Chemfort® is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration and preparation, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

Device Description

The Chemfort® Closed System Transfer Device (CSTD) is developed by Simplivia Healthcare Ltd. The system is used by pharmacists, nurses or other healthcare professionals to prepare drugs, including cytotoxic drugs, and allow the safe reconstitution of powder and liquid drugs transfer for infusion containers (infusion bags, semi-rigid bottles, and collapsible plastic containers), injection, or administration. It is supplied sterile with a sterility assurance level (SAL) of 10-6.

The Chemfort® Female Luer Lock Adaptor is part of the Chemfort® system of devices. The Chemfort® Female Luer Lock Adaptor is intended for the safe drug transfer from one syringe to another and allows closed access via Chemfort® devices to any standard male Luer connection (see below in more details).

Syringe to Syringe connection:
The Chemfort® Female Luer Lock Adaptor is connected to the Chemfort® Luer Lock Adaptor. The Chemfort® Luer Lock Adaptor port is connected to an empty / saline containing syringe (syringe "A"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock. A drug containing syringe (syringe "B"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock is connected to the Chemfort® Female Luer Lock Adaptor. This assembly of devices allows drug transfer from one syringe "A" to the other, syringe "B", for drug dilution (if syringe "A" contains saline) or drug dosage (if syringe "A" is empty). This procedure allows safe drug transfer from one syringe to another. The drug in Syringe "A" can then be injected to an intravenous (IV) bag through the Chemfort® spike or in a bolus through another Chemfort® Luer Lock Adaptor connected to a Y-site on an IV set.

Note that this procedure also involves the Chemfort® Vial Adaptor to allow to withdraw the drug from the drug vial to syringe "B".

Connection to IV sets:
The Chemfort® Female Luer Lock Adaptor is connected to an IV set through the luer lock connection (proximal end or infusion line). The Chemfort® port can then connect to one of the Chemfort® Closed Administration (CADM) IV sets. This setup transfers an open IV set connection to a closed connection.

The Chemfort® Female Luer Lock Adaptor can be in contact with concentrated or diluted drugs.

The Chemfort® Female Luer Lock Adaptor is a single-use device intended for use on adults, children and infants.

AI/ML Overview

The provided FDA 510(k) clearance letter and supporting documentation (Chemfort® Female Luer Lock Adaptor 510(k) Summary) describe the performance testing and acceptance criteria for a physical medical device, not a software or AI-driven diagnostic device.

Therefore, many of the requested categories in your prompt (e.g., number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how ground truth for training set was established, standalone performance) are not applicable to this type of device submission. These categories are typically relevant for AI/ML-based diagnostic devices where performance data relies heavily on expert annotations, comparative effectiveness studies involving human readers, and distinct training/test datasets.

However, I can extract the relevant acceptance criteria and performance data for the Chemfort® Female Luer Lock Adaptor based on the provided document.

Acceptance Criteria and Device Performance for Chemfort® Female Luer Lock Adaptor

This document outlines the performance data and acceptance criteria for the Chemfort® Female Luer Lock Adaptor, a physical medical device. The study performed demonstrates the device's adherence to established safety and performance standards for intravascular administration sets.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on established international standards and internal validation procedures for medical devices of this type. The "Results" column from the provided Table 2 in the 510(k) summary indicates that all tests met their acceptance criteria, demonstrating the device's compliance.

Test Name	Description	Acceptance Criteria (Implied by Standard/Procedure)	Reported Device Performance
Particulate Analysis	Chemfort® Female Luer Lock Adaptor fluid path was examined for particles.	Compliance with USP <788> "Particulate Matter in Injections, Method 1- Light Obscuration Particle Count Test" (i.e., particulate count within specified limits for injectables).	Pass
Bidirectional Flow	The ability of the device to deliver liquid throughout the system was verified.	Fluid delivery demonstrated to be effective and unimpeded as per internal procedure. (Specific quantitative criteria not provided but implied by "Pass").	Pass
Assembly's Connection	Evaluation of the connection force between Chemfort® Syringe Adaptor and Chemfort® Female Luer Lock Adaptor ports.	Connection forces within acceptable ranges to ensure secure attachment and proper function without excessive effort or accidental disconnection, as per internal procedure.	Pass
Air Tightness	This test demonstrated that there is no leakage between the Chemfort®'s Female Luer Lock Adaptor and the Chemfort® Syringe Adaptor ports connection.	No detectable air leakage between connected ports, ensuring a closed system, as per internal procedure.	Pass
Fluid Leakage	Ensure that the Chemfort® Female Luer Lock Adaptor's luer connector.	No detectable fluid leakage from the luer connector, as per internal procedure.	Pass
Luer Test	The luer lock connection complies with ISO 80369-20. This specifically refers to the functional and dimensional integrity of the luer connections, preventing misconnections and ensuring secure fit.	Compliance with ISO 80369-7:2021 "Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications" requirements for luer connections.	Pass
Biocompatibility	All device parts that contact the patient comply with ISO 10993-1. (This is a general statement from the summary implying testing was done to ensure no adverse biological reactions).	Compliance with ISO 10993 series (e.g., cytotoxicity, irritation, sensitization, systemic toxicity, hemocompatibility) for materials in contact with body fluids.	Compliance (Implicit)
Sterilization Residuals	Ethylene Oxide sterilization residuals.	Compliance with ISO 10993-7 requirements for acceptable levels of ethylene oxide and its byproducts.	Compliance (Implicit)
Shelf Life	The device is safe and effective throughout its intended shelf life (3 years). (This is a general statement, implying stability testing was conducted over time to support this claim).	Device maintains its safety and effectiveness characteristics over the declared 3-year shelf life, as demonstrated by stability testing (e.g., maintaining sterility, material integrity, functional performance).	Not explicitly detailed but implied by overall "Pass" and "safe and effective".

