(268 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and functionality of an empty fluid container, with no mention of any computational or analytical capabilities.
No
The device is described as an "Empty Fluid Container" used to hold and transfer fluids for intravenous administration. It does not exert any therapeutic action on the patient.
No
This device is an empty fluid container used for intravenous administration of fluids and medications. It functions as a container and a delivery system, not for identifying a disease or condition.
No
The device description clearly outlines a physical, single-use, sterile, nonpyrogenic flexible IV container/bag made of plastic film with ports and closures. It undergoes performance testing related to physical properties and biocompatibility, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "hold an admixture of compatible fluids for intravenous administration to a patient." This describes a container for delivering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a flexible bag with ports for filling and administering fluids. This aligns with the function of an IV bag used for drug delivery or hydration.
- Lack of IVD Characteristics: There is no mention of the device being used to analyze biological samples (blood, urine, tissue, etc.), detect markers of disease, or provide diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for containing and facilitating the delivery of fluids for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.
Product codes (comma separated list FDA assigned to the subject device)
KPE
Device Description
The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use.
The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.
For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder.
The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.
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
Adequately trained health care professionals or pharmacists, clinical setting
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Resistance to Temperature, Pressure and Leakage
- Resistance to Dropping
- Water Vapor Impermeability
- Spiking Port Penetration Ability
- Spiking Port Adhesion Strength
- Additive Port Liquid Tightness
- Hanger Tensile Strength
- Identification Clarity
- Particulate Non-contamination
- Impermeability to Microorganism
- 7-day Microbial Ingress Test
Biocompatibility: In accordance with ISO 10993-1: 2018, the ToxiSeal™ Vial Adaptor with External Balloon is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The biological safety and biocompatibility were evaluated, and found to have met their respective acceptance criteria. Conclusion to the biological evaluation of the eZSURE™ Empty Fluid Container was that upon completing the evaluation according to ISO 10993-1:2018, the results demonstrated that the eZSURE™ EFC met the biological safety and biocompatibility requirements when used as intended. Particulate matter testing was conducted in accordance with ISO 15747: 2018, Plastic containers for intravenous injections and USP Particulate Matter in Injections and found to have met the ISO and USP acceptance criteria.
Sterility, Shipping, and Shelf-Life: The Subject device complies with sterilization requirements of ISO 11135: 2014, Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices.
- Package Integrity Test
- Sterile Barrier Packaging Testing performed on the proposed device: Seal strength ASTM F88
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5025 I.V. container.
(a)
Identification. An I.V. container is a container made of plastic or glass used to hold a fluid mixture to be administered to a patient through an intravascular administration set.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The seal features an eagle emblem.
September 1, 2023
Epic Medical Pte Ltd Freddie Lee CEO 105 Cecil, 20-01 The Octagon Singapore, Singapore 069534 Singapore
Re: K223674
Trade/Device Name: eZSURE™ Empty Fluid Container (models 426030, 426110) Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: Class II Product Code: KPE Dated: August 2, 2023 Received: August 2, 2023
Dear Freddie Lee:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223674
Device Name
eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)
Indications for Use (Describe)
The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.
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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3
e Dil
K223674- 510(k) Summary
I. Submitter
Epic Medical Pte. Ltd. 105 Cecil Street #20-04, The Octagon, Singapore 069534. Phone: +65 9635 2618 / +66 81 761 5292
Contact Person: Mr. Freddie LEE, Chief Executive Officer/ Managing Director Date Prepared: September 1, 2023
II. Subject Device
| 510(k) Number: | K223674 |
|---|---|
| Proprietary/Trade Name: | eZSURE™ Empty Fluid Container (models 426030, 426040, |
- |
| Common/Usual Name: | Empty I.V. bag |
| Regulation Name: | I.V. Container |
| Product Code: | KPE |
| Regulation Number: | 21 CFR 880.5025 |
| Device Class: | Class: II |
Predicate Device III.
| 510(k) Number: | K181393 |
|---|---|
| Proprietary/Trade Name: | Empty EVA Bag (models FVM0134BP, FVM0135BP, |
| FVM0136BP, FVM0137BP, FVM0138BP, FVM0139BP, | |
| FVM0140BP, FVM0141BP) | |
| Common/Usual Name: | Empty I.V. bag |
| Regulation Name: | I.V. Container |
| Product Code: | KPE |
| Regulation Number: | 21 CFR 880.5025 |
| Device Class: | Class: II |
4
Device Description IV.
