(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.
FDA 510(k) Clearance Letter - SIGMA Spectrum Infusion Pump with Master Drug Library
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.08.00
July 28, 2025
Baxter Healthcare Corporation
Jessica Andreshak
Senior Manager, Regulatory Affairs
One Baxter Parkway
Deerfield, Illinois 60015
Re: K251640
Trade/Device Name: SIGMA Spectrum Infusion Pump with Master Drug Library
Regulation Number: 21 CFR 880.5725
Regulation Name: Infusion Pump
Regulatory Class: Class II
Product Code: FRN, PHC
Dated: May 29, 2025
Received: May 29, 2025
Dear Jessica Andreshak:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K251640 - Jessica Andreshak Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K251640 - Jessica Andreshak Page 3
Sincerely,
Jake K. Lindstrom -S
Jake Lindstrom, Ph.D.
Assistant Director, Infusion Devices
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K251640
Device Name: SIGMA Spectrum Infusion Pump with Master Drug Library
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Page 5
510(k) Summary
Date: July 14, 2025
Owner: Baxter Healthcare Corporation
711 Park Avenue
Medina, New York 14103
Registration No: 1314492
Contact: Jessica Andreshak
Sr. Manager, Regulatory Affairs
25212 W. Illinois Route 120
Round Lake, IL 60073
Telephone: (262) 716-3028
Jessica_Andreshak@Baxter.com
Trade / Device Name: SIGMA Spectrum Infusion Pump with Master Drug Library
Classification Panel: 80 General Hospital
Regulation Name: Pump, Infusion
Regulation Number: 21 CFR 880.5725
Regulatory Class: Class II
Product Code: FRN
Assoc. Product Code: PHC
Predicate Device: The subject device is substantially equivalent to the following predicate device:
- SIGMA Spectrum Infusion Pump with Master Drug Library; cleared March 31, 2023 (K230022).
Device Description: 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
Page 6
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 includes customers' dosing limits and additional pump configuration settings. 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.
Intended Use / Indications for Use:
The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical
Page 7
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.
Technological Characteristics:
The subject device is substantially equivalent to the primary predicate device (K230022) with regards to design, performance and intended use. The following table provides a comparison summary of the technical characteristics of each device.
| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| SIGMA Spectrum Infusion Pump | ||
| Pumping Mechanism | Linear peristaltic design | Linear peristaltic design |
| Modes of Delivery | Continuous, Intermittent | Continuous, Intermittent |
| Routes of Administration | • Intravenous• Arterial• Subcutaneous• Epidural | • Intravenous• Arterial• Subcutaneous• Epidural |
| User Interface Display | Color LCD | Color LCD |
| AC Power | • Input (P/N 35727): 115 VAC ±15%, 50 - 60 Hz / 300 mA Max | • Input (P/N 35727): 115 VAC ±15%, 50 - 60 Hz / 300 mA Max |
Page 8
| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| • Output (P/N 35727): 9 VDC/1200 mA, short circuit protected | • Output (P/N 35727): 9 VDC/1200 mA, short circuit protected | |
| Operational Conditions | • With Standard Battery or 802.11a/b/g/n WBM: Operating temperature: 15.6 to 32.2°C (60 to 90°F), 20 to 90% relative humidity non-condensing• With 802.11b/g WBM: Operating temperature: 15.6 to 26.7°C (60 to 80°F), 20 to 90% relative humidity non-condensing | • With Standard Battery or 802.11a/b/g/n WBM: Operating temperature: 15.6 to 32.2°C (60 to 90°F), 20 to 90% relative humidity non-condensing• With 802.11b/g WBM: Operating temperature: 15.6 to 26.7°C (60 to 80°F), 20 to 90% relative humidity non-condensing |
| Storage and Packing Conditions | • With Standard Battery: Storage temperature: -10 to +49°C (14 to 120°F), 10 to 90% relative humidity non-condensing• With Wireless Battery Module: Storage temperature: -10 to +49°C (14 to 120°F), 10 to 90% relative humidity non-condensing | • With Standard Battery: Storage temperature: -10 to +49°C (14 to 120°F), 10 to 90% relative humidity non-condensing• With Wireless Battery Module: Storage temperature: -10 to +49°C (14 to 120°F), 10 to 90% relative humidity non-condensing |