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not explicitly state the numerical sample sizes for each performance test (e.g., number of units tested for particulate analysis, bidirectional flow, etc.). However, it indicates that "Simplivia conducted several performance tests to demonstrate that the Chemfort® Female Luer Lock Adaptor is safe and effective..." implying a sufficient number of samples were tested to meet the requirements of the listed standards and internal procedures.
Data Provenance: The tests were conducted by Simplivia Healthcare LTD. (an Israeli company) for regulatory submission to the FDA. The data provenance is laboratory testing performed by the manufacturer, rather than clinical data from human subjects. The tests are prospective in nature, as they involve testing newly manufactured devices against predetermined specifications.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

This question is not applicable to the type of device being cleared. The "ground truth" for the performance of a physical device like the Chemfort® Female Luer Lock Adaptor is established by adherence to validated engineering specifications, material properties, and functionality defined by international standards (e.g., ISO, USP) and internal quality control procedures. It does not involve expert interpretations of images or signals for diagnostic purposes.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in expert annotations or interpretations, typically in studies involving human readers or AI outputs for diagnostic tasks. For a physical device, performance is evaluated against objective, measurable criteria with pass/fail outcomes, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. MRMC studies are specific to evaluating the diagnostic performance of medical imaging devices or AI algorithms, often comparing human reader performance with and without AI assistance across multiple cases. This device is an intravascular administration set, not an imaging or diagnostic AI device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

This question is not applicable. There is no "algorithm" to be evaluated in a standalone manner for this physical device. Its function is mechanical and fluidic.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on engineering specifications, material science, and compliance with recognized international standards (e.g., ISO 80369-7, ISO 10993 series, USP monographs). These standards define the acceptable performance characteristics, physical properties, and safety profiles for devices of this type. For example, for "Luer Test," the ground truth is defined by the dimensional and functional requirements of ISO 80369-7:2021. For "Biocompatibility," the ground truth is defined by the specific tests and acceptance criteria within the ISO 10993 series.

8. The Sample Size for the Training Set

This question is not applicable. This device is a physical product, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the same reason as #8.

Summary

FDA 510(k) Clearance Letter - Chemfort Female Luer Lock Adaptor

Page 1

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

Doc ID # 04017.08.00

August 5, 2025

Simplivia Healthcare LTD.
Shay Shaham
VP QA/RA
Kiryat Shmona, North Industrial Zone, Eli Horovitz 1
P.O. Box 888
Kiryat Shmona, 1101801
Israel

Re: K251411
Trade/Device Name: Chemfort Female Luer Lock Adaptor
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: Class II
Product Code: ONB
Dated: May 5, 2025
Received: May 7, 2025

Dear Shay Shaham:

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"

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K251411 - Shay Shaham 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).

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K251411 - Shay Shaham 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)
K251411

Device Name
Chemfort® Female Luer Lock Adaptor

Indications for Use (Describe)
Chemfort® is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration and preparation, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

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
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"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

CHEMFORT® FEMALE LUER LOCK ADAPTOR 510(K) SUMMARY

Page 1 of 6

Preparation Date: August 05, 2025

Device name: Chemfort® Female Luer Lock Adaptor

Type of 510(k) submission: Traditional

Date of Submission: May 07, 2025

Applicant's name: Simplivia Healthcare LTD.
North Industrial Zone
Kiryat Shmona, 1101801
Israel

