(200 days)
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 or 1500mL of infusion, whichever limit is reached first.
The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings.
Halo Ambulatory Infusion Pump: The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325). The Halo 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 Halo Pump components are widely used in the medical industry. The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
Halo Administration Set: The Halo Administration Set 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 Halo Administration Set can be used with Halo 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.
This document is a 510(k) summary for the Halo Ambulatory Infusion System, encompassing the Halo Ambulatory Infusion Pump and the Halo Administration Set. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally established for each test based on relevant standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents. The document states that "All testing met pre-established specifications," and provides a summary table of the verification and validation tests performed.
| Testing Performed | Acceptance Criteria Source (Implicit) | Reported Device Performance |
|---|---|---|
| Halo Administration Set testing (Biocompatibility, Pyrogenicity, Physical & Mechanical, Chemical, Sterility, Aging, DEHP, Integration with Halo Pump) | Reference B (Intravascular Administration Sets Premarket Notification Submissions), ISO / AAMI / ASTM standards | Pass |
| Halo Pump software verification and validation testing | Reference E (Software Contained in Medical Device) | Pass |
| Halo Ambulatory Infusion System basic safety and essential performance testing | IEC 60601-1 and 60601-2-24 | Pass |
| Halo Pump Electromagnetic Compatibility Testing | IEC 60606-1-2 | Pass |
| Halo Ambulatory Infusion System Alarm System Testing | IEC 60601-1-8 | Pass |
| Verification and Validation of Halo Ambulatory Infusion System used in the home healthcare environment | Reference C (Design Considerations for Devices Intended for Home Use), IEC 60601-1-11 | Pass |
| Additional Testing for Verification of Safety and Effectiveness | Reference A (Infusion Pump Premarket Notification Submissions), design requirements, hazard analysis | Pass |
| Usability Validation Testing of Halo Ambulatory Infusion System | References A, B, C, D (Human Factors and Usability Engineering), E; IEC 6060-1-6; IEC 62366 | Pass |
| Volumetric Accuracy (Halo Ambulatory Infusion Pump) | Predicate Devices (CADD-Legacy, ambIT, CADD-Solis VIP) all have +/- 6% | +/- 5% |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of infusion sets tested for biocompatibility, number of pumps for volumetric accuracy). It only mentions that "Zyno Medical performed extensive verification and validation testing."
The provenance of the data is implicit: it was generated through the manufacturer's (Zyno Medical, LLC, Natick, MA, USA) own verification and validation testing, which is generally conducted under controlled, prospective conditions for a new device submission. There is no mention of country of origin for the data or whether it was retrospective or prospective in the context of clinical studies, as clinical studies were "deemed unnecessary."
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. Given that the testing was primarily lab-based verification and validation against technical standards and safety requirements, clinical "experts" in the traditional sense for establishing ground truth on patient data were not involved as "Human clinical studies were deemed unnecessary." The "ground truth" for these tests would be the established performance specifications and regulatory standards.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes by multiple readers, which was not performed here.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Halo Ambulatory Infusion System." Therefore, there is no information on the effect size of human readers improving with or without AI assistance, as AI is not mentioned as a component.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a physical medical device (infusion pump and administration set), not an algorithm or AI system. Its performance is inherent to its mechanical and electrical function.
7. The Type of Ground Truth Used
The "ground truth" for the device's performance was established via:
- Technical Specifications and Regulatory Standards: Compliance with various international standards (ISO, AAMI, ASTM, IEC) and FDA guidance documents related to infusion pumps and administration sets.
- Predicate Device Performance: The "Equivalency Matrix" tables (Table 1 and 2) compare the Halo system's features and performance parameters (e.g., volumetric accuracy) against legally marketed predicate devices, implying that the established performance of these predicates served as a benchmark for equivalence.
- Design Requirements and Hazard Analysis: The testing included verification against internal design requirements and findings from hazard analysis.