| Overall Size (Pump) | With Standard Battery• Without IV pole clamp: Height 14.7 cm (5.8 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 14.7 cm (5.8 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in)With 802.11b/g WBM• Without IV pole clamp: Height 16 cm (6.3 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 16 cm (6.3 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in)With 802.11a/b/g/n WBM• Without IV pole clamp: Height 16.76 cm (6.6 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 16.76 cm (6.6 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in) | With Standard Battery• Without IV pole clamp: Height 14.7 cm (5.8 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 14.7 cm (5.8 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in)With 802.11b/g WBM• Without IV pole clamp: Height 16 cm (6.3 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 16 cm (6.3 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in)With 802.11a/b/g/n WBM• Without IV pole clamp: Height 16.76 cm (6.6 in); Width 10.6 cm (4.2 in); Depth 6.35 cm (2.5 in)• With IV pole clamp: Height 16.76 cm (6.6 in); Width 16.76 cm (6.6 in); Depth 11.93 cm (4.7 in) |
| Weight (Pump) | Pump with Standard Battery Module• Without IV pole clamp: 25.5oz ± 1.0 oz• With IV pole clamp: 33.5 oz ±1.0 oz | Pump with Standard Battery Module• Without IV pole clamp: 25.5oz ± 1.0 oz• With IV pole clamp: 33.5 oz ±1.0 oz |
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| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| Pump with Wireless Battery Module• Without IV pole clamp: 26.5oz ± 1.0 oz• With IV pole clamp: 34.5oz ±1.0 oz | Pump with Wireless Battery Module• Without IV pole clamp: 26.5oz ± 1.0 oz• With IV pole clamp: 34.5oz ±1.0 oz | |
| Timekeeping | Real Time Clock, battery backed, 10-year life | Real Time Clock, battery backed, 10-year life |
| Logging Memory | Yes | Yes |
| Single Fault Condition | A maximum bolus of 0.56 mL may be generated as a result of a Single Fault Condition (a failure of the SIGMA Spectrum Infusion Pump, which stops the pump motor and results in an alarm) | A maximum bolus of 0.56 mL may be generated as a result of a Single Fault Condition (a failure of the SIGMA Spectrum Infusion Pump, which stops the pump motor and results in an alarm) |
| Anti-Free Flow System | Set-based, utilizing IV set slide clamp | Set-based, utilizing IV set slide clamp |
| Auto-programming | No | No |
| Battery Power and Capacity | Standard Battery• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 8 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 8 hrs (at 125 mL/hr at the highest backlight settings)• 12 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off802.11b/g WBM• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hrs (at 125 mL/hr at the highest backlight settings)• 16 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off802.11a/b/g/n WBM• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hrs (at 125 mL/hr at the highest backlight settings) | Standard Battery• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 8 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 8 hrs (at 125 mL/hr at the highest backlight settings)• 12 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off802.11b/g WBM• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hrs (at 125 mL/hr at the highest backlight settings)• 16 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off802.11a/b/g/n WBM• Lithium Ion, 7.4 VDC nominal.• Capacity at intermediate rate 5 hrs (at 25 mL/hr at the highest backlight settings)• Capacity 4 hrs (at 125 mL/hr at the highest backlight settings) |
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| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| • 16 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off | • 16 hr. recharge time at 72°F ±2°F• Charging occurs if AC Power Adaptor is plugged in, whether the Pump is on or off | |
| Alarm Volume | Variable (three levels: high, medium and low) | Variable (three levels: high, medium and low) |
| Low Battery Alarm | Very Low Battery: ≤15 minutes of battery power remaining | Very Low Battery: ≤15 minutes of battery power remaining |
| Due for Inspection Alarm | Due for inspection: Preventive Maintenance and/or Network Certification. | Due for inspection: Preventive Maintenance and/or Network Certification. |
| Air-In-Line Alarm | Dual-beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass.• Detects air bubbles >2.5 cm (>1 in) (approximately 140 μL in Baxter sets)• Detects >1 mL of accumulated air over 15 min., excluding <10 μL bubbles, at room temperature• Detects >1.5 mL of accumulated air over 15 min., excluding <10 μL bubbles, at 15.5°C (60°F) | Dual-beam ultrasonic detector alarms for large bubbles but allows smaller bubbles to pass.• Detects air bubbles >2.5 cm (>1 in) (approximately 140 μL in Baxter sets)• Detects >1 mL of accumulated air over 15 min., excluding <10 μL bubbles, at room temperature• Detects >1.5 mL of accumulated air over 15 min., excluding <10 μL bubbles, at 15.5°C (60°F) |
