Chemfort® Catheter Adaptor 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, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® Catheter Adaptor prevents the introduction of microbial and airborne contaminants into the drug or fluid path for up to 7 days.

Device Description

The Chemfort® Catheter Adaptor enables drug transfer to the catheter, thus allowing drug administration to the patient's urinary bladder. The use of elastomeric seals of the Chemfort® Catheter Adaptor prevents hazardous drug contamination of healthcare professionals, the patient, and the environment.

The Chemfort® Catheter Adaptor is an addition to the cleared Chemfort® system (K192866). The Catheter Adaptor provides closed system protection during the following procedures:

a) Drug transfer from a standard luer lock syringe to the Catheter Adaptor through the Chemfort® Syringe Adaptor (K192866).
b) Closed system drug administration to the urinary bladder, through a urinary catheter. The Catheter Adaptor fits a wide range of standard catheter sizes and converts an open catheter connection to a closed Chemfort® connection.

The Chemfort® Catheter Adaptor allows the healthcare professional to have the option for safe drug administration to the urinary catheter and safe disconnection of the Chemfort® Syringe Adaptor (K192866) from the patient's urinary catheter.

AI/ML Overview

The provided text describes a medical device submission (K231286) for the Chemfort® Catheter Adaptor. This document is a 510(k) summary submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Crucially, the provided text does NOT contain information about acceptance criteria for a study, nor does it detail a study that proves the device meets specific performance criteria in the way requested.

The text mentions several performance tests were conducted to demonstrate compliance with standards and intended function, but it does not present the acceptance criteria for these tests or the reported device performance against those criteria. It lists various ISO standards and USP tests that the device complies with, but this is different from presenting specific acceptance criteria and detailed study results.

Therefore, I cannot fulfill all parts of your request based on the provided text. I can, however, extract relevant information about the device and the nature of its evaluation.

Here's what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "Simplivia Healthcare conducted several performance tests to demonstrate that the Chemfort® Catheter Adaptor complies with the following standards and that it functions as intended." However, it does not present a table with specific acceptance criteria (e.g., "Drug leakage must be less than X mg") and the quantitative reported device performance for these criteria. It only lists the standards against which various tests were performed (e.g., ISO 10993 series for biocompatibility, ISO 11135 for sterilization, USP tests for endotoxins and particulate matter).

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

Cannot be provided definitively. The document mentions "performance tests" but does not detail their methodology, including sample sizes, nor does it specify the provenance (country of origin, retrospective/prospective nature) of the data from these tests.

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)

Not applicable / Cannot be provided. This type of information is relevant for studies involving human interpretation (e.g., diagnostic imaging studies). The Chemfort® Catheter Adaptor is a physical medical device (Closed System Transfer Device - CSTD), and its performance evaluation would typically involve laboratory testing rather than expert-established ground truth on diagnostic cases.

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

Not applicable / Cannot be provided. As above, adjudication methods are typically used in studies where human readers are involved in making subjective assessments or interpretations, which is not the nature of the device testing described here.

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 device is not an AI-powered diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant.

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

Not applicable. This device is not an algorithm. Its "performance" refers to its mechanical and biological integrity, and its ability to prevent contamination and drug release.

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

Not applicable / Implicitly based on technical standards. For a physical device like this, "ground truth" refers to meeting established engineering, chemical, and biological specifications defined by standards (e.g., a device must be sterile, meaning it passes a sterility test; it must not leak hazardous drugs, meaning it passes a containment test). The document indicates compliance with various ISO and USP standards which define quantitative and qualitative benchmarks for device performance.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm that requires a training set.

Summary of what the document does provide regarding the device's evaluation:

The document states that the Chemfort® Catheter Adaptor has similar indications for use, technological characteristics, and principles of operation as its predicate device, Tevadaptor® Catheter Adaptor (K180489).

It highlights one specific difference in claims:

Predicate Device (Tevadaptor®): Tested and proved to prevent contaminants from entering the drug or fluid path for up to 3 days.
Proposed Device (Chemfort® Catheter Adaptor): Has been tested and approved for 7 days regarding the prevention of microbial and airborne contaminants into the drug or fluid path.

