(67 days)
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to meet the fluid delivery needs of today's evolving health care environment. The pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Fluid delivery applications include:
- parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, * analgesics, chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, etc.); and
- whole blood and blood products. *
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to meet the fluid delivery needs of today's evolving health care environment. The pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications. The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to accept a wide range of Baxter "s" suffix standard sets equipped with a keyed on/off slide clamp. The unidirectional on/off slide clamp on the sets facilitates appropriate set loading. The pump will accept a variety of currently marketed drug reservoirs, including glass bottles, plastic containers and syringes. The Baxter Colleague™ 2 and 3 Volumetric Infusion Pump will operate on 90 - 260 V.AC, 50/60 Hz. The device can also operate on an optional 12 VDC power adapter for an external power source. Alternatively, power may be supplied from a rechargeable battery integral to the device. None of the pump components or materials come in contact with the fluid path. All materials used to build the Baxter pump meet the requirements of standards applicable to infusion pumps and electronic devices. The Baxter Colleague™ 2 and 3 Volumetric Infusion Pump will operate from 0.1 to 1200 mL/hr.
Here's a breakdown of the acceptance criteria and the study information for the Baxter Volumetric Infusion Pumps, based on the provided document:
Acceptance Criteria and Device Performance for Baxter Volumetric Infusion Pumps
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps meet the specified performance criteria, demonstrating safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Baxter Colleague™ 2 & 3) |
|---|---|---|
| Flow Rate Range | N/A (Feature description, not an acceptance criterion) | 0.1 to 1200 mL/hr |
| Flow Rate Accuracy | Less than or equal to +/- 10% error at rates less than 1.0 mL/hr. Less than or equal to +/- 5% error at rates greater than or equal to 1.0 mL/hr, over any hour, or a collection volume of 0.5 mL increment, whichever is the greater volume. | The device operates within these specified accuracies. (Implied by "The Baxter Colleague™ 2 and 3 Volumetric Infusion Pump will operate from 0.1 to 1200 mL/hr. Flow rates will be less than or equal to +/- 10% error at rates less than 1.0 mL/hr, and less than or equal to +/- 5% error at rates greater than or equal to 1.0 mL/hr, over any hour, or a collection volume of 0.5 mL increment, whichever is the greater volume.") |
| Sustained Accuracy | Flow and rate accuracy will not degrade outside of the specified accuracy over a period of 72 hours using the same set and catheter at 100 mL/hr. | The devices meet this criterion. (Implied by "Flow and rate accuracy will not degrade outside of the specified accuracy over a period of 72 hours using the same set and catheter at 100 mL/hr.") |
| Head Height Operation | The devices will operate at all programmable flow rates with a head height ranging from -36 inches to +48 inches. | The devices meet this criterion. (Implied by "The devices will operate at all programmable flow rates with a head height ranging from -36 inches to +48 inches.") |
| No Flow Period | - Less than 40 seconds at 0.1 mL/hr.- Less than 20 seconds at 0.2 mL/hr.- Less than 10 seconds at 0.4 mL/hr.- For each subsequent doubling of rate (up to 99.9 mL/hr), the no flow period halves (e.g., 5 seconds at 0.8 mL/hr).- Less than or equal to 0.038 seconds for rates above 100 mL/hr. | The device meets these criteria. (Implied by "Fluid will not stop flowing for a period greater than 40 seconds at a rate of 0.1 mL/hr; 20 seconds at a rate of 0.2 mL/hr; and 10 seconds at a rate of 0.4 mL/hr. For each subsequent doubling of rate, up to 99.9 mL/hr, the no flow period halves - i.e., 5 seconds at a rate of 0.8 mL/hr. The no flow period will be less than or equal to 0.038 seconds for rates above 100 mL/hr.") |
| Static Back Pressure | Device operates within specified accuracy when subjected to static back pressures of 5.8 psi (+300 mm Hg) to -1.9 psi (-100 mm Hg). | The device meets this criterion. (Implied by "The device will operate within the specified accuracy when subjected to static back pressures of 5.8 psi (+300 mm Hg) to -1.9 psi (-100 mm Hg).") |
| Maximum Operating Pressure Degradation | Maximum drop-off of less than or equal to 1% incremental change per psi with up to the maximum operating back pressure of 15 psi (775 mm Hg). | The device meets this criterion. (Implied by "The device will deliver with a maximum drop-off of less than or equal to 1% incremental change per psi with up to the maximum operating back pressure of 15 psi (775 mm Hg).") |
| Environmental Conditions | Operations within 59°F to 100°F, 20% to 95% relative humidity (non-condensing), 700 hPa to 1060 hPa air pressure. | The device meets these criteria. (Implied by "Environmental criteria for the operation of the Baxter pump are 599F to 100°F; 20% to 95% relative humidity, non-condensing; 700 hPa to 1060 hPa air pressure.") |
| Blood Hemolysis | N/A (Implicitly, the device should not cause clinically significant hemolysis) | Results range from a low of 0.0000% to a high of 0.114% hemolysis from blood hemolysis testing. This range, particularly the peak of 0.114%, is typically considered acceptable in medical device applications to avoid clinically significant damage. |
2. Sample Size and Data Provenance
The document does not explicitly state the specific sample size (number of pumps, infusion sets, or test runs) used for each test.
