SMARTez elastomeric infusion pump

K151650 · Epic Medical Pte. , Ltd. · MEB · Apr 4, 2016 · General Hospital

Device Facts

• Record ID: K151650
• Device Name: SMARTez elastomeric infusion pump
• Applicant: Epic Medical Pte. , Ltd.
• Product Code: MEB · General Hospital
• Decision Date: Apr 4, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Indications for Use

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management. Routes of administration: intravenous and subcutaneous. The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery. Route of administration: intravenous. The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications. Routes of administration: intravenous and intra-arterial.

Device Story

SMARTeZ Pump is a single-use, disposable, non-electric elastomeric infusion pump. Device consists of an elastomeric fluid reservoir, administration tubing, and flow restrictor. Reservoir acts as energy source, exerting pressure on medication to drive fluid through tubing and restrictor. Flow rate is pre-determined by manufacturer using Hagen-Poiseuille theory based on fluid viscosity and restrictor dimensions. Used in clinical or home settings for continuous medication delivery. Healthcare providers fill the device; patient receives infusion via IV, subcutaneous, or intra-arterial routes. Device provides fixed, continuous flow, assisting in controlled medication administration.

Clinical Evidence

Bench testing only. Testing performed per ISO 28620:2010, including flow rate accuracy (nominal, temperature, viscosity, pressure, traction, and refrigeration conditions), leak-proof testing, and retrograde flow testing. All samples met acceptance criteria (mean flow rate tolerance ±15%). Biocompatibility testing (ISO 10993) confirmed non-cytotoxic, non-sensitizing, non-irritating, and non-hemolytic status. Human factors/usability testing confirmed no user errors in critical tasks.

Technological Characteristics

Non-electric, portable, fixed-flow elastomeric infusion pump. Components: elastomeric fluid reservoir, PVC (DEHP-free) administration tubing, flow restrictor. Flow control via Hagen-Poiseuille theory. Sterilization: Ethylene Oxide (EO) per ISO 11135:2014 (SAL 10^-6). Biocompatibility per ISO 10993. Shelf-life validated per ASTM F1980-07.

Indications for Use

Indicated for patients requiring continuous infusion of medications, including pain management (IV/subcutaneous), antibiotic delivery (IV), and chemotherapy (IV/intra-arterial).

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

• I-Flow Elastomeric Pump (Homepump/Easypump) (K052117)
• Infusor SV and LV Elastomeric Infusion Devices (K071222)
• AccuFlo, AccuFlux (K081905)
• Homepump C-Series (K991513)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 4, 2016

Epic Medical Pte. Ltd. c/o Mr. Dave Yungvirt Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041

Re K151650

Trade/Device Name: SMARTeZ Elastomeric Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: February 18, 2016 Received: February 22, 2016

Dear Mr. Yungvirt:

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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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,

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for 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

Enclosure

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# Indications for Use

510(k) Number (if known) K151650

Device Name SMARTeZ Pump

Indications for Use (Describe)

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusions for general infusion use, including pain management.

• Routes of administration: intravenous and subcutaneous.

The SMARTeZ Pump (Short infusion time article) is intended for continuous infusions for general infusion use, including antibiotic delivery.

· Route of administration: intravenous.

The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.

· Routes of administration: intravenous and intra-arterial.

| 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)

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Image /page/3/Picture/0 description: The image shows the word "EPIC" in a stylized, sans-serif font. The letters are connected and have a modern, geometric appearance. A small circle is positioned above the left side of the letter "E", adding a unique design element to the logo. A horizontal line underlines the entire word, providing a sense of stability and emphasis.

-SMARTeZ Pump Traditional 510(k) Submission

# Section § 5 : 510(k) Summary

Date Prepared: April 1, 2016

# 5.1 510(k) Owner Name

Epic Medical Pte. Ltd. 545 Orchard Road #09-01, Singapore 238882.

