(111 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of the IV administration sets, with no mention of AI or ML capabilities.
No.
The device administers intravenous fluids, which is a supportive rather than a therapeutic function.
No
Explanation: The device is described as an intravenous fluid administration set, used for delivering fluids to a patient's vascular system. Its purpose is for administration, not for diagnosis.
No
The device description clearly outlines physical components such as tubing, a multiport IV manifold, integrated back-check valves, needleless injection sites, a drip chamber, and roller clamps. The performance studies also focus on physical properties and testing of these hardware components.
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 into a patient's vascular system. This is a therapeutic/delivery function, not a diagnostic one.
- Device Description: The description details components for fluid delivery (tubing, drip chamber, clamps, injection sites), not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of the device being used to test or analyze samples (blood, urine, tissue, etc.) to provide information about a patient's health status or condition.
- Performance Studies: The performance studies focus on the physical and material properties of the device for safe and effective fluid delivery (bond strength, biocompatibility, sterilization, etc.), not on the accuracy or reliability of diagnostic results.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device operates in vivo (within the body) for therapeutic administration.
N/A
Intended Use / Indications for Use
The Q2 and CheckMate Multiport IV Administration Sets and Extension Sets are indicated for use for the following: 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 which may include a multiport IV manifold, integrated back-check valves, pre-attached needleless injection sites, drip chamber and roller clamps. The subject devices for this Premarket Notification are manufactured with tubing and drip chamber materials not made with the plasticizer Diethylhexylphthalate (DEHP).
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
Not Found
Intended User / Care Setting
clinicians in a variety of clinical settings such as operating rooms, chemotherapy regimens, ICUs, ext.
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 Testing: Functional performance testing including high pressure testing, bond strength testing, and solvent-exposure 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 devices.
Sterilization: Ethylene Oxide residuals testing performed for the devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals."
Shelf Life: Shelf life for the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber was verified to remain the same as for the current Q2 and CheckMate Multiport IV sets and Extension Sets at 3 years.
Biocompatibility: The materials of construction of a fully assembled representative IV Administration Set were tested according to ISO 10993-1:2009. Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Materialmediated Pyrogenicity tests were performed. Test results successfully verified that the IV Administration Set materials of construction, including the proposed new non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber, are biocompatible for their clinical application.
Pyrogen: Pyrogen testing for bacterial endotoxins was performed via the kinetic chromogenic LAL (Limulous Amebocyte Lysate) method. The results found that the proposed new materials do not introduce a level of endotoxin that exceed established guidelines.
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing right, with flowing lines suggesting movement or connection.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2016
Quest Medical, Inc. Amy Clendening-Wheeler Sr. Regulatory Affairs Specialist One Allentown Parkway Allen. Texas 75002
Re: K162304
Trade/Device Name: 020 Multiport IV Administration Sets and Extension Sets Checkmate® 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: November 9, 2016 Received: November 10, 2016
Dear Amy 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 (OS) 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,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang" in a document. The signature is a complex, looping design on the left side of the image. The name "Tina Kiang" is printed in a simple, sans-serif font, with a dash following the name. There is also a letter "S" below the name.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known)
Device Name
Q2 Multiport IV Administration Sets and Extension Sets CheckMate IV Administration Sets and Extensions Sets
Indications for Use (Describe)
The Q2 and CheckMate Multiport IV Administration Sets are indicated for use for the following: 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)
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 K162304
| DATE PREPARED: | December 5, 2016 | ||
|---|---|---|---|
| SUBMITTER: | Quest Medical, Inc. | ||
| One Allentown Parkway | |||
| Allen, TX 75002 USA | |||
| 972-390-9800/800-627-0226 | |||
| Contact: Amy Clendening-Wheeler | |||
| Phone: (972) 332-6228 | |||
| Fax: (469) 795-2338 | |||
| Email: awheeler@questmedical.com | |||
| DEVICE NAME: | Q2® Multiport IV Administration Sets and Extension Sets | ||
| CheckMate® IV Administration Sets and Extension Sets | |||
| COMMON NAME: | IV Administration Sets | ||
| CLASSIFICATION NAME: | Intravascular Administration Sets | ||
| PRODUCT CODE: | FPA, FPK | ||
| REGULATION: | 880.5440 | ||
| CLASS: | II | ||
| PREDICATE DEVICES: | Quest Medical, Inc. Q2 Multiport IV Administration Sets and Extension | ||
| Sets (K151079, K800825) and CheckMate IV Administration Sets and | |||
| Extension Sets (K040385) | |||
| DESCRIPTION: | Sterile, single use non-pyrogenic intravenous fluid administration sets | ||
| which may include a multiport IV manifold, integrated back-check | |||
| valves, pre-attached needleless injection sites, drip chamber and roller | |||
| clamps. The subject devices for this Premarket Notification are | |||
| manufactured with tubing and drip chamber materials not made with | |||
| the plasticizer Diethylhexylphthalate (DEHP). | |||
| INDICATIONS FOR USE: | The Q2 and CheckMate Multiport IV Administration Sets and | ||
| Extension Sets are indicated for use for the following: | |||
| For administration of intravenous fluids to a patient's vascular system |
4
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
Bench Testing
Functional performance testing including high pressure testing, bond strength testing, and solvent-exposure 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 devices.
