(301 days)
No
The document describes a standard infusion pump with a microprocessor for controlling the motor and sensors for error detection. There is no mention of AI, ML, or any learning or adaptive capabilities. The software updates are described as being made to accommodate hardware changes.
Yes.
The device is intended to deliver medications and/or fluids for therapeutic purposes, such as patient-controlled analgesia (PCA) delivery, indicating its use in medical treatment.
No
Explanation: The device is an infusion pump designed to deliver medications and/or fluids. Its purpose is therapeutic administration, not diagnosis. The text clearly states "intended to deliver medications and/or fluids" and "used to deliver medications and/or fluids". It does not mention any diagnostic capabilities.
No
The device description explicitly states that the system includes an "ambulatory infusion pump and administration set," which are hardware components. While software is mentioned as being updated, it is part of a larger hardware system.
Based on the provided information, the Halo II Ambulatory Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for delivering medications and/or fluids to a patient. This involves direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a pump and administration set designed to deliver fluids into the body (subcutaneous, perineural, epidural, intravenous). This is a drug delivery system, not a device used to examine specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body. The device's function is purely for administering substances into the body.
IVD devices are specifically designed to perform tests on samples taken from the body to provide information about a person's health. The Halo II Ambulatory Infusion System does not fit this definition.
N/A
Intended Use / Indications for Use
The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical or nonclinical environments, such as homes. The device is intended for subcutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.
Product codes
FRN, MEA, FPA
Device Description
Halo II Ambulatory Infusion System also will be marketed under the trade name "Nimbus II Ambulatory Infusion System" and "EVAA Ambulatory Infusion System"; there are no differences in these devices.
The Halo II Ambulatory Infusion System includes an ambulatory infusion pump and administration set. It is used to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. This is a device modified from its predicate device Halo Ambulatory Infusion System (K140783). Modifications include allowing users to change battery therefore enabling pump use beyond 240 hours / 1500mL. The original motor was replaced with a longer life one to support extended pump life. Software was updated accordingly to realize the changes. The administration set remains exactly the same.
Halo II Ambulatory Infusion Pump
The Halo II Ambulatory Infusion Pump has a microprocessor controlled motor that drives a peristaltic pumping mechanism to deliver fluid at a controlled rate, same as the Halo ambulatory infusion pump (K140783) and CADD-Solis VIP ambulatory infusion pump (K11275).
The pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for the Halo II pump components are widely used in the medical industry.
The pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
Halo II Administration Set
The Halo II Administration Set is exactly the same as Halo Administration Set (K140783). It is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient.
The administration set can be used with Halo II Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets (K120685), which can be used with Z-800 Infusion Pump or gravity infusion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous, percutaneous, perineural, epidural and intravenous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or other certified healthcare professional in clinical or nonclinical environments, such as 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
The following performance data was the basis for the substantial equivalence determination:
An assurance case was provided for the Halo II Ambulatory Infusion System, per the FDA guidance document for infusion pumps (Reference A listed above).
The stated goal of the assurance case is to document that the design of the Halo II Ambulatory Infusion System is adequately safe for its intended use.
The assurance case defined the device system, including the indications for use, system specifications, use environments, and user population. The supporting assurance arguments covered the following attributes:
- o All potential risks have been mitigated and residual risk is acceptable. Potential 14 types of harms resulting from 8 hazards and hazardous conditions have been extensively studied and analyzed. All potential risks have been adequately mitigated.
- o Design verification and validation of device specifications are adequate. Device description is presented in the Assurance Case Report, including design input requirements, design output, product specifications, and comparison with predicate devices. A traceability matrix is provided to establish a connection between design input and design output through verification and validation activities which have been completed to demonstrate adequate implementation of the respective design requirements.
- o Device reliability is adequate. Product reliability has been properly specified, verified, validated, and ensured through design and manufacturing process.
The following specific evidence was included within the assurance case:
Functionality
- · Testing to characterize the system functionality over expected conditions of use
- · Flow rate characterization and flow rate accuracy
- · Alarms testing.
- · Integrity of fluid pathway components
- · Reliability assessment
Software
- · Device Software Version 1.0.1 was developed in accordance with EN 62304:2006 and evaluated as part of this 510(k) Submission
- · Documentation for Major Level of Concern software was provided, as recommended by the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Reference E listed above)
- · Software verification and validation testing, including software static analysis
- Zero unresolved software anomalies were reported
Electrical Safety and Electromagnetic Compatibility
- · Electrical safety and electromagnetic compatibility were verified through testing in accordance with UL60601-1, IEC 60601-2-24 and IEC 60601-1-2
- · Ambulatory Infusion System Alarm System Testing Per IEC 60601-1-8
Biocompatibility
- ·Biocompatibility tested per ISO 10993-1:
- o Cytotoxicity per ISO 10993-5
- o Sensitization per ISO 10993-10
- o Hemolysis per ISO 10993-4
- o Irritation per ISO 10993-10
- o Acute Systemic Toxicity per ISO 10993-11
- o Subchronic Systemic Toxicity per ISO 10993-11
Sterility and Shelf Life
- · The administration set is sterilized with Ethylene Oxide gas.
