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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called eZSURE™ Empty Fluid Container. It does not contain information about a study proving the device meets acceptance criteria related to AI/algorithm performance, multi-reader multi-case studies, or the establishment of ground truth by experts.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device for a Class II medical device (an empty IV fluid container). The "acceptance criteria" and "study" described in the document relate to physical and biological performance testing of the container itself, not the performance of an AI algorithm in diagnostic imaging.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance related to AI.
Sample sizes, data provenance, number/qualifications of experts, or adjudication methods for an AI test set.
MRMC comparative effectiveness study details.
Standalone AI performance details.
Training set size or ground truth establishment for an AI.

The document describes the following types of acceptance criteria and studies for the physical medical device:

1. A table of acceptance criteria and the reported device performance (for the physical device, not AI):

The document does not provide a single, consolidated table directly mapping acceptance criteria to quantitative performance results for each test. Instead, it lists the types of tests performed and states that the device "met their respective acceptance criteria" or "complies with" relevant standards.

Summary of Acceptance Criteria and Reported Performance (extracted from Section VII):

Acceptance Criteria (Test Type)	Relevant Standard(s)	Reported Device Performance
Resistance to Temperature, Pressure and Leakage	ISO 15747:2018 (Plastic containers for IV injections)	Tested and demonstrated conformance to standards
Resistance to Dropping	ISO 15747:2018	Tested and demonstrated conformance to standards
Water Vapor Impermeability	ISO 15747:2018	Tested and demonstrated conformance to standards
Spiking Port Penetration Ability	ISO 15747:2018	Tested and demonstrated conformance to standards
Spiking Port Adhesion Strength	ISO 15747:2018	Tested and demonstrated conformance to standards
Additive Port Liquid Tightness	ISO 15747:2018	Tested and demonstrated conformance to standards
Hanger Tensile Strength	ISO 15747:2018	Tested and demonstrated conformance to standards
Identification Clarity	Not explicitly stated	Tested and demonstrated conformance to standards
Particulate Non-contamination	ISO 15747:2018, USP <788>	Met ISO and USP acceptance criteria
Impermeability to Microorganism	Not explicitly stated	Tested and demonstrated conformance to standards
7-day Microbial Ingress Test	Not explicitly stated	Tested and demonstrated conformance to standards
Biocompatibility	ISO 10993-1:2018	Met biological safety and biocompatibility requirements
Sterility (Ethylene Oxide)	ISO 11135:2014	Complies with sterilization requirements
Package Integrity Test (Seal strength)	ASTM F88	Performed
Shelf-life	ASTM F1980-16	3 years validated
Bacterial Endotoxins	ANSI/AAMI ST72/2019, USP 40 <151>, USP-NF <161>, USP-NF <85>	Tested and demonstrated conformance to standards
Luer Activated Valves (LAVs) Requirements	ANSI/AAMI CN27:2021	Tested and demonstrated conformance to standards
Seal leaks in porous medical device packaging	ASTM F1929-15	Tested and demonstrated conformance to standards
Packaging materials and systems (heat/self-sealable)	EN 868-5:2009	Tested and demonstrated conformance to standards
Transfer sets for pharmaceutical preparations	ISO 22413:2021	Tested and demonstrated conformance to standards
Infusion equipment for medical use (gravity feed)	ISO 8536-4:2019	Tested and demonstrated conformance to standards

2. Sample size used for the test set and the data provenance:
The document does not specify exact sample sizes for each test listed. It mentions "testing done" and "test methods" but not the number of units tested. Data provenance is not applicable here as it refers to physical testing of a manufactured device, not clinical data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the "ground truth" for this device's performance relates to physical and biological properties (e.g., whether it leaks, whether materials are biocompatible, whether it is sterile), which are established through standardized laboratory testing, not by expert human readers interpreting data.

4. Adjudication method for the test set:
Not applicable for physical/biological performance testing.

5. If a Multi-reader Multi-case (MRMC) comparative effectiveness study was done:
No, this type of study is for evaluating diagnostic performance of imaging devices or AI, which is irrelevant to an empty fluid container.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as there is no AI algorithm being evaluated for this physical device.

7. The type of ground truth used:
For the physical device, the "ground truth" is defined by the technical specifications and performance limits set by various ISO, ASTM, ANSI/AAMI, EN, and USP standards (e.g., a certain burst pressure, a specific level of particulate matter, absence of microbial growth).