The document lists the following standards against which performance tests were conducted (but does not provide the specific acceptance criteria or results for each):

Biocompatibility:
- ISO 10993-1:2018 (Biological Evaluation - General)
- ISO 10993-4:2017 (Interactions with blood)
- ISO 10993-5:2009 (In vitro cytotoxicity)
- ISO 10993-10:2021 (Irritation and skin sensitization)
- ISO 10993-11:2017 (Systemic toxicity)
- ISO 10993-18:2020 (Chemical characterization)
Sterilization:
- ISO 10993-7:2008/Amd 1:2019 (Ethylene oxide sterilization residuals)
- ISO 11135:2014 + Amd.1:2018 (Ethylene oxide sterilization requirements)
Packaging:
- ISO 11607-1:2019 (Packaging for terminally sterilized medical devices)
Risk Management:
- ISO 14971:2019 (Application of risk management to medical devices)
Pharmacopeial Tests:
- USP <85> (Bacterial Endotoxins Test)
- USP <161> (Transfusion and Infusion Assemblies and Similar Medical Devices)
- USP <788> (Particulate Matter in Injections)

The conclusion is that "Performance data demonstrated that the Chemfort® Catheter Adaptor is as safe and as effective as its predicate and does not raise any new safety and effectiveness issues." However, the specifics of these performance data (acceptance criteria, methodologies, sample sizes, and quantitative results) are not provided in this 510(k) summary.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym and name on the right. The FDA part of the logo is in blue, with the acronym in a square and the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

August 2, 2023

Simplivia Healthcare LTD. Shay Shaham VP QA/RA North Industrial Zone Kiryat Shmona, 1101801 Israel

Re: K231286

Trade/Device Name: Chemfort® Catheter Adaptor Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: ONB Dated: May 3, 2023 Received: May 4, 2023

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 (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/ofdocs/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.

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

{1}------------------------------------------------

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

Sincerely,

Danit 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K231286

Device Name Chemfort® Catheter Adaptor

Indications for Use (Describe)

Chemfort® Catheter Adaptor 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 tration, thus minimizing exposure of individuals, healthcare personnel, and the environment to hazardous drugs. Chemfort® Catheter Adaptor 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 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."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Simplivia. The logo consists of a green stylized letter S on the left and the word "SIMPLIVIA" in gray on the right. The letter S is made up of two curved lines that form an S shape, and the word "SIMPLIVIA" is in a sans-serif font.

K231286 510(K) SUMMARY

Preparation Date:	July 31, 2023
Device name:	Chemfort® Catheter Adaptor
Type of 510(k) submission:	Traditional
Date of Submission:	May 3, 2023
Applicant's name:	Simplivia Healthcare LTD.North Industrial ZoneKiryat Shmona, 1101801Israel
Phone:Fax:	(972) 4 6908826(972) 74 7652161
FDA Registration Number	9611423
Contact Person:	Shay ShahamVP QA / RA
FDA Product Code:	ONB
FDA Regulation Number:	21 CFR 880.5440
FDA Regulation Name:	Intravascular administration set
Classification Panel:	General Hospital
Common Name:	Closed Antineoplastic and Hazardous Drug Reconstitution andTransfer System
FDA Classification:	Class II
Predicate Device:	Tevadaptor® Catheter Adaptor (K180489)

{4}------------------------------------------------

Image /page/4/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 intersect in the middle, creating a sense of movement and flow.

Indications for Use

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

Device Description

The Chemfort® Catheter Adaptor is an addition to the cleared Chemfort® system (K192866). The Catheter Adaptor provides closed system protection during the following procedures:

a) Drug transfer from a standard luer lock syringe to the Catheter Adaptor through the Chemfort® Syringe Adaptor (K192866).
b) Closed system drug administration to the urinary bladder, through a urinary catheter. The Catheter Adaptor fits a wide range of standard catheter sizes and converts an open catheter connection to a closed Chemfort® connection.

{5}------------------------------------------------

Summary of Technological Characteristics:

The following table (Table 2) compares the Chemfort® Catheter Adaptor to the predicate device with respect to intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.