- · Sterilization validation methodology in accordance with ISO 11135 was described.
- · Ethylene oxide residuals for ethylene oxide and ethylene chlorohydrin specification limits were established per ISO 10993-7.
- · Sterility Assurance Level is 100
- Non-pyrogenic claims for the administration set were verified through Kinetic Chromogenic LAL per ANSI/AAMI ST72 and Rabbit pyrogen test per United States Pharmacopeia .
- · A Shelf Life of 3 years was established with accelerated aging data per ASTM F1980-07. Testing verified package integrity and functional attributes of the administration set remained within established specifications.
Home use environment
Verification and Validation of Halo II Ambulatory Infusion System used in the home healthcare environment per IEC 60601-1-11, and FDA guidance on Design Considerations for Devices Intended for Home Use (Reference C listed above).
Human Factors and Usability
- • Simulated use/human factors studies – A Clinical Evaluation was determined not to be required for the Halo II Ambulatory Infusion System. A simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur. The study was performed with reference to FDA guidance (Reference D listed above).
- · Usability Validation Testing of Halo II Ambulatory Infusion System (IEC 6060-1-6: IEC 62366)
The assurance case and referenced evidence demonstrate that the Halo II Ambulatory Infusion System functions as designed and can be operated by the user as intended through the user interface and instructions provided.
Study Conclusion
All testing met pre-established specifications, and demonstrated that the Halo Ambulatory Infusion System performed as intended. The testing results allowed for a conclusion to be made that the Halo II Ambulatory Infusion System, which includes ambulatory pump, administration set, and accessories, is substantially equivalent to the named predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Volumetric Accuracy: +-5%
Predicate Device(s)
Halo Ambulatory Infusion System (K140783), CADD-Solis VIP Ambulatory Infusion Pump (K111275)
Reference Device(s)
Zyno Medical Administration Set (K120685)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 30, 2016
Zyno Medical LLC Mei Zhang, PhD VP Of Engineering 177 Pine St Natick, Massachusetts 01760
Re: K153193
Trade/Device Name: Halo II Ambulatory Infusion System (also with trade names Nimbus II Ambulatory Infusion System; EVAA Ambulatory Infusion System) Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN. MEA. FPA Dated: July 11, 2016 Received: July 12, 2016
Dear Mei Zhang:
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 approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the 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 (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.
1
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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events 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 Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
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Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153193
Device Name
Halo II Ambulatory Infusion System (Also with trade names Nimbus II Ambulatory Infusion System; EVAA Ambulatory Infusion System)
Indications for Use (Describe)
The Halo II Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional in clinical or nonclinical environments, such as homes. The device is intended for subcutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.
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) |
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3
510(K) - K153193 - SUMMARY
Submitted By:
Mei Zhang, PhD VP of Engineering Zyno Medical, LLC 177 Pine Street Natick, MA 01760, USA Fax: 508-650-2006 Phone: 508-650-2008 x 205 Email: mei.zhang@zynomed.com
August 29th, 2016 Date Submitted: Establishment Registration No: 3006575795 Device Proprietary Name: Halo II Ambulatory Infusion System (also with trade names: Nimbus II Ambulatory Infusion System; EVAA Ambulatory Infusion System) Device Common, Usual or Classification Name: Infusion Pump Classification Regulation: 21CFR880.5725 Device Class: Class II Panel: 80 General Hospital Product codes: FRN, MEA, FPA Predicate Device: Halo Ambulatory Infusion System (K140783) CADD-Solis VIP Ambulatory Infusion Pump (K111275)
I. INDICATIONS FOR USE
The Halo II ambulatory infusion system is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, percutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery.
Zyno Medical Administration Set (K120685)
4
II. DEVICE DESCRIPTION
Halo II Ambulatory Infusion System also will be marketed under the trade name "Nimbus II Ambulatory Infusion System" and "EVAA Ambulatory Infusion System"; there are no differences in these devices.