The eZSURE™ Empty Fluid Container (EFC) devices are empty single-use, sterile, nonpyrogenic flexible IV container devices/ bags. These are discarded after use.
The Subject EFC device is composed of a flexible plastic film bag and two separate ports with closures, one for injection and another, infusion. An inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike. A transfer device with a male luer lock is used to connect to the filling-/ additive- port for filling. The additive port incorporates a needle-free valve; hence no injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the needle-free self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.
For administration to a patient, the device is then connected to an external IV set /IV line, via a bag spike. The IV bag is piped by inserting the spike point of a bag spike into the spiking-/administration- port of the IV bag, doing this by performing a twisting motion. When the bag is already filled, other medications can be added using the additive/ injection/ filling port, even during administration. Medication transfer in and out of the container is done using aseptic technique. The bags range in volume capacity of 100 mL, and 500 mL. The device has a hanger hole so it can be placed on an IV bag holder.
The EFC is made of non-PVC materials and provided in a two-port configuration: The needle free additive port which is used for filling the container and the other, the spiking -/ administration port, which is used for IV therapy administration from the EFC. The EFC sub-components are externally communicating devices with no contact to the blood path. The contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1 :2018 biocompatibility guidelines.
V. Indications for Use Statement
The Empty Fluid Container is used to hold an admixture of compatible fluids for intravenous administration to a patient. Medication transfer in and out of the container is done using aseptic technique.
VI. Comparison of Technological Characteristics
The eZSURE™ Empty Fluid Container devices and the Predicate devices share the following characteristics:
- . Same 2-port configuration - an additive/ filling port and a spiking/ administration port
- . Equivalent basic design features - clear, flexible, and empty IV fluid bag that allows for preparation and administration of IV therapies
- Equivalent means of attachment provided for an IV administration set/ line, for the delivery of IV therapy
5
GDIC
The overview table hereunder compares parameters between the Subject and Predicate devices.
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURETM
Empty Fluid Container
(EFC)
(K223674) | Comment/ Discussion |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
statement | "The Empty EVA Bag is an empty
container used for administration of
intravenous solutions to the patient
using an intravascular administration
set. Medication transfer in and out of
the container is done using aseptic
technique." | "The Empty Fluid Container is
used to hold an admixture of
compatible fluids for
intravenous administration to
a patient. Medication transfer
in and out of the container is
done using aseptic technique." | Same as Predicate
Both devices are intended for and
indicated for the use in holding
admixture fluids/IV solutions for the
subsequent administration/ transfer of
the IV solutions from the container to
an external IV administration set/
line, working in combination,
complementarily, applying aseptic
technique |
| Product code and
regulation number | KPE,
21 CFR 880.5025 | KPE,
21 CFR 880.5025 | Same as Predicate |
| Intended user
population/intended use
environment | Adequately trained
health care professionals or
pharmacists,
clinical setting | Adequately trained
health care professionals or
pharmacists,
clinical setting | Same as Predicate |
| IV drug
component bag
components/ access
components | Empty EVA Bag, has 2 access points:
- Additive port/ filling port
- Spiking/ administration port, IV
spike bag access for IV set/ IV line | eZSURETM EFC, has 2 access
points: - Additive port/ filling port
- Spiking/administration port,
IV spike bag access for IV
set/ IV line | Same as Predicate |
| Intended drug type(s) | Parenteral drugs | Parenteral drugs | Same as Predicate |
| Rx/
Prescription Use | R only | R only | Same as Predicate |
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURETM
Empty Fluid Container
(EFC)
(K223674) | Comment/Discussion |
| Principles of operation | The empty bags are filled by connecting
to containers containing one or more
solutions, e.g., through standard
syringes or automated filling devices
After filling, the bags are clamped to
secure the contents prior to
administration.
IV set/ IV line is attached through the
spiking/ administration port to
dispense IV therapy using a standard
spike and tubing | The empty bags are filled by
connecting to containers
containing one or more
solutions, e.g., through
standard syringes (without
needle) or automated filling
devices
The additive port is a self-
sealing needle- free female
luer lock connector, no
different from standard
injection site devices of
market-cleared IV sets.