Phone: (972) 4 6908826
Fax: (972) 74 7652161

FDA Registration Number: 9611423

Contact Person: Shay Shaham
VP QA / RA

FDA Product Code: ONB

FDA Regulation Number: 880.5440

FDA Regulation Name: Intravascular administration set

Classification Panel: General Hospital

Common Name: Closed Drug Reconstitution and Transfer System

FDA Classification: Class II

Predicate Device: Chemfort® Adaptors (K192866)

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Intended Use / Indications for Use

Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

Device Description

Syringe to Syringe connection:
The Chemfort® Female Luer Lock Adaptor is connected to the Chemfort® Luer Lock Adaptor. The Chemfort® Luer Lock Adaptor port is connected to an empty / saline containing syringe (syringe "A"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock. A drug containing syringe (syringe "B"), equipped with a Chemfort® Syringe Adaptor or Chemfort® Syringe Adaptor Lock is connected to the Chemfort® Female Luer Lock Adaptor. This assembly of devices allows drug transfer from one syringe "A" to the other, syringe "B", for drug dilution (if syringe "A" contains saline) or drug dosage (if syringe "A" is empty). This procedure allows safe drug transfer from one syringe to another. The drug in Syringe "A" can then be injected to an intravenous (IV) bag through the Chemfort® spike or in a bolus through another Chemfort® Luer Lock Adaptor connected to a Y-site on an IV set.

Note that this procedure also involves the Chemfort® Vial Adaptor to allow to withdraw the drug from the drug vial to syringe "B".
Connection to IV sets:
The Chemfort® Female Luer Lock Adaptor is connected to an IV set through the luer lock connection (proximal end or infusion line). The Chemfort® port can then connect to one of the Chemfort® Closed Administration (CADM) IV sets. This setup transfers an open IV set connection to a closed connection.

The Chemfort® Female Luer Lock Adaptor can be in contact with concentrated or diluted drugs.

The Chemfort® Female Luer Lock Adaptor is a single-use device intended for use on adults, children and infants.

Page 7

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Summary of Technological Characteristics:

The following table (Table 1) compares the Chemfort® Female Luer Lock Adaptor to the predicate devices with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

Table 1. Proposed Device and Predicate Device Comparation

Category	Proposed Device Chemfort® Female Luer Lock Adaptor	Predicate Device Chemfort Adaptors (K192866)	Equivalence to predicate
Device Class	Class II	Class II	Same
Classification Panel	General Hospital	General Hospital	Same
Product Code	ONB	ONB	Same
Regulation Description	Intravascular Administration Set	Intravascular Administration Set	Same
Regulation No.	21 C.F.R. §880.5440	21 C.F.R. §880.5440	Same
Indications for use	Chemfort® is a single use, sterile Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during administration and preparation, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.	Chemfort® is a Closed System Transfer Device (CSTD) that mechanically prohibits the release of drugs, including antineoplastic and hazardous drugs, in vapor, aerosol or liquid form during preparation, reconstitution, compounding and administration, minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.	Same
Components	Part of Chemfort®, a multicomponents system	Part of Chemfort®, a multicomponents system	Same
Interaction with other devices	The distal end connects to any male luer connection. The proximal end connects to Chemfort® Syringe Adaptor / Syringe Adaptor Lock.	Luer Lock Adaptor: the distal end connects to any female luer connection. The proximal end connects to Chemfort® Syringe Adaptor / Syringe Adaptor Lock.	Different – the devices differ in the Luer connection. Performance testing in compliance to ISO 80369-7:2021 demonstrates

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Category	Proposed Device Chemfort® Female Luer Lock Adaptor	Predicate Device Chemfort Adaptors (K192866)	Equivalence to predicate
			the difference will not raise any new or different questions of safety and effectiveness.
Re-use capability	Distal end: to maintain the closed system, the Female Luer Lock Adaptor should not be disconnected from the luer end. Proximal end: The Chemfort® port of the Female Luer Lock Adaptor can be connected and disconnected from the Syringe Adaptor port up to 10 times.	Distal end: to maintain the closed system, the Female Luer Lock Adaptor should not be disconnected from the luer end. Proximal end: The Chemfort® port of the Luer Lock Adaptor can be connected and disconnected from the Syringe Adaptor port up to 10 times.	Same
Principles of Operation	Multi-component system, components are intended to be used as a system, manually manipulated.	Multi-component system, components are intended to be used as a system, manually manipulated.	Same
Interaction with patient	No direct interaction- device interaction with the patient is achieved through the passage of fluids through Chemfort® devices.	No direct interaction- device interaction with the patient is achieved through the passage of fluids through Chemfort® devices.	Same
Interconnecting features	• Mechanical snap connections. • Luer connection	• Mechanical snap connections. • Luer connection	Same
Safety features	Septum to septum contact	Septum to septum contact	Same
Target users	Nurses, pharmacists or other healthcare professionals.	Nurses, pharmacists or other healthcare professionals.	Same
Technology	All of the Chemfort® devices ports are sealed with resealing Septum. When Syringe Adaptor and Chemfort® port are joined, the two septums are pressed together and then pierced by a needle (from the Syringe Adaptor or Syringe Adaptor Lock), thus creating a secured fluid path.	All of the Chemfort® devices ports are sealed with resealing Septum. When Syringe Adaptor and Chemfort® port are joined, the two septums are pressed together and then pierced by a needle (from the Syringe Adaptor or Syringe Adaptor Lock), thus creating a secured fluid path.	Same
Environment of use	Hospitals, compounding centers and clinics	Hospitals, compounding centers and clinics	Same
Sterilization method	Ethylene Oxide validated cycle SAL 10-6	Ethylene Oxide validated cycle SAL 10-6	Same

