(161 days)
Not Found
No
The summary describes a standard intravenous fluid administration set with mechanical components and does not mention any AI or ML capabilities.
No.
This device is designed for the administration of intravenous fluids, which is a supportive function, not a direct therapeutic treatment itself. It facilitates therapy but does not provide therapy.
No
This device is designed for administering intravenous fluids, not for diagnosing medical conditions. It facilitates treatment rather than identifying a disease or a patient's medical state.
No
The device description clearly outlines physical components such as a multiport IV manifold, integrated back-check valves, needleless injection sites, drip chamber, and roller clamps. The performance studies also focus on physical characteristics like sterilization, shelf life, bond strength, and biocompatibility, indicating a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the administration of intravenous fluids directly to a patient's vascular system. This is a therapeutic and delivery function, not a diagnostic one.
- Device Description: The description details components for fluid delivery (drip chamber, roller clamps, needleless injection sites, manifold), not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to test, examine, or analyze specimens derived from the human body to provide information for diagnostic purposes.
IVD devices are used in vitro (outside the body) to examine samples like blood, urine, or tissue to diagnose diseases or conditions. This device operates in vivo (within the body) for treatment.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FPA, FPK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinicians in a variety of clinical settings such as operating rooms, chemotherapy regimens, ICUs.
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)
Sterilization: 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: Verified to be 3 years.
Bench Testing: Functional performance testing including high pressure testing, bond strength testing, and solvent-exposure testing was completed with the proposed IV Administration Sets. Results 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
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
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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)
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510(k) SUMMARY
| DATE PREPARED | September 29, 2015 | |
|---|---|---|
| SUBMITTER: | Quest Medical, Inc. | |
| One Allentown Parkway | ||
| Allen, TX 75002 USA | ||
| 972-390-9800/800-627-0226 | ||
| Contact: Amy Clendening-Wheeler, Sr. Regulatory Affairs Specialist | ||
| Phone: (972) 332-6228 | ||
| Fax: (469) 795-2338 | ||
| Email: 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 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. | ||
| INTENDED USE: | 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. | ||
| 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 | | Modified
Device |
|--------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|--------------------|
| 510(k) | K800825 | K040385 | Under Review |
| Brand Name | Q2 Extension Set | Q2 Multiport® Manifold IV Set with
Swabable 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 |
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| | Predicate Devices | Modified
Device |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------|
| Clinical Use | based on the clinical need of the customer.
The devices are used by clinicians in a variety of clinical
settings such as operating rooms, chemotherapy regimens,
ICUs, ext. The devices have direct patient contact due to the
administration of fluids to the vascular system. A variety of
infusates such as anesthesia drugs, chemotherapeutics, total
parental nutrition (TPN) drugs, antibiotics, etc. The devices
themselves do not have any intended therapeutic claim. | SAME |
| Intended Use/
Indications for Use | 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. | SAME |
| Materials | | |
| Male Luer | Acrylic Cyro MED-2 plastic | Eastman Tritan
MX-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 of
Operation | 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 or
Reusable | 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.