The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

Device Description

The EZ™ IV Administration Set is a gravity, single use, disposable, intravenous administration set designed to deliver fluids from a container into a patient's vascular system. The device includes a vented bag spike (air vent 0.1µm) integrated to a drip chamber (not made with DEHP*) featuring a 5-μm particulate filter, a roller clamp, flexible IV tubing (not made with DEHP*), and one (1), two (2) or three (3) needle-free valve (NFV) Y-site connectors. It also features a Luer connector and a priming cap with a 3-μm filter.

The EZ™ IV Administration Set may be used in combination with standard IV therapy devices commonly used throughout the healthcare settings, such as bag spike, Luer lock adaptor, syringe (MLL) (without needle), and IV extension sets. It is configured to achieve the intended use when used with these standard complementary products.

*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the EZ™ IV Administration Set (K251814) describe the device's acceptance criteria and the studies conducted to demonstrate substantial equivalence to a predicate device. However, this document primarily focuses on demonstrating substantial equivalence rather than proving the device meets specific acceptance criteria for a novel device. It also describes a medical device rather than a software or AI-driven device, so several of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, training set details) are not applicable.

Here's an analysis based on the provided text, focusing on the available information:

Acceptance Criteria and Device Performance for EZ™ IV Administration Set (K251814)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the EZ™ IV Administration Set are primarily defined by adherence to recognized international and national standards for intravascular administration sets and specific functional performance metrics derived from these standards. The reported device performance indicates compliance with these standards.

Characteristic Compared	Acceptance Criteria (Standard Reference)	Reported Device Performance (Subject Device)
Performance Testing	Conformance with: - ISO 8536-4:2019 - ISO 22413:2021 - ISO 10993-1:2018 - ANSI/AAMI CN27:2021 - ISO 80369-7:2021 - ISO 80369-20:2015 - FDA Guidance for Intravascular Administration Sets	Comprehensive performance verification & validation testing performed; met the intended use.
Air-inlet device tests	ISO 8536-4:2019	Conformed to standard.
Flow rate test	ISO 8536-4:2019	Conformed to standard.
Piercing device penetration force test	ISO 22413:2021	Conformed to standard.
Protective cap removal test	ISO 8536-4:2019	Conformed to standard.
Drip chamber and drip tube tests	ISO 8536-4:2019	Conformed to standard.
Leak integrity tests	ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage)	Conformed to standard.
Tensile strength test	ISO 8536-4:2019	Conformed to standard.
Particulate contamination level	ISO 8536-4:2019, Annex A, A.2 USP <788> Particulate Matter in Injections	Met contamination index, N≤90. Conformed to standard.
Drops/mL	20 gtt/mL (as per Predicate)	20 gtt/mL
Tubing transparency	Sufficiently clear to observe air/water interface (normal/corrected vision)	Conformed to standard.
Connector type	External Fitting Male Luer Lock (ISO 80369-7:2021)	Conformed to standard.
Sterile barrier packaging	Medical grade paper and plastic film, heat sealed	Conformed to standard.
Sterilization process	Ethylene Oxide (EO), SAL 10⁻⁶	Ethylene Oxide (EO), SAL 10⁻⁶. Complies with ISO 11135:2014.
Shelf-life validation	3 years (36 months) via ASTM 1980-21	3 years (36 months) validated.
Biocompatibility	ISO 10993-1:2018 (Externally Communicating Device, Blood Path Indirect, Prolonged Contact) (Specific ISO 10993 parts for various tests)	Met biological safety specifications.
EO residues limits	ISO 10993-7:2008 & amendments	Conformed to standard.
Shipping	ASTM D 4169-16	Simulated shipping testing performed on K151650/S004.
Package integrity	ASTM F1980-21, ASTM F88/F88M-21, ASTM F1929-23, EN 868-5:2009	Testing performed on K151650.
Pyrogen tests	ANSI/AAMI ST72/2019, USP <151>, USP <161>, USP <85>	Testing performed on K151650 and "will be conducted on every lot."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: The document does not specify the exact sample sizes (number of devices/batches) used for each specific performance test mentioned (e.g., flow rate, leak integrity, tensile strength). The studies are focused on product characteristics and compliance with engineering standards, not clinical patient data.
Data Provenance: Not explicitly stated for each test. The submitter is "Epic Medical Pte. Ltd." based in Singapore, suggesting the testing data likely originated from or was managed by facilities associated with this company. The testing is for a medical device component, not a diagnostic algorithm, so there is no patient data involved in these performance tests.
Retrospective or Prospective: Not applicable, as these are engineering and materials performance tests conducted on the physical device itself.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this type of device submission. The "ground truth" here is defined by objective engineering specifications and international standards, rather than expert consensus on medical images or diagnoses. Qualification involves expertise in medical device testing, engineering, and regulatory compliance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective assessments, typically in clinical readings or evaluations where human interpretation introduces variability. These are objective physical and chemical tests on a medical device.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical medical device (IV administration set), not an AI-powered diagnostic tool, and therefore no MRMC studies were conducted or are relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance tests conducted on the EZ™ IV Administration Set is based on established international and national standards and their specific test methods and acceptance criteria. This includes standards like ISO 8536-4 for infusion sets, ISO 10993 for biocompatibility, and USP <788> for particulate matter. These standards provide objective, measurable criteria for device performance and safety.

