predicate. | "Same" as predicate device for all listed attributes (System delivery accuracy, Delivery Modes, Patient population, WiFi function, alarms, programming functions, infusion specifications, physical dimensions, power, and operating/storage environments). |
2. Sample sizes used for the test set and the data provenance
The document does not specify discrete "sample sizes" in terms of number of patients or cases for the various validation tests. The testing described is primarily non-clinical bench testing, software verification/validation, and human factors evaluations. For these types of tests, sample size generally refers to the number of test units (pumps, accessories) or test runs. These details are not provided in the summary.
Data provenance: The testing was carried out by the manufacturer, Q Core Medical Ltd., in Netanya, ISRAEL. The studies are prospective as they are conducted to validate modifications to an existing device for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document details that some changes (e.g., maximum clinician bolus, maximum epidural hourly volume) are "supported by literature and a reference device." This implies reliance on established medical knowledge and previously cleared device specifications rather than new expert consensus for ground truth on these specific parameters for the current submission. For human factors testing, experts (e.g., clinicians) would typically be involved, but their number and qualifications are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided, as the studies described are primarily technical performance validations and verifications, not clinical trials requiring independent expert adjudication of diagnostic outcomes.
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
No MRMC comparative effectiveness study was done. This is an infusion pump, not an AI-powered diagnostic imaging device. The concept of "human readers improving with AI assistance" is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept is not directly applicable to an infusion pump. The device itself is a "standalone" algorithmic system in the sense that it performs its infusion functions based on its programming. The software verification and validation activities essentially cover the "standalone" performance of the algorithm without human intervention in the infusion process itself. Human factors testing focuses on the human-device interface and user interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's validation is primarily based on:
- Engineering specifications and design requirements: For pump accuracy, delivery modes, alarm thresholds, physical characteristics, and material compatibility.
- Industry standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-12 (Electrical Safety in medical environment), IEC 60601-1-2 (EMC testing).
- Regulatory guidance: FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
- Literature references: For increased bolus volumes and hourly epidural volumes.
- Predicate device's established performance: The primary "ground truth" for substantial equivalence is the safety and effectiveness profile of the K141389 Sapphire Infusion Pump.
8. The sample size for the training set
Not Applicable. As described, this is a modification to an existing infusion pump, and the studies mentioned are verification and validation activities for hardware, software, and changes in use environment. There is no mention of "training sets" in the context of machine learning or AI algorithm development, which is typically where such terminology applies.
9. How the ground truth for the training set was established
Not Applicable, as there is no training set for a machine learning model mentioned in the document.
§ 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).