Sterilization
There is no change to the sterilization process for the proposed Q2 and CheckMate Multiport IV Administration Sets and Extension Sets. Ethylene Oxide residuals testing performed for the devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals."
Shelf Life
Shelf life for the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber was verified to remain the same as for the current Q2 and CheckMate Multiport IV sets and Extension Sets at 3 years.
Biocompatibility
The materials of construction of a fully assembled representative IV Administration Set were tested according to ISO 10993-1:2009. Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Materialmediated Pyrogenicity tests were performed. Test results successfully verified that the IV Administration Set materials of construction, including the proposed new non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber, are biocompatible for their clinical application.
5
Pyrogen
Pyrogen testing for bacterial endotoxins was performed via the kinetic chromogenic LAL (Limulous Amebocyte Lysate) method. The results found that the proposed new materials do not introduce a level of endotoxin that exceed established guidelines.
Comparison to Predicate:
The following table shows a comparison between the device components of the currently marketed Q2 and CheckMate Multiport IV Administration Sets and Extension Sets with the current PVC tubing and PVC Drip Chamber to the Q2 and CheckMate Multiport IV Administration sets and Extension Sets manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber.
| Predicate Device | Modified Device | |||
|---|---|---|---|---|
| 510(k) | K151079 | K040385 | K800825 | Under Review |
| Model # | 9520, 9525A, | |||
| 9525B, 9527B, | ||||
| 95902, 22-201V | 9600, 9620, | |||
| 9621, 9622, | ||||
| 9652, 9657, | 9219, 9250, 9541, 9543, | |||
| 9545, 9546, 95701, 95702, | ||||
| 95704, 95707, 95710, | ||||
| 95711, 95712, 95713 | SAME | |||
| Brand Name | Q2 Multiport IV | |||
| Administration | ||||
| Sets and Extension | ||||
| Sets | Checkmate | |||
| Multiport IV | ||||
| Sets with | ||||
| Swabable | ||||
| Valves | Q2 IV Extension Sets | SAME | ||
| Manufacturer | Quest Medical, Inc. | SAME | ||
| Device | ||||
| Description | Q2 and Checkmate Multiport IV Administration Sets and | |||
| Extension 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 based on the clinical need of the customer. | SAME | |||
| Clinical Use | 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. | SAME |
6
| Predicate Device | Modified Device | |
|---|---|---|
| Use of a needle-free system may aid in the prevention of | ||
| needlestick injuries. | ||
| Materials | ||
| Male Luer | Eastman Tritan MX-711 | SAME |
| Tubing | PVC, Colorite 5004A, clear | Single Laminate: |
| Alpha Gary 2235L-80 | ||
| Multi Laminate: | ||
| Outer Layer: Alpha Gary | ||
| 2222C-80 | ||
| Middle Layer: EVA Dupont | ||
| Elvax 265 | ||
| Inner Layer: LDPE Dow | ||
| 690 HT+ | ||
| 6 port Manifold | Polycarbonate housing, silicone stem, polyisoprene checkvalve | SAME |
| Filter | Copolyester housing, Durapel PVDF, Polyestersulfone | SAME |
| Swabable Y-site | Polycarbonate and silicone | SAME |
| Inline checkvalve | Plexi-Glas | SAME |
| Drip Chamber | ||
| Barrel | PVC: PTV-402-BT 1 clear | PVC: Colorite 7277G-402M |
| Spike | PVC, ABS, PP, LDPE | SAME |
| Technology | ||
| Energy Source | User Operated | SAME |
| Principle of | ||
| Operation | Luer activation | SAME |
| Sterilization/Pkg | ||
| Method | EtO, 100% | SAME |
| Minimum SAL | 1 x 10-6 | SAME |
| Packaging | Tyvek polyethylene/Mylar pouch; heat-sealed | SAME |
| Shelf Life | Three (3) Years | SAME |
| Disposable or | ||
| Reusable | Disposable | SAME |
CONCLUSION:
Results of all functional performance and biocompatibility testing conducted successfully demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets manufactured with the proposed non-DEHP patient-contacting tubing formulations and non-DEHP Drip Chamber are substantially equivalent to the legally marketed predicate devices.