(340 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Symbiq™ Infusion System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the "Accuracy" row in the comparison table with the predicate device. The results summary for the non-clinical tests all state "Pass," indicating conformity with the respective standards.
| Characteristic | Acceptance Criteria (from Predicate/Standard) | Reported Device Performance (Symbiq™ Infusion System) |
|---|---|---|
| Accuracy | ± 5% for rates > 1 mL/hour.± 10% for rates <= 1 mL/hour (Predicate device) | ± 5% at all rates |
| Electrical and Mechanical Safety | IEC 60601-1 (1988), Amd 1 (1991), Amd 2 (1995) for Type B equipment | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2 (2001) | Pass |
| Alarm Systems | IEC 60601-1-8 Ed.1 (2003-08) | Pass |
| Sets Biocompatibility | ISO 10993-1:2009 | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the numerical sample size used for the test set in terms of specific patient or simulated cases. It refers to "System verification and validation activities" and "Human Factors Use Safety Validation study."
- Sample Size for Test Set: Not explicitly quantifiable from the provided text for the performance tests (e.g., accuracy, safety). For the Human Factors Study, it only states "no instances of participants failing to complete tasks correctly," implying some number of participants were involved, but the exact count is not given.
- Data Provenance: The document does not specify the country of origin for any data. It does indicate that "System verification and validation activities" were conducted, as well as a "Human Factors Use Safety Validation study," suggesting these were prospective tests designed for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The document mentions "user needs and design inputs" being met, and a "Safety Assurance Case" being generated, but does not detail expert involvement in establishing ground truth for performance testing or the Human Factors study beyond general "trained healthcare professional" for data entry and validation of infusion parameters in the Intended Use section.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned. The device described is an infusion pump, and the studies mentioned are focused on the device's technical and user safety performance, not on AI-assisted interpretation by human readers.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done
The performance testing (e.g., accuracy, electrical/mechanical safety) evaluates the device's inherent functionality, which can be considered "standalone" in that it's testing the direct output of the pump system. The human factors study involved users, but the "Performance Test Summary-New Device" describes the system meeting "user needs and design inputs," and refers to "static analysis of the software code," which would be a standalone evaluation of the algorithm/software.
7. The Type of Ground Truth Used
Based on the nature of the device (infusion pump) and the tests described:
- Technical Performance (Accuracy, Safety, EMC, Alarms): The ground truth would be established by objective measurements against predefined engineering specifications and regulatory standards (e.g., measured flow rate vs. programmed flow rate, electrical safety limits, alarm signaling conditions).
- Biocompatibility: Established by laboratory testing against ISO 10993-1.
- Human Factors: The ground truth for correct task completion would be defined by the intended operational steps and the absence of user errors as observed during the study.
8. The Sample Size for the Training Set
The document does not mention a training set in the context of machine learning or AI. The "software" refers to drug safety software and system communication, implying a traditional software development and testing cycle, not a machine learning model that requires a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned in the context of machine learning/AI, this question is not applicable. For the software and system development, the "ground truth" would be the functional requirements and design specifications that the system was built to meet.
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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 RegistrationNumber | 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 MedNetSoftware, cleared under K041550 on 06/30/2004 |
| Reason for 510(k) submission | Cumulative changes |
| Device description | Symbiq™ Infusion System includes a volumetric piston-driveninfusion pump and utilizes dedicated disposable administrationsets for fluid delivery to the patient. The pump's plungercyclically pressurizes the administration set's cassettepumping chamber through an elastomeric diaphragm to deliverfluid.The device has a touchscreen user interface to programvarious therapies. At low flow rates the infusion pump isdesigned to maintain low flow continuity. The infusion pumputilizes drug safety software to set hospital drug dosingparameters.The system can communicate wired or wirelessly over thehospitals network infrastructure through Hospira MedNet™server software with Hospital Information Systems.The pump is available in one-channel and two-channelconfigurations. |
| Intended use of the device | Symbiq™ Infusion System is intended for the delivery of fluids,solutions, drugs, agents, nutritional, electrolytes, blood andblood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes ofadministration.It is intended primarily for use the hospital setting and can beused in other acute and non-acute care areas outside of thehospital under the supervision of the healthcare provider. Alldata entry and validation of infusion parameters is performedby a trained healthcare professional according to physician'sorders. |
