(340 days)
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No
The summary describes a standard infusion pump with drug safety software and network connectivity. There is no mention of AI, ML, or any related technologies. The performance studies focus on traditional verification, validation, risk management, and human factors, not AI/ML model performance.
Yes
The device is intended for the delivery of drugs, agents, nutritionals, electrolytes, blood and blood products, which are used to treat or manage medical conditions, thereby qualifying it as a therapeutic device.
No
Explanation: The device is an infusion system designed for delivering fluids, solutions, and drugs. It does not perform diagnostic functions such as identifying or analyzing diseases or conditions.
No
The device description explicitly states that the Symbiq™ Infusion System includes a "volumetric piston-driven infusion pump" and "dedicated disposable administration sets," which are hardware components. While it mentions "drug safety software" and "Hospira MedNet™ server software," these are part of a larger hardware system.
Based on the provided information, the Symbiq™ Infusion System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration." This describes a device used for administering substances into a patient's body, not for testing samples from a patient's body.
- Device Description: The description details a "volumetric piston-driven infusion pump" that delivers fluid to the patient. This aligns with the function of an infusion pump, not an IVD device which would typically involve analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Symbiq™ Infusion System's function is to deliver substances to the patient, which is a therapeutic or supportive function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Symbiq™ Infusion System is intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.
It is intended primarily for use in the hospital setting and can be used in other acute and non-acute care areas, such as, but not limited to Nursing Homes, Mobile Intensive Care, Ambulatory Infusion Centers, Hospice, Subacute Facilities, Outpatient/Surgical Centers, Long Term Care, Urgent Care, Transport and Physician Offices.
Product codes
FRN, FPA
Device Description
Symbiq™ Infusion System includes a volumetric piston-driven infusion pump and utilizes dedicated disposable administration sets for fluid delivery to the patient. The pump's plunger cyclically pressurizes the administration set's cassette pumping chamber through an elastomeric diaphragm to deliver fluid. The device has a touchscreen user interface to program various therapies. At low flow rates the infusion pump is designed to maintain low flow continuity. The infusion pump utilizes drug safety software to set hospital drug dosing parameters. The system can communicate wired or wirelessly over the hospitals network infrastructure through Hospira MedNet™ server software with Hospital Information Systems. The pump is available in one-channel and two-channel configurations.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
It is intended primarily for use the hospital setting and can be used in other acute and non-acute care areas outside of the hospital under the supervision of the healthcare provider. All data entry and validation of infusion parameters is performed by a trained healthcare professional according to physician's orders.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
SUMMARY OF NON-CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
- Performance Test Summary-New Device: System verification and validation activities for Symbig™ Infusion System confirmed that the system meets user needs and design inputs. All the testing met the acceptance criteria.
- Risk management activities are incorporated in to the design and development process and a Safety Assurance Case has been generated to demonstrate the safety of the Symbig™ Infusion System.
- Risk management as well as verification and validation activities incorporate the principles of applicable FDA guidance such as "Total Product Life Cycle: infusion Pump –Premarket Notification [510(k)] Submissions (DRAFT GUIDANCE)" issued in April 23, 2010 and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff," issued January 11, 2002. Human Factors studies have been conducted to validate the effectiveness of use related error mitigations.
- Electrical and Mechanical Safety: IEC 60601-1 (1988): Medical electrical equipment - Part 1: General requirements for safety, including Amendment 1 (1991) and Amendment 2 (1995) for Type B equipment. Results: Pass.
- Electromagnetic Compatibility: IEC 60601-1-2 (2001): Medical Electrical Equipment, Part 1-2: General Requirements for Safety, Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. Results: Pass.
- Alarm Systems: IEC 60601-1-8 Ed.1 (2003-08) Part 1-8: General requirements for safety - Collateral standard: Alarm systems. Results: Pass.
- Sets Biocompatibility: ISO 10993-1:2009: Biological Evaluation of Medical Devices Part 1: Evaluation and Testing. Results: Pass.
SUMMARY OF CLINICAL TESTS CONDUCTED FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE AND/OR OF CLINICAL INFORMATION
- Clinical evaluations and human factors studies have been conducted for the Symbig™ Infusion System. The Human Factors Use Safety Validation study showed that there were no instances of participants failing to complete tasks correctly during the study. The sum of clinical evaluation and human factors testing support the safety and effectiveness of Symbig™ Infusion System.
CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL DATA
- The results of the verification and validation testing with the results of human factors and clinical evaluations performed supported by static analysis of the software code and the Safety Assurance Case demonstrate that the modifications described in the submission do not introduce any additional issues of safety and effectiveness. The subject device is substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Accuracy: ± 5% at all rates (Subject Device)
- Predicate Device Accuracy: ± 5% for rates > 1 mL/hour. ± 10% for rates
§ 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
MAR - 5 2012
510(k) SUMMARY Safety and Effectiveness
| Submitter Information | |
|---|---|
| Name | Hospira, Inc. |
| Address | 275 North Field Dr, Lake Forest, IL 60045 |
| Phone number | 224-212-4897 |
| Fax number | 224-212-5401 |
| Establishment Registration | |
| Number | 3005579246 |
| Name of contact person | Ray Silkaitis/Yuliya Matlin |
| Date prepared | 03/05/2012 |
| Name of device | |
| Trade or proprietary name | Symbiq™ Infusion System |
| Common or usual name | Infusion Pump and Administration sets |
| Classification name | Infusion Pump /Administration Sets |
| Classification panel | 80 |
| Regulation | 880.5725 and 880.5440 |
| Product Code(s) | FRN and FPA |
| Legally marketed device(s) to which equivalence is claimed | Hospira Phoenix Infusion System with Hospira MedNet |
| Software, cleared under K041550 on 06/30/2004 | |
| Reason for 510(k) submission | Cumulative changes |
| Device description | Symbiq™ Infusion System includes a volumetric piston-driven |
| infusion pump and utilizes dedicated disposable administration | |
| sets for fluid delivery to the patient. The pump's plunger | |
| cyclically pressurizes the administration set's cassette | |
| pumping chamber through an elastomeric diaphragm to deliver | |
| fluid. | |
| The device has a touchscreen user interface to program | |
| various therapies. At low flow rates the infusion pump is | |
| designed to maintain low flow continuity. The infusion pump | |
| utilizes drug safety software to set hospital drug dosing | |
| parameters. | |
| The system can communicate wired or wirelessly over the | |
| hospitals network infrastructure through Hospira MedNet™ | |
| server software with Hospital Information Systems. | |
| The pump is available in one-channel and two-channel | |
| configurations. | |
| Intended use of the device | Symbiq™ Infusion System is intended for the delivery of fluids, |
| solutions, drugs, agents, nutritional, electrolytes, blood and | |
| blood products via parenteral, enteral, intravenous, intra- | |
| arterial, subcutaneous, epidural or irrigation routes of | |
| administration. | |
| It is intended primarily for use the hospital setting and can be | |
| used in other acute and non-acute care areas outside of the | |
| hospital under the supervision of the healthcare provider. All | |
| data entry and validation of infusion parameters is performed | |
| by a trained healthcare professional according to physician's | |
| orders. | |
| Indications for use | The Symbiq™ Infusion System is intended for the delivery of |
| fluids, solutions, drugs, agents, nutritionals, electrolytes, blood | |
| and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of | |
| administration. | |
| It is intended primarily for use in the hospital setting and can | |
| be used in other acute and non-acute care areas, such as, but | |
| not limited to Nursing Homes, Mobile Intensive Care, | |
| Ambulatory Infusion Centers, Hospice, Subacute Facilities, | |
| Outpatient/Surgical Centers, Long Term Care, Urgent Care, | |
| Transport and Physician Offices. |
1
.
| Predicate Device | Subject Device | ||
|---|---|---|---|
| Device Name | Hospira Phoenix Infusion System with | ||
| Hospira MedNet™ Software K041550 | Symbiq™ Infusion | ||
| System | |||
| Pump Type | Volumetric Piston Type | Same | |
| Number of dosing units | 66 | 91 | |
| Basic Dosing Units | ng/kg/min | ||
| mcg/kg/min | |||
| mcg/kg/hr | |||
| mcg/min | |||
| mcg/hr | |||
| mg/kg/hr | |||
| mg/min | |||
| mg/hr | grams/hr | ||
| U/kg/hr | |||
| U/min | |||
| U/hr | |||
| mUn/min | |||
| mEq/hr | |||
| mL/hr | Same | ||
| Routes of Administration | Parenteral, Intravenous, Arterial, Enteral, | ||
| Subcutaneous, Epidural, Irrigation | Same | ||
| Free Flow Protection | Administration set and pump based free | ||
| flow protection features | Same | ||
| Drug Library Feature | Yes | Same | |
| Drug Alerts | Soft and Hard Limits | Same | |
| Power Source | AC: 100-240 VAC and rechargeable | ||
| lithium ion battery | Same | ||
| Battery Life | With a fully charged battery, both one- | ||
| channel and two-channel infusers deliver | |||
| four hours of operation at 125 mL/hr with | |||
| the LCD backlight set to the Power | |||
| Saving mode | Same | ||
| Display | 8.4 in. diagonal; Color LCD | Same | |
| Physical characteristics | Width: 9.9 in. | ||
| Height: 10.2 in. | |||
| Depth: 8.6 in. | |||
| Depth with pole clamp: 13 in. | |||
| Weight: 10.7 lbs. | Similar | ||
| Depth increased 1.7 in | |||
| to add a pole | |||
| alignment guide | |||
| One Channel pump | |||
| Summary of the technological characteristics of the device compared to the | |||
| predicate device | |||
| Device Name | Predicate Device | ||
| Hospira Phoenix Infusion System with | |||
| Hospira MedNet™ Software K041550 | Subject Device | ||
| Symbiq™ Infusion | |||
| System | |||
| Physical characteristics | |||
| Two channel pump | Width: 10.9 in. | ||
| Height: 10.2 in. | |||
| Depth: 8.6 in. | |||
| Depth with pole clamp: 13 in. | |||
| Weight: 12.1 lbs. | |||
| Casing: High-impact plastic | Similar | ||
| Depth increased 1.7 in | |||
| to add a pole | |||
| alignment guide | |||
| Low Flow continuity | Yes with Microbore sets | Same | |
| Accuracy | ± 5% for rates > 1 mL/hour. | ||
| ± 10% for rates |