| Downstream Occlusion Alarms | When the Downstream Occlusion Automatic Restart is enabled, automatic restart occurs after the downstream occlusion is cleared. Actuation can be set to:• Low, 41 kPa ±27 kPa (6 ±4 psi)• Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi) | When the Downstream Occlusion Automatic Restart is enabled, automatic restart occurs after the downstream occlusion is cleared. Actuation can be set to:• Low, 41 kPa ±27 kPa (6 ±4 psi)• Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi) |
| Upstream Occlusion Time to Alarm | Time to detect USO is dependent on occlusion distance and flow rate. Time to detection for an USO 50.8 cm (20 in.) from the top of the pump at nominal temperature of 22.2°C±1.1°C (72°F±2°F) is as follows: | Time to detect USO is dependent on occlusion distance and flow rate. Time to detection for an USO 50.8 cm (20 in.) from the top of the pump at nominal temperature of 22.2°C±1.1°C (72°F±2°F) is as follows: |
| Infusion Modes | • Continuous (Primary and Secondary)• Multi-Step | • Continuous (Primary and Secondary)• Multi-Step |
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| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| • Cyclic TPN• Amount/Time (Primary/Secondary) | • Cyclic TPN• Amount/Time (Primary/Secondary) | |
| Dose Modes - Continuous Infusion | mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr, mg/kg/hr, mg/min, mg/kg/min, mg/kg/day, mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min, mcg/kg/day, ng/min, ng/kg/min, Units/hr, Units/kg/hr, Units/min, Units/kg/min, mUnits/min, mUnits/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr | mL/hr, mL/kg/min, mL/kg/hr, g/hr, mg/hr, mg/kg/hr, mg/min, mg/kg/min, mg/kg/day, mcg/hr, mcg/kg/hr, mcg/min, mcg/kg/min, mcg/kg/day, ng/min, ng/kg/min, Units/hr, Units/kg/hr, Units/min, Units/kg/min, mUnits/min, mUnits/kg/hr, mUnits/kg/min, mEq/hr, mEq/kg/hr, mmol/hr, mmol/kg/hr |
| Dose Modes – Loading Dose and Bolus | mL, mL/kg, g, g/kg, mg, mg/kg, mcg, mcg/kg, ng, ng/kg, Units, Units/kg, mUnits, mUnits/kg, mEq, mEq/kg, mmol, mmol/kg | mL, mL/kg, g, g/kg, mg, mg/kg, mcg, mcg/kg, ng, ng/kg, Units, Units/kg, mUnits, mUnits/kg, mEq, mEq/kg, mmol, mmol/kg |
| Dose Modes – Amount/Time Infusions | mL, mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2, mcg, mcg/kg, mcg/m2, Units, Units/kg, Units/m2, mEq, mEq/kg, mmol, mmol/kg | mL, mL/kg, g, g/kg, g/m2, mg, mg/kg, mg/m2, mcg, mcg/kg, mcg/m2, Units, Units/kg, Units/m2, mEq, mEq/kg, mmol, mmol/kg |
| Flow Rate | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr and 1.0 mL/hr increments from 100 to 999 mL/hr | 0.5 to 999 mL/hr with 0.1 mL/hr increments from 0.5 to 99.9 mL/hr and 1.0 mL/hr increments from 100 to 999 mL/hr |
| Low-Flow Continuity | The maximum period of no-flow is 90 seconds at a flow rate of 0.5 mL/hr. | The maximum period of no-flow is 90 seconds at a flow rate of 0.5 mL/hr. |
| Keep Vein Open (KVO) Rate | Yes | Yes |
| Downstream Occlusion Pressure | User adjustable downstream occlusion pressure settings:• Low, 41 kPa ±27 kPa (6 ±4 psi)• Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi)Maximum allowable pressure while in downstream occlusion:• 207 kPa (30 psi) | User adjustable downstream occlusion pressure settings:• Low, 41 kPa ±27 kPa (6 ±4 psi)• Medium, 89 kPa ±41 kPa (13 ±6 psi)• High, 131 kPa ±62 kPa (19 ±9 psi)Maximum allowable pressure while in downstream occlusion:• 207 kPa (30 psi) |
| Bolus Capability | Yes | Yes |
| Bolus Volume Accuracy | Bolus Volume with DEHP Administration SetsBolus Volume with N-DEHP Administration Sets | Bolus Volume with DEHP Administration SetsBolus Volume with N-DEHP Administration Sets |
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| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| Volumetric Accuracy (DEHP) | Accuracy is based on volume collected over one hour using compatible Baxter (DEHP) Standard IV Sets.Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F. | Accuracy is based on volume collected over one hour using compatible Baxter (DEHP) Standard IV Sets.Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F. |
| Rate | Accuracy |
|---|---|
| 0.5 – 1.9 mL/hr | ±0.1 mL/hr |
| 2.0 – 999 mL/hr | ±5% |
Specified accuracy is maintained on Baxter Standard IV Sets for up to 96 hours (maximum 12 liters) when tested at 72 +/-2 F.
