(30 days)
No
The device is a simple empty fluid container for IV administration and the description focuses on its physical properties, materials, and ports. There is no mention of any computational or analytical capabilities.
No.
Explanation: The device is described as an "Empty Fluid Container" used to hold an admixture of fluids for intravenous administration. It does not exert any therapeutic action on the patient but rather serves as a containment and delivery system for therapeutic agents. Its function is to facilitate the administration of medication, not to directly treat a condition.
No
Explanation: The device is described as an "Empty Fluid Container" used to hold an admixture of compatible fluids for intravenous administration. Its function is to contain and facilitate the transfer of fluids, not to diagnose medical conditions or analyze patient health.
No
The device description clearly outlines a physical, single-use, sterile, nonpyrogenic flexible IV container/bag made of non-PVC materials with ports and integrated components. This 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 or monitor a condition.
- Device Description: The description details a flexible bag with ports for filling and administration of fluids. This aligns with a container for IV therapy, not a device for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes (markers of disease, etc.)
- Providing information for diagnosis, monitoring, or screening.
The device is clearly designed for the preparation and administration of intravenous fluids, which falls under the category of medical devices used for treatment, not diagnosis.
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, ONB
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 is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures.
A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.
The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system (K240433) as follows:
- A double membrane septum design utilizing self-sealing elastomeric membranes tightly fit together when the system components engage. A cannula within the ProSeal™ Injector (or ProSeal™ Injector Plus) housing perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environments into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination.
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 capacities of 100 mL, 250 mL, and 500 mL.
The EFC sub-components are externally communicating devices with no contact to the blood path. 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)
A. Functional Performance
The sterile, single-use, non-pyrogenic flexible IV container devices/ bags described in this Summary were evaluated to be in conformance with the following ISO and FDA recognized standards:
- ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ISO 15747: 2018, Plastic containers for intravenous injections
- ISO 22413: 2021, Transfer sets for pharmaceutical preparations – Requirements and test methods
Bench performance verifications and validations performed on the Subject device:
- Resistance to Temperature, Pressure and Leakage test to ISO 15747 on the Subject device
- Resistance to Dropping test to ISO 15747 on the Subject device
- Additive Port Liquid Tightness (Air and Liquid Leakages) test to ISO 15747 on the Subject device
- Impermeability to Microorganism test to ISO 15747 on the Subject device
The ProSeal™ Injection Site (cleared K240433) incorporated as the Subject device's integrated additive port, described in section IV in this Summary, and its IR membrane subcomponent part, were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards and FDA guidance document:
- ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -Part 7, Connectors for intravascular or hypodermic applications
- US FDA Guidance for Industry and FDA Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], Issued on July 11, 2008
Bench performance verifications and validations were performed on clearance of the ProSeal™ Injection Site, cleared under K240433 incorporated in the Subject device's additive port:
- Positive pressure fluid leakage test
- Sub-atmospheric pressure air leakage test
- Stress cracking test
- Resistance to separation from axial load test
- Resistance to unscrewing test
- Resistance to overriding
- Device leakage integrity test
- Vapor containment test per NIOSH 2016 draft protocol
- Microbial ingress test per FDA guidance and AAMI CN27: 2021
B. Biocompatibility
In accordance with ISO 10993-1:2018, the Subject device, just like the existing device, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to, from testing data on the existing devices, cleared, as listed hereunder:
- Cytotoxicity to ISO 10993-5 under K223674 & K240433
- Sensitization to ISO 10993-10 under K223674 & K240433
- Intracutaneous Reactivity to ISO 10993-10 under K223674 & K240433
- Acute Systemic Toxicity to ISO 10993-11 under K223674 & K240433
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 & K240433
- In-vitro Hemolysis Assessment to ISO 10993-4 under K223674 & K240433
- Material Mediated Pyrogenicity to ISO 10993-11 under K223674 & K240433
- Chemical Characterization & Toxicological Risk Assessment to ISO 10993-18 & ISO 10993-17 under K223674 & K240433
Particulate matter testing was conducted in accordance with ISO 15747: 2018, Plastic containers for intravenous injections and USP Particulate Matter in Injections.