	Proposed DeviceChemfort® CatheterAdaptor	Predicate DeviceTevadaptor® CatheterAdaptor(K180489)	Equivalence to predicate
Device Class	Class II	Class II	Same
ClassificationPanel	General Hospital	General Hospital	Same
Product Code	ONB	ONB	Same
RegulationDescription	IntravascularAdministration Set	IntravascularAdministration Set	Same
Regulation No.	21 C.F.R. §880.5440	21 C.F.R. §880.5440	Same
Indications foruse	Chemfort® CatheterAdaptor is a single use,sterile Closed SystemTransfer Device (CSTD)that mechanically prohibitsthe release of drugs,including antineoplasticand hazardous drugs, invapor, aerosol or liquidform duringadministration, thusminimizing exposure ofindividuals, healthcarepersonnel, and theenvironment to hazardousdrugs.Chemfort® CatheterAdaptor prevents theintroduction of microbialand airborne contaminantsinto the drug or fluid pathfor up to 7 days.	Tevadaptor® is a ClosedSystem Drug TransferDevice (CSTD) thatmechanically prohibits therelease of the drug invapor, aerosol or liquidform during preparationand administration, andprevents the introductionof microbial and airbornecontaminants into the drugor fluid path, allowing thesystem to minimizeexposure of individuals,healthcare personnel, andthe environment tohazardous drugs.	First part:Same meaning.Second part: Tevadaptor®was tested and proved toprevent contaminants fromentering the drug or fluidpath for up to 3 days,Chemfort® has been testedand approved for 7 days
	Part of Chemfort®, a multi-components system	Part of Tevadaptor®, amulti-components system	Same
	components system	multi-components system
	including Catheter Adaptor	including Catheter Adaptor
Interaction withother devices	The distal end connects tothe urinary catheter.	The distal end connects tothe urinary catheter.	Same
	The distal end connects tothe urinary catheter.	The distal end connects tothe urinary catheter.
	The proximal end connects	The proximal end connects
	Proposed DeviceChemfort® CatheterAdaptor	Predicate DeviceTevadaptor® CatheterAdaptor(K180489)	Equivalence to predicate
	to Chemfort® SyringeAdaptor / Syringe AdaptorLock.	to Tevadaptor® SyringeAdaptor / Syringe AdaptorLock.
Re-usecapability	Distal end: to maintain theclosed system, the CatheterAdaptor should not bedisconnected from theurinary catheter.Proximal end: TheChemfort® port of theCatheter Adaptor can beconnected anddisconnected from theSyringe Adaptor port up to10 times.	Distal end: to maintain theclosed system, the CatheterAdaptor should not bedisconnected from theurinary catheter.Proximal end: TheTevadaptor® port of theCatheter Adaptor can beconnected anddisconnected from theSyringe Adaptor port up to10 times.	Same
Principles ofOperation	Multi-component system,components are intendedto be used as a system,manually manipulated.	Multi-component system,components are intendedto be used as a system,manually manipulated.	Same
Interaction withpatient	No direct interaction-device interaction with thepatient is achieved throughthe passage of fluidsthrough the urinarycatheter.	No direct interaction-device interaction with thepatient is achieved throughthe passage of fluidsthrough the urinarycatheter.	Same
Interconnectingfeatures	Mechanical snapconnections.	Mechanical snapconnections.	Same
Safety features	• Vented cap• Septum to septumcontact	• Vented cap• Septum to septumcontact	Same
Target users	Nurses or other healthcareprofessionals.	Nurses or other healthcareprofessionals.	Same
Technology	All of the Chemfort®devices ports are sealedwith resealing Septum.When Syringe Adaptorand Chemfort® port arejoined, the two septumsare pressed together andthen pierced by a needle(from the Syringe Adaptor	All of the Tevadaptor®devices ports are sealedwith resealing Septum.When Syringe Adaptorand Tevadaptor® port arejoined, the two septumsare pressed together andthen pierced by a needle(from the Syringe Adaptor	Same
	Proposed DeviceChemfort® CatheterAdaptor	Predicate DeviceTevadaptor® CatheterAdaptor(K180489)	Equivalence to predicate
	thus creating a securedfluid path.	thus creating a securedfluid path.
Environment ofuse	Hospitals, compoundingcenters and clinics	Hospitals, compoundingcenters and clinics	Same
Sterilizationmethod	Ethylene Oxide validatedcycle SAL 10-6	Ethylene Oxide validatedcycle SAL 10-6	Same
Biocompatibility	All Catheter Adaptor partsthat are in contact withpatient comply with therequirements of ISO10993-1	All Catheter Adaptor partsthat are in contact withpatient comply with therequirements of ISO10993-1	Same
Prescription use	Rx only	Rx only	Same

Table 1. Proposed Device, Refefance Device and Predicate Device Comparation

{6}------------------------------------------------

{7}------------------------------------------------

Performance Data

Simplivia Healthcare conducted several performance tests to demonstrate that the Chemfort® Catheter Adaptor complies with the following standards and that it functions as intended.

. 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.

{8}------------------------------------------------

. ISO 14971:2019 -Medical devices Medical devices -- Application of risk management to medical devices
USP <85>, Bacterial Endotoxins Test.
USP <161>, Transfusion and Infusion Assemblies and Similar Medical Devices. .
USP <788>, Particulate Matter in Injections ●

Substantial Equivalence

Simplivia Healthcare's Chemfort® Catheter Adaptor has similar indications for use, and similar technological characteristics and principles of operation as the predicate device, K180489. Performance data demonstrated that the Chemfort® Catheter 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® Catheter Adaptor is substantially equivalent to its predicate device, K180489.

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.