(272 days)
Not Found
No.
The device is a mechanical stopcock for fluid control, with its operation explicitly stated as "manual." There is no mention of any computational, analytical, or learning capabilities.
No.
Explanation: The device is intended as a flow control and delivery device for I.V. fluids, including Lipiodol, for injection into the patient's vascular system. It does not directly treat a disease or condition itself, but rather facilitates the delivery of therapeutic substances.
No
Explanation: The Qitexio® 4-Way Stopcock is described as a "flow control and delivery device" for injecting fluids into the vascular system. Its purpose is to facilitate the administration of substances like I.V. fluids and Lipiodol, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly defines a physical, mechanical medical device (a 4-Way Stopcock) made of a body with ports and a handle. There is no mention of software components, algorithms, or digital processing.
No.
The device is a stopcock for controlling the flow of IV fluids and is not stated to be used for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.
Product codes
FMG
Device Description
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.
Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed.
The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Patient's vascular system
Indicated Patient Age Range
All adult and pediatric population who may need an administration of Lipiodol® and other solutions
Intended User / Care Setting
Not Found
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)
Bench Test:
- Bore connectors with the Female & Male Luer Lock standard, Stopcock Body Pressure Withstand: Test results are satisfactory for the requirements based on ISO 80369-7 and ISO 80369-20.
- Mechanical and Chemical resistance to Lipiodol: Performance testing performed before and after 24h exposure to Lipiodol®. Lipiodol® analysis report is compliant with the Medex internal criteria.
- Stopcock Lever Rotation & Tightness: Verification of the stopcock requirement related to breakaway torque and mean torque during rotation. Verification results met the Medex internal criteria.
Sterilization & Package Integrity:
- Sterile Barrier Integrity Test: Test results are satisfactory for the requirements based on ISO 11607-1, ASTM F1980-21, and ASTM F1886/F1886M-16.
- Microbiological Validation of Sterilization Method: Test results are satisfactory for the requirements based on ISO 11137-1, ISO 11137-2, ISO 11737-1, and ISO 11737-2.
Biocompatibility:
- Cytotoxicity: Test results are satisfactory for the requirements based on ISO 10993-5.
- Irritation & Sensitization: ISO 10993-10
- Acute Systemic Toxicity: ISO 10993-11
- Hemocompatibility: ISO 10993-4, ISO 10993-12, ASTM F756-17
- Chemical Characterization - Extractables: ISO 10993-17, ISO 10993-18, ISO/TS 10993-19
- Material-mediated pyrogen: USP Pyrogen Test
- Particulate Contamination Study: Test results are satisfactory for the requirements based on USP.
Pyrogenicity:
- Bacterial Endotoxins Test: Test results are satisfactory for the requirements based on USP and ANSI/AAMI ST72.
Transportation:
- ISTA 3A Simulated Transportation Study: Test results are satisfactory for the requirements based on ISTA 3A-2018.
User Related Risk Analysis:
- Use Related Risk Analysis and Usability Engineering: No Use-related critical task was identified due to differences between the predicate and the Qitexio® 4-Way Stopcock. No Human Factors Validation study was conduct.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
FDA 510(k) Clearance Letter - Qitexio® 4-Way Stopcock
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 29, 2025
Medex
℅ Haewon Park
Regulatory Affairs Associate II
Guerbet LLC
214 Carnegie Center, Suite 300
Princeton, New Jersey 08540
Re: K242255
Trade/Device Name: Qitexio® 4-Way Stopcock (QIT014)
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: Class II
Product Code: FMG
Dated: March 26, 2025
Received: March 28, 2025
Dear Haewon Park:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
Page 2
K242255 - Haewon Park Page 2
(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K242255 - Haewon Park Page 3
Sincerely,
David Wolloscheck, Ph.D.
Assistant Director
DHT3C: Division of Drug Delivery and
General Hospital Devices, and
Human Factors
OHT3: Office of Gastrorenal, ObGyn,
General Hospital, and Urology Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K242255
Device Name: Qitexio® 4-Way Stopcock (QIT014)
Indications for Use (Describe):
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.
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."