8. The sample size for the training set

Not applicable. This pertains to the training of an algorithm or AI model. This submission is for a physical medical device.

9. How the ground truth for the training set was established

Not applicable. As above, this is for a physical medical device and does not involve a training set for an algorithm.

Summary of Study that Proves Device Meets Acceptance Criteria:

The study that proves the EZ™ IV Administration Set meets its acceptance criteria is a comprehensive set of performance verification and validation tests conducted on the subject device and, in some cases, leveraging data from the predicate device (K230343/S001) or an existing device (K151650 and K151650/S004).

These tests address:

Functional Performance: Evaluated against ISO 8536-4:2019, ISO 22413:2021, and FDA guidance documents, covering aspects like flow rate, leak integrity, piercing device penetration force, protective cap removal, drip chamber performance, and tensile strength.
Connection Integrity: Evaluated against ANSI/AAMI CN27:2021 (for luer-activated valves) and ISO 80369 series (for small-bore connectors like Luer lock).
Biocompatibility: Evaluated against ISO 10993 series (e.g., -5, -10, -11, -17, -18, -23) to assess cytotoxicity, sensitization, systemic toxicity, hemolysis, pyrogenicity, and chemical characterization. This classification was for "Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d)."
Sterility and Shelf-Life: Compliance with ISO 11135:2014 for Ethylene Oxide sterilization, ASTM D 4169-16 for shipping, and ASTM F1980-21 for accelerated aging (shelf-life validation of 3 years). Package integrity, pyrogen, and EO residue tests were also part of this.
Material Composition: Analysis and risk assessment were conducted given differences in materials between the subject and predicate devices, leveraging biocompatibility and chemical characterization data.

The submitter states that "All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device" and that the results "met the intended use." They explicitly noted for material and dimension differences that "analytical and functional testing were conducted" and "the results...demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant." This body of evidence constitutes the study proving the device meets its acceptance criteria, which are primarily compliance with the listed international and national standards.

Summary

FDA 510(k) Clearance Letter - EZ™ IV Administration Set

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

August 29, 2025

Epic Medical Pte. Ltd.
Freddie Lee
CEO/MD
105 Cecil Street #20-04, The Octagon
Singapore, SG 069534
Singapore

Re: K251814
Trade/Device Name: EZ™ IV Administration Set
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular administration set
Regulatory Class: Class II
Product Code: FPA
Dated: July 1, 2025
Received: July 1, 2025

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"

Page 2

K251814 - Freddie Lee Page 2

(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 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 (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-reporting-combination-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 Rule"). 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-advice-comprehensive-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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/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).

