(291 days)
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.
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.
The SMARTeZ Pump, an elastomeric infusion pump, underwent a series of bench tests to demonstrate its performance and safety, aligning with ISO 28620:2010 standards. The study aimed to prove that the device consistently delivers medication within specified flow rate tolerances under various conditions, including nominal operation, changes in ambient temperature and solution viscosity, and after exposure to physical stresses like pressure, traction, and drops, as well as refrigeration. It also verified leak-proof integrity and the absence of retrograde flow.
Here is a summary of the acceptance criteria and the reported device performance:
1. Table of acceptance criteria and the reported device performance:
| Bench Test Completed | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flow Rate Test (Nominal Condition) | - Mean flow rate: ±15% compared to nominal. - At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis confirmed flow accuracy within +/- 15% at 99% confidence (lower- and upper-bounds of -0.400% to +0.151%) when filled with nominal volume and delivering normal saline at 31°C with the pump 40cm below the catheter site. |
| Flow Rate Test (Change of Ambient Temperature) | Mean flow rates should be no more than 15% slower when compared to those tested at 31°C. | Passed. Mean flow rate was 14.07% slower, confirming the IFU claimed temperature effect. |
| Flow Rate Test (Change of Solution Viscosity) | Mean flow rates should be no more than 10% slower when compared to those tested with 0.9% NaCl as control solution. | Passed. Mean flow rate was 9.81% slower, confirming the IFU claimed fluid viscosity effect. |
| Flow Rate Test after Resistance to Pressure Test | - Mean flow rate: ±15% compared to nominal. - At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
| Leak-Proof Test after Resistance to Pressure Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
| Leak-Proof Test after Drop Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
| Flow Rate Test after Resistance to Traction Test | - Mean flow rate: ±15% compared to nominal. - At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both criteria. Statistical analysis showed flow rate accuracy was not affected. |
| Leak-Proof Test after Resistance to Traction Test | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
| Flow Rate Test after Refrigeration | - Mean flow rate: ±15% compared to nominal. - At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal. | Passed. All samples met both flow rate and leak integrity criteria. Statistical analysis showed flow rate accuracy was not affected. |
| Leak-Proof Test after Refrigeration | Device shall remain watertight; solution shall not become colored. | Passed. All samples met the criterion. |
| Retrograde Flow of Infusate Test | Retrograde flow should not be observed when back pressure applied ≤ 0.34bar (5 psi). | Passed. Retrograde flow was observed at 0.8 bar (11.6 psi), which is double the acceptance criteria. |
| Flow Rate Test under Non-Ambient Pressure (Influence of Routes of Administration) | - Mean flow rate: ±15% compared to nominal. - At least 80% nominal volume delivered at instantaneous flow rate within ±50% of nominal, independent of IV, intra-arterial, and subcutaneous routes. | Passed. Flow accuracy of +/- 15% was maintained, independent of the 3 routes of infusion administered. |
| Performance/Functionality Testing for Chemotherapy Articles | - Flow accuracies (nominal, after pressure/traction/refrigeration, non-ambient pressure): Mean flow rate ±15% of nominal, 80% nominal volume within ±50% instantaneous. - Watertight after pressure, traction, drop, and refrigeration. - No retrograde flow at back pressure ≤ 0.34bar (5 psi). | Passed. All samples met all acceptance criteria. |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the specific sample size (number of devices) used for each individual bench test. However, it consistently refers to "All test samples" passing the criteria. It also mentions "The samples were tested."
The data provenance is from bench testing, which implies a controlled laboratory environment. There is no information regarding the country of origin of the data or whether it was retrospective or prospective, as these types of studies are typically not applicable to physical bench tests of device functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the study described is a series of bench tests for device performance against predefined engineering and regulatory standards (ISO 28620:2010), not a study involving expert assessment or clinical ground truth.
4. Adjudication method for the test set:
This is not applicable as the study involves objective physical measurements and functional checks against quantitative acceptance criteria, not subjective human evaluations requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This is not applicable as the device is a physical infusion pump, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is a physical infusion pump, not an algorithm. The "standalone" performance here refers to the device's inherent mechanical and fluid dynamic performance.
7. The type of ground truth used:
The ground truth for the performance tests was established by objective measurements against quantitative engineering and regulatory standards (ISO 28620:2010), specifically defined numerical tolerances for flow rate, and observable physical properties like leak-proof integrity and retrograde flow.
8. The sample size for the training set:
This is not applicable as the device does not employ machine learning or AI models that require a training set.
9. How the ground truth for the training set was established:
This is not applicable as the device does not employ machine learning or AI models.
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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.
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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 (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,
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
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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: +65 9635 2618 / +66 81 761 5292
Email: freddie.lee@epic-med.com
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(Primary) | K071222 | K081905 | K991513 |
| 510(k)Submitter | I-FlowCorporation | Baxter HealthcareCorporation | Westmed, Inc.(B. Braun MedicalInc.) | I-FlowCorporation |
| TradeName | I-FlowElastomeric Pump(Homepump/Easypump) | Infusor SV andLV ElastomericInfusion 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
-
- Fill port
-
- Outer soft cover
-
- Multi-layered elastomeric membrane
-
- ON-OFF clamp
-
- PVC administration tubing not made from Phthalate (DEHP)
- Air and particulate eliminating filter 6.