Page 5
K242255 - 510K Summary
I. OWNER
Medex
240 Allée Jacques Monod
69800 Saint-Priest, Rhône-Alpes, France
II. Contact Person
Haewon Park, Ph.D.
Regulatory Affairs Associate II
Guerbet LLC
214 Carnegie Drive, Suite 300
Princeton, NJ 08540
Email: Haewon.park@guerbet.com
Phone: 1-609-423-9641
Date Prepared: April 29th, 2025
III. IDENTIFICATION OF THE SUBJECT DEVICE
Trade/Device Name: Qitexio® 4-Way Stopcock (QIT014)
Common Name: I.V. Set Stopcock
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular administration set
Regulatory Class: Class II
Product Code: FMG
IV. PREDICATE DEVICE INFORMATION
Trade/Device Name: Elcam High and Medium Pressure Stopcocks and Manifold (K123084)
Common Name: I.V. Set Stopcock
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular administration set
Regulatory Class: Class II
Product Code: FMG
V. DEVICE DESCRIPTION
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. Qitexio® 4-Way Stopcock is not intended to facilitate bi-directional flows, thus is not designed to be used in infusion. Qitexio® 4-Way Stopcock is designated for
Page 6
single use only (disposable) and is MR safe. Qitexio® 4-Way Stopcock is robust under medium pressure and is verified to be used for Lipiodol (Ethiodized oil) delivery.
Qitexio® 4-Way Stopcock is made of a body with four ports (3 female and one male) and one handle with a L-Shape diverter. The L-shaped diverter opens two neighboring ports at the same time, creating a L-shaped communication channel. The male connector includes a mobile ring assembled on the end of male port, and it enables connection locking over female Luer. A small amount of lubricant is applied on the handle stem before placing it in the Stopcock body. The neighboring female port(s) is connected to the I.V. set to accept the delivered drug or fluid. One female port, that is on the opposite side of the male port, does not directly communicate with the patient (male port). This extra port is designed to enable users to inject multiple I.V. fluids, if needed.
The operating mechanism is manual and with a simple twisting handle position to determine direction of the fluids. Qitexio® 4-Way Stopcock has only two ports communicating at a time.
VI. INDICATIONS FOR USE
Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol® (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion.
VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Qitexio® 4-Way Stopcock, the subject device, is substantially equivalent to the legally marketed predicate, Elcam High and Medium Pressure Stopcock and Manifolds (K123084). Both are intended to serve as flow control and delivery devices for I.V. fluids injection to the patient's vascular system. Both devices are for single use only and are provided in the individually sterilized packages. Both devices have one male Luer that connects to patient with a mobile/rotating ring, which secures locking over female connection. Both devices can resist medium pressure up to 500 psi, making them ideal for the administration of I.V. fluids that require higher pressure.
Qitexio® 4-Way Stopcock is indicated to provide access ports for the delivery of Lipiodol, the iodinated contrast imaging agent. Medex has performed non-clinical bench performance and biocompatibility testing, to show that this technological difference does not raise any concerns for the safety or effectiveness of the subject device compared to the predicate.