Page 3

K251814 - Freddie Lee Page 3

Sincerely,

David Wolloscheck -S

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

Page 4

FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K251814

Device Name: EZ™ IV Administration Set

Indications for Use (Describe):
The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 5

K251814 – 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: August 25, 2025
Content and Format: Prepared in accordance with 21 CFR 807.92
Type of Submission: Traditional 510(k)

II. Subject Device

Field	Value
510(k) Number:	K251814
Trade/ Device Name:	EZ™ IV Administration Set
Common/ Usual Name:	I.V. Administration Set
Regulation Number:	Set, Administration, Intravascular
Regulation Name:	21 CFR 880.5440
Regulatory Class:	Class: II
Product Code:	FPA

III. Predicate

Field	Value
510(k) Number:	K230343
Trade/ Device Name:	ProSeal™ Closed System Administration Set
Common/ Usual Name:	I.V. Administration Set
Regulation Number:	Set, Administration, Intravascular
Regulation Name:	21 CFR 880.5440
Regulatory Class:	Class: II
Product Code:	FPA

Page 6

IV. Purpose of Submission and Device Description

The EZ™ IV Administration Set, the Subject device in this Submission, is a modified series of IV Administration Set, adding to the existing IV Administration Set (cleared K230343). This addition further enhances the completeness of the portfolio of Epic Medical Pte. Ltd.'s IV Administration Sets.

*DEHP – Di (2-ethylhexyl) phthalate (DEHP), a plasticizer to make PVC soft and flexible. It is a substance known to cause cancer or reproductive toxicity.

V. Indications for Use Statement

The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.

VI. Comparison of Intended Use & Technological Characteristics

The Subject device, EZ™ IV Administration Set, and the Predicate device, ProSeal™ Closed System Administration Set, share the same intended use and exhibit comparable technological characteristics. A summary of these similarities is provided below:

A. Intended Use Comparison

There are no differences between the Subject and Predicate devices that would alter their overall intended use. Both devices are intravenous administration sets intended for the delivery of medications and fluids from a container into a patient's vascular system. The following aspects are equivalent:

Indications for Use statements
Primary product code and regulation number
Intended user population/intended use environment
Intended drug type
Prescription status (℞ only)
Mode of IV fluid therapy delivery (gravity-based)

B. Technological Characteristics Comparison

Equivalencies – Technology & Design

The EZ™ IV Administration Set and the Predicate device share the following design characteristics:

Performance testing (including functional evaluation)
Tubing transparency
Drops factor (drops/mL)
Connector type at distal end (Luer lock)
Particulate contamination level
Sterile barrier packaging
Sterilization process
Shelf-life validation
Single-use designation
Labeling specifications (in accordance with 21 CFR 801)

C. Summary

i. No substantial differences were identified that would raise new questions of safety or effectiveness. The Subject device maintains the same intended use and fundamental technological characteristics as the Predicate device. A detailed comparison table is provided below, with additional context and comments included in the Submitter's Comments section.

Page 7

Comparison of intended use characteristics and the technological characteristics

Characteristic compared	Predicate Device (K230343) ProSeal™ Closed System Administration Set	Subject Device (K251814) EZ™ IV Administration Set
Intended use and Indications for Use statement	The Administration Sets are intravenous administration sets intended for delivery of medications and fluids from a container into a patient's vascular system.	Same
Primary product code and regulation number	FPA 21 CFR 880.5440	Same
Intended user population/ intended use environment	Adequately trained health care professionals/ clinical setting	Same
Intended drug type	Parenteral drugs	Same
Prescription use or over-the-counter use	℞ only	Same
Mode of IV fluid therapy delivery	Gravity administration	Same
Performance testing (including functional evaluation)	Met requirements of ISO 8536-4:2019, ISO 22413:2021, ISO 10993-1:2018, ANSI/AAMI CN27:2021, ISO 22413:2021, and Intravascular-Administration-Sets-Premarket-Notification-Submissions-[510(k)]---Guidance-for-Industry-and-FDA-Staff	Same

Page 8

Comparison of intended use characteristics and the technological characteristics (continued)

Characteristic compared	Predicate Device (K230343) ProSeal™ Closed System Administration Set	Subject Device (K251814) EZ™ IV Administration Set	Comment
Device construction Device final assembly	[Device diagram]	[Device diagram]	Different, see Comment #1
Bag spike or injector	Closed system injector	Integrated bag spike
Drip chamber and IV administration tubings	Present	Present
Check valve	Not present	Present
Needleless Y-site	Not present	Present
MLL connector and priming cap	Present	Present