Silicone valve of the additive
port self- seals/ re-seals when
mating component devices
are disconnected from one
another
IV set/ IV line is attached
through the spiking/
administration port to dispense
IV therapy using a standard
spike and tubing | Different, but Substantially Equivalent
to Predicate:
Both the Subject device and the
Predicate device comprise two ports –
the additive port and the spiking/
administration port. Both the Subject
devices and Predicate devices are
bulk-filled by the user through the
additive port. Subject devices allow
additional-filling through the additive
port, whereas the additive/ filling port
on the Predicate device is designed to
be used to filled once and clamped
with inviolable clamp after filling
Both the Subject device and Predicate
device comprise a spiking/
administration port to connect an IV
administration set/ line for the
delivery of IV therapy to the patient
Both the Subject and Predicate devices
provide a mechanism for safe filling
of the bag and the administration of
IV therapy to the patient using an IV
administration set/ line. Performance
testing of the subject device
demonstrates that the differences do
not raise new or different questions of
safety and effectiveness. |
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURE™
Empty Fluid Container
(EFC)
(K223674) | Comment/ Discussion |
| Technology and design | The EVA bag device includes an
administration port and an additive
port. The administration port
provides a connection to the IV set/
line. The additive port is a connector
by which medications can be added to
the bag/ container using the
medication port before IV
administration. A capsule closes the
medication port after use. The bags/
containers are clamped after filling by
the means of inviolable clamps
An IV set/ IV line is connected to the
fluid container/ bag to dispense IV
therapy | The EFC device includes an
administration port and an
additive port. The
administration port provides a
connection to the IV set/ line.
The additive port, a needle-free
female luer lock connector,
like the injection sites of other
market- cleared IV sets, allows
for medication(s) to be added
to the bag/container prior to
and during IV administration.
Silicone valve of the additive
port self-seals/ re- seals when
mating component devices are
disconnected from one another
An IV set/ IV line is connected
to the fluid container/ bag to
dispense IV therapy | Different, but Equivalent to Predicate:
Though a difference in securing the
fluid container content after being
filled – silicone valve of the sterile
additive port self-seals/ re-seals when
mating component devices are
disconnected from one another in the
case of the Subject device. This
contrasts with the Predicate device in
which the user clamps the port after
filling by means of an inviolable
clamp.
Performance testing of the subject
device demonstrates that the
differences do not raise new or
different questions of safety and
effectiveness. |
| Technology and design | The bag is manufactured by welding a
plastic attachment to the bag body and
assembling the bottom with entry and
exit connectors/ ports | The bag is manufactured by
welding a plastic attachment to
the bag body and assembling
the bottom with entry and exit
connectors/ ports | Same as Predicate |
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURE™
Empty Fluid Container
(EFC)
(K223674) | Comment/ Discussion |
| Material
of empty fluid
container body | Ethylene-vinyl acetate (EVA) | Sealed Air Corp's
Medical Packaging Film, Nexcel®
Film,
Grade M315, Polyolefin | Different, but Substantially Equivalent
to Predicate:
Though a difference in the material
used to build the fluid container main
body exists, it did not raise additional
questions of safety or of performance
effectiveness. This is because both
materials are highly transparent clear,
flexible plastic film formulated for its
intended use as primary medical film
for bag body of medical IV bags -
free of PVC, plasticizers, adhesives,
latex - that could potentially leach
into certain solutions, and both are
suitable for EO sterilization
Performance, shelf life, and
biocompatibility testing of the subject
device demonstrates that the differences
do not raise new or different questions of
safety and effectiveness. |
| Materials of additive/
filling port | Polyisoprene, Polypropylene
Acrylonitrile Butadiene Styrene | Polypropylene Polycarbonate
Liquid Silicone Rubber | Different, but Substantially Equivalent
to Predicate:
Though a difference in the materials
used for the additive port exists, it did
not raise additional questions of
safety or of performance
effectiveness.
The valve material, Silicone, QP1-30, is
an USP (U.S. Pharmacopoeia) class
VI elastomer silicone rubber that does
not contain phthalates nor latex. |
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURE™
Empty Fluid Container
(EFC)
(K223674) | Comment/ Discussion |
| | | | additives. It is recommended for
medical devices including those
implanted in humans for less than 30
days besides non-implant applications
Performance, shelf life, and
biocompatibility testing of the subject
device demonstrates that the
differences do not raise new or
different questions of safety and
effectiveness. |
| Material of spiking/
administration port | PVC not made with DEHP | Thermoplastic elastomer | Different, but Equivalent to Predicate.:
Though a difference in the materials
used for the spiking/ administration
port exists, it did not raise additional
questions of safety or of performance
effectiveness. This is because
eZSURE™ EFC does not use PVC, not
even those not made with plasticizer
DEHP - that could potentially leach
into certain solutions.
