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.

Device Description

The Chemfort™ Closed System Transfer Device (CSTD) is a system of components that allows the reconstitution of liquid or pre-dissolved powder drugs into infusion bags, flexible bottles or syringes. Single, partial or multiple vials can be used for each infusion container. The Chemfort™ CSTD prevents contamination of the user or the environment by the drug through the use of elastomeric seals and an active carbon filter. Sterility of the drug in the vial is maintained because any air entering the vial during pressure equalization enters through of a hydrophobic acrylic copolymer membrane with a pore size of 0.2 micron.

The components of the Chemfort™ CSTD system are:

. Vial Adaptor 20 mm with 13 mm Vial Converter
Vial Adaptor 28 mm
Vial Adaptor 32 mm
Syringe Adaptor
Syringe Adaptor Lock
Luer Lock Adaptor
Bag Adaptor SP

Each of the Chemfort™ system components is available separately.

AI/ML Overview

The acceptance criteria for the Chemfort™ Closed System Transfer Device (CSTD) and the study that proves it meets these criteria are detailed through various non-clinical performance tests. The device aims to mechanically prohibit the release of drugs (including antineoplastic and hazardous drugs) in vapor, aerosol, or liquid form during preparation, compounding, and administration, thereby minimizing exposure to hazardous drugs. It also prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

1. Table of Acceptance Criteria and Reported Device Performance:

The document lists performance tests conducted to demonstrate equivalence with the predicate device (TEVADAPTOR®) and to support the new indication concerning microbial ingress. While specific quantitative acceptance criteria are not explicitly detailed in the provided text for each test, the general reporting indicates that the device "successfully passed" or "has been carried out" with tests demonstrating equivalence or functionality. The conclusion states that the device "does not raise new types of safety and effectiveness questions" and is "substantially equivalent" to the predicate.

Here's a table summarizing the tests and the reported performance:

Acceptance Criteria/Test Type	Reported Device Performance
Disconnection force tests	Successfully passed (implied by "successful bench testing")
Assembly connection force tests	Successfully passed (implied by "successful bench testing")
Breakage of Syringe Adaptor Lock Luer retention teeth	Successfully passed (implied by "successful bench testing")
Bidirectional flow tests	Successfully passed (implied by "successful bench testing")
Air tightness tests	Successfully passed (implied by "successful bench testing")
Fluid tightness tests	Successfully passed (implied by "successful bench testing")
Residual volume tests	Successfully passed (implied by "successful bench testing")
Microbial ingress tests (7 days)	Passed ("verified by means of bench tests")
Particulate matter tests per USP <788>	Successfully passed (implied by "successful bench testing")
Filter efficiency tests	Successfully passed (implied by "successful bench testing")
ISO 8536-4 & ISO 80369-7 tests (Gauging, Resistance for overriding, Unscrewing torque, Ease of assembly, Liquid leakage, Air leakage, Separation force of conical fitting assembly, Stress cracking)	Successfully passed (implied by "successful bench testing")
Resistance to cytotoxic drugs	Successfully passed (implied by "successful bench testing")
Packaging integrity (Visual, Peel, Dye penetration, Leakage, Burst)	Successfully passed (implied by "successful bench testing")
Seven-day filter exposure test	Successfully passed (implied by "successful bench testing")
Vapor containment	Successfully passed (implied by "successful bench testing")
Sterility validation (ISO 11135-1)	Successfully passed (implied by "successful bench testing")
ETO residuals (ISO 10993-7)	Successfully passed (implied by "successful bench testing")
Bacterial endotoxins (USP <85> and <161>)	Successfully passed (implied by "successful bench testing")
Biocompatibility (ISO 10993-5, 10, 11, 4, 18, 8536-4)	Successfully passed (implied by "successful biocompatibility testing")
Extractables and Leachables Tests	Successfully passed (implied by "successful biocompatibility testing")

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

The document does not specify the exact sample sizes used for each test. It generally refers to "bench testing" and "biocompatibility tests" being "carried out on the Chemfort™ system components." The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. Given that it's bench testing for a medical device submission, it would typically be prospective testing conducted in a laboratory setting.

