(111 days)
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.
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).
Acceptance Criteria and Device Performance for Q2 and CheckMate Multiport IV Administration Sets and Extension Sets
This document describes the acceptance criteria and the studies performed to demonstrate that the Q2 and CheckMate Multiport IV Administration Sets and Extension Sets (with non-DEHP tubing and drip chamber) meet these criteria, thereby proving substantial equivalence to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Functional Performance | ||
| High Pressure Testing | Perform as intended (similar to predicate devices). | Successfully demonstrated that the proposed devices perform similarly to the predicate devices. |
| Bond Strength Testing | Perform as intended (similar to predicate devices). | Successfully demonstrated that the proposed devices perform similarly to the predicate devices. |
| Solvent-Exposure Testing | Perform as intended (similar to predicate devices). | Successfully demonstrated that the proposed devices perform similarly to the predicate devices. |
| Sterilization | ||
| Ethylene Oxide Residuals | Complies with ISO 10993-7:2008 "Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals." | 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. |
| Shelf Life | ||
| Shelf Life | Maintain a shelf life of 3 years. | Verified to remain the same as for the current Q2 and CheckMate Multiport IV sets and Extension Sets at 3 years. |
| Biocompatibility | ||
| Overall Biocompatibility | Materials of construction, including proposed new non-DEHP PVC tubing and Drip Chamber, are biocompatible for clinical application based on ISO 10993-1:2009. | 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. This included Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Material-mediated Pyrogenicity tests. |
| Pyrogenicity | Proposed new materials do not introduce a level of endotoxin that exceeds established guidelines. | Pyrogen testing for bacterial endotoxins via the kinetic chromogenic LAL method found that the proposed new materials do not introduce a level of endotoxin that exceeds established guidelines. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific numerical sample sizes used for each of the test sets (e.g., how many units were subjected to high pressure testing, how many for biocompatibility). However, it indicates that testing was performed on "the proposed IV Administration Sets" and "a fully assembled representative IV Administration Set" and "devices manufactured with the proposed non-DEHP polyvinyl chloride tubing formulations and non-DEHP Drip Chamber."
The data provenance is internal to Quest Medical, Inc. The studies appear to be prospective as they were conducted specifically for this 510(k) submission to demonstrate the performance of the modified device. The country of origin of the data is implicitly the USA, where Quest Medical, Inc. is located.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This document describes performance testing for medical devices (IV administration sets), not diagnostic or interpretative studies requiring expert ground truth establishment for a test set. Therefore, this section is not applicable in the context of this submission. The "ground truth" for these tests is defined by established international standards (e.g., ISO 10993) and engineering specifications.
4. Adjudication Method for the Test Set
Adjudication methods (e.g., 2+1, 3+1, none) are typically used in clinical studies or studies involving human expert interpretation to resolve discrepancies in diagnoses or assessments. Given that this is a submission for an IV administration set based on functional and biocompatibility bench testing, an adjudication method for a "test set" in this context is not applicable. The results are quantitative measurements against predetermined specifications or qualitative observations of performance according to established test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically conducted for diagnostic imaging devices or algorithms where human readers interpret medical cases, and the effectiveness of an AI system, with or without human assistance, is evaluated. This submission pertains to an IV administration set, a non-diagnostic medical device.
6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done
This question is geared towards AI/algorithmic devices. Given that the device is an IV administration set, there is no algorithm involved, and thus, no standalone (algorithm-only) study was performed. The performance evaluation focuses on the physical and chemical properties of the device components.
7. The Type of Ground Truth Used
For this device, the "ground truth" for evaluating its performance is based on established industry standards, regulatory guidelines, and scientific protocols. Specifically:
- Bench Testing: Performance specifications derived from engineering principles and comparison to predicate devices.
- Sterilization: Compliance with ISO 10993-7:2008 for Ethylene Oxide residuals.
- Shelf Life: Internal validation protocols to confirm stability over time.
- Biocompatibility: Adherence to ISO 10993-1:2009 for material biocompatibility. Specific tests like Hemocompatibility, Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Subchronic Toxicity, and Material-mediated Pyrogenicity are part of this standard.