8. The sample size for the training set:
Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established:
Not applicable, as there is no AI model or training set.

In conclusion, the provided FDA 510(k) summary is for a standard medical device (an empty fluid container) and demonstrates its substantial equivalence based on physical, chemical, and biological performance testing, rather than the performance of an AI algorithm.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K223674

Device Name

eZSURE™ Empty Fluid Container (models 426030, 426040, 426110)

Indications for Use (Describe)

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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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, 426040,426110)
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

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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

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

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GDIC

The overview table hereunder compares parameters between the Subject and Predicate devices.

Parameter compared	Predicate DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURETMEmpty Fluid Container(EFC)(K223674)	Comment/ Discussion
Indications for Usestatement	"The Empty EVA Bag is an emptycontainer used for administration ofintravenous solutions to the patientusing an intravascular administrationset. Medication transfer in and out ofthe container is done using aseptictechnique."	"The Empty Fluid Container isused to hold an admixture ofcompatible fluids forintravenous administration toa patient. Medication transferin and out of the container isdone using aseptic technique."	Same as PredicateBoth devices are intended for andindicated for the use in holdingadmixture fluids/IV solutions for thesubsequent administration/ transfer ofthe IV solutions from the container toan external IV administration set/line, working in combination,complementarily, applying aseptictechnique
Product code andregulation number	KPE,21 CFR 880.5025	KPE,21 CFR 880.5025	Same as Predicate
Intended userpopulation/intended useenvironment	Adequately trainedhealth care professionals orpharmacists,clinical setting	Adequately trainedhealth care professionals orpharmacists,clinical setting	Same as Predicate
IV drugcomponent bagcomponents/ accesscomponents	Empty EVA Bag, has 2 access points:1. Additive port/ filling port2. Spiking/ administration port, IVspike bag access for IV set/ IV line	eZSURETM EFC, has 2 accesspoints:1. Additive port/ filling port2. Spiking/administration port,IV spike bag access for IVset/ 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 DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURETMEmpty Fluid Container(EFC)(K223674)	Comment/Discussion
Principles of operation	The empty bags are filled by connectingto containers containing one or moresolutions, e.g., through standardsyringes or automated filling devicesAfter filling, the bags are clamped tosecure the contents prior toadministration.IV set/ IV line is attached through thespiking/ administration port todispense IV therapy using a standardspike and tubing	The empty bags are filled byconnecting to containerscontaining one or moresolutions, e.g., throughstandard syringes (withoutneedle) or automated fillingdevicesThe additive port is a self-sealing needle- free femaleluer lock connector, nodifferent from standardinjection site devices ofmarket-cleared IV sets.Silicone valve of the additiveport self- seals/ re-seals whenmating component devicesare disconnected from oneanotherIV set/ IV line is attachedthrough the spiking/administration port to dispenseIV therapy using a standardspike and tubing	Different, but Substantially Equivalentto Predicate:Both the Subject device and thePredicate device comprise two ports –the additive port and the spiking/administration port. Both the Subjectdevices and Predicate devices arebulk-filled by the user through theadditive port. Subject devices allowadditional-filling through the additiveport, whereas the additive/ filling porton the Predicate device is designed tobe used to filled once and clampedwith inviolable clamp after fillingBoth the Subject device and Predicatedevice comprise a spiking/administration port to connect an IVadministration set/ line for thedelivery of IV therapy to the patientBoth the Subject and Predicate devicesprovide a mechanism for safe fillingof the bag and the administration ofIV therapy to the patient using an IVadministration set/ line. Performancetesting of the subject devicedemonstrates that the differences donot raise new or different questions ofsafety and effectiveness.
Parameter compared	Predicate DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURE™Empty Fluid Container(EFC)(K223674)	Comment/ Discussion