8. The Sample Size for the Training Set
This question is not applicable. The Halo Ambulatory Infusion System is a conventional medical device (infusion pump), not a machine learning or AI system that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features the department's name encircling a symbol of three stylized human profiles facing right, representing health and well-being. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the circular emblem.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 17, 2014
Zyno Medical LLC Mei Zhang Director of Engineering 177 Pine Street Natick, MA 01760
Re: K140783
Trade/Device Name: Halo Ambulatory Infusion System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN, MEA, FPA Dated: September 19, 2014 Received: September 24, 2014
Dear Ms. 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.
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Page 2 - Ms. Zhang
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), 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,
Susan Runno DDS, MA
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name Halo Ambulatory Infusion System
Indications for Use (Describe)
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 or 1500mL of infusion, whichever limit is reached first.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
] Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(K) SUMMARY for the Halo Ambulatory Infusion System
Submitted By:
Mei Zhang, PhD Director 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
| Date Submitted: | September 19th, 2014 |
|---|---|
| Establishment Registration No: | 3006575795 |
| Device Proprietary Name: | Halo Ambulatory Infusion System |
| Device Common, Usual or Classification Name: | Ambulatory Infusion System |
| Device Class: | Class II |
| Panel: | 80 General Hospital |
| Product codes: | Infusion Pump, product code FRN (21 CFR 880.5725);PCA Infusion Pump, product code MEA (21 CFR 880.5725); andAdministration Set, product code FPA (21 CFR 880.5440) |
| Predicate Device: | CADD-Legacy PCA Model 6300 (K982839)ambIT Continuous Ambulatory Infusion Pump (K033325)CADD-Solis VIP Ambulatory Infusion Pump (K111275)Zyno Medical Administration Set (K120685) |
I. INTENDED USE
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 health care 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.
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II. DEVICE DESCRIPTION
The Halo Ambulatory Infusion System includes Halo Ambulatory Infusion Pump ("Halo Pump'') and Halo Administration Set. The system provides measured drug / fluid therapy for subcutaneous, perineural, evidural and intravenous delivery to patient under the direction or supervision of physician or other certified health care professional. The design philosophy was "Simplicity = Safety". Verification and validation data have demonstrated that this is a simple, safe and reliable infusion device for patient in the clinical and non-clinical environments, including but not limited to hospital, homecare, and outpatient settings.
Halo Ambulatory Infusion Pump
The Halo Ambulatory Infusion Pump ("Halo Pump") has a microprocessor controlled motor that drives a mechanical pumping mechanism to deliver fluid at a controlled rate, same as the CADD-Legacy PCA 6300 Ambulatory Infusion Pump (K982839) and ambIT Continuous Ambulatory Infusion Pump (K033325).
The Halo 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 Halo Pump components are widely used in the medical industry.
The Halo Pump is intended for therapies that require a continuous infusion with optional Patient Controlled Analgesia (PCA).
Halo Administration Set
The Halo Administration Set 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 Halo Administration Set can be used with Halo 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.