Tel: [phone]

Email: [e-mail]

Contact Person Name: Mr. Freddie Lee

# 5.2 Device Name & Classification

In accordance with FDA's product classification database, the SMARTeZ Pump is determined to be a Class II device, further details as below table.

| Common/Usual Name | Elastomeric Infusion Pump |
|------------------------|-----------------------------|
| Proprietary/Trade Name | SMARTEZ Pump |
| Device Name | Pump, Infusion, Elastomeric |
| Regulation Description | Infusion Pump |
| Review Panel | General Hospital |
| Product Code | MEB |
| Regulation Number | 21 CFR 880.5725 |
| Device Class | II |

Table 5-1. Classification of SMARTeZ Pump

# 5.3 Predicate Devices

One primary legally marketed device and three (3) secondary legally marketed devices as shown in Table 5-2 were selected as predicate devices for the substantial equivalence discussion. These devices were selected due to the fact that the intended use and technological characteristics of SMARTeZ Pump are equivalent to these devices.

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| Predicate Devices | | | | |
|---------------------|-------------------------------------------------------|------------------------------------------------------|---------------------------------------------|-----------------------|
| 510(k) No. | K052117<br>(Primary) | K071222 | K081905 | K991513 |
| 510(k)<br>Submitter | I-Flow<br>Corporation | Baxter Healthcare<br>Corporation | Westmed, Inc.<br>(B. Braun Medical<br>Inc.) | I-Flow<br>Corporation |
| Trade<br>Name | I-Flow<br>Elastomeric Pump<br>(Homepump/<br>Easypump) | Infusor SV and<br>LV Elastomeric<br>Infusion Devices | AccuFlo,<br>AccuFlux | Homepump C-<br>Series |

| Table 5-2. Predicate devices SMARTeZ Pump is substantial equivalent (SE3*) with |
|---------------------------------------------------------------------------------|
|---------------------------------------------------------------------------------|

(*SE: Substantial Equivalence)

# 5.4 Device Description

The SMARTeZ Pump, is a single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line (see Figure 5-1). The constriction of elastomeric fluid reservoir drives the medication through the tubing and eventually through a flow restrictor out into the patient connection. Drug products should be stored in their approved containers and closures.

## Figure 5-1. Diagram of the SMARTeZ Pump

# SMARTez™ Pump

Portable single use elastomeric infusion pump

- 1. Fill port
- 2. Outer soft cover
- 3. Multi-layered elastomeric membrane
- 4. ON-OFF clamp
- 5. PVC administration tubing not made from Phthalate (DEHP)
- Air and particulate eliminating filter 6.
- 7. Flow restrictor
- 8. Patient connector
- 9. Patient end cap
- 10. Fill port cap (tethered)
- 11. Labelling Fill volume & infusion time
- 12. Labelling Flow rate

Image /page/4/Picture/24 description: The image shows a diagram of a medical device with several labeled parts. The device includes a bottle-like container at the top, labeled with numbers 1, 2, and 3. A tube extends from the bottom of the container, passing through a clamp labeled 4 and a regulator labeled 6, with the tube itself labeled 5. The other tube is labeled 7, 8, and 9.

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Image /page/5/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized font. The letters are black, and there is a horizontal line underneath the word. The dot on top of the "i" is a filled circle.

# 5.5 Indications for Use Statements

The SMARTeZ Pump (Long infusion time article) is intended for continuous infusion of medications for general infusion use, including pain management.

- Routes of administration: intravenous and subcutaneous.
The SMARTeZ Pump (Short infusion time article) is intended for continuous infusion of medications for general infusion use, including antibiotic delivery.

- Route of administration: intravenous. ●
The SMARTeZ Pump (Chemotherapy article) is intended for continuous infusion of chemotherapy medications.

- Routes of administration: intravenous and intra-arterial. •
The Indications for Use statement of the SMARTeZ Pump is not identical to the predicate devices; however, the differences in infusion routes do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicates. All devices have the same intended use for the continuous infusion of medications.

