HALO AMBULATORY INFUSION SYSTEM

K140783 · Zyno Medical, LLC · FRN · Oct 17, 2014 · General Hospital

Device Facts

• Record ID: K140783
• Device Name: HALO AMBULATORY INFUSION SYSTEM
• Applicant: Zyno Medical, LLC
• Product Code: FRN · General Hospital
• Decision Date: Oct 17, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

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 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.

Device Story

Halo Ambulatory Infusion System consists of Halo Pump and Halo Administration Set; delivers medications/fluids via subcutaneous, perineural, epidural, or intravenous routes. Pump uses microprocessor-controlled motor driving mechanical pumping mechanism; interfaces via keypad, LED, and LCD. Sensors detect upstream/downstream occlusion, cassette loading errors, and malfunction; alerts via LCD, LED, and audio. Used in clinical/non-clinical settings (hospital, homecare, outpatient) by healthcare professionals. Administration set includes spike, cassette, slide clamp, filter, and luer lock; air-eliminating filter prevents air entry. System supports continuous infusion and optional Patient Controlled Analgesia (PCA). Design philosophy emphasizes simplicity for safety; provides measured therapy; battery-powered.

Clinical Evidence

No clinical data. Safety and effectiveness established via bench testing, including biocompatibility, pyrogenicity, physical/mechanical testing, sterility, software verification/validation (per IEC 62304/FDA guidance), basic safety/essential performance (IEC 60601-1, 60601-2-24), electromagnetic compatibility (IEC 60601-1-2), alarm system testing (IEC 60601-1-8), and usability validation (IEC 62366).

Technological Characteristics

Mechanical pumping mechanism driven by microprocessor-controlled motor. Materials: standard medical-grade plastics (PVC tubing). Power: battery. Connectivity: standalone. User interface: keypad, LCD, LED. Sterilization: EtO (administration set). Software: embedded firmware. Standards: IEC 60601-1, IEC 60601-2-24, IEC 60601-1-8, IEC 60601-1-11, ISO 8536, ISO 10993.

Indications for Use

Indicated for patients requiring subcutaneous, perineural, epidural, or intravenous delivery of medications and/or fluids under the direction or supervision of a physician or certified healthcare professional.

Regulatory Classification

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.

Predicate Devices

• CADD-Legacy PCA Model 6300 (K982839)
• ambIT Continuous Ambulatory Infusion Pump (K033325)
• CADD-Solis VIP Ambulatory Infusion Pump (K111275)
• Zyno Medical Administration Set (K120685)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

K140783

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: [phone] Phone: [phone] x 205 Email: [e-mail]