Performance, shelf life, and
biocompatibility testing of the subject
device demonstrates that the
differences do not raise new or
different questions of safety and
effectiveness. |
| Biocompatibility | Acceptable biological risks established by
demonstrating that
the device meets ISO 10993-1 | Acceptable biological risks
established by demonstrating
that the device meets ISO 10993-1 | Same as Predicate |
| Sterilization method | Ethylene Oxide, EO, SAL 10-6 | Ethylene Oxide, EO, SAL 10-6 | Same as Predicate |
| Parameter compared | Predicate Device
Empty EVA Bag
(K181393) | Subject Device
eZSURETM
Empty Fluid Container
(EFC)
(K223674) | Comment/ Discussion |
| Shelf life | 3 years (36 months) | 5 years | Different, but Equivalent to Predicate:
Device performance and shelf-life
testing of the subject device
demonstrates that the differences do not
raise new or different questions of
safety and effectiveness. |
| Reuse or single-use | Single-use only | Single-use only | Same as Predicate |
| Primary package top web | Medical grade paper and medical
plastic film, heat sealed | Medical grade paper and
medical plastic film, heat sealed | Same as Predicate |
6
@DIC
7
GDIC
8
집 1 C
9
@DIC
10
GDIC
11
Discussion of differences in technological characteristics
The preceding table summarizes the technological comparisons between the eZSURE™ EFC and the Predicate devices identifying differences in materials of construction: a) empty fluid container body, b) additive/ filling port and c) administration port. Although the Subject devices contain differences in material composition compared to the Predicate devices, these differences between the Subject and Predicate devices were evaluated and do not raise new questions of safety and effectiveness. These differences were further addressed and evaluated for safety and effectiveness through non-clinical performance testing, biocompatibility evaluation and sterilization and shelf-life studies, and summarized in VII below. The outcome of the evaluation and testing demonstrates that data within this submission support that the eZSURE™ Empty Fluid Container devices are substantially equivalent to the Submitter designated Predicate devices in terms of safety and performance effectiveness.
Performance Data Supporting Substantial Equivalence VII.
- A. The sterile, single-use, non-pyrogenic flexible IV container devices/ bags described in this Summary were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards:
- . ANSI/AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
- . ANSI/AAMI ST72/ 2019, Bacterial endotoxins – Test methods, routing monitoring, and alternatives to batch testing
- . ASTM F1929-15, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration
- ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices
- . EN 868-5: 2009. Packaging materials and systems for medical devices which are to be sterilized – Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction – Requirements and test methods
- ISO 15747: 2018, Plastic containers for intravenous injections
- ISO 22413: 2021, Transfer sets for pharmaceutical preparations – Requirements and test methods
- . ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- USP 40 , Pyrogen test (USP rabbit test)
- USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests
- USP-NF , Bacterial Endotoxins Test ●
12
Testing done:
- . Resistance to Temperature, Pressure and Leakage
- . Resistance to Dropping
- Water Vapor Impermeability
- Spiking Port Penetration Ability
- Spiking Port Adhesion Strength ●
- Additive Port Liquid Tightness ●
- Hanger Tensile Strength
- Identification Clarity ●
- . Particulate Non-contamination
- Impermeability to Microorganism .
- . 7-day Microbial Ingress Test
B. Biocompatibility
In accordance with ISO 10993-1: 2018, the ToxiSeal™ Vial Adaptor with External Balloon is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The biological safety and biocompatibility were evaluated, and found to have met their respective acceptance criteria.
Conclusion to the biological evaluation of the eZSURE™ Empty Fluid Container was that upon completing the evaluation according to ISO 10993-1:2018, the results demonstrated that the eZSURE™ EFC met the biological safety and biocompatibility requirements when used as intended.
Particulate matter testing was conducted in accordance with ISO 15747: 2018, Plastic containers for intravenous injections and USP Particulate Matter in Injections and found to have met the ISO and USP acceptance criteria.
-
C. Sterility, Shipping, and Shelf-Life
The Subject device complies with sterilization requirements of ISO 11135: 2014, Sterilization of Health Care Products - Ethylene Oxide - Part 1: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices. -
Package Integrity Test ●
-
Sterile Barrier Packaging Testing performed on the proposed device: Seal strength ASTM . F88
-
. Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
13
VIII. Conclusion
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The eZSURE™ EFC is substantially equivalent to the predicate, Empty EVA Bag, with respect to the indications for use, principles of operation and technological characteristics.