(30 days)
No
The description focuses on mechanical features and performance related to containment and sterility, with no mention of AI or ML.
No
The device is a component of a Closed System Drug Transfer Device (CSTD) that minimizes exposure to hazardous drugs and prevents microbial contamination. It does not directly provide therapy to a patient.
No.
The device is described as a component of a Closed System Drug Transfer Device (CSTD) that mechanically prohibits environmental contaminants and the escape of drug/vapor concentrations, and prevents microbial contamination. Its function is to facilitate the injection and infusion of IV fluids and drug solutions and minimize exposure to contaminants and drug vapors, not to diagnose a condition or disease.
No
The device description clearly states it is a physical component ("part of the ProSeal™ Closed System drug Transfer Device (CSTD)") with physical features (Luer lock connector, IV bag spike) and undergoes bench performance verifications and validations related to physical properties (airtightness, tensile strength, spike penetration force, etc.).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a component of a Closed System Drug Transfer Device (CSTD) system used for injecting and infusing IV fluids and drug solutions. This is a drug delivery and handling function, not a diagnostic one.
- Device Description: The description focuses on the mechanical aspects of preventing contamination and exposure during drug transfer. It mentions compatibility with IV bags and Luer connectors, all related to drug administration.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide information about a patient's health status or disease.
- Performance Studies: The performance studies listed are related to the physical integrity, containment, and microbial ingress of the device, which are relevant to drug handling and administration, not diagnostic testing.
In Vitro Diagnostic devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not perform any such function.
N/A
Intended Use / Indications for Use
The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
Product codes
ONB
Device Description
The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).
This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.
The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).
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
health care professionals including 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 Subject device in this Summary was evaluated to be in conformance with the following ISO and FDA recognized standards, and FDA guidance document:
- ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated . into medical devices for intravascular applications
- ISO 8536-4: 019, Infusion equipment for medical use Part 4: Infusion sets for single use, ● gravity feed
- ISO 15747: 2018, Plastic containers for intravenous injections ●
- ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
- ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -● Part 7, Connectors for intravascular or hypodermic application
- . NIOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
- . Intravascular-Administration-Sets-Premarket-Notifications-[510(k)]---Guidancefor-Industry-and-FDA-Staff
Bench performance verifications and validations referred-to and performed:
- Airtightness & water leak integrity tests (functional) per ISO 8536-4:2019, paragraph 7.2 and ● Annex 3, performed on Subject device
- Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject device
- . Spike penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject device
- Spike protective cap tests (functional) per ISO 8536-4:2019, Section 7.13, performed on ● Subject device
- Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data . on the Subject device's NFV (LAV) connector
- . Microbial ingress test per FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 (functional) from testing data on device cleared under K223674/S001
B. Biocompatibility
In accordance with ISO 10993-1:2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on devices cleared under K151650,K223674/S001:
- Cytotoxicity to ISO 10993-5 ●
- Sensitization to ISO 10993-10 ●
- . Intracutaneous Reactivity to ISO 10993-10
- Acute Systemic Toxicity to ISO 10993-11 ●
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 ●
- In-vitro Hemolysis Assessment to ISO 10993-4
- Material Mediated Pyrogenicity to ISO 10993-11
- . Chemical Requirements to ISO 15747, Annex B on device under K223674
- Chemical Characterization and Toxicological Risk Assessment under K151650 .
Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP Particulate Matter in Injections.
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 and the following testing/ evaluations conducted on devices cleared under K222929;
- Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing ● of Shipping Containers and Systems
- Package Integrity Tests per ASTM F1980-21, 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: Dye Penetration - ASTM F1929-23. 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 and testing will be conducted on every lot
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K223674, K241442, K240433, K151650, K222929
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
January 22, 2025
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" surrounding a graphic. To the right of the seal, there is a blue square with the letters "FDA" in white. Next to the blue square, the text "U.S. FOOD & DRUG ADMINISTRATION" is written in blue.
