SMARTez elastomeric infusion pump

• K Number: K151650
• Device Name: SMARTez elastomeric infusion pump
• Manufacturer: Epic Medical Pte Ltd
• Date Cleared: 2016-04-04 ( 291 days)
• Product Code: MEB
• Regulation Number: 880.5725

Intended 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 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.

Predicate Devices

K052117, K071222, K081905, K991513

Reference Devices

K052117, K071222, K081905, K991513

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the mechanical properties and flow rate accuracy of a non-electric, elastomeric infusion pump. There is no mention of AI, ML, or any computational processing.

Therapeutic

Yes
The device is described as an "infusion pump" intended for "continuous infusions for general infusion use, including pain management" and "antibiotic delivery," as well as "continuous infusion of chemotherapy medications." These applications directly involve treating or managing medical conditions, which falls under the definition of a therapeutic device.

Diagnostic

No

This device is an infusion pump, designed for continuous delivery of medications. Its function is therapeutic (delivering drugs), not diagnostic (identifying or monitoring a condition).

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "single-use disposable, non-electric infusion pump that consists of an elastomeric fluid reservoir as energy source with an integrated administration line." This describes a physical hardware device, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, the SMARTeZ Pump is not an IVD (In Vitro Diagnostic) device.

Here's why:

• Intended Use: The intended use clearly states that the device is for the continuous infusion of medications (pain management, antibiotics, chemotherapy) directly into the patient's body (intravenous, subcutaneous, intra-arterial). This is a therapeutic function, not a diagnostic one.
• Device Description: The description details a pump that delivers fluid to the patient, not a device that analyzes samples from the body to provide diagnostic information.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic results.
• Bench Tests: The performance studies focus on the physical and functional aspects of the pump's ability to deliver fluid accurately and safely, not on the accuracy of diagnostic measurements.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The SMARTeZ Pump's function is to administer treatment, not to diagnose.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

MEB

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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

Bench Test Completed: Flow Rate Test (Nominal Condition)
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2. The samples were tested for flow rate under conditions specified by manufacturer for which the claimed flow rate accuracy is achieved.
Acceptance Criteria: The mean flow rate shall have a tolerance of ±15% compared to the nominal flow rate. At least 80% of the nominal volume shall be delivered at an instantaneous flow rate within ±50% of the nominal flow rate.
Test Results: Passed. All test samples passed both acceptance criteria. It is confirmed through statistical analysis that when the subject device is filled at nominal volume, flow accuracy is within +/- 15% of the nominal (label) flow rate (at 99% confidence level, lower- and upper-bounds of -0.400 % to +0.151 %) when delivering normal saline at 88 deg F (31 deg C) with pump positioned at 16" (40 cm) below the catheter site.

Bench Test Completed: Flow Rate Test (Change of Ambient Temperature)
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2. The samples were tested for flow rate with flow restrictor at 25±1℃.
Acceptance Criteria: The mean flow rates of samples should be no more than 15% slower when compared with that tested with flow restrictor temperature at 31°C.
Test Results: Passed. The results show mean flow rate of the samples is 14.07% slower. The results confirmed the IFU claimed temperature effect to flow rate accuracy.

Bench Test Completed: Flow Rate Test (Change of Solution Viscosity)
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2. The samples were tested for flow rate using 5% Dextrose as control solution.
Acceptance Criteria: The mean flow rates of samples should be no more than 10% slower when compared with that tested with 0.9% NaCl as control solution.
Test Results: Passed. The results show mean flow rate of the samples is 9.81% slower. The results confirmed the IFU claimed fluid viscosity effect to flow rate accuracy.

Bench Test Completed: Flow Rate Test after Resistance to Pressure Test
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2 & 6.3. The entire fluid reservoir of the samples were under a force of 150N for 5s. After pressure is removed, the samples were tested for flow rate.
Acceptance Criteria: The mean flow rate shall have a tolerance of ±15% compared to the nominal flow rate. At least 80% of the nominal volume shall be delivered at an instantaneous flow rate within ±50% of the nominal flow rate.
Test Results: Passed. All the samples passed both acceptance criteria. The flow rate results were compared with that of the same article (model) from Flow Rate Test at Nominal Condition. The statistical analysis showed the flow rate accuracy was not affected by resistance to pressure test.

Bench Test Completed: Leak-Proof Test after Resistance to Pressure Test
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.3 & 6.5. The entire fluid reservoir of the samples were under a force of 150N for 5s. After pressure is removed, the samples were inspected for leakage.
Acceptance Criteria: After resistance to pressure test: The device shall remain watertight, and the solution in container shall not became colored.
Test Results: Passed. All test samples passed the acceptance criteria.

Bench Test Completed: Leak-Proof Test after Drop Test
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.4 & 6.5. The samples were filled with dyed solution then dropped twice from one (1) meter height. After drop, the samples were inspected for leakage.
Acceptance Criteria: After drop test: The device shall remain watertight, and the solution in container shall not became colored.
Test Results: Passed. All test samples passed the acceptance criteria.