Page 7
Table 1. Substantial Equivalence Table for the Qitexio® 4-Way Stopcock and its predicate
| Description | Qitexio® 4-Way Stopcock K242255 (subject device) | Elcam High and Medium Pressure Stopcocks and Manifold K123084 (predicate device) | Technological Features Differences |
|---|---|---|---|
| Indications for use | Qitexio® 4-Way Stopcock is intended to serve as a flow control and delivery device for I.V. fluids injection to the patient's vascular system. The device is indicated for medium pressure injection of fluids. It is also used for delivery of Lipiodol (Ethiodized Oil) injection. It is intended for single use only. The device is not indicated for use in infusion. | Elcam's High and Medium Pressure Stopcocks and High and Premium High-Pressure Manifolds are intended to serve as flow control and delivery devices for I.V fluids injection to the patient's vascular system. The devices are indicated for medium and high-pressure injection of fluids such as, but not limited to, fluids used during angiography and angioplasty and during interventional radiology and cardiology procedures. Devices indication for medium and high pressure does not preclude its use for low pressure procedures. The High and Medium Pressure Stopcocks and High and Premium High-Pressure Manifolds are intended for single use only. | Different - Some technological differences such as Lipiodol compatibility of the stopcock have been tested and demonstrated that such differences do not raise new or different questions of safety or effectiveness. |
| Intended Patient Population | All adult and pediatric population who may need an administration of Lipiodol® and other solutions | All populations who may be subject to the device's intended use | Lipiodol compatibility of the stopcock has been evaluated under performance test. |
| Design - Number of side ports | 4 ports (3 female / 1 male) | 3 ports (2 female / 1 male) | Difference in female port numbers was addressed under Use-Related Risk Analysis Study. |
| Number of flow ways | 4-Way | 4-Way |
Page 8
| Description | Qitexio® 4-Way Stopcock K242255 (subject device) | Elcam High and Medium Pressure Stopcocks and Manifold K123084 (predicate device) | Technological Features Differences |
|---|---|---|---|
| Single use? | Yes | Yes | No difference |
| Packaging | PET/PE pouch sealed with Tyvek lid | Tyvek or paper/polyethylene pouch | Different; The difference arises from adherence to two different industry practices and does not introduce any new or different questions of safety or effectiveness. |
| Transportation and Storage Condition | No special storage or transportation condition. Recommends to store in room temperature; store in dry and warm place, and not exposed to strong light. | NA | Industrial standards The sponsor assumes no significance difference |
| Principle of Operation | Manual twisting of handle Manually connect and/or disconnect with any compatible Luer fittings | Manual twisting of handle Manually connect and/or disconnect with any compatible Luer fittings | No difference |
Page 9
| Description | Qitexio® 4-Way Stopcock K242255 (subject device) | Elcam High and Medium Pressure Stopcocks and Manifold K123084 (predicate device) | Technological Features Differences |
|---|---|---|---|
| Overall shape | Body with 4 ports and a handle on the top | Body with 3 ports and a handle on the top | Different - The overall shape of the subject device was evaluated for its dimensions, leakage, biocompatibility, and Luer connectivity under performance tests. This difference does not raise any new or different questions of safety or effectiveness. |
| Device Dimension | 52.5mm(L) x 44mm(D) x 26.8mm(H) | NA | The sponsor assumes no significance difference |
| Maximum pressure | Up to 550 psi | MP stopcocks: Up to 500 psi HP stopcocks: Up to 1200 psi | Different - The subject device has a maximum pressure rating of up to 550 psi, which falls within the range of medium- and high-pressure ratings of the predicate device. Therefore, this difference does not raise any new or different questions of safety or effectiveness. |
| Material | Polyamide (Body and rotator) Polybutylene terephthalate (Handle) | Polycarbonate LEXAN (Body, rotator) Acetal Ultraform (Handle) | Material differences are tested for biocompatibility, chemical characterization, torque, and burst tests. |
Page 10
| Description | Qitexio® 4-Way Stopcock K242255 (subject device) | Elcam High and Medium Pressure Stopcocks and Manifold K123084 (predicate device) | Technological Features Differences |
|---|---|---|---|
| Biocompatibility | Biocompatible according to ISO 10993-1 | Biocompatible according to ISO 10993-1 | No difference. Biocompatibility has been tested according to the same ISO standard. |
| Sterilization Method | Gamma Irradiation | EtO | Different; Industrial standards |
| Chemical resistance to Lipid | Yes (Lipiodol) | No | Lipiodol resistance of the subject device has been evaluated for 24 hours |
| Shelf life | 3 years | Up to 1 year | Different - The shelf life of the subject device has been verified by both accelerated and real-time aging. Therefore, this difference does not raise any new or different questions of safety or effectiveness. |
Page 11
As summarized in Table 1, Qitexio® 4-way Stopcock, the subject device, has the same intended use as the predicate device, with a restriction related to the fact that the subject device is not intended to high pressure injection of fluids.
The engineering design, physical shape, principle of operation, and the intended use of the subject device are substantially equivalent to the predicate device. Both devices are for the single use only, and both devices are provided in the individual sterilized packages. Both, the subject device and the predicate device, have one male Luer that connects to patient with a mobile/rotating ring that secures locking over female connection. Both subject device and the predicate device can resist medium pressure up to 500 psi, making them ideal for the administration of I.V. fluids that require higher pressure. In terms of chemical characteristics, such as Lipiodol resistance, shelf-life, and sterilization method, the sponsor has provided test reports that support the sponsor's claim that those differences do not raise any concern for using the subject device.