# 5.6 Technological Characteristics

The SMARTeZ Pump is a non-electrically driven, portable fixed flow rate infusion pump. The flow rate of the device is pre-determined by the manufacturer using Hagen-Poiseuille theory, which calculates the volumetric flow rate of a fluid with certain viscosity passing through a cylindrical pipe.

The device consists of three (3) critical components that control the factors that determine the flow rate: The fluid reservoir, the micro bore tube and the flow restrictor. The fluid reservoir holds the medication to be infused and exert pressure onto the medication as the energy source of the device. The micro bore tube and the flow restrictor on each device are calibrated to match with the fluid reservoir so the medication will pass through them under a fixed pre-determined flow rate.

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Image /page/6/Picture/0 description: The image shows a logo with the letters "EPIC" in a stylized font. The letters are bold and blocky, with a thick line underlining the entire word. The dot above the "i" is a solid circle. The logo is simple and modern.

-

# 5.6.1 Range of Articles (Model Numbers)

The following devices cleared under K151650 are shown in Table 5-3.

## Table 5-3. Range of SMARTeZ Pump articles (model numbers) cleared under K151650

| Type | Tubing Specifications | | No. of products in<br>packaging | | Designation | Nominal<br>volume<br>(ml) | Nominal<br>flow rate<br>(ml/h) | Nominal<br>time (h) | Article<br>Number<br>(REF) |
|-----------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------|--------------------------------|---------------------|---------------------------|--------------------------------|---------------------|----------------------------|
| | Administration<br>tube | Flow<br>restrictor –<br>Micro bore<br>tube* | Per<br>sterile<br>barrier<br>system | Per<br>protective<br>packaging | | | | | |
| Long<br>Infusion<br>Time<br>Articles/<br>Model<br>Numbers | OD:<br>2.4 mm<br><br>ID:<br>1.0 mm<br><br>Length:<br>90 cm | OD:<br>2.4 mm<br><br>ID:<br>0.1 ~ 0.2 mm<br><br>Length:<br>15 ~ 40 cm | 1 ea | 12 ea | SMARTEZ 60-5-12h | 60 | 5 | 12 | 480011 |
| | | | | | SMARTEZ 80-5-16h | 80 | 5 | 16 | 480021 |
| | | | | | SMARTEZ 125-5-25h | 125 | 5 | 25 | 480031 |
| | | | | | SMARTEZ 270-10-27h | 270 | 10 | 27 | 480041 |
| | | | | | SMARTEZ 60-2-30h | 60 | 2 | 30 | 480051 |
| | | | | | SMARTEZ 120-4-30h | 120 | 4 | 30 | 480061 |
| | | | | | SMARTEZ 400-10-40h | 400 | 10 | 40 | 480071 |
| | | | | | SMARTEZ 100-2-50h | 100 | 2 | 50 | 480081 |
| | | | | | SMARTEZ 270-5-54h | 270 | 5 | 54 | 480091 |
| | | | | | SMARTEZ 120-2-60h | 120 | 2 | 60 | 480101 |
| | | | | | SMARTEZ 400-5-80h | 400 | 5 | 80 | 480111 |
| | | | | | SMARTEZ 100-1.5-67h | 100 | 1.5 | 67 | 480121 |
| | | | | | SMARTEZ 270-4-68h | 270 | 4 | 68 | 480131 |