The Halo II Ambulatory Infusion System includes an ambulatory infusion pump and administration set. It is used to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. This is a device modified from its predicate device Halo Ambulatory Infusion System (K140783). Modifications include allowing users to change battery therefore enabling pump use beyond 240 hours / 1500mL. The original motor was replaced with a longer life one to support extended pump life. Software was updated accordingly to realize the changes. The administration set remains exactly the same.
Halo II Ambulatory Infusion Pump
The Halo II Ambulatory Infusion Pump has a microprocessor controlled motor that drives a peristaltic pumping mechanism to deliver fluid at a controlled rate, same as the Halo ambulatory infusion pump (K140783) and CADD-Solis VIP ambulatory infusion pump (K11275).
The pump interfaces with user via keypad, LED and LCD. Infusion parameters can be set up by operating the keypad, and displayed on the LCD. The pump includes sensors for detection of upstream occlusion, downstream occlusion, cassette loading error, and pumping mechanism malfunction. Error conditions can be displayed on LCD, and redundantly indicated by a LED light and audio alert. The electronics is powered by a battery. The materials of construction for the Halo II pump components are widely used in the medical industry.
The pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
Halo II Administration Set
The Halo II Administration Set is exactly the same as Halo Administration Set (K140783). It is designed to administer fluids / medication from a container to a patient through a needle or a catheter. Major components include spike, cassette, slide clamp, filter, and luer lock. The air-eliminating filter prevents air from entering into a patient.
The administration set can be used with Halo II Pump or for gravity infusion. It is similar to the predicate device, Zyno Medical Administration Sets (K120685), which can be used with Z-800 Infusion Pump or gravity infusion.
5
III. SUMMARY OF STUDIES
References:
Zyno Medical performed extensive verification and validation testing on the ambulatory pump and administration Set. Testing was completed in accordance with FDA's Guidance / draft guidance listed below:
- A. Guidance for Industry and FDA Staff: Infusion Pumps Total Product Life Cycle, issued on December 2, 2014
- B. Guidance for Industry and FDA Staff Premarket Notification Submissions [510(k)] issued on July 11, 2008
- C. Guidance for Industry and FDA Staff: Design Considerations for Devices Intended for Home Use, issued on November 24, 2014
- D. Guidance for Industry and FDA Administration Staff –Applying Human Factors and Usability Engineering to Medical Devices issued on February 3, 2016
- E. Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Device. Issued on: May 11, 2005
Performance Testing Summary:
The following performance data was the basis for the substantial equivalence determination:
An assurance case was provided for the Halo II Ambulatory Infusion System, per the FDA guidance document for infusion pumps (Reference A listed above).
The stated goal of the assurance case is to document that the design of the Halo II Ambulatory Infusion System is adequately safe for its intended use.
The assurance case defined the device system, including the indications for use, system specifications, use environments, and user population. The supporting assurance arguments covered the following attributes:
- o All potential risks have been mitigated and residual risk is acceptable. Potential 14 types of harms resulting from 8 hazards and hazardous conditions have been extensively studied and analyzed. All potential risks have been adequately mitigated.
- o Design verification and validation of device specifications are adequate. Device description is presented in the Assurance Case Report, including design input requirements, design output, product specifications, and comparison with predicate devices. A traceability matrix is provided to establish a connection between design input and design output through verification and validation activities which have been completed to demonstrate adequate implementation of the respective design requirements.
6
- o Device reliability is adequate. Product reliability has been properly specified, verified, validated, and ensured through design and manufacturing process.
The following specific evidence was included within the assurance case:
Functionality
- · Testing to characterize the system functionality over expected conditions of use
- · Flow rate characterization and flow rate accuracy
- · Alarms testing.
- · Integrity of fluid pathway components
- · Reliability assessment
Software
· Device Software Version 1.0.1 was developed in accordance with EN 62304:2006 and evaluated as part of this 510(k) Submission
· Documentation for Major Level of Concern software was provided, as recommended by the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Reference E listed above)
- · Software verification and validation testing, including software static analysis
- Zero unresolved software anomalies were reported
Electrical Safety and Electromagnetic Compatibility
· Electrical safety and electromagnetic compatibility were verified through testing in accordance with UL60601-1, IEC 60601-2-24 and IEC 60601-1-2
· Ambulatory Infusion System Alarm System Testing Per IEC 60601-1-8
Biocompatibility
·Biocompatibility tested per ISO 10993-1:
- o Cytotoxicity per ISO 10993-5
- o Sensitization per ISO 10993-10
- o Hemolysis per ISO 10993-4
- o Irritation per ISO 10993-10
- o Acute Systemic Toxicity per ISO 10993-11
- o Subchronic Systemic Toxicity per ISO 10993-11
Sterility and Shelf Life
- · The administration set is sterilized with Ethylene Oxide gas.