- Test Set Data Provenance: The document states "Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard." This suggests in-lab testing. No information is provided regarding the country of origin or whether the data was retrospective or prospective, though in-lab testing is typically prospective for device validation.
- Blood Hemolysis Testing: "Blood hemolysis testing was performed on aged packed red blood cells using an infusion pump with a shuttle mechanism similar to the one used for the proposed volumetric infusion pump." This also points to in-lab testing.
3. Number of Experts and Qualifications for Ground Truth
This type of device (volumetric infusion pump) does not typically rely on human expert interpretation for its primary performance metrics like flow rate accuracy or hemolysis. Its ground truth is established through physical measurements against defined standards and calibrated equipment. Therefore, information on experts for "ground truth" establishment in the context of diagnostic performance (e.g., radiologists interpreting images) is not applicable here.
4. Adjudication Method for the Test Set
Not applicable. The performance characteristics (flow rate accuracy, pressure response, etc.) are measured directly by instruments against objective criteria rather than relying on human judgment that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is a medical device for fluid delivery, not an AI diagnostic tool. Therefore, comparing human reader performance with and without AI assistance is not relevant.
6. Standalone Performance Study
Yes, a standalone performance study was done for the algorithm (the pump's mechanics and control system). The description of the device's accuracy, no-flow periods, pressure responses, and environmental operating conditions directly reflects the standalone performance of the pump itself, independent of human interaction beyond initial programming.
- Accuracy Data: "Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard." This indicates a direct measurement of the device's performance against a standard.
- Blood Hemolysis: Hemolysis testing was performed directly on the pump mechanism.
7. Type of Ground Truth Used
The ground truth used for the performance testing is based on objective physical measurements and internationally recognized technical standards.
- Accuracy: Calibrated measurement equipment determining actual fluid volume delivered over time, conforming to IEC 601-2-24 standard.
- Pressure Response: Calibrated pressure sensors and flow measurements.
- Environmental: Environmental chambers simulating temperature, humidity, and atmospheric pressure.
- Hemolysis: Laboratory analysis of red blood cell lysis after passing through the pump mechanism.
8. Sample Size for the Training Set
Not applicable. This device is a hardware and embedded software system with defined physical laws governing its operation, not a machine learning or AI model that requires a "training set" in the conventional sense. Its design is based on engineering principles and validated through testing against standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for an AI algorithm. The device's operational parameters and safety features are established through engineering design, risk assessment, and adherence to relevant medical device standards like UL 2601-1, IEC 601-2-24, IEC 601-1-2, NFPA 99, and various electromagnetic compatibility standards (MDS-201-0004, MIL-STD-461C, CISPR 11, IEC 801-1, IEC 801-2, IEC 801-3, IEC 801-4, VDE 0871).
