(161 days)
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
Sterile, single use non-pyrogenic intravenous fluid administration sets with a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The reason for the submission was a material change to the male luer component.
The acceptance criteria and study proving device performance are described below for the Q2® Multiport IV Administration Sets and Extension Sets.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Ethylene Oxide Residuals Testing complies with ISO 10993-7:2008 | Complies with ISO 10993-7:2008 |
| Shelf Life | Verified to remain at 3 years |
| Bench Testing (high pressure, bond strength, solvent exposure) demonstrates performance similar to predicate device | Successfully demonstrated similar performance to predicate device |
| Biocompatibility of materials (new male luer: Tritan MX-711) for clinical application | Test results successfully verified biocompatibility |
2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes used for each individual test (sterilization residuals, shelf life, bench testing, biocompatibility). It generally refers to "the proposed IV Administration Sets" and "the materials of construction of a fully assembled IV Administration Set."
The data provenance is from bench testing and laboratory testing performed by Quest Medical, Inc., the device manufacturer. No specific country of origin for the data is mentioned beyond the company's US address. The nature of these tests suggests they are prospective in relation to the submission, as they were conducted to support the substantial equivalence claim for the modified device.
3. Number of Experts and Qualifications for Ground Truth:
This device is an IV administration set, not an AI or diagnostic imaging device that typically requires human expert consensus for ground truth. Therefore, the concept of "experts used to establish the ground truth" in the traditional sense of medical image interpretation or clinical diagnosis does not apply directly here.
Instead, the "ground truth" for the performance criteria is established by:
- Industry standards and regulations: ISO 10993-7:2008 for sterilization residuals, and general biocompatibility testing principles per ISO 10993-1:2009.
- Engineering and materials science principles: For bench testing (high pressure, bond strength, solvent exposure) to ensure functional integrity.
The "experts" involved would be the engineers, toxicologists, and quality assurance personnel who designed, executed, and interpreted these technical tests according to established protocols and standards. Their qualifications would stem from their expertise in relevant engineering, materials science, and regulatory compliance fields.
4. Adjudication Method for the Test Set:
Not applicable in the human-in-the-loop sense. The "adjudication" is based on objective measurements against predetermined specifications and accepted industry standards (e.g., meeting ISO limits, specified bond strengths, no adverse reactions in biocompatibility tests). There is no mention of a human adjudicator reviewing conflicting interpretations of results, as the tests produce objective data.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a medical device (IV administration set), not a diagnostic algorithm or AI-assisted diagnostic tool. Therefore, a MRMC study to compare human reader performance with and without AI assistance is not relevant to this submission.
6. Standalone (Algorithm Only) Performance:
No. This device does not involve an algorithm or AI. It is a physical medical device.
7. Type of Ground Truth Used:
The ground truth is established through:
- Objective laboratory measurements and tests: For physical performance (e.g., pressure resistance, bond strength).
- Compliance with recognized international standards: Such as ISO 10993-7:2008 for Ethylene Oxide Residuals and ISO 10993-1:2009 for Biocompatibility.
- Comparison to the legally marketed predicate device: Demonstrating that the modified device performs "similarly to the predicate device" in functional tests.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set. The "training" for such a device effectively comes from the established engineering principles, design specifications, and manufacturing processes, rather than a data-driven model.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as no training set (in the AI/ML sense) is involved. The "ground truth" for the design and manufacturing of such a device is established through:
- Historical performance of predicate devices.
- Industry best practices and engineering standards.
- Regulatory requirements.
- Material properties and scientific understanding of their behavior.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2015
Quest Medical, Inc. Ms. Amy Clendening-Wheeler Senior Regulatory Affairs Specialist One Allentown Parkway Allen, Texas 75002
Re: K151079
Trade/Device Name: Q2® Multiport IV Administration Sets and Extension Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA, FPK Dated: April 20, 2015 Received: April 22, 2015
Dear Ms. Clendening-Wheeler:
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. 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.