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#### SMARTeZ Pump -

Traditional 510(k) Submission

| Type | Tubing Specifications | | No. of products in packaging | | Designation | Nominal volume (ml) | Nominal flow rate (ml/h) | Nominal time (h) | Article Number (REF) |
|---------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|------------------------------|--------------------------|----------------------|---------------------|--------------------------|------------------|----------------------|
| | Administration tube | Flow restrictor – Micro bore tube* | Per sterile barrier system | Per protective packaging | | | | | |
| Long Infusion Time Articles/ Model Numbers | OD:<br>2.4 mm<br><br>ID:<br>1.0 mm<br><br>Length:<br>90 cm | OD:<br>2.4 mm<br><br>ID:<br>0.1 ~ 0.2 mm<br><br>Length:<br>15 ~ 40 cm | 1 ea | 12 ea | SMARTEZ 400-4-100h | 400 | 4 | 100 | 480141 |
| | SMARTEZ 65-0.5-130h | 65 | | | 0.5 | 130 | 480151 | | |
| | SMARTEZ 270-2-135h | 270 | | | 2 | 135 | 480161 | | |
| | SMARTEZ 300-2-150h | 300 | | | 2 | 150 | 480171 | | |
| | SMARTEZ 100-0.5-200h | 100 | | | 0.5 | 200 | 480181 | | |
| | SMARTEZ 270-1-270h | 270 | | | 1 | 270 | 480191 | | |
| Short Infusion Time Articles/ Model Numbers | OD:<br>2.4 mm<br><br>ID:<br>1.0 mm<br><br>Length:<br>90 cm | OD:<br>2.4 mm<br><br>ID:<br>0.2 ~ 0.5 mm<br><br>Length:<br>15 ~ 40 cm | 1 ea | 24 ea | SMARTEZ 100-200-30m | 100 | 200 | 0.5 | 481012 |
| | SMARTEZ 250-500-30m | 250 | | | 500 | 0.5 | 481022 | | |
| | SMARTEZ 50-50-60m | 50 | | | 50 | 1 | 481032 | | |
| | SMARTEZ 100-100-60m | 100 | | | 100 | 1 | 481042 | | |
| | SMARTEZ 250-250-60m | 250 | | | 250 | 1 | 481052 | | |
| | SMARTEZ 250-175-90m | 250 | | | 175 | 1.5 | 481062 | | |
| | SMARTEZ 100-50-120m | 100 | | | 50 | 2 | 481092 | | |
| | | | | | SMARTEZ 200-100-120m | 200 | 100 | 2 | 481112 |

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### SMARTeZ Pump

|

| Type | Tubing Specifications | | No. of products in<br>packaging | | | Nominal<br>volume<br>(ml) | Nominal<br>flow rate<br>(ml/h) | Nominal<br>time (h) | Article<br>Number<br>(REF) |
|------------------------------------------------------------|------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------|--------------------------------|----------------------|---------------------------|--------------------------------|---------------------|----------------------------|
| | Administration<br>tube | Flow<br>restrictor –<br>Micro bore<br>tube* | Per<br>sterile<br>barrier<br>system | Per<br>protective<br>packaging | Designation | | | | |
| Short<br>Infusion<br>Time<br>Articles/<br>Model<br>Numbers | OD:<br>2.4 mm<br><br>ID:<br>1.0 mm<br><br>Length:<br>90 cm | OD:<br>2.4 mm<br><br>ID:<br>0.2 ~ 0.5 mm<br><br>Length:<br>15 ~ 40 cm | 1 ea | 24 ea | SMARTeZ 250-100-150m | 250 | 100 | 2.5 | 481122 |
| | | | | | SMARTeZ 250-125-120m | 250 | 125 | 2 | 481132 |
| | | | 1 ea | | SMARTeZ 200-200-60m | 200 | 200 | 1 | 481142 |
| | | | | | SMARTeZ 250-50-300m | 250 | 50 | 5 | 481152 |
| | | | 1 ea | 12 ea | SMARTeZ 400-200-120m | 400 | 200 | 2 | 481071 |
| | | | | | SMARTeZ 500-250-120m | 500 | 250 | 2 | 481081 |
| | | | | | SMARTeZ 400-100-240m | 400 | 100 | 4 | 481101 |
| Chemo-<br>therapy<br>Articles/<br>Model<br>Numbers | OD:<br>2.4 mm<br><br>ID:<br>1.0 mm<br><br>Length:<br>90 cm | OD:<br>2.4 mm<br><br>ID:<br>0.1 ~ 0.2 mm<br><br>Length:<br>15 ~ 40 cm | 1 ea | 12 ea | SMARTeZ C100-2-50h | 100 | 2 | 50 | 484011 |
| | | | | | SMARTeZ C270-2-135h | 270 | 2 | 135 | 484021 |
| | | | | | SMARTeZ C120-4-30h | 120 | 4 | 30 | 484031 |
| | | | | | SMARTeZ C270-5-54h | 270 | 5 | 54 | 484041 |
| | | | | | SMARTeZ C270-10-27h | 270 | 10 | 27 | 484051 |
| | | SMARTeZ C270-10-27h | 270 | 10 | 27 | 484051 | | | |