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510(k) Premarket Notification Volumetric Infusion Pumps
JL - 8 888
APPENDIX 1.1
SUMMARY OF SAFETY AND EFFECTIVENESS
BAXTER VOLUMETRIC INFUSION PUMPS
APR 3 0 1996 784
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SUMMARY OF SAFETY AND EFFECTIVENESS
BAXTER VOLUMETRIC INFUSION PUMPS
Submitted by:
Tamima Itani, Ph.D. Manager, Regulatory Affairs Baxter Healthcare Corporation I.V. Systems Division Rte. 120 and Wilson Road Round Lake, IL 60073
Date Prepared:
April 30, 1996
Proposed Device:
Colleague™ 2 Volumetric Infusion Pump Colleague™ 3 Volumetric Infusion Pump
Predicate Devices:
- The Colleague™ Volumetric Infusion Pump, by Baxter, cleared under K953098 on ﮯ December 22, 1995
- The Flo-Gard® 6301 Volumetric Infusion Pump, by Baxter, cleared under K915522 on -February 28, 1995.
Device Description and Statement of Intended Use:
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to meet the fluid delivery needs of today's evolving health care environment. The pump can be utilized for continuous or intermittent delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), subcutaneous, epidural or irrigation of fluid spaces applications.
Fluid delivery applications include:
- parenteral fluids, drugs and electrolytes (e.g. cardiovascular drugs, antibiotics, anesthetics, * analgesics, chemotherapy agents, total parenteral nutrition products, lipids, solutions for irrigation procedures, etc.); and
- whole blood and blood products. *
APR 3 0 1996
785
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The Baxter Volumetric Infusion Pumps are designed to travel the continuum of care, following the patient into a variety of care areas, including, but not limited to:
Hospital: General Floor Medical/Surgical Critical/Intensive Care Areas Pediatrics/Neonatal I Cularios/Nost Partum OR/Anesthesia
Post Anesthesia/Recovery Cardiac Catheter Lab Emergency Room Burn/ Trauma Units Oncology Oncology Oncology
-
Blood Centers
-
Nuclear Medicine
-
Hospice
- Subacute Facilities A
- A Outpatient/Surgical Centers
- Long Term Care A
- Nursing Homes
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are designed to accept a wide range of Baxter "s" suffix standard sets equipped with a keyed on/off slide clamp. The unidirectional on/off slide clamp on the sets facilitates appropriate set loading. The pump will accept a variety of currently marketed drug reservoirs, including glass bottles, plastic containers and syringes.
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pump will operate on 90 - 260 V.AC, 50/60 Hz. The device can also operate on an optional 12 VDC power adapter for an external power source. Alternatively, power may be supplied from a rechargeable battery integral to the device.
None of the pump components or materials come in contact with the fluid path. All materials used to build the Baxter pump meet the requirements of standards applicable to infusion pumps and electronic devices.
The Baxter Colleague™ 2 and 3 Volumetric Infusion Pump will operate from 0.1 to 1200 mL/hr. Flow rates will be less than or equal to +/- 10% error at rates less than 1.0 mL/hr, and less than or equal to +/- 5% error at rates greater than or equal to 1.0 mL/hr, over any hour, or a collection volume of 0.5 mL increment, whichever is the greater volume.
Flow and rate accuracy will not degrade outside of the specified accuracy over a period of 72hours using the same set and catheter at 100 mL/hr. The devices will operate at all programmable flow rates with a head height ranging from -36 inches to +48 inches.
As with any electronic infusion device, flow profile is dependent on flow rate. Fluid will not stop flowing for a period greater than 40 seconds at a rate of 0.1 mL/hr; 20 seconds at a rate of 0.2 mL/hr; and 10 seconds at a rate of 0.4 mL/hr. For each subsequent doubling of rate, up to 99.9 mL/hr, the no flow period halves - i.e., 5 seconds at a rate of 0.8 mL/hr. The no flow period will be less than or equal to 0.038 seconds for rates above 100 mL/hr.
The device will operate within the specified accuracy when subjected to static back pressures of 5.8 psi (+300 mm Hg) to -1.9 psi (-100 mm Hg). The device will deliver with a maximum
{3}------------------------------------------------
drop-off of less than or equal to 1% incremental change per psi with up to the maximum operating back pressure of 15 psi (775 mm Hg).