C. Sterility, Shipping, and Shelf-Life
The Subject device, like the existing device cleared under K223674, complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide -Part I: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/ evaluations:
- Package Integrity Tests per ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration, 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
- Pyrogen Tests per ANSI/AAMI ST72/ 2019, Bacterial endotoxins Test methods, routing monitoring, and alternatives to batch testing, USP 40 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , Bacterial Endotoxins Test
- 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.
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 logos of the U.S. Food and Drug Administration (FDA) and the Department of Health & Human Services. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. The Department of Health & Human Services logo is a symbol with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" surrounding it.
June 21, 2024
Epic Medical Pte. Ltd. Freddie Lee CEO/md 105 Cecil Street #20-04, The Octagon Singapore, SG 069534 Singapore
Re: K241442
Trade/Device Name: eZSURE™ Empty Fluid Container with ProSeal™ Injection Site Regulation Number: 21 CFR 880.5025 Regulation Name: I.V. Container Regulatory Class: Class II Product Code: KPE, ONB Dated: May 22, 2024 Received: May 22, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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 Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K241442
Device Name
eZSURE™ Empty Fluid Container with ProSeal™ Injection Site
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
K241442 – 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: June 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special
II. Subject Device
| 510(k) Number: | K241442 |
|---|---|
| Proprietary/ | |
| Trade/ Device Name: | eZSURE™ Empty Fluid Container with ProSeal™ Injection Site |
| Common/Usual/Generic | |
| Name: | Empty I.V. bag |
| Classification Name/ | |
| Regulation Name: | I.V. container |
| Device Classification | |
| Regulation Number: | 21 CFR 880.5025 |
| Regulatory/ Device Class: | Class: II |
| Classification Product | |
| Code: | KPE (primary) and ONB (secondary) |
III. Predicate
| 510(k) Number: | K223674 |
|---|---|
| Proprietary/ | |
| Trade/ Device Name: | eZSURE™ Empty Fluid Container |
| (models 426030, 426040, 426110) | |
| Common/Usual/Generic | |
| Name: | Empty I.V. bag |
| Classification Name/ | |
| Regulation Name/ | |
| Description: | I.V. container |
| Device Classification | |
| Regulation Number: | 21 CFR 880.5025 |
| Classification Product | |
| Code: | KPE |
| Regulatory/ Device Class: | Class: II |
4
IV. Device Description
The purpose of this Special 510(k) Submission is to seek FDA clearance prior to the introduction in the US, of a modified design of the existing eZSURE™ Empty Fluid Container - the Subject eZSURE™ Empty Fluid Container with ProSeal™ Injection Site. This device is an addition to the ProSeal™ CSTD system of devices (cleared K240433). The existing device, and also the nominated Predicate device, is the eZSURE™ Empty Fluid Container (cleared K223674).
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 is made of non-PVC materials. The Nexcel Film for IV bag of the Subject EFC device is composed of a flexible plastic film bag and the device is provided in a two-port configuration with closures.
A closed system inlet-/ entry-/ additive- port is used for filling one or more compatible fluid(s) into the bag by a transfer set/ syringe without needle with the ProSeal™ Injector or ProSeal™ Injector Plus (cleared K240171) attached, and another port, the spiking/ administration port, is used for accessing the infusate in the bag with a standard bag spike in an IV therapy administration from the EFC. The transfer device with a male Luer lock attached with the ProSeal™ Injector (or ProSeal™ Injector Plus) is used to connect to the filling-/ additive- port for filling. The additive port incorporates a ProSeal™ Injection Site (cleared K240433) as its integrated subcomponent; hence no other injection needle/ cannula is needed. The transfer device is removed at the end of the preparation step, and the self-sealing additive-/ injection-/ filling- port secures the admixture contents until their administration.