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Category	Proposed Device Chemfort® Female Luer Lock Adaptor	Predicate Device Chemfort Adaptors (K192866)	Equivalence to predicate
Biocompatibility	All of the device parts that are in contact with patient comply with the requirements of ISO 10993-1	All of the device's parts that are in contact with patient comply with the requirements of ISO 10993-1	Same
Raw Material in the fluid path	Polypropylene and Polyisoprene	Chemfort Vial Adaptor- Polypropylene and Polyisoprene	Same
Prescription use	Rx only	Rx only	Same

Performance Data

Simplivia conducted several performance tests to demonstrate that the Chemfort® Female Luer Lock Adaptor is safe and effective throughout it's intended shelf life (3 years) and that it functions as intended, according to its specifications, in a safe and effective manner, see in the Table 2 the main tests performed.

Table 2. Performance testis and their applicable standards

Test name	Description	Results	Standard
Particulate Analysis	Chemfort® Female Luer Lock Adaptor fluid path was examined for particles	Pass	USP <788>, Particulate Matter in Injections, Method 1- Light Obscuration Particle Count Test.
Bidirectional flow	The ability of the device to deliver liquid throughout the system was verified.	Pass	Internal procedure
Assembly's Connection	Evaluation of the connection force between Chemfort® Syringe Adaptor and Chemfort® Female Luer Lock Adaptor ports.	Pass	Internal procedure
Air Tightness	This test demonstrated that there is no leakage between the Chemfort®'s Female Luer Lock Adaptor and the Chemfort® Syringe Adaptor ports connection.	Pass	Internal procedure
Fluid Leakage	Ensure that the Chemfort® Female Luer Lock Adaptor's luer connector.	Pass	Internal procedure
Luer test	The luer lock connection complies with ISO 80369-20	Pass	ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications

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Other relevant standards:

ISO 80369-7:2021 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
ISO 10993‐1:2018, Biological Evaluation of Medical Devices. Part 1: Evaluation and testing within a risk management process.
ISO 10993‐4:2017, Biological Evaluation of Medical Devices. Part 4: Selection of tests for interactions with blood.
ISO 10993‐5:2009, Biological Evaluation of Medical Devices. Part 5: Tests for in vitro cytotoxicity.
ISO 10993‐7:2008/Amd 1:2019, Biological Evaluation of Medical Devices. Part 7: Ethylene oxide sterilization residuals.
ISO 10993‐10:2021, Biological Evaluation of Medical Devices. Part 10: Tests for irritation and skin sensitization.
ISO 10993‐11:2017, Biological Evaluation of Medical Devices. Part 11: Tests for systemic toxicity.
ISO 10993‐18:2020, Biological Evaluation of Medical Devices. Part 18: Chemical characterization of medical device materials within a risk management process.
ISO 11135:2014 + Amd.1:2018, Sterilization of health-care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices.
ISO 11607‐1:2019, Packaging for terminally sterilized medical devices ‐ Part 1: Requirements for materials, sterile barrier systems and packaging systems.
ISO 14971:2019 –Medical devices—Application of risk management to medical devices
USP <85>, Bacterial Endotoxins Test.
USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices.

Substantial Equivalence

Simplivia Healthcare's Chemfort® Female Luer Lock Adaptor has similar indications for use, raw material and similar technological characteristics and principles of operation as the predicate device, K192866. Performance data demonstrated that the Chemfort® Female Luer Lock Adaptor is as safe and as effective as its predicate and does not raise any new safety and effectiveness issues. Thus, Simplivia Healthcare's Chemfort® Female Luer Lock Adaptor is substantially equivalent to its predicate device, K192866.

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.