- · Sterilization validation methodology in accordance with ISO 11135 was described.
- · Ethylene oxide residuals for ethylene oxide and ethylene chlorohydrin specification limits were established per ISO 10993-7.
- · Sterility Assurance Level is 100
• Non-pyrogenic claims for the administration set were verified through Kinetic Chromogenic LAL per ANSI/AAMI ST72 and Rabbit pyrogen test per United States Pharmacopeia .
7
· A Shelf Life of 3 years was established with accelerated aging data per ASTM F1980-07. Testing verified package integrity and functional attributes of the administration set remained within established specifications.
Home use environment
Verification and Validation of Halo II Ambulatory Infusion System used in the home healthcare environment per IEC 60601-1-11, and FDA guidance on Design Considerations for Devices Intended for Home Use (Reference C listed above).
Human Factors and Usability
• Simulated use/human factors studies – A Clinical Evaluation was determined not to be required for the Halo II Ambulatory Infusion System. A simulated use study of human factors was conducted with intended users in the intended use environment that evaluated device performance, possible use error and user perception of difficulties with pump use. The study assessed the critical tasks or use scenarios where use related errors are most likely to occur. The study was performed with reference to FDA guidance (Reference D listed above).
· Usability Validation Testing of Halo II Ambulatory Infusion System (IEC 6060-1-6: IEC 62366)
The assurance case and referenced evidence demonstrate that the Halo II Ambulatory Infusion System functions as designed and can be operated by the user as intended through the user interface and instructions provided.
Study Conclusion
All testing met pre-established specifications, and demonstrated that the Halo Ambulatory Infusion System performed as intended. The testing results allowed for a conclusion to be made that the Halo II Ambulatory Infusion System, which includes ambulatory pump, administration set, and accessories, is substantially equivalent to the named predicates.
IV. STATEMENT OF EQUIVALENCE
The Halo Ambulatory Pump and Halo Administration Set are substantially equivalent to the predicate devices, based on comparisons of the device classifications, intended use, and technological characteristics. Verification and validation tests confirmed the suitability of the devices for their intended uses. The test results confirmed that the Halo II Ambulatory Pump and Administration Set are substantially equivalent to the predicate devices.
8
| Parameter | Halo II Ambulatory Infusion Pump | Halo Ambulatory Infusion Pump (K140783) | CADD -Solis VIP Ambulatory Infusion Pump (K111275) |
|---|---|---|---|
| Pump Type | Ambulatory Infusion Pump | Ambulatory Infusion Pump | Ambulatory Infusion Pump |
| Indications for use* | The Halo II ambulatory infusion system is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, percutaneous, perineural, epidural and intravenous infusion, including but not limited to patient controlled analgesia (PCA) delivery. | The Halo Ambulatory Infusion System is intended to deliver medications and/or fluids to a patient under the direction or supervision of physician or other certified healthcare professional. The device is intended for subcutaneous, perineural, epidural and intravenous infusion. The device is intended for 240 hours or1500mL of infusion, whichever limit is reached first. | The CADD -Solis VIP Ambulatory Infusion Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, perineural, surgical site, epidural space, or subarachnoid space infusion. PCA(Patient-controlled analgesia) delivery is used for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both, such as patient-controlled analgesia. Continuous delivery allows the infusion of drug/fluid at a constant, programmed rate. Intermittent delivery allows the infusion of a specific volume of drug/fluid at a regular, programmed interval. Step delivery allows an incremental increase in infusion rate to a specified maximum infusion rate for a specified total infusion volume Taper delivery allows a plateau rate of infusion with the option of tapering at the beginning and/or end and has a programmable KVO rate at the end of the infusion |
| Parameter | Halo II Ambulatory | ||
| Infusion Pump | Halo Ambulatory | ||
| Infusion Pump | |||
| (K140783) | CADD -Solis VIP | ||
| Ambulatory Infusion | |||
| Pump (K111275) | |||
| Infusion | |||
| Mode | Continuous Mode | ||