(*Only ranges for each ID and length of micro bore tube. This is due to the fact that every unit piece of flow restrictor is calbrated during production. Flow restrictors of appropriate ID's selected with appropriate cut lengths are the results from this 100% calibration.)

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Image /page/9/Picture/0 description: The image shows the word "EPIC" in a bold, sans-serif font. The letters are all capitalized and black. There is a small, solid black circle above the left side of the letter "E". A horizontal line underlines the entire word.

SMARTeZ Pump | |

# 5.7 Summary of Substantial Equivalence Discussion

The SMARTeZ Pump is substantially equivalent to the I-Flow Elastomeric Pump (K052117). The intended use and technological characteristics of the SMARTeZ Pump raise no new questions of safety and effectiveness compared to the I-Flow Elastomeric Infusion Pump (K052117).

# 5.8 Summary of Performance Testing

The following performance data was the bases for the substantial equivalence determination.

An assurance case was provided in the submission for the SMARTEZ Pump as recommended in the FDA guidance document, Infusion Pump Total Product Life Cycle.

The stated goal of the assurance case is:

- The design of the SMARTeZ Pump is an adequately safe infusion means in the context of all indications for use, patient types, . users, use conditions, environments of use and list of devices cleared under K151650.
The assurance case defined the device system, including the indications for use, system specifications and use environments. The supporting assurance arguments covered the following attributes:

- Adequate design verification/validation, .
- Acceptability of risk mitigation, .
- Adequate device reliability. .

The assurance case and referenced evidence demonstrate that the SMARTEZ Pump functions as designed and can be operated by the user as intended with the instructions provided.

The following evidence was included in the assurance case: Functionality

Section §5: 510(k) Summary (K151650)