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

The document does not mention the use of experts or their qualifications for establishing ground truth for the test set. All mentioned studies are non-clinical bench tests performed according to recognized standards (e.g., ISO, USP, ASTM). These types of tests typically rely on standardized protocols and quantitative measurements rather than expert consensus on subjective evaluations.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned. This is consistent with non-clinical performance testing where results are objective measurements against predefined specifications, rather than subjective interpretations requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not conducted. This type of study is relevant for AI/radiology devices where human interpretation is a key component. The Chemfort™ CSTD is a mechanical device, and its performance is evaluated through bench testing against physical and chemical criteria.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

A standalone performance study for an algorithm was not conducted as the Chemfort™ CSTD is a mechanical medical device, not an AI/software device. The performance data presented are for the device itself.

7. Type of Ground Truth Used:

The ground truth for the device's performance is based on objective measurements and results from standardized non-clinical bench tests. These tests evaluate physical properties, chemical integrity, microbial barrier efficacy, and other performance characteristics against established industry standards (e.g., ISO, USP, ASTM) and the specifications of the predicate device. For example, "microbial ingress tests (7 days)" would confirm the device's ability to prevent contamination, which is a measurable outcome.

8. Sample Size for the Training Set:

This question is not applicable. The Chemfort™ CSTD is a mechanical device, not an AI or machine learning model that requires a training set.

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

This question is not applicable, as there is no training set for a mechanical device.

Summary

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May 7, 2020

Simplivia Healthcare Ltd. % Roger Gray VP Quality and Regulatory Donawa Lifescience Consulting Piazza Albania 10 Rome, 00153 ITALY

Re: K192866

Trade/Device Name: Chemfort™ Closed System Transfer Device (CSTD) Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: April 2, 2020 Received: April 7, 2020

Dear Roger Gray:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Tina Kiang, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192866

Device Name

Chemfort Closed System Transfer Device (CSTD)

Indications for Use (Describe)

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, 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.

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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510(k) Summary in accordance with 21 CFR 807.92(c)

Device Name:	Chemfort™ Closed System Transfer Device (CSTD)
Type of 510(k) submission:	Abbreviated
Date Prepared:	1 March 2020
510(k) Owner & Submitter	Simplivia Healthcare Ltd.North Industrial Zone P.O. Box 888Kiryat ShmonaIsrael 1101801
Phone:	+972-4-6908830
Fax:	+972-9-892-1659
FDA Registration Number:	9611423
510(k) Application Correspondent:	Mr Roger GrayVP Quality and RegulatoryDonawa Lifescience ConsultingPiazza Albania 1000153 RomeItalyPhone: +39 06 578 2665Fax: +30 06 574 3786Email: rgray@donawa.com
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
Indications for Use:	Chemfort™ is a Closed System Transfer Device (CSTD) thatmechanically prohibits the release of drugs, includingantineoplastic and hazardous drugs, in vapor, aerosol or liquidform during preparation, reconstitution, compounding andadministration, minimizing exposure of individuals, healthcarepersonnel, and the environment to hazardous drugs.Chemfort™ prevents the introduction of microbial and airbornecontaminants into the drug or fluid path for up to 7 days.

Predicate Device:

The predicate device selected for comparison with the Chemfort™ Closed System Transfer Device (CSTD) is:

Predicate Device Name: TEVADAPTOR® Closed Drug Reconstitution and Transfer System

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510(k) Sponsor:	Teva Medical
510(k) Number:	K141448
Clearance Date:	23 January 2015
FDA Product Code:	ONB
Regulation Name:	Intravascular administration set
Regulation Number:	880.5440

Device Description:

The components of the Chemfort™ CSTD system are:

. Vial Adaptor 20 mm with 13 mm Vial Converter
Vial Adaptor 28 mm
Vial Adaptor 32 mm
Syringe Adaptor
Syringe Adaptor Lock
Luer Lock Adaptor
Bag Adaptor SP

Each of the Chemfort™ system components is available separately.

The environment of use is unchanged from that of the predicate TEVADAPTOR® system cleared under K141448.

The device labeling includes the following statement: "The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding manufacturer's labeling recommendations for the storage and expiration dating. Refer to drug manufacturer's recommendations and USP compounding quidelines for shelf life and sterility information."

This submission for the Chemfort™ CSTD includes identification of changes in certain materials that are used in the predicate device in order to improve durability when used with drugs containing aggressive solvents, such as N'N' Dimethylacetamide. Design changes has also been made to the Vial Adaptor 20mm, Syringe Adaptor Hub, Luer Lock Adaptor, and Bag Adaptor SP.