{1}------------------------------------------------
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name
Q2 Multiport IV Administration Sets and Extension Sets
Indications for Use (Describe)
For administration of intravenous fluids to a patient's vascular system utilizing needleless components and an I.V. manifold for multiple simultaneous intravenous therapy via gravity, syringe, or infusion pump. Use of a needle-free system may aid in the prevention of needle-stick injuries.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X 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}------------------------------------------------
510(k) SUMMARY
| DATE PREPARED | September 29, 2015 | |
|---|---|---|
| SUBMITTER: | Quest Medical, Inc.One Allentown ParkwayAllen, TX 75002 USA972-390-9800/800-627-0226 | |
| Contact: Amy Clendening-Wheeler, Sr. Regulatory Affairs SpecialistPhone: (972) 332-6228Fax: (469) 795-2338Email: awheeler@questmedical.com | ||
| DEVICE NAME: | Q2® Multiport IV Administration Sets and Extension Sets | |
| COMMON NAME: | IV Administration Set | |
| CLASSIFICATION NAME | Intravascular Administration Set | |
| Product Code: | FPA, FPK | |
| Regulation Number: | 880.5440 | |
| Class: | II | |
| PREDICATE DEVICES: | Quest Medical, Inc. Extension Sets (K800825)Quest Medical, Inc. IV Administration Sets (K040385) | |
| DESCRIPTION: | Sterile, single use non-pyrogenic intravenous fluid administration setswith a multiport IV manifold and integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. Thereason for the submission was a material change to the male luercomponent. | |
| INTENDED USE: | For administration of intravenous fluids to a patient's vascular systemutilizing needleless components and an I.V. manifold for multiplesimultaneous intravenous therapy via gravity, syringe, or infusion pump. | |
| Use of a needle-free system may aid in the prevention of needle-stickinjuries. | ||
| SUBSTANTIAL EQUIVALENCE |
Performance Testing
{4}------------------------------------------------
Sterilization
There is no change to the sterilization process for the proposed Q2® Multiport IV Administration Sets and Extension Sets. Ethylene Oxide residuals testing performed for the modified Male Luer made from Tritan MX711 complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals."
Shelf Life
Shelf life for the proposed Q2® Multiport IV Administration Sets and Extension Sets was verified to remains the same as for the current Q2® Multiport IV Administration Sets and Extension Sets at 3 years.
Bench Testing
Functional performance testing including high pressure testing, bond strength testing, and solventexposure testing was completed with the proposed IV Administration Sets to demonstrate that the sets perform as intended. Results of testing successfully demonstrated that the proposed devices perform similarly to the predicate device.
Biocompatibility
The materials of construction of a fully assembled IV Administration Set were tested according to ISO 10993-1:2009. Test results successfully verified that the IV Administration Set materials of construction, including the male luer comprised of the Tritan MX-711 material, are biocompatible for their clinical application.
Comparison to Predicate:
The following table shows a comparison between the device components of the currently marketed Q2® Multiport IV Administration Sets and Extension Sets with the current Male Luer connector to the proposed Q2® Multiport IV Administration Sets and Extension Sets with new material Male Luer.
| Predicate Devices | ModifiedDevice | ||
|---|---|---|---|
| 510(k) | K800825 | K040385 | Under Review |
| Brand Name | Q2 Extension Set | Q2 Multiport® Manifold IV Set withSwabable Valves | SAME |
| Model # | 95902 | 9520, 9525A, 9526B, 9527B, 22-201-V | SAME |
| Manufacturer | Quest Medical, Inc. | SAME | |
| Device Description | Q2 extension sets and iv administration sets are sterile, non-pyrogenic, single-use intravenous fluid delivery devices. Some models have a multiport IV manifold with backcheck valves, pre-attached needleless injections sites, drip chamber and roller clamps. They are non-invasive devices for short-term use. They deliver either a single infusate or multiple infusates | SAME |
{5}------------------------------------------------
| Predicate Devices | ModifiedDevice | |
|---|---|---|
| Clinical Use | based on the clinical need of the customer.The devices are used by clinicians in a variety of clinicalsettings such as operating rooms, chemotherapy regimens,ICUs, ext. The devices have direct patient contact due to theadministration of fluids to the vascular system. A variety ofinfusates such as anesthesia drugs, chemotherapeutics, totalparental nutrition (TPN) drugs, antibiotics, etc. The devicesthemselves do not have any intended therapeutic claim. | SAME |
| Intended Use/Indications for Use | For administration of intravenous fluids to a patient's vascularsystem utilizing needleless components and an I.V. manifoldfor multiple simultaneous intravenous therapy via gravity,syringe, or infusion pump.Use of a needle-free system may aid in the prevention ofneedle-stick injuries. | SAME |
| Materials | ||
| Male Luer | Acrylic Cyro MED-2 plastic | Eastman TritanMX-711 |
| Tubing | PVC | Identical |
| 6 port Manifold | Polycarbonate housing, silicone stem, polyisoprene checkvalve | Identical |
| Filter | Copolyester housing, Durapel PVDF, Polyestersulfone | Identical |
| Swabable Y-site | Polycarbonate and silicone | Identical |
| Inline checkvalve | Plexi-Glas | Identical |
| Drip Chamber | PVC | Identical |
| Spike | PVC, ABS, PP, LDPE | Identical |
| Technology | ||
| Energy Source | User Operated | Identical |
| Principle ofOperation | Luer activation | Identical |
| Sterilization/Pkg | ||
| Method | EtO, 100% | Identical |
| Minimum SAL | $1 \times 10^{-6}$ | Identical |
| Packaging | Tyvek polyethylene; heat-sealed | Identical |
| Shelf Life | Three (3) Years | Identical |
| Disposable orReusable | Disposable | Identical |
CONCLUSION:
Results of functional performance and biocompatibility testing conducted with the proposed and predicate devices demonstrate that the Q2® Multiport IV Administration Sets and Extension Sets are substantially equivalent to the legally marketed predicate device.
§ 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.