Epic Medical Pte. Ltd. Freddie Lee CEO/MD 105 Cecil Street #20-04, The Octagon Singapore, SG 069534 Singapore
Re: K243976
Trade/Device Name: ZeroClear™ Bag Access (423100) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: December 20, 2024 Received: December 23, 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"
1
(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).
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 OS 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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).
2
Sincerely,
Daniel Walloschek
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
Enclosure
3
Indications for Use
510(k) Number (if known) K243976
Device Name ZeroClear™ Bag Access (423100)
Indications for Use (Describe)
The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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4
으킨 미
K243976- 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: December 20, 2024 Content and Format: Prepared in accordance with 21 CFR 807.92 Type of Submission: Special
II. Subject Device
| 510(k) Number: | K243976 |
|---|---|
| Trade/ Device Name: | ZeroClearTM Bag Access |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and |
| Transfer System | |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |
Predicate III.
| 510(k) Number: | K241988 |
|---|---|
| Trade/ Device Name: | ProSeal™ Closed System Bag Access |
| Common/ Usual Name: | Closed Antineoplastic and Hazardous Drug Reconstitution and |
| Transfer System | |
| Regulation Number: | 21 CFR 880.5440 |
| Regulation Name: | Intravascular administration set |
| Regulatory Class: | Class: II |
| Product Code: | ONB |
5
IV. Device Description
The ZeroClear" Bag Access is a part of the ProSeal™ Closed System drug Transfer Device (CSTD), used for injecting and infusing IV fluids and drug solutions from a standard IV bag to a patient. It features a bi-directional Luer lock connector, compatible with ISO 80369-7:2021 male Luer connectors and an ISO 8536-4:2019 compliant IV bag spike, including the applicant's eZSURE™ Empty Fluid Container (cleared K223674) and eZSURE™ Empty Fluid Container with ProSeal™ Injection Site (cleared K241442).
This sterile, single-use device used with the appropriate connecting devices, ensures dry connections, minimizes exposure to contaminants and drug vapors, and reduces microbial ingress for up to 7 days. It is intended for use by health care professionals in clinical settings for handling hazardous drugs.
The Subject device will be a part of a grouping of currently, twelve (12) cleared component device offerings, to the ProSeal™ CSTD system together with Epic Medical's most recently FDA cleared CSTD devices (K241988).
V. Indications for Use Statement
The ZeroClear™ Bag Access is a component of the ProSeal™ Closed System drug Transfer Device (CSTD) system. The ProSeal™ CSTD mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
VI. Comparison of Intended Use & Technological Characteristics
The Subject device and the Predicate device share the following characteristics:
Intended Use comparison
-
- Indications for use statements (similar)
-
- Intended drug type
- Single use or reusable, single patient use
-
- Primary product code and regulation number
-
- Intended user population/ intended use environment
Technological characteristics comparison Equivalencies - Technology & Design
The ZeroClear™ Bag Access and the Predicate device share the following design characteristics, and from the evaluation in the comparison table, there was no substantial difference from the Predicate device identified, that would raise a different question:
-
- Principles of operation
-
- Number of access points
-
- Sterilization process
-
- Shelf-life
-
- Sterile barrier packaging
6
GDIC
An overview table summarizing the comparison between the key characteristics between the Subject and the Predicate device is provided hereunder.