-
- Flow restrictor
-
- Patient connector
-
- Patient end cap
-
- Fill port cap (tethered)
-
- Labelling Fill volume & infusion time
-
- 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 inpackaging | Designation | Nominalvolume(ml) | Nominalflow rate(ml/h) | Nominaltime (h) | ArticleNumber(REF) | ||
|---|---|---|---|---|---|---|---|---|---|
| Administrationtube | Flowrestrictor –Micro boretube* | Persterilebarriersystem | Perprotectivepackaging | ||||||
| LongInfusionTimeArticles/ModelNumbers | OD:2.4 mmID:1.0 mmLength:90 cm | OD:2.4 mmID:0.1 ~ 0.2 mmLength: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:2.4 mmID:1.0 mmLength:90 cm | OD:2.4 mmID:0.1 ~ 0.2 mmLength: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 mmID:1.0 mmLength:90 cm | OD:2.4 mmID:0.2 ~ 0.5 mmLength: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 inpackaging | Nominalvolume(ml) | Nominalflow rate(ml/h) | Nominaltime (h) | ArticleNumber(REF) | |||
|---|---|---|---|---|---|---|---|---|---|
| Administrationtube | Flowrestrictor –Micro boretube* | Persterilebarriersystem | Perprotectivepackaging | Designation | |||||
| ShortInfusionTimeArticles/ModelNumbers | OD:2.4 mmID:1.0 mmLength:90 cm | OD:2.4 mmID:0.2 ~ 0.5 mmLength: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-therapyArticles/ModelNumbers | OD:2.4 mmID:1.0 mmLength:90 cm | OD:2.4 mmID:0.1 ~ 0.2 mmLength: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 TestCompleted | Applicable Standard & Clause | Acceptance Criteria | Test Results |
|---|---|---|---|
| Flow Rate Test(NominalCondition) | ISO 28620:2010, Sub-clause 6.2.The samples were tested for flowrate under conditions specified bymanufacturer for which the claimedflow rate accuracy is achieved. | The mean flow rate shall havea tolerance of ±15% comparedto the nominal flow rate. At least 80% of the nominalvolume shall be delivered at aninstantaneous flow rate within±50% of the nominal flow rate. | Passed.All test samples passed both acceptancecriteria. It is confirmed through statistical analysisthat when the subject device is filled atnominal volume, flow accuracy is within+/- 15% of the nominal (label) flow rate (at99% confidence level, lower- and upper-bounds of -0.400 % to +0.151 %) whendelivering normal saline at 88 deg F (31deg C) with pump positioned at 16" (40cm) below the catheter site. |
| Flow Rate Test(Change ofAmbientTemperature) | ISO 28620:2010, Sub-clause 6.2.The samples were tested for flowrate with flow restrictor at 25±1℃. | The mean flow rates ofsamples should be no morethan 15% slower whencompared with that tested withflow restrictor temperature at31°C. | Passed.The results show mean flow rate of thesamples is 14.07% slower. The results confirmed the IFU claimedtemperature effect to flow rate accuracy. |
| Flow Rate Test(Change ofSolutionViscosity) | ISO 28620:2010, Sub-clause 6.2.The samples were tested for flowrate using 5% Dextrose as controlsolution. | The mean flow rates ofsamples should be no morethan 10% slower whencompared with that tested with0.9% NaCl as control solution. | Passed.The results show mean flow rate of thesamples is 9.81% slower. The results confirmed the IFU claimedfluid viscosity effect to flow rate accuracy. |
| Flow Rate Testafter Resistance toPressure Test | ISO 28620:2010, Sub-clause 6.2 &6.3. | The mean flow rate shall havea tolerance of ±15% comparedto the nominal flow rate. | Passed.All the samples passed both acceptancecriteria. |
| Bench TestCompleted | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| The entire fluid reservoir of thesamples were under a force of150N for 5s. After pressure isremoved, the samples were testedfor flow rate. | At least 80% of the nominal•volume shall be delivered at aninstantaneous flow rate within±50% of the nominal flow rate. | Passed.• The flow rate results were compared withthat of the same article (model) from FlowRate Test at Nominal Condition.• The statistical analysis showed the flowrate accuracy was not affected byresistance to pressure test. | |
| Leak-Proof Testafter Resistance toPressure Test | ISO 28620:2010, Sub-clause 6.3 &6.5.The entire fluid reservoir of thesamples were under a force of150N for 5s. After pressure isremoved, the samples wereinspected for leakage. | After resistance to pressure test:• The device shall remainwatertight, and the solution incontainer shall not becamecolored. | Passed.• All test samples passed the acceptancecriteria. |
| Leak-Proof Testafter Drop Test | ISO 28620:2010, Sub-clause 6.4 &6.5.The samples were filled with dyedsolution then dropped twice fromone (1) meter height. After drop,the samples were inspected forleakage. | After drop test:• The device shall remainwatertight, and the solution incontainer shall not becamecolored. | Passed.• All test samples passed the acceptancecriteria. |
| Flow Rate Testafter Resistance toTraction Test | ISO 28620:2010, Sub-clause 6.2 &6.6.The samples were applied a forceof 15N for 15s between each endsof the device. After force is | • The mean flow rate shall havea tolerance of ±15% comparedto the nominal flow rate.• At least 80% of the nominalvolume shall be delivered at an | Passed.• All test samples passed both acceptancecriteria.• The flow rate results were compared withthat of the same article (model) from FlowRate Test at Nominal Condition. |