| 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);<br>PCA Infusion Pump, product code MEA (21 CFR 880.5725); and<br>Administration Set, product code FPA (21 CFR 880.5440) |
| Predicate Device: | CADD-Legacy PCA Model 6300 (K982839)<br>ambIT Continuous Ambulatory Infusion Pump (K033325)<br>CADD-Solis VIP Ambulatory Infusion Pump (K111275)<br>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,<br>Pyrogenicity, Physical & Mechanical Testing, Chemical Testing,<br>Sterility Testing, Aging testing, DEHP, Integration Testing with Halo<br>Pump (Per reference B above, ISO / AAMI / ASTM standards) | Pass |
| Halo Pump software verification and validation testing (Per reference<br>E) | Pass |
| Halo Ambulatory Infusion System basic safety and essential<br>performance testing: (Per IEC 60601-1 and 60601-2-24) | Pass |
| Halo Pump Electromagnetic Compatibility Testing (Per IEC 60606-1-<br>2) | Pass |
| Halo Ambulatory Infusion System Alarm System Testing (Per IEC<br>60601-1-8) | Pass |
| Verification and Validation of Halo Ambulatory Infusion System used<br>in the home healthcare environment (Per reference C above and IEC<br>60601-1-11) | Pass |
| Additional Testing for Verification of Safety and Effectiveness (Per<br>reference A, design requirements, and hazard analysis) | Pass |
| Usability Validation Testing of Halo Ambulatory Infusion System<br>(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 | Halo<br>Ambulatory<br>Infusion Pump | CADD-<br>Legacy PCA<br>6300 Model<br>(K982839) | ambIT Continuous<br>Infusion Pump<br>(K033325) | CADD -Solis VIP<br>Ambulatory Infusion<br>Pump (K111275) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pump Type | Ambulatory<br>Infusion Pump | Ambulatory<br>Infusion Pump | Ambulatory Infusion<br>Pump | Ambulatory Infusion Pump |
| Intended use | The Halo<br>Ambulatory<br>Infusion System is<br>intended to deliver<br>medications and/or<br>fluids to a patient<br>under the direction<br>or supervision of<br>physician or other<br>certified healthcare<br>professional. The<br>device is intended<br>for subcutaneous,<br>perineural, epidural<br>and intravenous<br>infusion. The<br>device is intended<br>for 240 hours<br>or1500mL of<br>infusion, whichever<br>limit is reached<br>first. | The CADD-<br>Legacy pump is<br>suitable for<br>intravenous,<br>intra-arterial,<br>subcutaneous,<br>intraperitoneal,<br>epidural space, or<br>subarachnoid<br>space infusion. | The ambIT Infusion<br>Pump is intended for<br>continuous volumetric<br>delivery of intravenous<br>medicines and /or fluids<br>into patient at a<br>consistent volume for<br>prescriptive treatment<br>by a physician. | The CADD -Solis VIP<br>Ambulatory Infusion Pump<br>is indicated for intravenous,<br>intra-arterial, subcutaneous,<br>intraperitoneal, perineural,<br>surgical site, epidural space,<br>or subarachnoid space<br>infusion.<br>PCA(Patient-controlled<br>analgesia) delivery is used<br>for therapies that require a<br>continuous rate of infusion,<br>patient-controlled demand<br>doses, or both, such as<br>patient-controlled analgesia.<br>Continuous delivery allows<br>the infusion of drug/fluid at<br>a constant, programmed<br>rate.<br>Intermittent delivery allows<br>the infusion of a specific<br>volume of drug/fluid at a<br>regular, programmed<br>interval.<br>Step delivery allows an<br>incremental increase in<br>infusion rate to a specified<br>maximum infusion rate for a<br>specified total infusion<br>volume<br>Taper delivery allows a<br>plateau rate of infusion with<br>the option of tapering at the<br>beginning and/or end and<br>has a programmable KVO<br>rate at the end of the<br>infusion |
| Infusion<br>Mode | Continuous Mode<br>Bolus Mode (PCA) | Continuous Mode<br>with Bolus<br>(PCA) | Continuous Mode | PCA, Continuous,<br>Intermittent, Step, Taper |
| Parameter | Halo<br>Ambulatory<br>Infusion Pump | CADD-<br>Legacy PCA<br>6300 Model<br>(K982839) | ambIT Continuous<br>Infusion Pump<br>(K033325) | CADD –Solis VIP<br>Ambulatory Infusion<br>Pump (K111275) |
| Fundamental<br>Technology | Mechanical<br>pumping<br>mechanism driven<br>by a motor which is<br>controlled by a<br>microprocessor | Mechanical<br>pumping<br>mechanism<br>driven by a motor<br>which is<br>controlled by a<br>microprocessor | Mechanical pumping<br>mechanism driven by a<br>motor which is<br>controlled by a<br>microprocessor | Mechanical pumping<br>mechanism driven by a<br>motor which is controlled<br>by a microprocessor |
| Volumetric<br>Accuracy | +-5% | +-6% | +-6% | +-6% |
| Display | LCD, LED | LCD, LED | LCD, LED | LCD, LED |
| Operating<br>Temperature | +5°C to +40°C<br>(+41°F to +104°F) | +2°C to+ 40°C<br>(+35°F to<br>+104°F) | +10°C to +43°C<br>(+50°F to +110°F) | +15°C to +40°C<br>(+59°F to +104°F) |
| Alarms / Alert<br>/ Status<br>Display | •Run Indicator<br>Light & Icon on<br>LCD<br>• Pause Indicator<br>• Upstream<br>Occlusion<br>• Downstream<br>Occlusion<br>• Battery Empty<br>• Pump End of Life<br>• Cassette Loading<br>error<br>• Pumping System<br>Error<br>• Firmware Error<br>• Infusion<br>Completed<br>• Pump Unattended<br>• Incorrect<br>Programming<br>• Bolus Blocked<br>• Keypad Locked /<br>Unlocked | • Battery Low<br>• Battery<br>Depleted<br>• Battery<br>Dislodged<br>• Pump Stopped<br>• Pump Fault<br>• Low Reservoir<br>Volume<br>• High Delivery<br>Pressure<br>• Air-In-Line<br>• Disposable not<br>attached when<br>run attempted<br>• Service due<br>• Motor Locked<br>• Upstream<br>Occlusion<br>• Reservoir<br>Volume Empty<br>• Program<br>incomplete<br>• Remote Dose<br>Cord Removed<br>• Key Stuck<br>• Disposable<br>Detached | • Run Indicator Light<br>• Pause Indicator<br>• Downstream<br>Occlusion<br>• Cassette not Mounted<br>on Pump<br>• Low Battery<br>• Dead Battery<br>• Malfunction<br>• Infusion Complete | • Battery Low<br>• Battery Depleted<br>• Battery Removed<br>• Battery Unusable<br>• Pump Stopped<br>• Pump Fault<br>• Pressure Sensor Faulty<br>• Air-In-Line<br>• Upstream Occlusion<br>• Reservoir Volume Empty<br>• Program incomplete<br>• Remote Dose Cord Key<br>Stuck<br>• Key Stuck<br>• Disposable type invalid<br>• Disposable not latched<br>• Disposable Detached<br>• AC adaptor disconnected<br>• Preventive Maintenance<br>Due |
| Use<br>Environment | Clinical and non-<br>clinical | Clinical and non-<br>clinical | Clinical and non-<br>clinical | Clinical and non-clinical |