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SMARTeZ Pump

| Bench Test<br>Completed | Applicable Standard & Clause | Acceptance Criteria | Test Results |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow Rate Test<br>(Nominal<br>Condition) | ISO 28620:2010, Sub-clause 6.2.<br>The samples were tested for flow<br>rate under conditions specified by<br>manufacturer for which the claimed<br>flow rate accuracy is achieved. | The mean flow rate shall have<br>a tolerance of ±15% compared<br>to the nominal flow rate. At least 80% of the nominal<br>volume shall be delivered at an<br>instantaneous flow rate within<br>±50% of the nominal flow rate. | Passed.<br>All test samples passed both acceptance<br>criteria. It is confirmed through statistical analysis<br>that when the subject device is filled at<br>nominal volume, flow accuracy is within<br>+/- 15% of the nominal (label) flow rate (at<br>99% confidence level, lower- and upper-<br>bounds of -0.400 % to +0.151 %) when<br>delivering normal saline at 88 deg F (31<br>deg C) with pump positioned at 16" (40<br>cm) below the catheter site. |
| Flow Rate Test<br>(Change of<br>Ambient<br>Temperature) | ISO 28620:2010, Sub-clause 6.2.<br>The samples were tested for flow<br>rate with flow restrictor at 25±1℃. | The mean flow rates of<br>samples should be no more<br>than 15% slower when<br>compared with that tested with<br>flow restrictor temperature at<br>31°C. | Passed.<br>The results show mean flow rate of the<br>samples is 14.07% slower. The results confirmed the IFU claimed<br>temperature effect to flow rate accuracy. |
| Flow Rate Test<br>(Change of<br>Solution<br>Viscosity) | ISO 28620:2010, Sub-clause 6.2.<br>The samples were tested for flow<br>rate using 5% Dextrose as control<br>solution. | The mean flow rates of<br>samples should be no more<br>than 10% slower when<br>compared with that tested with<br>0.9% NaCl as control solution. | Passed.<br>The results show mean flow rate of the<br>samples is 9.81% slower. The results confirmed the IFU claimed<br>fluid viscosity effect to flow rate accuracy. |
| Flow Rate Test<br>after Resistance to<br>Pressure Test | ISO 28620:2010, Sub-clause 6.2 &<br>6.3. | The mean flow rate shall have<br>a tolerance of ±15% compared<br>to the nominal flow rate. | Passed.<br>All the samples passed both acceptance<br>criteria. |
| Bench Test<br>Completed | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| | The entire fluid reservoir of the<br>samples were under a force of<br>150N for 5s. After pressure is<br>removed, the samples were tested<br>for flow rate. | At least 80% of the nominal<br>•<br>volume shall be delivered at an<br>instantaneous flow rate within<br>±50% of the nominal flow rate. | Passed.<br>• The flow rate results were compared with<br>that of the same article (model) from Flow<br>Rate Test at Nominal Condition.<br>• The statistical analysis showed the flow<br>rate accuracy was not affected by<br>resistance to pressure test. |
| Leak-Proof Test<br>after Resistance to<br>Pressure Test | ISO 28620:2010, Sub-clause 6.3 &<br>6.5.<br>The entire fluid reservoir of the<br>samples were under a force of<br>150N for 5s. After pressure is<br>removed, the samples were<br>inspected for leakage. | After resistance to pressure test:<br>• The device shall remain<br>watertight, and the solution in<br>container shall not became<br>colored. | Passed.<br>• All test samples passed the acceptance<br>criteria. |
| Leak-Proof Test<br>after Drop Test | ISO 28620:2010, Sub-clause 6.4 &<br>6.5.<br>The samples were filled with dyed<br>solution then dropped twice from<br>one (1) meter height. After drop,<br>the samples were inspected for<br>leakage. | After drop test:<br>• The device shall remain<br>watertight, and the solution in<br>container shall not became<br>colored. | Passed.<br>• All test samples passed the acceptance<br>criteria. |
| Flow Rate Test<br>after Resistance to<br>Traction Test | ISO 28620:2010, Sub-clause 6.2 &<br>6.6.<br>The samples were applied a force<br>of 15N for 15s between each ends<br>of the device. After force is | • The mean flow rate shall have<br>a tolerance of ±15% compared<br>to the nominal flow rate.<br>• At least 80% of the nominal<br>volume shall be delivered at an | Passed.<br>• All test samples passed both acceptance<br>criteria.<br>• The flow rate results were compared with<br>that of the same article (model) from Flow<br>Rate Test at Nominal Condition. |
| Bench Test<br>Completed | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| | removed, the samples were tested<br>for flow rate. | instantaneous flow rate within<br>$\pm$ 50% of the nominal flow rate. | Passed.<br>• The statistical analysis showed the flow<br>rate accuracy was not affected by<br>resistance to pressure test. |