| Volumetric Accuracy (Non-DEHP) | Accuracy is based on volume collected over one hour using compatible Baxter non-DEHP Standard IV Sets. | Accuracy is based on volume collected over one hour using compatible Baxter non-DEHP Standard IV Sets. |
| Rate | Accuracy | Tubing use |
|---|---|---|
| 10 -125 mL/ hr | ±10% | < 36 hrs |
| 126- 250 mL/ hr | ±10% | < 4 hrs |
| Rate or Dose Limits | 0.5 – 999 mL/hr | 0.5 – 999 mL/hr |
| Wireless Capability | Yes | Yes |
| Wireless Security | WPA/WPA2/802.11i• Encryption: TKIP, CCMP (AES), Mixed-Mode (AES+TKIP)• Wireless Security: WPA-PSK, WPA2-PSK• 802.1X authentication: PEAP/MSCHAPv2; EAP-FAST; EAP-TLS; EAP-TTLS/PAP; EAP-TTLS/MSCHAPv2 | WPA/WPA2/802.11i• Encryption: TKIP, CCMP (AES), Mixed-Mode (AES+TKIP)• Wireless Security: WPA-PSK, WPA2-PSK• 802.1X authentication: PEAP/MSCHAPv2; EAP-FAST; EAP-TLS; EAP-TTLS/PAP; EAP-TTLS/MSCHAPv2 |
Master Drug Library
| Drug Library Capacity | • Number of Care Areas: 32• Number of Drugs: 5000• Number of Clinical Advisories: 400• Number of Modifiers: 500 | • Number of Care Areas: 32• Number of Drugs: 5000• Number of Clinical Advisories: 400• Number of Modifiers: 500 |
| Available Limits | • Upper Hard Limit must be greater than or equal to Upper Soft Limit. | • Upper Hard Limit must be greater than or equal to Upper Soft Limit. |
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| Characteristic | Subject Device | Predicate Device (K230022) |
|---|---|---|
| • Upper Soft Limit must be greater than or equal to a Starting Rate.• Starting Rate must be greater than or equal to a Lower Soft Limit.• Lower Soft Limit must be greater than or equal to a Lower Hard Limit.• Lower Hard Limit must be less than or equal to a Lower Soft Limit• All Rates and Drug Library Limits must fall within Spectrum Pump operational range of 0.5 to 999 mL/hr. | • Upper Soft Limit must be greater than or equal to a Starting Rate.• Starting Rate must be greater than or equal to a Lower Soft Limit.• Lower Soft Limit must be greater than or equal to a Lower Hard Limit.• Lower Hard Limit must be less than or equal to a Lower Soft Limit• All Rates and Drug Library Limits must fall within Spectrum Pump operational range of 0.5 to 999 mL/hr. | |
| Security Roles | • Read-Only Access• Limited Access• Full Access | • Read-Only Access• Limited Access• Full Access |
| Reports | • Standard and custom Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc.• Audit reports for a list of changes made to the Drug Library along with the date the change was performed | • Standard and custom Drug and Fluid Report for Drugs/Fluids, Concentration Limits, Configurations, etc.• Audit reports for a list of changes made to the Drug Library along with the date the change was performed |
| Gateway | CareEverywhere Gateway Version 16 and higher. | CareEverywhere Gateway Version 16 and higher. |
Summary of Testing: Non-clinical testing has been executed against requirements for performance and safety, and to provide objective evidence that the subject device's intended use is met. Testing compared the subject device to a previous version of the subject device (K133081). Non-clinical testing met all acceptance criteria, demonstrating that the device is safe and effective for its intended use.
Conclusion: The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The SIGMA Spectrum Infusion Pump with Master Drug Library is substantially equivalent to the SIGMA Spectrum Infusion Pump with Master Drug Library cleared under K230022 with respect to the indications for use, target
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populations, treatment method, and technological characteristics.
§ 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).