| Characteristic
compared | Predicate Device (K241988)
ProSeal™ Closed System Bag Access | Subject Device (K243976)
ZeroClear™ Bag Access | Comment/
Discussion |
|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------|
| Intended use
and
Indications for Use
statement | "The ProSeal™ Closed System drug Transfer Device
(CSTD) mechanically prohibits environmental
contaminants from entering the system and the
escape of drug or vapor concentrations from the
system, thereby minimizing individual and
environmental exposure to drug vapor, aerosols,
and spills. The ProSeal™ system also prevents the
introduction of microbial contaminations into the
drug or fluid path for up to 7 days when used as
intended." | "The ZeroClear™ Bag Access is a component of the
ProSeal™ Closed System drug Transfer Device
(CSTD) system. The ProSeal™ CSTD mechanically
prohibits environmental contaminants from entering
the system and the escape of drug or vapor
concentrations from the system, thereby minimizing
individual and environmental exposure to drug vapor,
aerosols, and spills. The ProSeal™ system also
prevents the introduction of microbial contaminations
into the drug or fluid path for up to 7 days when used
as intended." | Similar,
Subject component
device's brand name
ZeroClear™ is
included in the IFU
statement |
| Primary product code
and regulation number | ONB
21 CFR 880.5440 | ONB
21 CFR 880.5440 | Same |
| Intended user
population/ intended use
environment | Adequately trained
health care professionals including pharmacists/
clinical setting | Adequately trained
health care professionals including pharmacists/
clinical setting | Same |
| Intended drug type | Parenteral drugs | Parenteral drugs | Same |
| Single use or reusable | Single use only, single patient use | Single use only, single patient use | Same |
| Principles
of operation | The infusion bag is connected with the bag
access and, in order to create a fluid path
connection between the infusion bag and the
bag access, they are connected with a
matching component device incorporated with
a compatible connector.
All system components when connected, are
sealed airtight and leakage-proof during the
fluid transfer process. Transfer is performed
through the connection of a matching
component device incorporated with a
compatible connector, for dispensing into the
human veins. | The infusion bag is connected with the bag access
and, in order to create a fluid path connection
between the infusion bag and the bag access, they
are connected with a matching component device
incorporated with a compatible connector.
All system components when connected, are sealed
airtight and leakage-proof during the fluid
transfer process. Transfer is performed through
the connection of a matching component device
incorporated with a compatible connector, for
dispensing into the human veins. | Same |
| Characteristic
compared | Predicate Device (K241988)
ProSeal™ Closed System Bag Access | Subject Device (K243976)
ZeroClear™ Bag Access | Comment/
Discussion |
| Number
of access points | Device has 2 access points:
- Spiking/ administration port, IV spike bag
access - Injection port/administration port, medication
access | Device has 2 access points: - Spiking/ administration port, IV spike bag
access - Injection port/administration port, medication
access | Same |
| Composition
of fluid path materials | Spike material: Polypropylene (PP)
Medication port material: polyisoprene (IR)
and polypropylene (PP) | Spike material: Acrylonitrile Butadiene Styrene
( (ABS) )
Medication port material: acrylonitrile
butadiene styrene, polycarbonate, and silicone | Different,
See Comment #1 |
| Intended
connector type to be
used with the bag spike
adapter | Its ProSeal™ Injection Site port is intended
to be connected to Epic Medical Pte Ltd
manufacturer's cleared ProSeal™ Injector
or Injector Plus (K240433) male Luer lock
tip, connected to an external standard
MLL syringe | The needle-free Luer activated valve port is
directly connected to a component device
incorporated with a standard male Luer
connector e.g. syringe without needle that
complies with ISO 80389-7:2021 | Different,
See Comment #1 |
| Sterile barrier packaging | Medical grade paper and
medical plastic film, heat sealed | Medical grade paper and
medical plastic film, heat sealed | Same |
| Sterilization process | Ethylene Oxide (EO), SAL 10-6 | Ethylene Oxide (EO), SAL 10-6 | Same |
| Shelf-life validation | 3 years (36 months) | 3 years (36 months) | Same |
7
Discussion of difference in technological characteristics
Comment #1
Though the Subject device's bag spice and materials differ from the Predicat, the spile is of the same material the same subcomponents of the same materials) as the incorporated LAV in the cleared eZSURE " Empty Fluid Container (K223674). The materials of the spike and the LAV subasemby's subcomponents are with their corresponding cleared devices in formulation, processing, sterlization, and geometry. Pocessing is performed at the same modely processes at our US HDA registered establishment - Epo international (Thailand) Co. Ltd. - and no other chemicals are being additives, cleaning agents, mold release agents,
Functional tests, viz. the microbial ingress test per the ANSI AAM CN27:2021 and the ISO 80369-7:2021 had been conducted on the cleared device (K223674/800); and the leak megnty test per 130 8536-4:2019 had also been performed on the Subject device. Vapor contament test to NOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy and Administration of Hazardous Drugs had also been conducted for the Subject device 's the difference was considered and addressed in the vertication testing of the Subject device over its shelf life, to the aforementioned standards, and found it did not raise any new or different questions, its safety and effectiveness are assured.