Composition of fluid-path / -contacting materials:

Bag spike – Not present | Bag spike – Acrylonitrile butadiene styrene (ABS) | Different, see Comment #2
Injector – PP, SUS 304 Steel, TPE | Injector – Not present
IV tubing – PVC (not made with DEHP) | IV tubing – PVC (not made with DEHP)
Check valve – Not present | Check valve – ABS, silicone
MLL connector – ABS | MLL connector – ABS
Drip chamber – PVC (not made with DEHP), ABS, polyethylene terephthalate (PET) | Drip chamber – PVC (not made with DEHP), ABS, polyethylene terephthalate (PET)
Needleless Y-site – Not present | Needleless Y-site – PP, ABS, silicone
Priming cap – PP, Polytetrafluoroethylene (PTFE) | Priming cap – PP, Polytetrafluoroethylene (PTFE)

Page 9

Comparison of intended use characteristics and the technological characteristics (continued)

Characteristic compared	Predicate Device (K230343) ProSeal™ Closed System Administration Set	Subject Device (K251814) EZ™ IV Administration Set	Comment
Tubing transparency	The IV tubings are transparent and sufficiently clear so that the interface of air and water during the passage of air bubbles can be observed with normal or corrected vision	Same
Dimensions of IV set	• Overall set length: - 210 cm (model 423500) • PVC tubing: - Inner diameter (ID): 3.0 mm - Outer diameter (OD): 4.0 mm	• Overall set length: - 200 cm (model 429170) - 240 cm (model 429150) - 280 cm (model 429160) • PVC tubing: - Inner diameter (ID): 3.0 mm - Outer diameter (OD): 4.0 mm	Different, see Comment #1
Drops/mL	20 gtt/mL	Same
Priming volume (including Y-site needlefree connectors' residual volumes in the Subject device)	11.9 mL (without Y-site connector)	For model 429170, 1-Y-site, 200 cm (79'') tubing length 14.6 mL For model 429150, 2-Y-site, 240 cm (96'') tubing length 17.4 mL For model 429160, 3-Y-site, 280 cm (109'') tubing length 20.4 mL	Different, see Comment #1
Connector type at distal side of IV admin set.	External Fitting Male Luer Lock (ISO 80369-7:2021)	Same
Particulate contamination level	Met contamination index, N≤90 according to ISO 8536-4, Infusion Equipment for Medical Use, Part 4: Infusion sets for single use, gravity feed, Annex A, A.2 - Test for particulate contamination and USP <788> Particulate Matter in Injections	Same
Sterile barrier packaging	Medical grade paper and medical plastic film, heat sealed	Same
Sterilization process	Ethylene Oxide (EO), SAL 10⁻⁶	Same
Shelf-life validation	3 years (36 months)	Same
Reuse or single-use	Single use only	Same
Labeling specifications	Met the requirements specified in 21 CFR 801	Same

Page 10

ii. Submitter's Comments

Comment #1
The Subject devices differ from the Predicate device in terms of device construction, overall set lengths and priming volumes. These differences did not raise new questions of safety or effectiveness, as both analytical and functional testing were conducted. The results of these tests, summarized in Section VII.A, demonstrated that the performance of the Subject devices met the intended use. Therefore, the differences were considered not significant

Comment #2
The Subject devices differ from the Predicate device in material composition. This variation did not raise new questions of safety or effectiveness, as analytical and functional testing were also completed. Biocompatibility testing, chemical characterization and risk analysis – based on data from previously cleared devices – were evaluated for the Subject devices and are summarized in Section VII.B. The results confirmed that the devices met biological safety specifications, and the differences were considered not significant

VII. Performance Data Supporting Substantial Equivalence

All performance testing demonstrated and confirmed the safety and effectiveness of the Subject device

A. Performance Testing (including functional evaluations)

The Subject device was evaluated for conformance with the following ISO standards and guidance documents:

