(90 days)
No
The summary describes a mechanical closed system transfer device and does not mention any AI or ML components or functionalities.
No
The device is a Closed System Transfer Device (CSTD) designed to prevent exposure to hazardous drugs during administration and prevent contamination of the drug itself. Its primary function is a drug handling and delivery tool, not to diagnose, cure, mitigate, treat, or prevent disease.
No
The device is a closed system transfer device (CSTD) designed to prevent the release of hazardous drugs and protect from contamination during the administration of drugs to the urinary bladder. It is not used to diagnose a medical condition.
No
The device description clearly indicates it is a physical adaptor with elastomeric seals and is part of a hardware system for drug transfer and administration.
Based on the provided information, the Chemfort® Catheter Adaptor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a Closed System Transfer Device (CSTD) for mechanically prohibiting the release of drugs during administration and preventing microbial contamination. It is used for administering drugs to the patient's urinary bladder.
- Device Description: The description reinforces its function as an adaptor for drug transfer and administration to the urinary bladder via a catheter.
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes.
IVD devices are specifically designed to perform tests on samples like blood, urine, tissue, etc., outside of the body to diagnose or monitor a medical condition. The Chemfort® Catheter Adaptor is a device used for the delivery of a substance (drug) into the body, not for analyzing a sample from the body.
N/A
Intended Use / 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.
Product codes
ONB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
urinary bladder, urinary catheter
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Nurses or other healthcare professionals.
Hospitals, compounding centers and clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- . ISO 14971:2019 -Medical devices Medical devices -- Application of risk management to medical devices
- USP , Bacterial Endotoxins Test.
- USP , Transfusion and Infusion Assemblies and Similar Medical Devices. .
- USP , Particulate Matter in Injections ●
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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) |
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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 Zone | |
| Kiryat Shmona, 1101801 | |
| Israel | |
| Phone: | |
| Fax: | (972) 4 6908826 |
| (972) 74 7652161 | |
| FDA Registration Number | 9611423 |
| Contact Person: | Shay Shaham |
| 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 |
| Transfer 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 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.
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 Device
Chemfort® Catheter
Adaptor | Predicate Device
Tevadaptor® Catheter
Adaptor
(K180489) | 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® 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. | Tevadaptor® is a Closed
System Drug Transfer
Device (CSTD) that
mechanically prohibits the
release of the drug in
vapor, aerosol or liquid
form during preparation
and administration, and
prevents the introduction
of microbial and airborne
contaminants into the drug
or fluid path, allowing the
system to minimize
exposure of individuals,
healthcare personnel, and
the environment to
hazardous drugs. | First part:
Same meaning.
Second part: Tevadaptor®
was tested and proved to
prevent contaminants from
entering the drug or fluid
path for up to 3 days,
Chemfort® has been tested
and approved for 7 days |
| | Part of Chemfort®, a multi-
components system | Part of Tevadaptor®, a
multi-components system | Same |
| | components system | multi-components system | |
| | including Catheter Adaptor | including Catheter Adaptor | |
| Interaction with
other devices | The distal end connects to
the urinary catheter. | The distal end connects to
the urinary catheter. | Same |
| | The distal end connects to
the urinary catheter. | The distal end connects to
the urinary catheter. | |
| | The proximal end connects | The proximal end connects | |
| | Proposed Device
Chemfort® Catheter
Adaptor | Predicate Device
Tevadaptor® Catheter
Adaptor
(K180489) | Equivalence to predicate |
| | to Chemfort® Syringe
Adaptor / Syringe Adaptor
Lock. | to Tevadaptor® Syringe
Adaptor / Syringe Adaptor
Lock. | |
| Re-use
capability | Distal end: to maintain the
closed system, the Catheter
Adaptor should not be
disconnected from the
urinary catheter.
Proximal end: The
Chemfort® port of the
Catheter Adaptor can be
connected and
disconnected from the
Syringe Adaptor port up to
10 times. | Distal end: to maintain the
closed system, the Catheter
Adaptor should not be
disconnected from the
urinary catheter.
Proximal end: The
Tevadaptor® port of the
Catheter 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 the urinary
catheter. | No direct interaction-
device interaction with the
patient is achieved through
the passage of fluids
through the urinary
catheter. | Same |
| Interconnecting
features | Mechanical snap
connections. | Mechanical snap
connections. | Same |
| Safety features | • Vented cap
• Septum to septum
contact | • Vented cap
• Septum to septum
contact | Same |
| Target users | Nurses or other healthcare
professionals. | Nurses 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 | All of the Tevadaptor®
devices ports are sealed
with resealing Septum.
When Syringe Adaptor
and Tevadaptor® port are
joined, the two septums
are pressed together and
then pierced by a needle
(from the Syringe Adaptor | Same |
| | Proposed Device
Chemfort® Catheter
Adaptor | Predicate Device
Tevadaptor® Catheter
Adaptor
(K180489) | Equivalence to predicate |
| | thus creating a secured
fluid path. | thus creating a secured
fluid path. | |
| 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 |
| Biocompatibility | All Catheter Adaptor parts
that are in contact with
patient comply with the
requirements of ISO
10993-1 | All Catheter Adaptor parts
that are in contact with
patient comply with the
requirements of ISO
10993-1 | 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 , Bacterial Endotoxins Test.
- USP , Transfusion and Infusion Assemblies and Similar Medical Devices. .
- USP , 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.