Environmental criteria for the operation of the Baxter pump are 599F to 100°F; 20% to 95% relative humidity, non-condensing; 700 hPa to 1060 hPa air pressure.
The marketed product will meet the requirements of the following standards:
- UL 2601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety .
- IEC 601-2-24, Biological Evaluation of Medical Devices -
- IEC 601-1-2, Medical Electrical Equipment, Part 1. -
- NFPA 99. Standard for Health Care Facilities, National Fire Protection Association. dated 02/12/93, ANSI/NFPA
It will also meet the requirements of applicable portions of the following standards:
- Electromagnetic Compatibility Standard for Medical Devices, MDS-201-0004 .
- Electromagnetic Emissions and Susceptibility Requirements for the Control of -Electromagnetic Interference, MIL-STD-461C
- Limits and Methods of Measurement of Radio Interference Characteristics of a Industrial, Scientific and Medical (ISM) Radio-Frequency equipment (excluding surgical diathermy apparatus), CISPR 11
- Electromagnetic Compatibility for Industrial Process Measurement and Control -Equipment, IEC 801-1
- -Electrostatic Discharge Requirements, IEC 801-2
- -Radiated Electromagnetic Field Requirements, IEC 801-3
- -Electrical Fast Transient/Burst Requirements, IEC 801-4
- -Radio Interference Suppression of Radio Frequency for Equipment for Industrial, Scientific, and Medical and Similar Purposes, VDE 0871
Summary of Technological Characteristics of New Device to Predicate Devices
A table, comparing the Baxter Volumetric Infusion Pump to predicate devices is attached.
{4}------------------------------------------------
Discussion of Non Clinical Tests; Conclusions Drawn from Nonclinical Tests
Blood hemolysis testing was performed on aged packed red blood cells using an infusion pump with a shuttle mechanism similar to the one used for the proposed volumetric infusion pump. Aged packed red blood cells were tested because our previous experience with infusion pump indicates that they represent the worst case scenario relative to possible hemolysis. The results range from a low of 0.0000% to a high of 0.114% hemolysis.
Accuracy data was generated in accordance with the testing methodology defined by the IEC 601-2-24 standard.
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Comparison of the Baxter Multichannel Volumetric Infusion Pumps
to Organison of Other Lares Vel to Other Large Volume Infusion Pumps
| Feature | BAXTERColleague™ 2 | BAXTERColleague™ 3 | BAXTERColleague™ | BAXTERFlo-Gard®6301 |
|---|---|---|---|---|
| Pump Mechanism | Shuttle | Shuttle | Shuttle | LinearPeristaltic |
| Number of Channels | 2 | 3 | 1 | 2 |
| Set Used | StandardBaxter "s"Sets | StandardBaxter "s"Sets | StandardBaxter "s"Sets | StandardBaxter "s"Sets |
| Rate Range (mL/hr) | 0.1 - 99.91.0 - 1,200 | 0.1 - 99.91.0 - 1,200 | 0.1 - 99.91.0 - 1,200 | 1.0 - 99.91.0 - 1,999 |
| VTBI (mL) | 0.1 - 9,999 | 0.1 - 9,999 | 0.1 - 9,999 | 1 - 9,999 |
| Adjustable MaximumRate Limit | ● | ● | ● | ● |
| Adjustable MaximumVTBI | ● | ● | ● | ● |
| Source Containers | ||||
| Bags | ● | ● | ● | ● |
| Bottles | ● | ● | ● | ● |
| Syringes | ● | ● | ● | ○ |
| Stated Accuracy | ≤ 10% at ratesless than1.0 mL/hr:≤ ± 5%otherwise | ≤ 10% at ratesless than1.0 mL/hr:≤ ± 5%otherwise | ≤ 10% at ratesless than1.0 mL/hr:≤ ± 5%otherwise | ≤ ± 10% |
| Motor Resolution | 3414 parts percc | 3414 parts percc | 3414 parts percc | 4000 parts percc |
| Air-in-line Detection | ● | ● | ● | ● |
| Upstream Occlusion | 4 Settings | 4 Settings | 4 Settings | 2 Settings |
| Occlusion Pressure | Minimum,Moderate,Maximum, RateDependent2 PSI - 15 PSI | Minimum,Moderate,Maximum, RateDependent:2 PSI - 15 PSI | Minimum,Moderate,Maximum, RateDependent2 PSI - 15 PSI | 7 - 17 PSIAdjustable to7, 12, 17 PSI |
Available .