- Pyrogenicity: Compliance with established guidelines for endotoxin levels, measured using the kinetic chromogenic LAL method.
8. The Sample Size for the Training Set
This document does not describe a machine learning algorithm, and therefore, there is no training set in the conventional sense. The "training" or development of the device itself would involve engineering design and prototype testing, but not a dataset for training an algorithm.
9. How the Ground Truth for the Training Set was Established
As there is no training set for an algorithm, this question is not applicable. The development of the device relies on design inputs, engineering specifications, and adherence to quality system regulations, rather than ground truth established from a training dataset.
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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.
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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,
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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
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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)
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510(k) SUMMARY K162304
| DATE PREPARED: | December 5, 2016 | ||
|---|---|---|---|
| SUBMITTER: | Quest Medical, Inc.One Allentown ParkwayAllen, TX 75002 USA972-390-9800/800-627-0226 | ||
| Contact: Amy Clendening-WheelerPhone: (972) 332-6228Fax: (469) 795-2338Email: awheeler@questmedical.com | |||
| DEVICE NAME: | Q2® Multiport IV Administration Sets and Extension SetsCheckMate® 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 ExtensionSets (K151079, K800825) and CheckMate IV Administration Sets andExtension Sets (K040385) | ||
| DESCRIPTION: | Sterile, single use non-pyrogenic intravenous fluid administration setswhich may include a multiport IV manifold, integrated back-checkvalves, pre-attached needleless injection sites, drip chamber and rollerclamps. The subject devices for this Premarket Notification aremanufactured with tubing and drip chamber materials not made withthe plasticizer Diethylhexylphthalate (DEHP). | ||
| INDICATIONS FOR USE: | The Q2 and CheckMate Multiport IV Administration Sets andExtension Sets are indicated for use for the following:For administration of intravenous fluids to a patient's vascular system |
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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.
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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 IVAdministrationSets and ExtensionSets | CheckmateMultiport IVSets withSwabableValves | Q2 IV Extension Sets | SAME |
| Manufacturer | Quest Medical, Inc. | SAME | ||
| DeviceDescription | Q2 and Checkmate Multiport IV Administration Sets andExtension Sets are sterile, non-pyrogenic, single-use intravenousfluid delivery devices. Some models have a multiport IV manifoldwith backcheck valves, pre-attached needleless injections sites,drip chamber and roller clamps. They are non-invasive devices forshort-term use. They deliver either a single infusate or multipleinfusates based on the clinical need of the customer. | SAME | ||
| Clinical Use | The devices are used by clinicians in a variety of clinical settingssuch as operating rooms, chemotherapy regimens, ICUs, ext. Thedevices have direct patient contact due to the administration offluids to the vascular system. A variety of infusates such asanesthesia drugs, chemotherapeutics, total parental nutrition(TPN) drugs, antibiotics, etc. The devices themselves do not haveany intended therapeutic claim. | SAME | ||
| Intended Use/Indications forUse | For administration of intravenous fluids to a patient's vascularsystem utilizing needleless components and an I.V. manifold formultiple simultaneous intravenous therapy via gravity, syringe, orinfusion pump. | SAME |
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| Predicate Device | Modified Device | |
|---|---|---|
| Use of a needle-free system may aid in the prevention ofneedlestick injuries. | ||
| Materials | ||
| Male Luer | Eastman Tritan MX-711 | SAME |
| Tubing | PVC, Colorite 5004A, clear | Single Laminate:Alpha Gary 2235L-80Multi Laminate:Outer Layer: Alpha Gary2222C-80Middle Layer: EVA DupontElvax 265Inner Layer: LDPE Dow690 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 ChamberBarrel | PVC: PTV-402-BT 1 clear | PVC: Colorite 7277G-402M |
| Spike | PVC, ABS, PP, LDPE | SAME |
| Technology | ||
| Energy Source | User Operated | SAME |
| Principle ofOperation | 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 orReusable | 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.
§ 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.