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510(k) Data Aggregation
(60 days)
The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, or epidural. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.
The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.
The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.
SIGMA Spectrum is a large volume pump within the SIGMA Spectrum infusion system used by clinicians at the patient bedside to control the delivery of medications from a bag. The pump moves fluid from the bag to the patient via specified administration sets using a peristaltic pumping action. The pump offers various programmable delivery modes to address specific patient care needs. The delivery modes available to support the patient are determined by how the pump and its associated drug library are configured.
The pump provides delivery of fluids into a patient in a controlled manner, as identified in 21 CFR 880.5725. The system includes a software controlled, electromechanical pump used for the controlled administration of fluids including pharmaceutical drugs, blood, blood products, and mixtures of required patient therapy through administration sets at clinician's selectable rates and volumes.
The pump is intended for the controlled administration of fluids through the following clinically accepted routes of administration: intravenous, arterial, subcutaneous, and epidural. The pump is intended to be used in conjunction with legally marketed and compatible administration sets, as indicated in the device labeling, and medications provided by the user. The subject device is suitable for patient care in hospitals and outpatient health care facilities.
The Master Drug Library (MDL) is a stand-alone (not embedded in the pump) software application installed on a hospital-provided computing platform and used to create a drug library file. MDL facilitates the generation, configuration, and management of a facility-specific drug library file for dedicated infusion pumps. The drug library file is intended to be distributed to all compatible infusion pumps in the hospital.
This submission includes software design and labeling changes to address the issues leading to recalls Z-0530-2022 and Z-2103-2023.
This FDA 510(k) clearance letter pertains to an infusion pump, not an AI/ML powered medical device. Therefore, many of the requested categories in your prompt (such as "Number of experts used to establish the ground truth," "Adjudication method," "MRMC study," "Standalone performance," "Type of ground truth," and "Training set sample size/ground truth establishment") are not applicable to this type of medical device submission.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through a comparison of technical characteristics and verification of performance against established requirements.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the overall device in a quantifiable manner that would typically be found in an AI/ML context (e.g., specific sensitivity, specificity, or AUC targets). Instead, it demonstrates compliance with a range of technical specifications, which inherently act as acceptance criteria for the design and performance. The "Reported Device Performance" is implied by the statement that "Non-clinical testing met all acceptance criteria."
Below is a table summarizing key technical characteristics that function as performance criteria for the infusion pump. Since the subject device is deemed "substantially equivalent" to the predicate, and no new performance claims are made that deviate from the predicate, their performance characteristics are identical as presented.
| Characteristic | Acceptance Criteria (Subject Device & Predicate K230022) | Reported Device Performance (Subject Device) |
|---|---|---|
| Pumping Mechanism | Linear peristaltic design | Linear peristaltic design |
| Modes of Delivery | Continuous, Intermittent | Continuous, Intermittent |
| Routes of Admin. | Intravenous, Arterial, Subcutaneous, Epidural | Intravenous, Arterial, Subcutaneous, Epidural |
| User Interface Display | Color LCD | Color LCD |
| AC Power Input | 115 VAC ±15%, 50 - 60 Hz / 300 mA Max | 115 VAC ±15%, 50 - 60 Hz / 300 mA Max |
| AC Power Output | 9 VDC/1200 mA, short circuit protected | 9 VDC/1200 mA, short circuit protected |
| Operating Temp (Std/WBM) | 15.6 to 32.2°C (60 to 90°F), 20-90% RH non-condensing | 15.6 to 32.2°C (60 to 90°F), 20-90% RH non-condensing |
| Operating Temp (802.11b/g) | 15.6 to 26.7°C (60 to 80°F), 20-90% RH non-condensing | 15.6 to 26.7°C (60 to 80°F), 20-90% RH non-condensing |
| Storage Temp. | -10 to +49°C (14 to 120°F), 10-90% RH non-condensing | -10 to +49°C (14 to 120°F), 10-90% RH non-condensing |
