Chemfort® Catheter Adaptor

K231286 · Simplivia Healthcare , Ltd. · ONB · Aug 2, 2023 · General Hospital

Device Facts

• Record ID: K231286
• Device Name: Chemfort® Catheter Adaptor
• Applicant: Simplivia Healthcare , Ltd.
• Product Code: ONB · General Hospital
• Decision Date: Aug 2, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Chemfort® Catheter Adaptor is a sterile, single-use Closed System Transfer Device (CSTD) component. It functions as an interface between a standard luer lock syringe (via Chemfort® Syringe Adaptor) and a urinary catheter. Operation involves mechanical snap-connection to the catheter and a septum-to-septum connection to the syringe adaptor; when joined, internal septums are pressed together and pierced by a needle to establish a closed fluid path. Used in hospitals, clinics, and compounding centers by nurses or healthcare professionals. The device prevents drug release (vapor, aerosol, liquid) and microbial/airborne contamination for up to 7 days. It enables safe drug administration to the urinary bladder and safe disconnection of the syringe adaptor. Benefits include reduced hazardous drug exposure for patients and healthcare staff.

Clinical Evidence

Bench testing only. Compliance demonstrated with ISO 10993 series (biocompatibility, cytotoxicity, irritation, sensitization, systemic toxicity, chemical characterization), ISO 11135 (EO sterilization), ISO 11607-1 (packaging), ISO 14971 (risk management), and USP standards (<85> bacterial endotoxins, <161> transfusion/infusion assemblies, <788> particulate matter).

Technological Characteristics

Multi-component CSTD system; utilizes resealing septums for closed fluid path. Materials comply with ISO 10993-1. Sterilization via Ethylene Oxide (SAL 10^-6). Connectivity: mechanical snap-fit to urinary catheters and luer lock syringe adaptors. No software or electronic components.

Indications for Use

Indicated for use by healthcare professionals to facilitate safe administration of hazardous drugs, including antineoplastic agents, to the urinary bladder via a urinary catheter while minimizing exposure to personnel and the environment.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Tevadaptor® Catheter Adaptor (K180489)

Submission Summary (Full Text)

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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

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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 [phone] 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

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# 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) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size:10pt;"> </span> <span style="font-size:10pt;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </span> |
| | <span> <span style="font-size:10pt;"> </span> <span style="font-size:10pt;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </span> |

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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.<br>North Industrial Zone<br>Kiryat Shmona, 1101801<br>Israel |
| Phone:<br>Fax: | (972) 4 6908826<br>(972) 74 7652161 |
| FDA Registration Number | 9611423 |
| Contact Person: | Shay Shaham<br>VP 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 and<br>Transfer System |
| FDA Classification: | Class II |
| Predicate Device: | Tevadaptor® Catheter Adaptor (K180489) |

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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 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.