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III. SUMMARY OF STUDIES
References:
Zyno Medical performed extensive verification and validation testing on the Halo Pump and Administration Set. Testing was completed in accordance with FDA's Guidance / draft guidance listed below:
- A. Guidance for Industry and FDA Staff Total Product Life Cycle: Infusion Pump -Premarket Notification [510(k)] Submissions, issued on April 23, 20 10
- B. Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] issued on July 11, 2008
- C. Draft Guidance for Industry and FDA Administration Staff –Design Considerations for Devices Intended for Home Use, issued on December 12, 2012
- D. Draft Guidance for Industry and FDA Administration Staff –Applying Human Factors and Usability Engineering to Optimize Medical Device Design issued on June 22, 2011
- 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
Safety and Effectiveness Verification and Validation
A summary of the verification and validation testing performed is provided below:
| Testing Performed | Results |
|---|---|
| Halo Administration Set testing, including Biocompatibility,Pyrogenicity, Physical & Mechanical Testing, Chemical Testing,Sterility Testing, Aging testing, DEHP, Integration Testing with HaloPump (Per reference B above, ISO / AAMI / ASTM standards) | Pass |
| Halo Pump software verification and validation testing (Per referenceE) | Pass |
| Halo Ambulatory Infusion System basic safety and essentialperformance testing: (Per IEC 60601-1 and 60601-2-24) | Pass |
| Halo Pump Electromagnetic Compatibility Testing (Per IEC 60606-1-2) | Pass |
| Halo Ambulatory Infusion System Alarm System Testing (Per IEC60601-1-8) | Pass |
| Verification and Validation of Halo Ambulatory Infusion System usedin the home healthcare environment (Per reference C above and IEC60601-1-11) | Pass |
| Additional Testing for Verification of Safety and Effectiveness (Perreference A, design requirements, and hazard analysis) | Pass |
| Usability Validation Testing of Halo Ambulatory Infusion System(Per reference A, B, C, D, E above; IEC 6060-1-6; IEC 62366) | Pass |
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Testing Conclusion
All testing met pre-established specifications, and successfully demonstrated that the Halo Ambulatory Infusion System performed as intended. The testing results allowed for a conclusion to be made that the Halo Ambulatory Infusion System, which includes Halo Ambulatory Pump, Halo Administration Set, and accessories is as safe and effective as the predicate devices.
Clinical Studies
Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the Halo Ambulatory Infusion System.
STATEMENT OF EQUIVALENCE VI.
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 did not raise any safety or performance questions, and confirmed that the Halo Ambulatory Pump and Halo Administration Set are substantially equivalent to the predicate devices.
Table 1: Equivalency Matrix of Halo Ambulatory Infusion Pump and Predicate Devices
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| Parameter | HaloAmbulatoryInfusion Pump | CADD-Legacy PCA6300 Model(K982839) | ambIT ContinuousInfusion Pump(K033325) | CADD -Solis VIPAmbulatory InfusionPump (K111275) |
|---|---|---|---|---|
| Pump Type | AmbulatoryInfusion Pump | AmbulatoryInfusion Pump | Ambulatory InfusionPump | Ambulatory Infusion Pump |
| Intended use | The HaloAmbulatoryInfusion System isintended to delivermedications and/orfluids to a patientunder the directionor supervision ofphysician or othercertified healthcareprofessional. Thedevice is intendedfor subcutaneous,perineural, epiduraland intravenousinfusion. Thedevice is intendedfor 240 hoursor1500mL ofinfusion, whicheverlimit is reachedfirst. | The CADD-Legacy pump issuitable forintravenous,intra-arterial,subcutaneous,intraperitoneal,epidural space, orsubarachnoidspace infusion. | The ambIT InfusionPump is intended forcontinuous volumetricdelivery of intravenousmedicines and /or fluidsinto patient at aconsistent volume forprescriptive treatmentby a physician. | The CADD -Solis VIPAmbulatory Infusion Pumpis indicated for intravenous,intra-arterial, subcutaneous,intraperitoneal, perineural,surgical site, epidural space,or subarachnoid