Comparison with Predicate Device:

Table 1 provides a comparison of the Chemfort™ CSTD with the identified predicate device.

Table 1: Predicate device comparison
Item	Subject device: ChemfortTM CSTD	Predicate device: TEVADAPTOR®	Equivalence toPredicate
Device name	ChemfortTM Closed System DrugTransfer Device (CSTD)	TEVADAPTOR® Closed DrugReconstitution and Transfer System	N/A
Manufacturer	Simplivia Healthcare, Israel	Teva Medical, Israel	N/A
510(k) number	K192866	K141448	N/A
Table 1: Predicate device comparison
ltem	Subject device: Chemfort™ CSTD	Predicate device: TEVADAPTOR®	Equivalence toPredicate
Product Code	ONB	ONB	Same
Reg No	880.5440	880.5440	Same
Indications for use	Chemfort™ is a Closed SystemTransfer Device (CSTD) thatmechanically prohibits the release ofdrugs, including antineoplastic andhazardous drugs, in vapor, aerosol orliquid form during preparation,reconstitution, compounding andadministration, minimizing exposureof individuals, healthcare personnel,and the environment to hazardousdrugs.Chemfort™ prevents theintroduction of microbial andairborne contaminants into the drugor fluid path for up to 7 days.	TEVADAPTOR® is a Closed SystemDrug Transfer Device (CSTD) thatmechanically prohibits the release ofthe drug in vapor, aerosol or liquidform during preparation andadministration, and prevents theintroduction of microbial andairborne contaminants into the drugor fluid path, allowing the system tominimize exposure of individuals,healthcare personnel, and theenvironment to hazardous drugs.	Very similar
Components	Vial Adaptor 20 mm with 13 mm VialConverterVial Adaptor 28 mmVial Adaptor 32 mmSyringe AdaptorSyringe Adaptor LockLuer Lock AdaptorBag Adaptor SP	Vial Adaptor 20 mm with 13 mm VialConverterVial Adaptor 28 mmNo equivalentSyringe AdaptorSyringe Adaptor Lock (K170680)Luer Lock AdaptorSpike Port Adaptor	Equivalent - thedevices differ indetails, but thecombination ofcomponents isintended toachieve anequivalentintended use.
Reuse capability	All components are for single useonly	All components are for single useonly	Same
Vial venting/microbial barrier	Vial venting through 0.2 micronmicrobial membrane barrier	Vial venting through 0.2 micronmicrobial membrane barrier	Same
Prevents escape ofdrug or vaporconcentration	Yes	Yes	Same
Closed drugtransfer mechanism	Elastomeric double membrane	Elastomeric double membrane	Same
Interconnectingfeatures	Mechanical snap connections, withelastomeric double membrane	Mechanical snap connections, withelastomeric double membrane	Same
Activationmechanism	Push-together connection with cliplocks	Push-together connection with cliplocks	Same
Safety features	0.2 micron venting membraneCharcoal clothNeedle tip protectorSeptum to septum contact	0.2 micron venting membraneCharcoal clothNeedle tip protectorSeptum to septum contact	Same
Direct interactionwith patient	No direct interaction	No direct interaction	Same
Indirect interactionwith patient	Indirect interaction with the patientis achieved through the passage of IVfluids through the central lumen ofthe applicable components	Indirect interaction with the patientis achieved through the passage of IVfluids through the central lumen ofthe applicable components	Same
Table 1: Predicate device comparison
Item	Subject device: Chemfort™ CSTD	Predicate device: TEVADAPTOR®	Equivalence toPredicate
Interaction withother devices	Normal use would involve connectionof device components with vial,syringe, IV line, IV bag - see followingrows for further details	Normal use would involve connectionof device components with vial,syringe, IV line, IV bag - see followingrows for further details	Same
Connection toexternal syringe	Luer connections with permanentlocking feature which preventsremoval and remains protectivethrough preparation, use anddisposal	Luer connections with permanentlocking feature which preventsremoval and remains protectivethrough preparation, use anddisposal	Same
Connection toexternal standardIV line	Luer lock or spike port	Luer lock or spike port	Same
Connection toexternal standardIV bag	Spike	Spike	Same
Sterilization	Ethylene oxide SAL 10⁻⁶	Ethylene oxide SAL 10⁻⁶	Same
Materials	Thermoplastics, silicone rubber andstainless steel:• Polypropylene RTP 199 X 143425 ANS, E-202384 White or PETEastman Tritan CopolyesterMX731 with white colorant EMD-202914;• PET Eastman Tritan CopolyesterMX731;• PET Eastman Tritan CopolyesterMX731 with orange colorant EC-481953 MB 4% PC TRANS.	Thermoplastics, silicone rubber andstainless steel:• ABS Polylac 757 White A79614B5;• Polycarbonate LEXAN 144R-112;• Polycarbonate LEXAN 144R-112with orange colorant EC-481953MB 4% PC TRANS.	Specificdifferences
Safety mechanism	Sleeve	Sleeve	Same
Powerrequirements	None	None	Same
Biocompatibility	In accordance with ISO 10993 andFDA guidance	In accordance with ISO 10993 andFDA guidance	Same
Prescription use	Rx only	Rx only	Same
Meets the NIOSHand ISOPPdefinition of a CSTD	Yes	Yes	Same