O Not Available
Unknown -
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| Feature | BAXTERColleague™ 2 | BAXTERColleague™ 3 | BAXTERColleague™ | BAXTERFlo-Gard®6301 |
|---|---|---|---|---|
| Auto Restart | ● | ● | ● | ● |
| Free Flow Protection | ● | ● | ● | ● |
| RS232 | ● | ● | ● | ● |
| Computer Monitoring | ● | ● | ● | ● |
| Computer Control | ○ | ○ | ○ | ● |
| Pump ConfigurationUtility | ● | ● | ● | ● |
| Panel Lockout | ● | ● | ● | ● |
| Set Removal Lockout | ● | ● | ● | ○ |
| Automatic Piggybacking | ● | ● | ● | ● |
| Flow Check | ● | ● | ● | ● |
| Adjustable Alarm/AlertIntervals | ● | ● | ● | ● |
| Secondary Complete Alert | ● | ● | ● | ● |
| Blood Infusion | ● | ● | ● | ● |
| Epidural Infusion | ● | ● | ● | ● |
| Event Recorder | ● | ● | ● | ○ |
| Change Rate whilerunning | ● | ● | ● | ● |
| Power Sources | InternalRechargeable | InternalRechargeable | InternalRechargeable | InternalRechargeable |
| Back Light | ● | ● | ● | ● |
| Battery Life Indicator | ● | ● | ● | ○ |
| Battery Capacity | 5 hr at100 mL/hr | 4 hr at100 mL/hr | 5 hr at100 mL/hr | 6 hr at1400 mL/hr |
| Multidirectional PoleClamp | ○ | ○ | ● | ○ |
| Automatic Tube Loading | ● | ● | ● | ○ |
| Tube Misload Detection | ● | ● | ● | ● |
- Available
• Available
© Not Available
-Unknown
{7}------------------------------------------------
| Feature | BAXTERColleague™ 2 | BAXTERColleague™ 3 | BAXTERColleague™ | BAXTERFlo-Gard®6301 |
|---|---|---|---|---|
| Infusion Modes | ||||
| mL/hr | ● | ● | ● | ◯ |
| mg/hr | ● | ● | ● | ◯ |
| mg/kg/hr | ● | ● | ● | ◯ |
| mcg/hr | ● | ● | ● | ◯ |
| mcg/kg/hr | ● | ● | ● | ◯ |
| units/hr | ● | ● | ● | ◯ |
| units/kg/hr | ● | ● | ● | ◯ |
| mcg/m²/hr | ● | ● | ● | ◯ |
| mg/min | ● | ● | ● | ◯ |
| mg/kg/min | ● | ● | ● | ◯ |
| mcg/min | ● | ● | ● | ◯ |
| mcg/kg/min | ● | ● | ● | ◯ |
| units/min | ● | ● | ● | ◯ |
| units/min | ● | ● | ● | ◯ |
| mcg/m²/hr | ● | ● | ● | ◯ |
| units/m²/hr | ● | ● | ● | ◯ |
| Volume - Time | ● | ● | ● | ● |
| Ramping | ● | ● | ● | ● |
| KVO (mL/hr) | 0.1 - 5 | 0.1 - 5 | 0.1 - 5 | 1.0 - 5.0 |
| Device Diagnostics | ● | ● | ● | ● |
| Label Library | ● | ● | ● | ◯ |
| Drop Sensor | ● | ● | ● | ◯ |
| Volume History | Optional | Optional | Optional | |
| Volume History | ● | ● | ● | ● |
| Nurse call Via ExternalAdapter | ● | ● | ● | ● |
| 12 VDC External CableConnector (accessory) | ● | ● | ● | ◯ |
| Pump Personality | ● | ● | ● | ◯ |
- Available
"・・
•
- . Unknown
s:\510k..\SMDA
APR 3 0 1996 નવા
§ 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).