| Leak-Proof Test<br>after Resistance to<br>Traction Test | ISO 28620:2010, Sub-clause 6.5 &<br>6.6.<br>The samples were applied a force<br>of 15N for 15s between each ends<br>of the device. After force is<br>removed, the samples were<br>inspected for leakage. | After resistance to traction test:<br>• The device shall remain<br>watertight, and the solution in<br>container shall not became<br>colored. | Passed.<br>• All test samples passed the acceptance<br>criteria. |
| Flow Rate Test<br>after Refrigeration | ISO 28620:2010, Sub-clause 6.2.<br>The samples were filled and<br>refrigerated (2~8°C) for 72 hours.<br>After return to room temperature,<br>the samples were tested for flow<br>rate. | • The mean flow rate shall have<br>a tolerance of $\pm$ 15% compared<br>to the nominal flow rate.<br>• At least 80% of the nominal<br>volume shall be delivered at an<br>instantaneous flow rate within<br>$\pm$ 50% of the nominal flow rate. | Passed.<br>• All test samples passed both flow rate and<br>leak integrity acceptance criteria.<br>• The flow rate results were compared with<br>that of the same article (model) from Flow<br>Rate Test at Nominal Condition.<br>• The statistical analysis showed the flow<br>rate accuracy was not affected by<br>refrigeration. |
| Bench Test<br>Completed | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| Leak-Proof Test<br>after Refrigeration | ISO 28620:2010, Sub-clause 6.2.<br>The samples were filled and<br>refrigerated (2~8°C) for 72 hours.<br>After return to room temperature,<br>the samples were inspected for<br>leakage. | After refrigeration:<br>The device shall remain<br>watertight, and the solution in<br>container shall not become<br>colored. | Passed.<br>All test samples passed the acceptance<br>criteria. |
| Retrograde Flow<br>of Infusate Test | The infusion completed samples<br>were applied with a back pressure<br>from distal connector to obverse<br>the retrograde flow of infusate. | Retrograde flow of infusate should<br>not be observed when back<br>pressure applied $\leq$ 0.34bar (5 psi,<br>the maximum possible back<br>pressure during the actual use). | Passed.<br>The back pressure that retrograde flow of<br>infusate observed was 0.8bar (11.6 psi),<br>which is double that of the acceptance<br>criteria. |
| Flow Rate Test<br>under Non-<br>Ambient Pressure<br>(Influence of<br>Routes of<br>Administration) | ISO 28620:2010, Sub-clause 6.2.<br>The samples were tested for flow<br>rate under conditions specified by<br>manufacturer for which the claimed<br>flow rate accuracy is achieved. | To study the influence on flow rate<br>from the following routes of<br>infusion: intravenous, intra-arterial<br>and subcutaneous routes; and to<br>confirm that:<br>The mean flow rate shall have<br>a tolerance of ±15% compared<br>to the nominal flow rate. At least 80% of the nominal<br>volume shall be delivered at an<br>instantaneous flow rate within<br>±50% of the nominal flow rate<br>are maintained, independent of the<br>3 routes of infusion administered. | Passed.<br>The influence on flow rate from the<br>following routes of infusion: intravenous,<br>intra-arterial and subcutaneous routes;<br>were established. It is confirmed that flow<br>accuracy of +/- 15% of the nominal (label)<br>flow rate is maintained, independent of the<br>3 routes of infusion administered. |
| Bench Test<br>Completed | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| Performance<br>/Functionality<br>Testing for<br>Chemotherapy<br>Articles | ISO 28620:2010, Sub-clauses 6.2,<br>6.3, 6.4, 6.5 and 6.6.<br>Note: In chemotherapy articles the<br>range of flow rates and fill volume<br>combinations are fully represented<br>in all the bench test protocols. | Flow accuracies, in nominal<br>●<br>conditions, after resistance to<br>pressure, after resistance to<br>traction, under non-ambient<br>pressure and after refrigeration:<br>The mean flow rate shall<br>O<br>have a tolerance of ±15%<br>compared to the nominal<br>flow rate.<br>At least 80% of the<br>O<br>nominal volume shall be<br>delivered at an<br>instantaneous flow rate<br>within ±50% of the<br>nominal flow rate.<br>The device shall remain<br>●<br>watertight after resistance to<br>pressure, after resistance to<br>traction, after being dropped<br>and after refrigeration.<br>Retrograde flow of infusate<br>●<br>should not be observed when<br>back pressure applied ≤<br>0.34bar (5 psi, the maximum<br>possible back pressure during<br>the actual use). | Passed.<br>All test samples passed all acceptance<br>●<br>criteria. |