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Substantial Equivalence Discussion

The Chemfort™ CSTD includes two new system components that were not included with the predicate device, these being the Vial Adaptor 32 mm and the Syringe Adaptor Lock. The introduction of these new system components raises no new issues of safety and/or effectiveness, because of their close similarity to components included in the predicate device. In addition, the Syringe Adaptor Lock was separately FDA-cleared under K170680.

Chemfort™ CSTD components that are the result of design and/or material changes from the predicate and reference devices have been subjected to successful bench, biocompatibility, shelf life and usability testing, in addition to sterilization validation, and there are no new questions of safety and/or effectiveness have been identified.

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Image /page/7/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green, stylized "S" shape on the left, followed by the word "SIMPLIVIA" in gray, sans-serif font. The "S" shape is made up of two curved lines that create a sense of movement and flow.

The introduction of the additional wording "Chemfort prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days" in the indications for use statement has been verified by means of bench tests. The ability to prevent microbial ingress for up to 7 days should not be interpreted as modifying, extending, or superseding manufacturer's labeling recommendations for drug storage and expiration dating, however.

Non-Clinical Performance Testing:

Bench testing has been carried out on the Chemfort™ system components to demonstrate equivalence with the predicate device, including a number of tests at the labeled 12-month shelf life:

Disconnection force tests ●
. Assembly connection force tests
Breakage of Syringe Adaptor Lock Luer retention teeth
Bidirectional flow tests
Air tightness tests
Fluid tightness tests
Residual volume tests
Microbial ingress tests (7 days)
Particulate matter tests per USP <788>
Filter efficiency tests
ISO 8536-4 & ISO 80369-7 tests, including: ●
- Gauging test O
- Resistance for overriding O
- Unscrewing torque o
- O Ease of assembly
- Liquid leakage O
- Air leakage O
- Separation force of conical fitting assembly O
- Stress cracking o
Resistance to cytotoxic drugs
Packaging integrity ●
- o Visual (ASTM F1886)
- Peel (ASTM F88/F88M O
- Dye penetration (ASTM F1929) O
- Leakage (ASTM F2096) O
- Burst (ASTM F1140/F1140M) O
Seven-day filter exposure test
Vapor containment
Sterility validation (ISO 11135-1)
ETO residuals (ISO 10993-7)
. Bacterial endotoxins (USP <85> and <161>)

Biocompatibility

Biocompatibility tests have been carried out on sterile components from the Chemfort™ system in accordance with ISO 10993 and FDA guidance, including:

ISO 10993-5:2009: Cytotoxicity
ISO 10993-10:2010: Sensitization, Irritation
ISO 10993-11:2006: Acute Systemic Toxicity, Material Mediated Pyrogenicity
ISO 10993-4: 2006: Hemocompatibility
ISO 10993-18:2005, Chemical Characterization ●
ISO 8536-4:2010: Chemical Tests
Extractables and Leachables Tests ●

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Substantial Equivalence Conclusion:

Based on the performance testing conducted on the subject device, the Chemfort™ CSTD, does not raise new types of safety and effectiveness questions. It is concluded that the Chemfort™ CSTD is substantially equivalent to the identified predicate device TEVADAPTOR®.

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.