The closed transfer of liquid that takes place with the use of the ProSeal™ CSTD system (K240433) as follows:
- · A double membrane septum design utilizing self-sealing elastomeric membranes tightly fit together when the system components engage. A cannula within the ProSeal™ Injector (or ProSeal™ Injector Plus) housing perforates the double membrane for the transfer of liquid. When the cannula is retracted, the membranes seal off the transfer of environments into the system and/or escape of drug or vapor concentrations outside the system, thereby minimizing the individual and environmental exposure to drug vapor, aerosols, and spills, and also minimizing the risk of microbial contamination.
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 capacities of 100 mL, 250 mL, and 500 mL.
The EFC sub-components are externally communicating devices with no contact to the blood path. Contact duration is categorized as B-prolonged, (>24h to 30d), per ISO 10993-1: 2018 biocompatibility guidelines.
5
집 미 I
The only modification proposed in this Submission is the change of the fill port design from the needle free valve to the ProSeal™ Injection Site (cleared K240433).
The modified and existing device have the same intended use, and the ProSeal™ Injection Site is a cleared CSTD component device (K220433). The principles of operation, indications for use statement, and the user-applications remain the same.
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 Subject device and the Predicate device share the following key characteristics:
- Same 2-port configuration an additive/ filling port and a spiking/ administration port ●
- Same basic design features clear, flexible, and empty IV fluid bag that allows for ● preparation and administration of IV therapies
- Same means of attachment provided for an IV administration set/ line, for the delivery of IV therapy
An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided from the next page.
6
| Characteristic
compared | Predicate Device
eZSURE™ Empty Fluid Container (K223674) | Subject Device
eZSURE™ Empty Fluid Container
with ProSeal™ Injection Site (K241442) | Comment/
Discussion |
|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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." | "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 |
| Primary product code
and regulation number | KPE
21 CFR 880.5025 | KPE
21 CFR 880.5025 | Same |
| 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 |
| IV bag
components/
access
components | Device has 2 access points:
- Additive port/ filling port
- Spiking/administration port, IV spike bag
access for IV set/ IV line | Device has 2 access points: - Additive port/ filling port
- Spiking/ administration port, IV spike bag
access for IV set/ IV line | Same |
| Characteristic
compared | Predicate Device
eZSURE™ Empty Fluid Container (K223674) | Subject Device
eZSURE™ Empty Fluid Container
with ProSeal™ Injection Site (K241442) | Comment/
Discussion |
| System
component
devices | 1. ProSeal™ Injector (model 421010) (K240433) - ProSeal™ Injector Plus (model 421050) (K240433)
- ProSeal™ Connector (model 422010) (K240433)
- ProSeal™ Injection Site Extended Male Luer
Lock (K240433) - ProSeal™ Vial Adaptor (3 models 4200X0,
for options of vial neck sizes and pressure
equalizations) (K240433) - ToxiSeal™ Vial Adaptor with External
Balloon (K222929) - ProSeal™ Assembly Fixture (Fixture for
ProSeal™ Vial Adaptor assembly, model
- ProSeal™ Injector Plus (model 421050) (K240433)
- ProSeal™ Connector (422010) (K240433)
- ProSeal™ Injection Site Extended Male Luer Lock (K240433)
- ProSeal™ Vial Adaptor (3 models 4200X0, for options of vial neck sizes and pressure equalizations) K240433)
- ToxiSeal™ Vial Adaptor with External Balloon (K222929)
- ProSeal™ Assembly Fixture (Fixture for ProSeal™ Vial Adaptor assembly, model 424010) (K240433)
- eZSURE™ Empty Fluid Container with ProSeal™ Injection Site ((K241442) the Subject device) | Different
The Subject system
component device
(#8 in the column
Subject Device), is
an addition to the
existing seven (7)
component devices
of ProSeal™ CSTD
(K240433) and the
ToxiSeal™ Vial
Adaptor with
External Balloon
(K222929), indicate
in bold face texts .