The subject device is different from the predicate in the following three main categories:
- Difference in Physical Design
- Difference in Chemical Composition of Materials
- Difference in Lipiodol Resistance
The sponsor has addressed the differences in the above three categories as follows.
Physical Design:
Compared to the predicate, the subject device includes an extra female port and opens two ports at the same time using the L-shape diverter. The risks associated with the design differences, such as the additional female port and L-shaped diverter, have been addressed in URRA for US stopcock report. In the URRA report, the sponsor concluded that there was no use-related critical task due to the differences between the predicate device and the subject device. In addition, the overall shape of the Qitexio stopcock was evaluated for its dimensions, leakage, biocompatibility, and Luer connectivity. From URRA report, the sponsor concluded the differences between the subject device and the primary predicate device did not affect device safety and effectiveness.
Chemical Composition of Materials
The differences in the materials used for the stopcock construction have been evaluated through the biocompatibility studies per ISO 10993-1 series and through the chemical characterization study per ISO 10993-18 requirements. The housing body and mobile ring of the subject device are both made of polyamide, while the handle of Qitexio stopcock is made of polybutylene terephthalate.
Page 12
In this chemical characterization study, the sponsor used hexane as the extraction solvent as representative of the clinical use of the device based on the non-polar physical properties of hexane being similar to nonpolar Lipiodol (Ethiodized Oil). Because hexane can extract organic additives better than Lipiodol, it was chosen as the worst-case extraction solvent.
Lipiodol Resistance:
Instead of evaluating the resistance of Qitexio® stopcock to lipids, such as triglycerides phospholipids and sterols, the sponsor evaluated 24 hours of physical resistance of Qitexio to Lipiodol to make the evaluation clinically more meaningful. Performance tests verified breakaway torque, mean torque during rotation, withstands pressure, and stop resistance torque of stopcock, demonstrating that the subject device maintains its physical performance characteristics after 24 hrs of exposure to Lipiodol®.
VIII. Performance Data
Sponsor used the FDA Guidance "Intravascular Administration Sets Premarket Notification Submissions," issued on July 11, 2008, to guide the list of performance data and standards. In this submission, the sponsor has identified the following regulatory standards and non-clinical performance tests for conformity.
Table 2. Performance Testing
| Type of Tests | Recognized Consensus Standards | Conclusions |
|---|---|---|
| Bench Test | ||
| Bore connectors with the Female & Male Luer Lock standard, Stopcock Body Pressure Withstand | ISO 80369-7 Second edition: 2021-05, Small bore connectors for liquids and gases in healthcare applications, part 7: Connectors for intravascular or hypodermic applications |
ISO 80369-20 First edition: 2015-05-15, Small-bore connectors for liquids and gases in healthcare applications – Part 20: Common test methods | The test results are satisfactory for the requirements. |
| Mechanical and Chemical resistance to Lipiodol | Performance testing performed before and after 24h exposure to Lipiodol®. | Lipiodol® analysis report is compliant with the Medex internal criteria. |
| Stopcock Lever Rotation & Tightness | Verification of the stopcock requirement related to breakaway torque and mean torque during rotation. | Verification results met the Medex internal criteria. |
Page 13
| Type of Tests | Recognized Consensus Standards | Conclusions |
|---|---|---|
| Sterilization & Package Integrity | ||
| Sterile Barrier Integrity Test | ISO 11607-1 Second edition:2019-02 (including AMD1:2023), Packaging for terminally sterilized medica devices – Part 1: Requirements for materials sterile barrier systems and packaging systems |
ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems and Medical Devices
ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection | The test results are satisfactory for the requirements. |
| Microbiological Validation of Sterilization Method | ISO 11137-1:2006, Sterilization of healthcare products – Radiation Part 1-Requirements for development, validation and routine control of a sterilization process for medical devices