| Indications for use | The Symbiq™ Infusion System is intended for the delivery offluids, solutions, drugs, agents, nutritionals, electrolytes, bloodand blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes ofadministration.It is intended primarily for use in the hospital setting and canbe used in other acute and non-acute care areas, such as, butnot 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. |
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| Predicate Device | Subject Device | ||
|---|---|---|---|
| Device Name | Hospira Phoenix Infusion System withHospira MedNet™ Software K041550 | Symbiq™ InfusionSystem | |
| Pump Type | Volumetric Piston Type | Same | |
| Number of dosing units | 66 | 91 | |
| Basic Dosing Units | ng/kg/minmcg/kg/minmcg/kg/hrmcg/minmcg/hrmg/kg/hrmg/minmg/hr | grams/hrU/kg/hrU/minU/hrmUn/minmEq/hrmL/hr | Same |
| Routes of Administration | Parenteral, Intravenous, Arterial, Enteral,Subcutaneous, Epidural, Irrigation | Same | |
| Free Flow Protection | Administration set and pump based freeflow protection features | Same | |
| Drug Library Feature | Yes | Same | |
| Drug Alerts | Soft and Hard Limits | Same | |
| Power Source | AC: 100-240 VAC and rechargeablelithium ion battery | Same | |
| Battery Life | With a fully charged battery, both one-channel and two-channel infusers deliverfour hours of operation at 125 mL/hr withthe LCD backlight set to the PowerSaving 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. | SimilarDepth increased 1.7 into add a polealignment guide | |
| One Channel pump | |||
| Summary of the technological characteristics of the device compared to thepredicate device | |||
| Device Name | Predicate DeviceHospira Phoenix Infusion System withHospira MedNet™ Software K041550 | Subject DeviceSymbiq™ InfusionSystem | |
| Physical characteristicsTwo 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 | SimilarDepth increased 1.7 into add a polealignment guide | |
| Low Flow continuity | Yes with Microbore sets | Same | |
| Accuracy | ± 5% for rates > 1 mL/hour.± 10% for rates <=1 mL/hour | ± 5% at all rates | |
| Delivery Rate Ranges | 0.1 to 99.9 mL/hr (in 0.1 mL increments) 100 to 1000 mL/hr (in 1 mL increments) | Same | |
| VTBI (Volume to be Infused)Ranges | 0.1 to 99.9 mL (in 0.1 mL increments) 100 to 9999 mL (in 1 mL increments) | Same | |
| Occlusion Settings | Distal: User specified range in either psi (from 1 to 15 in increments of 0.5) or mmHg (from 50 to 775 in increments of 25) Proximal: -5 psi/250 mmHg | Same | |
| Primary Alarms conditions | Check Cassette, Proximal Occlusion,Distal Occlusion, Air-in-line, Low Battery,Depleted Battery, Service Battery, PowerLoss, Callback, End of Infusion,Emergency Stop, Nearing End of Infusion | Same |
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PERFORMANCE DATA
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.
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
|---|---|---|
| Electrical and Mechanical Safety | IEC 60601-1 (1988): Medical electricalequipment - Part 1: Generalrequirements for safety, includingAmendment 1 (1991) and Amendment2 (1995) for Type B equipment | Pass |
| Electromagnetic Compatibility | IEC 60601-1-2 (2001): MedicalElectrical Equipment, Part 1-2:General Requirements for Safety,Collateral Standard: ElectromagneticCompatibility - Requirements andTests | Pass |
| Alarm Systems | IEC 60601-1-8 Ed.1 (2003-08) Part 1-8: General requirements for safety -Collateral standard: Alarm systems | Pass |
| Sets Biocompatibility | ISO 10993-1:2009: BiologicalEvaluation of Medical Devices Part 1:Evaluation and Testing | 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.
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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. In the center of the seal is an abstract image of an eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Dr. Ray Silkaitis Director Global Regulatory Affairs, Device Development Hospira, Inc. 275 North Field Drive Lake Forest, Illinois 60045
MAR - 5 2012
Re: K110901
Trade/Device Name: Symbiq™ Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, FPA Dated: February 28, 2012 Received: February 29, 2012
Dear Dr. Silkaitis:
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 (Act) that do not require approval of a premarket the Federal Pood, Drag, Drag, therefore, market the device, subject to the general approval upprisation (vhe Act. 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 If your de not is classince (so itional controls. Existing major regulations affecting your (1 wirty, it thay be basjon . Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Dr. Silkaitis
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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), 11 you acon http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to Compilance if fication" (21CFR Part 807.97). For questions regarding the reporting of premartevents under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the I ou may betain of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (unknown at this time)
Symbiq™ Infusion System Device Name:
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.
lt 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.
Prescription Use __ X (Part 21 CFR 801 Subpart D) · AND/OR
Over-The-Counter Use (Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alil Chyz 3/5/12
(Division Sign Off)
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K110690
§ 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).