| Bench TestCompleted | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| removed, the samples were testedfor flow rate. | instantaneous flow rate within$\pm$ 50% of the nominal flow rate. | Passed.• The statistical analysis showed the flowrate accuracy was not affected byresistance to pressure test. | |
| Leak-Proof Testafter Resistance toTraction Test | ISO 28620:2010, Sub-clause 6.5 &6.6.The samples were applied a forceof 15N for 15s between each endsof the device. After force isremoved, the samples wereinspected for leakage. | After resistance to traction test:• The device shall remainwatertight, and the solution incontainer shall not becamecolored. | Passed.• All test samples passed the acceptancecriteria. |
| Flow Rate Testafter Refrigeration | ISO 28620:2010, Sub-clause 6.2.The samples were filled andrefrigerated (2~8°C) for 72 hours.After return to room temperature,the samples were tested for flowrate. | • The mean flow rate shall havea tolerance of $\pm$ 15% comparedto the nominal flow rate.• At least 80% of the nominalvolume shall be delivered at aninstantaneous flow rate within$\pm$ 50% of the nominal flow rate. | Passed.• All test samples passed both flow rate andleak integrity acceptance criteria.• The flow rate results were compared withthat of the same article (model) from FlowRate Test at Nominal Condition.• The statistical analysis showed the flowrate accuracy was not affected byrefrigeration. |
| Bench TestCompleted | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| Leak-Proof Testafter Refrigeration | ISO 28620:2010, Sub-clause 6.2.The samples were filled andrefrigerated (2~8°C) for 72 hours.After return to room temperature,the samples were inspected forleakage. | After refrigeration:The device shall remainwatertight, and the solution incontainer shall not becomecolored. | Passed.All test samples passed the acceptancecriteria. |
| Retrograde Flowof Infusate Test | The infusion completed sampleswere applied with a back pressurefrom distal connector to obversethe retrograde flow of infusate. | Retrograde flow of infusate shouldnot be observed when backpressure applied $\leq$ 0.34bar (5 psi,the maximum possible backpressure during the actual use). | Passed.The back pressure that retrograde flow ofinfusate observed was 0.8bar (11.6 psi),which is double that of the acceptancecriteria. |
| Flow Rate Testunder Non-Ambient Pressure(Influence ofRoutes ofAdministration) | ISO 28620:2010, Sub-clause 6.2.The samples were tested for flowrate under conditions specified bymanufacturer for which the claimedflow rate accuracy is achieved. | To study the influence on flow ratefrom the following routes ofinfusion: intravenous, intra-arterialand subcutaneous routes; and toconfirm that:The mean flow rate shall havea tolerance of ±15% comparedto the nominal flow rate. At least 80% of the nominalvolume shall be delivered at aninstantaneous flow rate within±50% of the nominal flow rateare maintained, independent of the3 routes of infusion administered. | Passed.The influence on flow rate from thefollowing routes of infusion: intravenous,intra-arterial and subcutaneous routes;were established. It is confirmed that flowaccuracy of +/- 15% of the nominal (label)flow rate is maintained, independent of the3 routes of infusion administered. |
| Bench TestCompleted | Applicable Standard & Clause | Acceptance Criteria | Test Results |
| Performance/FunctionalityTesting forChemotherapyArticles | ISO 28620:2010, Sub-clauses 6.2,6.3, 6.4, 6.5 and 6.6.Note: In chemotherapy articles therange of flow rates and fill volumecombinations are fully representedin all the bench test protocols. | Flow accuracies, in nominal●conditions, after resistance topressure, after resistance totraction, under non-ambientpressure and after refrigeration:The mean flow rate shallOhave a tolerance of ±15%compared to the nominalflow rate.At least 80% of theOnominal volume shall bedelivered at aninstantaneous flow ratewithin ±50% of thenominal flow rate.The device shall remain●watertight after resistance topressure, after resistance totraction, after being droppedand after refrigeration.Retrograde flow of infusate●should not be observed whenback pressure applied ≤0.34bar (5 psi, the maximumpossible back pressure duringthe 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)
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SMARTeZ Pump
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SMARTeZ Pump
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SMARTeZ Pump -
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SMARTeZ Pump
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/extractablehazardous substances andheavy metals |
| Cytotoxicity | ISO 10993-5 | Non-cytotoxic |
| Sensitization | ISO 10993-10 | Non-sensitizing |
| Irritation or intracutaneousreactivity | 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.
§ 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).