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## 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 Device<br>Chemfort® Catheter<br>Adaptor | Predicate Device<br>Tevadaptor® Catheter<br>Adaptor<br>(K180489) | Equivalence to predicate |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Class | Class II | Class II | Same |
| Classification<br>Panel | General Hospital | General Hospital | Same |
| Product Code | ONB | ONB | Same |
| Regulation<br>Description | Intravascular<br>Administration Set | Intravascular<br>Administration Set | Same |
| Regulation No. | 21 C.F.R. §880.5440 | 21 C.F.R. §880.5440 | Same |
| Indications for<br>use | Chemfort® Catheter<br>Adaptor is a single use,<br>sterile Closed System<br>Transfer Device (CSTD)<br>that mechanically prohibits<br>the release of drugs,<br>including antineoplastic<br>and hazardous drugs, in<br>vapor, aerosol or liquid<br>form during<br>administration, thus<br>minimizing exposure of<br>individuals, healthcare<br>personnel, and the<br>environment to hazardous<br>drugs.<br>Chemfort® Catheter<br>Adaptor prevents the<br>introduction of microbial<br>and airborne contaminants<br>into the drug or fluid path<br>for up to 7 days. | Tevadaptor® is a Closed<br>System Drug Transfer<br>Device (CSTD) that<br>mechanically prohibits the<br>release of the drug in<br>vapor, aerosol or liquid<br>form during preparation<br>and administration, and<br>prevents the introduction<br>of microbial and airborne<br>contaminants into the drug<br>or fluid path, allowing the<br>system to minimize<br>exposure of individuals,<br>healthcare personnel, and<br>the environment to<br>hazardous drugs. | First part:<br>Same meaning.<br>Second part: Tevadaptor®<br>was tested and proved to<br>prevent contaminants from<br>entering the drug or fluid<br>path for up to 3 days,<br>Chemfort® has been tested<br>and approved for 7 days |
| | Part of Chemfort®, a multi-<br>components system | Part of Tevadaptor®, a<br>multi-components system | Same |
| | components system | multi-components system | |
| | including Catheter Adaptor | including Catheter Adaptor | |
| Interaction with<br>other devices | The distal end connects to<br>the urinary catheter. | The distal end connects to<br>the urinary catheter. | Same |
| | The distal end connects to<br>the urinary catheter. | The distal end connects to<br>the urinary catheter. | |
| | The proximal end connects | The proximal end connects | |
| | Proposed Device<br>Chemfort® Catheter<br>Adaptor | Predicate Device<br>Tevadaptor® Catheter<br>Adaptor<br>(K180489) | Equivalence to predicate |
| | to Chemfort® Syringe<br>Adaptor / Syringe Adaptor<br>Lock. | to Tevadaptor® Syringe<br>Adaptor / Syringe Adaptor<br>Lock. | |
| Re-use<br>capability | Distal end: to maintain the<br>closed system, the Catheter<br>Adaptor should not be<br>disconnected from the<br>urinary catheter.<br>Proximal end: The<br>Chemfort® port of the<br>Catheter Adaptor can be<br>connected and<br>disconnected from the<br>Syringe Adaptor port up to<br>10 times. | Distal end: to maintain the<br>closed system, the Catheter<br>Adaptor should not be<br>disconnected from the<br>urinary catheter.<br>Proximal end: The<br>Tevadaptor® port of the<br>Catheter Adaptor can be<br>connected and<br>disconnected from the<br>Syringe Adaptor port up to<br>10 times. | Same |
| Principles of<br>Operation | Multi-component system,<br>components are intended<br>to be used as a system,<br>manually manipulated. | Multi-component system,<br>components are intended<br>to be used as a system,<br>manually manipulated. | Same |
| Interaction with<br>patient | No direct interaction-<br>device interaction with the<br>patient is achieved through<br>the passage of fluids<br>through the urinary<br>catheter. | No direct interaction-<br>device interaction with the<br>patient is achieved through<br>the passage of fluids<br>through the urinary<br>catheter. | Same |
| Interconnecting<br>features | Mechanical snap<br>connections. | Mechanical snap<br>connections. | Same |
| Safety features | • Vented cap<br>• Septum to septum<br>contact | • Vented cap<br>• Septum to septum<br>contact | Same |
| Target users | Nurses or other healthcare<br>professionals. | Nurses or other healthcare<br>professionals. | Same |
| Technology | All of the Chemfort®<br>devices ports are sealed<br>with resealing Septum.<br>When Syringe Adaptor<br>and Chemfort® port are<br>joined, the two septums<br>are pressed together and<br>then pierced by a needle<br>(from the Syringe Adaptor | All of the Tevadaptor®<br>devices ports are sealed<br>with resealing Septum.<br>When Syringe Adaptor<br>and Tevadaptor® port are<br>joined, the two septums<br>are pressed together and<br>then pierced by a needle<br>(from the Syringe Adaptor | Same |
| | Proposed Device<br>Chemfort® Catheter<br>Adaptor | Predicate Device<br>Tevadaptor® Catheter<br>Adaptor<br>(K180489) | Equivalence to predicate |
| | thus creating a secured<br>fluid path. | thus creating a secured<br>fluid path. | |
| Environment of<br>use | Hospitals, compounding<br>centers and clinics | Hospitals, compounding<br>centers and clinics | Same |
| Sterilization<br>method | Ethylene Oxide validated<br>cycle SAL 10-6 | Ethylene Oxide validated<br>cycle SAL 10-6 | Same |
| Biocompatibility | All Catheter Adaptor parts<br>that are in contact with<br>patient comply with the<br>requirements of ISO<br>10993-1 | All Catheter Adaptor parts<br>that are in contact with<br>patient comply with the<br>requirements of ISO<br>10993-1 | Same |
| Prescription use | Rx only | Rx only | Same |

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

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### 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.

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- . 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.