spaceinfusion.PCA(Patient-controlledanalgesia) delivery is usedfor therapies that require acontinuous rate of infusion,patient-controlled demanddoses, or both, such aspatient-controlled analgesia.Continuous delivery allowsthe infusion of drug/fluid ata constant, programmedrate.Intermittent delivery allowsthe infusion of a specificvolume of drug/fluid at aregular, programmedinterval.Step delivery allows anincremental increase ininfusion rate to a specifiedmaximum infusion rate for aspecified total infusionvolumeTaper delivery allows aplateau rate of infusion withthe option of tapering at thebeginning and/or end andhas a programmable KVOrate at the end of theinfusion |
| InfusionMode | Continuous ModeBolus Mode (PCA) | Continuous Modewith Bolus(PCA) | Continuous Mode | PCA, Continuous,Intermittent, Step, Taper |
| Parameter | HaloAmbulatoryInfusion Pump | CADD-Legacy PCA6300 Model(K982839) | ambIT ContinuousInfusion Pump(K033325) | CADD –Solis VIPAmbulatory InfusionPump (K111275) |
| FundamentalTechnology | Mechanicalpumpingmechanism drivenby a motor which iscontrolled by amicroprocessor | Mechanicalpumpingmechanismdriven by a motorwhich iscontrolled by amicroprocessor | Mechanical pumpingmechanism driven by amotor which iscontrolled by amicroprocessor | Mechanical pumpingmechanism driven by amotor which is controlledby a microprocessor |
| VolumetricAccuracy | +-5% | +-6% | +-6% | +-6% |
| Display | LCD, LED | LCD, LED | LCD, LED | LCD, LED |
| OperatingTemperature | +5°C to +40°C(+41°F to +104°F) | +2°C to+ 40°C(+35°F to+104°F) | +10°C to +43°C(+50°F to +110°F) | +15°C to +40°C(+59°F to +104°F) |
| Alarms / Alert/ StatusDisplay | •Run IndicatorLight & Icon onLCD• Pause Indicator• UpstreamOcclusion• DownstreamOcclusion• Battery Empty• Pump End of Life• Cassette Loadingerror• Pumping SystemError• Firmware Error• InfusionCompleted• Pump Unattended• IncorrectProgramming• Bolus Blocked• Keypad Locked /Unlocked | • Battery Low• BatteryDepleted• BatteryDislodged• Pump Stopped• Pump Fault• Low ReservoirVolume• High DeliveryPressure• Air-In-Line• Disposable notattached whenrun attempted• Service due• Motor Locked• UpstreamOcclusion• ReservoirVolume Empty• Programincomplete• Remote DoseCord Removed• Key Stuck• DisposableDetached | • Run Indicator Light• Pause Indicator• DownstreamOcclusion• Cassette not Mountedon Pump• Low Battery• Dead Battery• Malfunction• Infusion Complete | • 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 KeyStuck• Key Stuck• Disposable type invalid• Disposable not latched• Disposable Detached• AC adaptor disconnected• Preventive MaintenanceDue |
| UseEnvironment | Clinical and non-clinical | Clinical and non-clinical | Clinical and non-clinical | Clinical and non-clinical |
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| Parameter | HaloAmbulatoryInfusion Pump | CADD-Legacy PCA6300 Model(K982839) | ambIT ContinuousInfusion Pump(K033325) | CADD -Solis VIPAmbulatory InfusionPump (K111275) |
|---|---|---|---|---|
| Size | 4.2 in. x 2.3 in. x1.6 in.(108mm x 58mm x40 mm) | 4.4 in. x 3.8 in. x1.6 in.(112mm x 96 mmx 40mm) | 6.875 in. x 2.16 in. x1.4 in.(175 mm x 55 mm x36 mm) | 5 in x 4 in x1.6 in(127 mm x 102 mm x 41mm) |
| Weight | 6.1 ounces(173 grams) | 13.8 ounces(391 grams) | 6.4 ounces(181.4 grams) | 21 ounces(595 grams) |
Table 2: Equivalency Matrix of Halo Administration Set and the Predicate Device
| Parameter | Halo Administration Set | Zyno Medical Administration Set(K120685) |
|---|---|---|
| Device Type | Administration Set | Administration Set |
| Intended use | To administer fluids from acontainer to a patient through aneedle or a catheter | To administer fluids from a container to apatient's vascular system through a needleor a catheter inserted into a vein |
| Tubing material | Standard PVC | Standard PVC |
| Single use? | Yes | Yes |
| Sterile? | Yes | Yes |
| Sterilizationmethod | EtO | EtO |
| Set based FreeFlow Protection | Yes | Yes |
| Components | Spike, tubing, cassette, slideclamp, filter, Luer Lock | Spike, drip chamber, tubing, roller clamp,slide clamp, pinch clamp, filter, Y-site,Luer Lock |
| ISO 8536compliant? | Yes | Yes |
| ISO 10993compliant? | Yes | Yes |
§ 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).