(200 days)
Not Found
No
The description focuses on standard microprocessor-controlled motor, sensors for error detection, and user interface via keypad and LCD. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes
The device is intended to deliver medications and/or fluids to a patient, which directly contributes to therapy or treatment.
No
This device is described as an "Ambulatory Infusion System" intended to "deliver medications and/or fluids to a patient." Its purpose is therapeutic delivery, not diagnosis.
No
The device description explicitly details hardware components like a microprocessor-controlled motor, mechanical pumping mechanism, keypad, LED, LCD, sensors, and a battery, in addition to the software. The testing performed also includes hardware-related standards (IEC 60601 series).
Based on the provided information, the Halo Ambulatory Infusion System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to "deliver medications and/or fluids to a patient". This is a direct therapeutic action on the patient's body.
- Device Description: The device is described as a pump that "provides measured drug / fluid therapy". This further emphasizes its role in administering substances to the patient.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or compatibility testing. IVD devices are specifically designed for these purposes.
The Halo Ambulatory Infusion System is a medical device used for drug delivery, which is a different category than IVD devices.
N/A
Intended Use / Indications for 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.
Product codes
FRN, MEA, FPA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous, perineural, epidural and intravenous
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician or other certified healthcare professional. The device is intended for 240 hours or1500mL of infusion, whichever limit is reached first.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- Halo Administration Set testing, including Biocompatibility, Pyrogenicity, Physical & Mechanical Testing, Chemical Testing, Sterility Testing, Aging testing, DEHP, Integration Testing with Halo Pump (Per reference B above, ISO / AAMI / ASTM standards) - Pass
- Halo Pump software verification and validation testing (Per reference E) - Pass
- Halo Ambulatory Infusion System basic safety and essential performance 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 IEC 60601-1-8) - Pass
- Verification and Validation of Halo Ambulatory Infusion System used in the home healthcare environment (Per reference C above and IEC 60601-1-11) - Pass
- Additional Testing for Verification of Safety and Effectiveness (Per reference 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
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
CADD-Legacy PCA Model 6300 (K982839), ambIT Continuous Ambulatory Infusion Pump (K033325), CADD-Solis VIP Ambulatory Infusion Pump (K111275), Zyno Medical Administration Set (K120685)
Reference Device(s)
Not Found
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
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.
1
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
2
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)
3
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); and | |
| Administration 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.
4
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.
5
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 Halo | |
| Pump (Per reference B above, ISO / AAMI / ASTM standards) | Pass |
| Halo Pump software verification and validation testing (Per reference | |
| E) | Pass |
| Halo Ambulatory Infusion System basic safety and essential | |
| performance testing: (Per IEC 60601-1 and 60601-2-24) | Pass |
| Halo Pump Electromagnetic Compatibility Testing (Per IEC 60606-1- |
-
| Pass |
| Halo Ambulatory Infusion System Alarm System Testing (Per IEC
60601-1-8) | Pass |
| Verification and Validation of Halo Ambulatory Infusion System used
in the home healthcare environment (Per reference C above and IEC
60601-1-11) | Pass |
| Additional Testing for Verification of Safety and Effectiveness (Per
reference 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 |
6
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
7
| Parameter | Halo
Ambulatory
Infusion Pump | CADD-
Legacy PCA
6300 Model
(K982839) | ambIT Continuous
Infusion Pump
(K033325) | CADD -Solis VIP
Ambulatory Infusion
Pump (K111275) |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pump Type | Ambulatory
Infusion Pump | Ambulatory
Infusion Pump | Ambulatory Infusion
Pump | Ambulatory Infusion Pump |
| 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
or1500mL of
infusion, whichever
limit is reached
first. | The CADD-
Legacy pump is
suitable for
intravenous,
intra-arterial,
subcutaneous,
intraperitoneal,
epidural space, or
subarachnoid
space infusion. | The ambIT Infusion
Pump is intended for
continuous volumetric
delivery of intravenous
medicines and /or fluids
into patient at a
consistent volume for
prescriptive treatment
by a physician. | 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 |
| Infusion
Mode | Continuous Mode
Bolus Mode (PCA) | Continuous Mode
with Bolus
(PCA) | Continuous Mode | PCA, Continuous,
Intermittent, Step, Taper |
| Parameter | Halo
Ambulatory
Infusion Pump | CADD-
Legacy PCA
6300 Model
(K982839) | ambIT Continuous
Infusion Pump
(K033325) | CADD –Solis VIP
Ambulatory Infusion
Pump (K111275) |
| 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 | Mechanical pumping
mechanism driven by a
motor which is controlled
by a microprocessor |
| Volumetric
Accuracy | +-5% | +-6% | +-6% | +-6% |
| Display | LCD, LED | LCD, LED | LCD, LED | LCD, LED |
| Operating
Temperature | +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
/ Status
Display | •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
Dislodged
• Pump Stopped
• Pump Fault
• Low Reservoir
Volume
• High Delivery
Pressure
• Air-In-Line
• Disposable not
attached when
run attempted
• Service due
• Motor Locked
• Upstream
Occlusion
• Reservoir
Volume Empty
• Program
incomplete
• Remote Dose
Cord Removed
• Key Stuck
• Disposable
Detached | • Run Indicator Light
• Pause Indicator
• Downstream
Occlusion
• Cassette not Mounted
on 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 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 | Clinical and non-clinical |
8
9
| Parameter | Halo
Ambulatory
Infusion Pump | CADD-
Legacy PCA
6300 Model
(K982839) | ambIT Continuous
Infusion Pump
(K033325) | CADD -Solis VIP
Ambulatory Infusion
Pump (K111275) |
|-----------|-------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------|----------------------------------------------------------|
| Size | 4.2 in. x 2.3 in. x
1.6 in.
(108mm x 58mm x
40 mm) | 4.4 in. x 3.8 in. x
1.6 in.
(112mm x 96 mm
x 40mm) | 6.875 in. x 2.16 in. x
1.4 in.
(175 mm x 55 mm x
36 mm) | 5 in x 4 in x1.6 in
(127 mm x 102 mm x 41
mm) |
| 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 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 |
| Single use? | Yes | Yes |
| Sterile? | Yes | Yes |
| Sterilization
method | EtO | EtO |
| Set based Free
Flow Protection | Yes | Yes |
| Components | 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 |
| ISO 10993
compliant? | Yes | Yes |