| Bolus Mode (PCA) | Continuous Mode | ||
| Bolus Mode (PCA) | PCA, Continuous, | ||
| Intermittent, Step, Taper | |||
| Fundamental | |||
| Technology | Mechanical pumping | ||
| mechanism driven by a | |||
| motor which is controlled | |||
| by a microprocessor | Mechanical pumping | ||
| mechanism driven by a | |||
| motor which is controlled | |||
| by a microprocessor | Mechanical pumping | ||
| mechanism driven by a | |||
| motor which is controlled | |||
| by a microprocessor | |||
| Volumetric | |||
| Accuracy | +-5% | +-5% | +-6% |
| Display | LCD, LED | LCD, LED | LCD, LED |
| Operating | |||
| Temperature | +5°C to +40°C | ||
| (+41°F to +104°F) | +5°C to +40°C | ||
| (+41°F to +104°F) | +15°C to +40°C | ||
| (+59°F to +104°F) | |||
| Alarms / Alert | |||
| / Status | |||
| Display | • Run Indicator Light & | ||
| Icon on LCD | |||
| • Pause Indicator | |||
| • Upstream Occlusion | |||
| • Downstream Occlusion | |||
| • Battery Empty | |||
| • Pump Service Due | |||
| • Cassette Loading error | |||
| • Pumping System Error | |||
| • Firmware Error | |||
| • Infusion Completed | |||
| • Pump Unattended | |||
| • Incorrect Programming | |||
| • Bolus Blocked | |||
| • Keypad Locked / | |||
| Unlocked | • Run Indicator Light & | ||
| Icon on LCD | |||
| • Pause Indicator | |||
| • Upstream Occlusion | |||
| • Downstream Occlusion | |||
| • Battery Empty | |||
| • Pump End of Life | |||
| • Cassette Loading error | |||
| • Pumping System Error | |||
| • Firmware Error | |||
| • Infusion Completed | |||
| • Pump Unattended | |||
| • Incorrect Programming | |||
| • Bolus Blocked | |||
| • Keypad Locked / | |||
| Unlocked | • Battery Low | ||
| • Battery Depleted | |||
| • Battery Removed | |||
| • Battery Unusable | |||
| • Pump Stopped | |||
| • Pump Fault | |||
| • Pressure Sensor Faulty | |||
| • Air-In-Line | |||
| • Upstream Occlusion | |||
| • Reservoir Volume Empty | |||
| • Program incomplete | |||
| • Remote Dose Cord Key | |||
| Stuck | |||
| • Key Stuck | |||
| • Disposable type invalid | |||
| • Disposable not latched | |||
| • Disposable Detached | |||
| • AC adaptor disconnected | |||
| • Preventive Maintenance | |||
| Due | |||
| Use | |||
| Environment | Clinical and non-clinical | Clinical and non-clinical | Clinical and non-clinical |
| Size | 4.2 in. x 2.3 in. x 1.6 in. | ||
| (108mm x 58mm x 40 | |||
| mm) | 4.2 in. x 2.3 in. x 1.6 in. | ||
| (108mm x 58mm x 40 | |||
| mm) | 5 in x 4 in x1.6 in | ||
| (127 mm x 102 mm x 41 | |||
| mm) | |||
| Weight | 6.1 ounces | ||
| (173 grams) | 6.1 ounces | ||
| (173 grams) | 21 ounces | ||
| (595 gramps) |
Table 1: Equivalency Matrix of Halo II Ambulatory Infusion Pump and Predicate Devices
9
*Although there are differences in the wording of indications for use statements, the differences are not critical to the intended use of the devices are all intended to deliver medications / fluids to a patient. The new indications for use does not include a time limit of the device, this does not change the intended use or raise new questions of safety and effectiveness, because the device service life is still monitored by an internal odometer, the same way as the predicate device. The extended use is verified through testing under normal use conditions, as
10
well as under extreme conditions, such as continuously operated under specified lowest and highest temperature. The reliability has been assessed as adequate based on testing results and analysis.
| Parameter | Halo II
Administration
Set | Halo
Administration Set
(K140783) | Zyno Medical
Administration Set
(K120685) |
|--------------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Device Type | Administration Set | Administration Set | Administration Set |
| Intended use | To administer fluids from a container to a patient through a needle or a catheter | To administer fluids from a container to a patient through a needle or a catheter | To administer fluids from a container to a patient's vascular system through a needle or a catheter inserted into a vein |
| Tubing
material | Standard PVC | Standard PVC | Standard PVC |
| Single use? | Yes | Yes | Yes |
| Sterile? | Yes | Yes | Yes |
| Sterilization
method | EtO | EtO | EtO |
| Set based Free
Flow
Protection | Yes | Yes | Yes |
| Components | Spike, tubing, cassette, slide clamp, filter, Luer Lock | Spike, tubing, cassette, slide clamp, filter, Luer Lock | Spike, drip chamber, tubing, roller clamp, slide clamp, pinch clamp, filter, Y-site, Luer Lock |
| ISO 8536
compliant? | Yes | Yes | Yes |
| ISO 10993
compliant? | Yes | Yes | Yes |