ANSI/AAMI CN27:2021, General requirements for Luer activated valves (LAVs) incorporated into medical devices for intravascular applications
ISO 80369-7:2021, Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
ISO 80369-20:2015, Small-bore connectors for liquids and gases in healthcare applications (Part 20: Common test methods)
ISO 8536-4:2019, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed
ISO 22413:2021, Transfer sets for pharmaceutical preparations — Requirements and test methods
Intravascular-Administration-Sets-Premarket-Notification-Submissions-[510(k)] – Guidance-for-Industry-and-FDA-Staff

Comprehensive performance verification and validation testing was performed on the Subject device. Additionally, relevant testing data from the Predicate device (K230343/S001) were leveraged to support and demonstrate substantial equivalence. Testing conducted:

On Subject device

Air-inlet device tests per ISO 8536-4:2019
Flow rate test per ISO 8536-4:2019
Piercing device penetration force test per ISO 22413:2021
Protective cap removal test per ISO 8536-4:2019
Drip chamber and drip tube tests per ISO 8536-4:2019
Leak integrity tests per ISO 8536-4:2019 (air leakage under positive pressure, air leakage under negative pressure and fluid leakage)
Tensile strength test per ISO 8536-4:2019

On Predicate device – K230343/S001

Particulate contamination tests per ISO 8536-4:2019
Leak integrity tests per ISO 8536-4:2019
Tensile strength test per ISO 8536-4:2019
Tubing tests per ISO 8536-4:2019
Fluid filter test per ISO 8536-4:2019
Drip chamber and drip tube tests per ISO 8536-4:2019
Flow rate test per ISO 8536-4:2019
Luer Lock connection test per ISO 80369-7:2021

On K230343 (during initial review, tested with Y-connector)

Testing to relevant subclauses in Clauses 4 and 5 of ANSI/AAMI CN27:2021 on the LAV connector

Page 11

B. Biocompatibility Testing

In accordance with ISO 10993-1:2018, the Subject device is classified as: Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hr to 30 d). The following tests were conducted on both the Predicate (under K230343/S001) and the Subject device:

Cytotoxicity per ISO 10993-5:2009
Sensitization per ISO 10993-10:2021
Intracutaneous reactivity per ISO 10993-23:2021
Acute systemic toxicity per ISO 10993-11:2017
Subacute/subchronic systemic toxicity per ISO 10993-11:2017
In-vitro hemolysis per ISO 10993-4:2017 & ASTM F756-17
Material mediated pyrogenicity per ISO 10993-11:2017 & USP <151>
Chemical characterization and toxicological risk assessment per ISO 10993-18:2020/AMD-1: 2022 & ISO 10993-17:2002
Particulate matter testing per ISO 8536-4:2019, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed and USP <788> Particulate Matter in Injections, on the Predicate and Subject devices
EO residues limits per ISO 10993-7:2008, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals/Technical Corrigendum 1:2009/Amd.1:2019 for neonates and infants, as defined by the amended standard's patient population categories on the Subject device

C. Sterility, Shipping, and Shelf-Life Validation

The Subject device complies with sterilization requirements outlined in 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.

The following testing and evaluations were performed on the existing device (K151650), the Predicate device (K230343) and the Subject device:

Simulated shipping testing per ASTM D 4169-16, Standard Practice for Performance Testing of Shipping Containers and Systems under K151650/S004
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 under K151650
Pyrogen tests per ANSI/AAMI ST72/2019, Bacterial endotoxins – Test methods, routing monitoring, and alternatives to batch testing, USP 42-NF 37 <151>, Pyrogen test (USP rabbit test), USP 42-NF 37 <161>, Medical Devices-Bacterial Endotoxin and Pyrogen Tests, USP 42-NF 37 <85>, Bacterial Endotoxins Test under K151650 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 on the Subject device

VIII. Clinical Tests

Not applicable

IX. Conclusion

Based on the comparative analysis and performance data, the EZ™ IV Administration Set does not raise new questions of safety or effectiveness. Therefore it is substantially equivalent to the Predicate device, ProSeal™ CS Administration Set (K230343), per US FDA 510(k) requirements

Regulation Number and Section

§ 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.