8
VIL. Performance Data Supporting Substantial Equivalence
A. Functional Performance
The Subject device in this Summary was evaluated to be in conformance with the following ISO and FDA recognized standards, and FDA guidance document:
- ANSI AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated . into medical devices for intravascular applications
- ISO 8536-4: 019, Infusion equipment for medical use Part 4: Infusion sets for single use, ● gravity feed
- ISO 15747: 2018, Plastic containers for intravenous injections ●
- ISO 22413:2010, Transfer sets for pharmaceutical preparations Requirements and test ● methods
- ISO 80369-7: 2016, Small-bore connectors for liquids and gases in healthcare application -● Part 7, Connectors for intravascular or hypodermic application
- . NIOSH 2016, Performance Test (draft) Protocol for Closed System Transfer Devices Used During Pharmacy Compounding and Administration of Hazardous Drugs
- . Intravascular-Administration-Sets-Premarket-Notifications-[510(k)]---Guidancefor-Industry-and-FDA-Staff
Bench performance verifications and validations referred-to and performed:
- Airtightness & water leak integrity tests (functional) per ISO 8536-4:2019, paragraph 7.2 and ● Annex 3, performed on Subject device
- Tensile strength test (functional) per ISO 8536-4:2019, paragraph 7.3 and Annex A.4, . performed on Subject device
- . Spike penetration force test (functional) - per ISO 22413:2021, Section 6.6, Annex A.7, performed on Subject device
- Spike protective cap tests (functional) per ISO 8536-4:2019, Section 7.13, performed on ● Subject device
- Vapor containment test per NIOSH CSTD 2016 draft test protocol (functional) from testing data . on the Subject device's NFV (LAV) connector
- . Microbial ingress test per FDA guidance, ANSI AAMI CN27:2021 and ISO 80369-7:2021 (functional) from testing data on device cleared under K223674/S001
- B. Biocompatibility
In accordance with ISO 10993-1:2018, the Subject device just like the existing ProSeal™ CSTD devices, is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24hr to 30d). The following testing were performed on devices cleared under K151650,K223674/S001:
- Cytotoxicity to ISO 10993-5 ●
- Sensitization to ISO 10993-10 ●
- . Intracutaneous Reactivity to ISO 10993-10
- Acute Systemic Toxicity to ISO 10993-11 ●
- 14-day Subacute/ Subchronic Acute Systemic Toxicity to ISO 10993-11 under K223674 ●
- In-vitro Hemolysis Assessment to ISO 10993-4
- Material Mediated Pyrogenicity to ISO 10993-11
- . Chemical Requirements to ISO 15747, Annex B on device under K223674
- Chemical Characterization and Toxicological Risk Assessment under K151650 .
9
다. 이 대
Particulate matter testing was conducted on the Subject device, in accordance with ISO 8536-4: 2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed and USP Particulate Matter in Injections.
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 and the following testing/ evaluations conducted on devices cleared under K222929;
- Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing ● of Shipping Containers and Systems
- Package Integrity Tests per ASTM F1980-21, 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: Dye Penetration - ASTM F1929-23. 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 and testing will be conducted on every lot
- Shelf-life of 3 years has been validated using the FDA recognized standard, ASTM 1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
VIII. Clinical Tests
Not applicable.
IX. Conclusion
The difference between the Predicate and the Subject device does not raise any new or different questions of safety or effectiveness. The Subject device - ZeroClear™ Bag Access - is substantially equivalent to the Predicate device, ProSeal™ Closed System Bag Access (K241988) - with respect to its indications for use, principles of operation and technological characteristics.