Differences are
addressed in
Discussion of
differences in
technological
characteristics:
Comments #1 and #2
under this table, on
page 8. |
| Intended
drug type | Parenteral drugs | Parenteral drugs | Same |
| R/
Prescription use | R only | R only | Same |
| Characteristic
compared | Predicate Device
eZSURE™ Empty Fluid Container (K223674) | Subject Device
eZSURE™ Empty Fluid Container
with ProSeal™ Injection Site (K241442) | Comment/
Discussion |
| Principles
of operation | The empty bags are filled by connecting
transfer devices, e.g., through standard
male Luer lock 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
Image: Filling Port and Spiking port with protective cap | The empty bags are filled by connecting
transfer devices, e.g., through standard
male Luer lock syringes (without needle)
or automated filling devices, attached to
the ProSeal™ Injector (or the ProSeal™
Injector Plus)
The additive port is a self-sealing closed
system ProSeal™ Injection Site.
Membrane of the additive port self-seals/
re-seals when mating component devices
are disconnected from one another
Image: Filling Port and Spiking port with protective cap | Different
See Comment #1 |
| | IV set/ IV line is attached through the
spiking/ administration port to dispense IV
therapy using a standard spike and tubing | IV set/ IV line is attached through the
spiking/ administration port to dispense IV
therapy using a standard spike and tubing | Same |
| 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 |
| Material
of empty fluid
container body | Sealed Air Corp's Medical Packaging Film,
Nexcel® Film, Grade M315, Polyolefin | Sealed Air Corp's Medical Packaging Film,
Nexcel® Film, Grade M315, Polyolefin | Same |
| Characteristic
compared | Predicate Device
eZSURE™ Empty Fluid Container (K223674) | Subject Device
eZSURE™ Empty Fluid Container
with ProSeal™ Injection Site (K241442) | Comment/
Discussion |
| Material of
additive filling port | Polypropylene, Polycarbonate,
Liquid Silicone Rubber | Polypropylene, Polyisoprene Rubber (IR) | Different
See Comment #1 |
| Material of spiking/
administration port | Thermoplastic elastomer | Thermoplastic elastomer | Same |
| Intended Injector for
filling the empty fluid
container | ProSeal™ Injector (model 421010)
(cleared K192075)
Male Luer Lock tip | ProSeal™ Injector (model 421010) or
ProSeal™ Injector Plus (model 421050) (cleared
K241071)
both Male Luer Lock tip | Different
See Comment #2 |
| Primary
package top web | Medical grade paper and
medical plastic film, heat sealed | Medical grade paper and
medical plastic film, heat sealed | Same |
| Sterilization method | Ethylene Oxide, EO, SAL 10-6 | Ethylene Oxide, EO, SAL 10-6 | Same |
| Validated
Shelf life | 3 years (36 months) | 3 years (36 months) | Same |
| Reuse
or single-use | Single-use only | Single-use only | Same |
| Labeling
specifications | Meets the requirements
specified in 21 CFR 801 | Meets the requirements
specified in 21 CFR 801 | Same |
7
8
집 1 C
9
10
Discussion of differences in technological characteristics
Comment #1
The membrane material of Subject device's closed system ProSeal™ Injection Site Extended Male Luer Lock (model 422140) (ProSeal™ Injection Site) is made of polyisoprene rubber (IR), the same as the IR present in Epic Medical Pte Ltd's cleared K240433, ProSeal™ Injection Site, in the same design configuration and it had been biologically evaluated to have conformed with ISO 10993-1: 2018. Therefore, biocompatibility testing was leveraged from K240433. Moreover, the functional performance of the assembled ProSeal™ Injection Site in the Subject device, had been adequately evaluated and as such, performance testing was leveraged form K240443. In additional bench top performance verification testing of the subject device over the shelf life was conducted to the standards listed in section VII.A second paragraph, hereunder, to demonstrate that the difference in technological characteristics do not raise different questions of safety and effectiveness.
Comment #2
The 2024-03-28 cleared ProSeal™ Injector Plus (cleared K240171), a modified version of ProSeal™ Injector, is another option of an Injector available for users to use with the Subject Emptv Fluid Container devices. This difference does not raise new questions of safety and effectiveness of the Subject device.