Bench Test Completed: Flow Rate Test after Resistance to Traction Test
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2 & 6.6. The samples were applied a force of 15N for 15s between each ends of the device. After force is removed, the samples were tested for flow rate.
Acceptance Criteria: The mean flow rate shall have a tolerance of ±15% compared to the nominal flow rate. At least 80% of the nominal volume shall be delivered at an instantaneous flow rate within ±50% of the nominal flow rate.
Test Results: Passed. All test samples passed both acceptance criteria. The flow rate results were compared with that of the same article (model) from Flow Rate Test at Nominal Condition. The statistical analysis showed the flow rate accuracy was not affected by resistance to pressure test.

Bench Test Completed: Leak-Proof Test after Resistance to Traction Test
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.5 & 6.6. The samples were applied a force of 15N for 15s between each ends of the device. After force is removed, the samples were inspected for leakage.
Acceptance Criteria: After resistance to traction test: The device shall remain watertight, and the solution in container shall not became colored.
Test Results: Passed. All test samples passed the acceptance criteria.

Bench Test Completed: Flow Rate Test after Refrigeration
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2. The samples were filled and refrigerated (2~8°C) for 72 hours. After return to room temperature, the samples were tested for flow rate.
Acceptance Criteria: The mean flow rate shall have a tolerance of ± 15% compared to the nominal flow rate. At least 80% of the nominal volume shall be delivered at an instantaneous flow rate within ± 50% of the nominal flow rate.
Test Results: Passed. All test samples passed both flow rate and leak integrity acceptance criteria. The flow rate results were compared with that of the same article (model) from Flow Rate Test at Nominal Condition. The statistical analysis showed the flow rate accuracy was not affected by refrigeration.

Bench Test Completed: Leak-Proof Test after Refrigeration
Applicable Standard & Clause: ISO 28620:2010, Sub-clause 6.2. The samples were filled and refrigerated (2~8°C) for 72 hours. After return to room temperature, the samples were inspected for leakage.
Acceptance Criteria: After refrigeration: The device shall remain watertight, and the solution in container shall not become colored.
Test Results: Passed. All test samples passed the acceptance criteria.

Bench Test Completed: Retrograde Flow of Infusate Test
Applicable Standard & Clause: The infusion completed samples were applied with a back pressure from distal connector to obverse the retrograde flow of infusate.
Acceptance Criteria: Retrograde flow of infusate should not be observed when back pressure applied

Regulation Number and Section

§ 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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, resembling a bird-like shape.

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.

1

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (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,

Image /page/1/Picture/8 description: The image shows a signature followed by the name "Tina Kiang". Below the name is the letter "S" with a dash in front of it. In the background, the letters "FDA" are visible in a light gray color.

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

2

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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.

4

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

5

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.

6

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
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:
2.4 mm

ID:
1.0 mm

Length:
90 cm | OD:
2.4 mm

ID:
0.1 ~ 0.2 mm

Length:
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 |

7

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:
2.4 mm

ID:
1.0 mm

Length:
90 cm | OD:
2.4 mm

ID:
0.1 ~ 0.2 mm

Length:
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:
2.4 mm

ID:
1.0 mm

Length:
90 cm | OD:
2.4 mm

ID:
0.2 ~ 0.5 mm

Length:
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 |

8

SMARTeZ Pump

|

| Type | Tubing Specifications | | No. of products in
packaging | | | 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 | Designation | | | | |
| Short
Infusion
Time
Articles/
Model
Numbers | OD:
2.4 mm

ID:
1.0 mm

Length:
90 cm | OD:
2.4 mm

ID:
0.2 ~ 0.5 mm

Length:
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-
therapy
Articles/
Model
Numbers | OD:
2.4 mm

ID:
1.0 mm

Length:
90 cm | OD:
2.4 mm

ID:
0.1 ~ 0.2 mm

Length:
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.)

9

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)

10

SMARTeZ Pump

| Bench Test

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

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

Section §5: 510(k) Summary (K151650)

11

Image /page/11/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized font. The letters are connected, and there is a small circle above the "E". A horizontal line underlines the entire word. The logo is in black and white.

SMARTeZ Pump

12

Image /page/12/Picture/0 description: The image shows a logo for EPIC. The logo is in black and white. The letters are stylized and bolded. There is a horizontal line underneath the letters.

SMARTeZ Pump

13

Image /page/13/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized, bold font. The letters are connected and have a modern, geometric appearance. A horizontal line underlines the entire word, adding emphasis to the logo.

SMARTeZ Pump -

14

Image /page/14/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized font. The letters are bold and blocky, with a horizontal line running beneath them. The dot above the "i" is a solid circle, and the letters are all capitalized and in a dark color, possibly black or a dark gray.

SMARTeZ Pump

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

15

Image /page/15/Picture/0 description: The image shows a logo with the word "EPIC" in a stylized font. The letters are bold and connected, with a horizontal line running beneath them. A small circle is positioned above the "E", adding a distinctive element to the design. The logo is presented in black against a white background, creating a clear contrast.

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.

16

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
hazardous substances and
heavy metals
Cytotoxicity	ISO 10993-5	Non-cytotoxic
Sensitization	ISO 10993-10	Non-sensitizing
Irritation or intracutaneous
reactivity	ISO 10993-10	Intracutaneously non-
irritating
System toxicity (acute)	ISO 10993-11	Systemically non-toxic
(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.