| Single Fault Bolus | Max 0.56 mL | Max 0.56 mL |
| Anti-Free Flow System | Set-based, utilizing IV set slide clamp | Set-based, utilizing IV set slide clamp |
| Low Battery Alarm | ≤15 minutes of battery power remaining | ≤15 minutes of battery power remaining |
| Air-In-Line Detection | >2.5 cm air bubbles (140 μL in Baxter sets); >1 mL accumulated air over 15 min (room temp); >1.5 mL accumulated air over 15 min (15.5°C) | Meets criteria |
| Downstream Occlusion Alarms | User adjustable Low (41 kPa ±27 kPa), Medium (89 kPa ±41 kPa), High (131 kPa ±62 kPa) | User adjustable, meets specified values |
| Max Downstream Occlusion Press. | 207 kPa (30 psi) | 207 kPa (30 psi) |
| Flow Rate Range | 0.5 to 999 mL/hr | 0.5 to 999 mL/hr |
| Low-Flow Continuity | Max period of no-flow is 90 seconds at 0.5 mL/hr | Max period of no-flow is 90 seconds at 0.5 mL/hr |
| Volumetric Accuracy (DEHP sets) - 0.5-1.9 mL/hr | ±0.1 mL/hr (over 1 hr, up to 96 hrs) | ±0.1 mL/hr (over 1 hr, up to 96 hrs) |
| Volumetric Accuracy (DEHP sets) - 2.0-999 mL/hr | ±5% (over 1 hr, up to 96 hrs) | ±5% (over 1 hr, up to 96 hrs) |
| Volumetric Accuracy (Non-DEHP sets) - 10-125 mL/hr | ±10% (< 36 hrs tubing use) | ±10% (< 36 hrs tubing use) |
| Volumetric Accuracy (Non-DEHP sets) - 126-250 mL/hr | ±10% (< 4 hrs tubing use) | ±10% (< 4 hrs tubing use) |
| Drug Library Capacity - Care Areas | 32 | 32 |
| Drug Library Capacity - Drugs | 5000 | 5000 |
| Drug Library Capacity - Clinical Advisories | 400 | 400 |
| Drug Library Capacity - Modifiers | 500 | 500 |
| All Rates/Drug Library Limits | Within 0.5 to 999 mL/hr operational range | Within 0.5 to 999 mL/hr operational range |
2. Sample Size Used for the Test Set and Data Provenance
The document indicates that "Non-clinical testing has been executed against requirements for performance and safety." However, it does not specify the sample sizes for this testing.
The "data provenance" is implied to be from internal lab testing ("Non-clinical testing") conducted by Baxter Healthcare Corporation for verification of the device's functional and safety requirements. Details regarding country of origin or whether it's retrospective/prospective are not provided, but typically such testing for physical devices like infusion pumps would be prospective, controlled lab experiments.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable and therefore not provided in the document. For an infusion pump, "ground truth" is typically defined by physical and engineering measurements against established standards and specifications, rather than expert interpretation of data.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. Adjudication is a concept typically relevant to human review of (often ambiguous) data in clinical studies or AI performance evaluations, which is not the primary mechanism for verifying an infusion pump's compliance with engineering specifications.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
This information is not applicable and therefore not provided. The device is an infusion pump, not an AI-assisted diagnostic or therapeutic device used by human readers for interpretation.
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. While the infusion pump contains software (algorithms), the "standalone performance" concept as typically applied to AI refers to the algorithm's performance in interpreting data directly without human intervention. The pump's performance is intrinsically linked to its electromechanical components and its interaction with fluids, administration sets, and clinical settings.
7. The Type of Ground Truth Used
For this infusion pump, the "ground truth" is established through design specifications, engineering standards, and direct physical/electrical measurements. For example, flow rate accuracy is measured against known volumes over time, alarm thresholds are tested against specific pressure or bubble sizes, and battery life is measured under defined operating conditions. This is not "expert consensus," "pathology," or "outcomes data" in the AI/ML sense.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. Infusion pumps are not typically "trained" using data sets in the way AI/ML models are. Their functionality is programmed based on engineering principles and validated through testing.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided for the reasons outlined in point 8. The "ground truth" for developing an infusion pump's functionality is its detailed engineering design and the physical laws and medical requirements it must adhere to.
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