VII. Performance Data Supporting Substantial Equivalence
A. Functional Performance
The sterile, single-use, non-pyrogenic flexible IV container devices/ bags described in this Summary were evaluated to be in conformance with the following ISO and FDA recognized standards:
- ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- ISO 15747: 2018, Plastic containers for intravenous injections ●
- . ISO 22413: 2021, Transfer sets for pharmaceutical preparations – Requirements and test methods
Bench performance verifications and validations performed on the Subject device:
- Resistance to Temperature, Pressure and Leakage test to ISO 15747 on the Subject device ●
- Resistance to Dropping test to ISO 15747 on the Subject device ●
- . Additive Port Liquid Tightness (Air and Liquid Leakages) test to ISO 15747 on the Subject device
- Impermeability to Microorganism test to ISO 15747 on the Subject device ●
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The ProSeal™ Injection Site (cleared K240433) incorporated as the Subject device's integrated additive port, described in section IV in this Summary, and its IR membrane subcomponent part, were tested and demonstrated to be in conformance with the following ISO and FDA recognized standards and FDA guidance document:
- ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
- . ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -Part 7, Connectors for intravascular or hypodermic applications
- . US FDA Guidance for Industry and FDA Staff, Intravascular Administration Sets Premarket Notification Submissions [510(k)], Issued on July 11, 2008
Bench performance verifications and validations were performed on clearance of the ProSeal™ Injection Site, cleared under K240433 incorporated in the Subject device's additive port:
- Positive pressure fluid leakage test
- Sub-atmospheric pressure air leakage test .
- Stress cracking test
- Resistance to separation from axial load test ●
- . Resistance to separation from unscrewing test
- . Resistance to overriding
- . Device leakage integrity test
- Vapor containment test per NIOSH 2016 draft protocol ●
- Microbial ingress test per FDA guidance and AAMI CN27: 2021 ●
- B. Biocompatibility
In accordance with ISO 10993-1:2018, the Subject device, just like the existing device, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing are referred to, from testing data on the existing devices, cleared, as listed hereunder :
- Cytotoxicity to ISO 10993-5 under K223674 & K240433 ●
- Sensitization to ISO 10993-10 under K223674 & K240433 ●
- Intracutaneous Reactivity to ISO 10993-10 under K223674 & K240433 .
- Acute Systemic Toxicity to ISO 10993-11 under K223674 & K240433 ●
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 & . K240433
- . In-vitro Hemolysis Assessment to ISO 10993-4 under K223674 & K240433
- Material Mediated Pyrogenicity to ISO 10993-11 under K223674 & K240433 .
- Chemical Characterization & Toxicological Risk Assessment to ISO 10993-18 & ISO 10993-17 . under K223674 & K240433
Particulate matter testing was conducted in accordance with ISO 15747: 2018, Plastic containers for intravenous injections and USP Particulate Matter in Injections.
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C. Sterility, Shipping, and Shelf-Life
The Subject device, like the existing device cleared under K223674, complies with sterilization requirements of ISO 11135:2014, Sterilization of Health Care Products - Ethylene Oxide -Part I: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices and the following testing/ evaluations: -
Package Integrity Tests per ASTM F1980-16, Standard guide for accelerated aging of sterile barrier systems for medical devices and Sterile Barrier Packaging Testing performed on the proposed device: Seal strength – ASTM F88/F88M-21, Standard test method for seal strength of flexible barrier materials, ASTM F1929-15, Standard test method for detecting seal leaks in porous medical device packaging by dye penetration, 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
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Pyrogen Tests per ANSI/AAMI ST72/ 2019, Bacterial endotoxins Test methods, routing ● monitoring, and alternatives to batch testing, USP 40 , Pyrogen test (USP rabbit test), USP-NF , Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP-NF , Bacterial Endotoxins Test
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. 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.
VIII. Clinical Tests
Not applicable.
IX. Conclusion
The differences between the Predicate and the Subject device do not raise any new or different questions of safety or effectiveness. The Subject, eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (fill port) is substantially equivalent to the Predicate, the eZSURE™ Empty Fluid Container (with needle-free valve fill port), with respect to the indications for use, principles of operation and technological characteristics.