Technology and design	The EVA bag device includes anadministration port and an additiveport. The administration portprovides a connection to the IV set/line. The additive port is a connectorby which medications can be added tothe bag/ container using themedication port before IVadministration. A capsule closes themedication port after use. The bags/containers are clamped after filling bythe means of inviolable clampsAn IV set/ IV line is connected to thefluid container/ bag to dispense IVtherapy	The EFC device includes anadministration port and anadditive port. Theadministration port provides aconnection to the IV set/ line.The additive port, a needle-freefemale luer lock connector,like the injection sites of othermarket- cleared IV sets, allowsfor medication(s) to be addedto the bag/container prior toand during IV administration.Silicone valve of the additiveport self-seals/ re- seals whenmating component devices aredisconnected from one anotherAn IV set/ IV line is connectedto the fluid container/ bag todispense IV therapy	Different, but Equivalent to Predicate:Though a difference in securing thefluid container content after beingfilled – silicone valve of the sterileadditive port self-seals/ re-seals whenmating component devices aredisconnected from one another in thecase of the Subject device. Thiscontrasts with the Predicate device inwhich the user clamps the port afterfilling by means of an inviolableclamp.Performance testing of the subjectdevice demonstrates that thedifferences do not raise new ordifferent questions of safety andeffectiveness.
Technology and design	The bag is manufactured by welding aplastic attachment to the bag body andassembling the bottom with entry andexit connectors/ ports	The bag is manufactured bywelding a plastic attachment tothe bag body and assemblingthe bottom with entry and exitconnectors/ ports	Same as Predicate
Parameter compared	Predicate DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURE™Empty Fluid Container(EFC)(K223674)	Comment/ Discussion
Materialof empty fluidcontainer body	Ethylene-vinyl acetate (EVA)	Sealed Air Corp'sMedical Packaging Film, Nexcel®Film,Grade M315, Polyolefin	Different, but Substantially Equivalentto Predicate:Though a difference in the materialused to build the fluid container mainbody exists, it did not raise additionalquestions of safety or of performanceeffectiveness. This is because bothmaterials are highly transparent clear,flexible plastic film formulated for itsintended use as primary medical filmfor bag body of medical IV bags -free of PVC, plasticizers, adhesives,latex - that could potentially leachinto certain solutions, and both aresuitable for EO sterilizationPerformance, shelf life, andbiocompatibility testing of the subjectdevice demonstrates that the differencesdo not raise new or different questions ofsafety and effectiveness.
Materials of additive/filling port	Polyisoprene, PolypropyleneAcrylonitrile Butadiene Styrene	Polypropylene PolycarbonateLiquid Silicone Rubber	Different, but Substantially Equivalentto Predicate:Though a difference in the materialsused for the additive port exists, it didnot raise additional questions ofsafety or of performanceeffectiveness.The valve material, Silicone, QP1-30, isan USP (U.S. Pharmacopoeia) classVI elastomer silicone rubber that doesnot contain phthalates nor latex.
Parameter compared	Predicate DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURE™Empty Fluid Container(EFC)(K223674)	Comment/ Discussion
			additives. It is recommended formedical devices including thoseimplanted in humans for less than 30days besides non-implant applicationsPerformance, shelf life, andbiocompatibility testing of the subjectdevice demonstrates that thedifferences do not raise new ordifferent questions of safety andeffectiveness.
Material of spiking/administration port	PVC not made with DEHP	Thermoplastic elastomer	Different, but Equivalent to Predicate.:Though a difference in the materialsused for the spiking/ administrationport exists, it did not raise additionalquestions of safety or of performanceeffectiveness. This is becauseeZSURE™ EFC does not use PVC, noteven those not made with plasticizerDEHP - that could potentially leachinto certain solutions.Performance, shelf life, andbiocompatibility testing of the subjectdevice demonstrates that thedifferences do not raise new ordifferent questions of safety andeffectiveness.
Biocompatibility	Acceptable biological risks established bydemonstrating thatthe device meets ISO 10993-1	Acceptable biological risksestablished by demonstratingthat 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 DeviceEmpty EVA Bag(K181393)	Subject DeviceeZSURETMEmpty Fluid Container(EFC)(K223674)	Comment/ Discussion
Shelf life	3 years (36 months)	5 years	Different, but Equivalent to Predicate:Device performance and shelf-lifetesting of the subject devicedemonstrates that the differences do notraise new or different questions ofsafety and effectiveness.
Reuse or single-use	Single-use only	Single-use only	Same as Predicate
Primary package top web	Medical grade paper and medicalplastic film, heat sealed	Medical grade paper andmedical plastic film, heat sealed	Same as Predicate

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@DIC

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GDIC

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집 1 C

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@DIC

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GDIC

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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 <151>, Pyrogen test (USP rabbit test)
- USP-NF <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests
- USP-NF <85>, Bacterial Endotoxins Test ●

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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 <788> 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.

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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.

Regulation Number and Section

§ 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).