### Table 5-4. Summary of Bench Test Results for Long Infusion Time and Chemotherapy Articles

### Section §5: 510(k) Summary (K151650)

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### SMARTeZ Pump

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SMARTeZ Pump

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#### SMARTeZ Pump -

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### SMARTeZ Pump

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All the performance test results and their evaluations met the acceptance criteria.

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SMARTeZ Pump | | -

# 5.9 Human Factors and Usability Testing

The design of Human Factors (HF) testing is supported by the analysis of the hazards arising from human factors/usability in operating the device. The critical operating tasks included dilution, filling, priming and infusing, and the HF testing results show that there were no user errors identified even though the participants were not coached.

#### Shelf-life Testing to Verify Sterility and Performance at Expirv 5.10

The SMARTeZ Pump is provided sterile and not to be re-sterilized. The sterilization process uses the traditional method of Ethylene Oxide (EO) with the subject devices placed in a fixed chamber.

The Ethylene Oxide (EO) sterilization process for SMARTeZ Pump was validated using the overkill approach with compliance to Annex B of ISO 11135:2014 to achieve a Sterility Assurance Level (SAL) of 10-6.

The subject device was tested for a 3-year shelf-life using accelerated conditioning prescribed in ASTM F1980-07 (2011), "Standard guide for accelerated aging of sterile barrier systems for medical devices, reapproved 2011", and with test methods prescribed in F 1929-12, "Standard test method for detecting seal leaks in porous medical packaging by dye penetration" and F1886/ F1886M-09, "Standard test method for determining integrity of seals for flexible packaging by visual inspection".

It was verified that the subject device packaging integrity and functional attributes remained within specifications. A real-time protocol was evaluated to assure ongoing stability.

#### Biocompatibility Testing 5.11

The biocompatibility evaluation and chemical characterization activities were performed for SMARTeZ Pump in its final finished presentation intended for the market. The SMARTeZ Pump was evaluated to have complied with the following:

- "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical -Devices Part 1: Evaluation and Testing', Draft Guidance for Industry and Food and Drug Administration Staff".
- ANSI/AAMI/ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process".
- FDA TPLC guidance "Infusion Pumps Total Product Life Cycle Guidance for -Industry and FDA Staff" issued on: December 2, 2014, Biological Safety sub-section.

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SMARTeZ Pump -

The biocompatibility evaluation and chemical characterization activities were performed for SMARTeZ Pump. The SMARTeZ Pump was evaluated and have complied with the "Use of International Standard ISO 10993-1. "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", Draft Guidance for Industry and Food and Drug Administration Staff", ANSI/AAMI/ISO 10993-1:2009/(R)2013, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" and FDA TPLC guidance "Infusion Pumps Total Product Life Cycle - Guidance for Industry and FDA Staff' issued on: December 2, 2014, Biological Safety sub-section.

# Test results:

Table 5-5. Summary of Biocompatibility Tests and Chemical Characterizations

| Test | Method* | Result |
|--------------------------------------------|--------------|----------------------------------------------------------------------|
| Leachables/Extractables | ISO 10993-18 | No leachable/extractable<br>hazardous substances and<br>heavy metals |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Irritation or intracutaneous<br>reactivity | ISO 10993-10 | Intracutaneously non-<br>irritating |
| System toxicity (acute) | ISO 10993-11 | Systemically non-toxic<br>(acute) |
| Haemocompatibility | ISO 10993-4 | Non-hemolytic |

*Method refers to testing sponsored by Epic Medical Pte. Ltd.

The biocompatibility studies and chemical characterization conducted on sterile SMARTeZ Pump in its final finished presentation intended for the market have confirmed the acceptable biocompatibility and leachables/extractables statuses of the device.

#### Conclusion 5.12

The overall evaluation of SMARTeZ Pump, the subject device, demonstrated that it is substantially equivalent with the predicate devices.