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| Parameter | Halo<br>Ambulatory<br>Infusion Pump | CADD-<br>Legacy PCA<br>6300 Model<br>(K982839) | ambIT Continuous<br>Infusion Pump<br>(K033325) | CADD -Solis VIP<br>Ambulatory Infusion<br>Pump (K111275) |
|-----------|-------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|
| Size | 4.2 in. x 2.3 in. x<br>1.6 in.<br>(108mm x 58mm x<br>40 mm) | 4.4 in. x 3.8 in. x<br>1.6 in.<br>(112mm x 96 mm<br>x 40mm) | 6.875 in. x 2.16 in. x<br>1.4 in.<br>(175 mm x 55 mm x<br>36 mm) | 5 in x 4 in x1.6 in<br>(127 mm x 102 mm x 41<br>mm) |
| Weight | 6.1 ounces<br>(173 grams) | 13.8 ounces<br>(391 grams) | 6.4 ounces<br>(181.4 grams) | 21 ounces<br>(595 grams) |

## Table 2: Equivalency Matrix of Halo Administration Set and the Predicate Device

| Parameter | Halo Administration Set | Zyno Medical Administration Set<br>(K120685) |
|-----------------------------------|-----------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Device Type | Administration Set | Administration Set |
| Intended use | To administer fluids from a<br>container to a patient through a<br>needle or a catheter | To administer fluids from a container to a<br>patient's vascular system through a needle<br>or a catheter inserted into a vein |
| Tubing material | Standard PVC | Standard PVC |
| Single use? | Yes | Yes |
| Sterile? | Yes | Yes |
| Sterilization<br>method | EtO | EtO |
| Set based Free<br>Flow Protection | Yes | Yes |
| Components | Spike, tubing, cassette, slide<br>clamp, filter, Luer Lock | Spike, drip chamber, tubing, roller clamp,<br>slide clamp, pinch clamp, filter, Y-site,<br>Luer Lock |
| ISO 8536<br>compliant? | Yes | Yes |
| ISO 10993<br>compliant? | Yes | Yes |