(67 days)
Not Found
No
The document describes a standard volumetric infusion pump and does not mention any AI or ML capabilities. The performance studies focus on flow accuracy and hemolysis, typical for this type of device.
No
The device is an infusion pump designed for fluid delivery, not for treating or curing a disease or condition itself. It is a delivery mechanism for therapeutic agents.
No
This device is an infusion pump designed to deliver fluids, drugs, and blood products to a patient. It does not perform any task that would diagnose a medical condition.
No
The device description clearly describes a physical infusion pump with hardware components such as a shuttle mechanism, power adapters, and a rechargeable battery. It is not solely software.
Based on the provided text, the Baxter Colleague™ 2 and 3 Volumetric Infusion Pumps are not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for delivering fluids, drugs, and blood products into a patient through various routes of administration (IV, IA, subcutaneous, epidural, irrigation). This is an in vivo application, meaning it's used within a living organism.
- Device Description: The description focuses on the mechanical aspects of fluid delivery and the components that come into contact with the fluid path before it enters the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used to perform tests on samples taken from the body, not to administer substances into the body.
N/A
Intended Use / Indications for 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. *
Product codes (comma separated list FDA assigned to the subject device)
LHR
Device Description
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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.
5
Comparison of the Baxter Multichannel Volumetric Infusion Pumps
to Organison of Other Lares Vel to Other Large Volume Infusion Pumps
| Feature | BAXTER
Colleague™ 2 | BAXTER
Colleague™ 3 | BAXTER
Colleague™ | BAXTER
Flo-Gard®
6301 |
|----------------------------------|-----------------------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------|
| Pump Mechanism | Shuttle | Shuttle | Shuttle | Linear
Peristaltic |
| Number of Channels | 2 | 3 | 1 | 2 |
| Set Used | Standard
Baxter "s"
Sets | Standard
Baxter "s"
Sets | Standard
Baxter "s"
Sets | Standard
Baxter "s"
Sets |
| Rate Range (mL/hr) | 0.1 - 99.9
1.0 - 1,200 | 0.1 - 99.9
1.0 - 1,200 | 0.1 - 99.9
1.0 - 1,200 | 1.0 - 99.9
1.0 - 1,999 |
| VTBI (mL) | 0.1 - 9,999 | 0.1 - 9,999 | 0.1 - 9,999 | 1 - 9,999 |
| Adjustable Maximum
Rate Limit | ● | ● | ● | ● |
| Adjustable Maximum
VTBI | ● | ● | ● | ● |
| Source Containers | | | | |
| Bags | ● | ● | ● | ● |
| Bottles | ● | ● | ● | ● |
| Syringes | ● | ● | ● | ○ |
| Stated Accuracy | ≤ 10% at rates
less than
1.0 mL/hr:
≤ ± 5%
otherwise | ≤ 10% at rates
less than
1.0 mL/hr:
≤ ± 5%
otherwise | ≤ 10% at rates
less than
1.0 mL/hr:
≤ ± 5%
otherwise | ≤ ± 10% |
| Motor Resolution | 3414 parts per
cc | 3414 parts per
cc | 3414 parts per
cc | 4000 parts per
cc |
| Air-in-line Detection | ● | ● | ● | ● |
| Upstream Occlusion | 4 Settings | 4 Settings | 4 Settings | 2 Settings |
| Occlusion Pressure | Minimum,
Moderate,
Maximum, Rate
Dependent
2 PSI - 15 PSI | Minimum,
Moderate,
Maximum, Rate
Dependent:
2 PSI - 15 PSI | Minimum,
Moderate,
Maximum, Rate
Dependent
2 PSI - 15 PSI | 7 - 17 PSI
Adjustable to
7, 12, 17 PSI |
Available .
O Not Available
Unknown -
6
| Feature | BAXTER
Colleague™ 2 | BAXTER
Colleague™ 3 | BAXTER
Colleague™ | BAXTER
Flo-Gard®
6301 |
|-------------------------------------|--------------------------|--------------------------|--------------------------|-----------------------------|
| Auto Restart | ● | ● | ● | ● |
| Free Flow Protection | ● | ● | ● | ● |
| RS232 | ● | ● | ● | ● |
| Computer Monitoring | ● | ● | ● | ● |
| Computer Control | ○ | ○ | ○ | ● |
| Pump Configuration
Utility | ● | ● | ● | ● |
| Panel Lockout | ● | ● | ● | ● |
| Set Removal Lockout | ● | ● | ● | ○ |
| Automatic Piggybacking | ● | ● | ● | ● |
| Flow Check | ● | ● | ● | ● |
| Adjustable Alarm/Alert
Intervals | ● | ● | ● | ● |
| Secondary Complete Alert | ● | ● | ● | ● |
| Blood Infusion | ● | ● | ● | ● |
| Epidural Infusion | ● | ● | ● | ● |
| Event Recorder | ● | ● | ● | ○ |
| Change Rate while
running | ● | ● | ● | ● |
| Power Sources | Internal
Rechargeable | Internal
Rechargeable | Internal
Rechargeable | Internal
Rechargeable |
| Back Light | ● | ● | ● | ● |
| Battery Life Indicator | ● | ● | ● | ○ |
| Battery Capacity | 5 hr at
100 mL/hr | 4 hr at
100 mL/hr | 5 hr at
100 mL/hr | 6 hr at
1400 mL/hr |
| Multidirectional Pole
Clamp | ○ | ○ | ● | ○ |
| Automatic Tube Loading | ● | ● | ● | ○ |
| Tube Misload Detection | ● | ● | ● | ● |
- Available
• Available
© Not Available
-Unknown
7
| Feature | BAXTER
Colleague™ 2 | BAXTER
Colleague™ 3 | BAXTER
Colleague™ | BAXTER
Flo-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 External
Adapter | ● | ● | ● | ● |
| 12 VDC External Cable
Connector (accessory) | ● | ● | ● | ◯ |
| Pump Personality | ● | ● | ● | ◯ |
- Available
"・・
•
- . Unknown
s:\510k..\SMDA
APR 3 0 1996 નવા