ISO 11137-2:2013, Sterilization of healthcare products – Radiation Part 2 – Establishing the sterilization dose
ISO 11737-1:2018, Sterilization of healthcare products – Microbiological methods Part 1- Determination of a population of microorganisms on products
ISO 11737-2:2019, Sterilization of healthcare products – Microbiological methods Part 2 – Tests of sterility performed in the definition, validation and maintenance of a sterilization process | The test results are satisfactory for the requirements. |
| Biocompatibility | | |
| Cytotoxicity | ISO 10993-5, 3rd edition 2009-06-01, Biological Evaluation of Medical Devices, Part 5: Tests for In Vitro Cytotoxicity. | The test results are satisfactory for the requirements. |
| Irritation & Sensitization | ISO 10993-10, 4th edition 2021-11, Biological Evaluation of Medical Devices, Part 10: Tests for skin sensitization | |
| Acute Systemic Toxicity | ISO 10993-11, 3rd edition 2017 Biological Evaluation of Medical Devices, Part 11: Tests for systemic toxicity. | |
Page 14
| Type of Tests | Recognized Consensus Standards | Conclusions |
|---|---|---|
| Hemocompatibility | ISO 10993-4, 3rd edition 2017-04, Biological Evaluation of Medical Devices, Part 4: Selection of Tests for Interactions with Blood. |
ISO 10993-12, 5th edition 2021-01, Biological Evaluation of Medical Device, Part 12: Sample preparation and reference materials
ASTM F756-17: Standard practice for assessment of hemolytic properties of materials | |
| Chemical Characterization - Extractables | ISO 10993-17, 2nd edition 2023, Biological Evaluation of Medical Devices, Part 17: Toxicological risk assessment of medical device constituents
ISO 10993-18, 2nd edition 2020-01, Biological Evaluation of Medical Device, Part 18: Chemical Characterization of medical device material within a risk management process
ISO/TS 10993-19, 2nd edition 2020, Biological Evaluation of Medical Device, Part 19: Physico-chemical, morphological and topological characterization of materials | |
| Material-mediated pyrogen | USP Pyrogen Test | |
| Particulate Contamination Study | USP Particulate Matter in Injection | The test results are satisfactory for the requirements. |
| Pyrogenicity | | |
| Bacterial Endotoxins Test | USP Bacterial Endotoxins Tests
ANSI/AAMI ST72 (2011/R2016): bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing. | The test results are satisfactory for the requirements. |
| Transportation | | |
| ISTA 3A Simulated Transportation Study | ISTA 3A-2018: Packaged-products for parcel delivery system shipment 70kg (150Lb) or less | The test results are satisfactory for the requirements. |
| User Related Risk Analysis | | |
| Use Related Risk Analysis and Usability Engineering | FDA Guidance "Human Factors and Usability Engineering to Medical Devices," Feb 2016
IEC 62366-1:2015, Medical Devices Part 1: Application of usability engineering to medical devices | No Use-related critical task was identified due to differences between the predicate and the Qitexio® 4-Way Stopcock.
No Human Factors Validation study was conduct. |
Page 15
IX. CONCLUSIONS
The Qitexio® 4-Way Stopcock is substantially equivalent to its predicate device. The intended use of the Qitexio® 4-Way Stopcock aligns with that of the predicate device, with the restriction that it is not intended for high-pressure injection of fluids.
Both devices are single use, individually sterilized, and feature a male Luer connection with a mobile/rotating ring for secure locking over a female connection. Both devices can withstand medium pressure up to 500 psi, allowing for administering IV fluids requiring higher pressure. Differences in Lipiodol resistance, shelf-life, and sterilization methods have been evaluated via non-clinical performance testing according to international standards and FDA guidance and demonstrated that these differences do not impact the device's safety or effectiveness, as confirmed by test reports.
The technological differences between the Qitexio® 4-Way Stopcock and the predicate device are minor and do not raise new questions of safety or effectiveness. The device's performance, as demonstrated through bench testing and biocompatibility studies (including chemical characterization), confirms that the Qitexio® 4-Way Stopcock performs as intended. The Qitexio® 4- Way Stopcock is substantially equivalent to the legally marketed predicate device, with no new concerns regarding safety or effectiveness.