Q2 IV Administration Sets

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. June 2, 2022 Quest Medical, Inc. Tosan Eweka Regulatory Affairs Manager One Allentown Parkway Allen, Texas 75002 Re: K213588 Trade/Device Name: O2 IV Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: May 2, 2022 Received: May 3, 2022 ## Dear Tosan Eweka: 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. 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 located 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. 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 {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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). Sincerely, Payal Patel 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K213588 Device Name Q2 IV Administration Sets Indications for Use (Describe) IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. 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) Notification K213588 # GENERAL INFORMATION [807.92(a)(1)] #### Applicant: Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 Fax: 972-390-2881 #### Contact Person: Tosan Eweka Regulatory Affairs Manager Quest Medical, Inc. One Allentown Parkway Allen, TX 75002-4211 USA Phone: 972-332-6338 972-390-2881 Fax: Email: teweka@questmedical.com ## Date Prepared: November 9, 2021 # DEVICE INFORMATION [807.92(a)(2)] Trade Name: Q2 IV Administration Sets # Generic/Common Name: Intravascular Administration Set #### Classification: Class II per 21CFR§880.5440 #### Product Code: FPA {4}------------------------------------------------ ## PREDICATE DEVICE(S) [807.92(a)(3)] B.Braun Medical IV Administration Sets (K170595) ## DEVICE DESCRIPTION [807.92(a)(4)] Quest Medical's Q2 IV Administration Sets are single use, disposable intravenous administration sets used to deliver fluids from a container into a patient's vascular system. These sets may be comprised of various components including insertion spike, drip chamber, clamp, check valye, stopcock, tubing, luer connections and needleless connector, ## INDICATIONS FOR USE [807.92(a)(5)] The IV Administration Sets are intended for delivery of fluids from a container into a patient's vascular system. These devices may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness for the solution being infused and duration of therapy. ## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE [807.92(a)(6)] The O2 IV Administration Sets has the same intended use, indications for use, and principles of operation as the predicate device, and has similar design features and technological characteristics as the predicate device. The table below outlines the similarities and differences between the subject device and the predicate device. {5}------------------------------------------------ | Element of<br>Comparison | Predicate Device – Extension<br>Sets with B.Braun Medical IV<br>Administration<br>Sets(K170595) | Subject Device | Analysis of Differences | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product Code | FPA | FPA | Same | | Regulation<br>Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Same | | Regulation Name | Intravascular Administration Set | Intravascular Administration Set | Same | | Class | II | II | Same | | Indications for<br>Use | The IV Administration Sets are<br>intravenous administration sets<br>intended for delivery of fluids<br>from a container into a patient's<br>vascular system. These devices<br>may be used for any patient<br>population with consideration<br>given to adequacy of vascular<br>anatomy and appropriateness for<br>the solution being infused and<br>duration of therapy. | The IV Administration Sets<br>are intended for delivery of<br>fluids from a container into<br>a patient's vascular system.<br>These devices may be used<br>for any patient population<br>with consideration given to<br>adequacy of vascular<br>anatomy and<br>appropriateness for the<br>solution being infused and<br>duration of therapy. | Removed "intravenous<br>administration sets" from the<br>subject device indications to avoid<br>repetition. There is no difference<br>in the actual indications for use.<br>The indications for use for the<br>subject device and predicate<br>device are therefore substantially<br>equivalent. | | Components | Insertion spike<br>drip chamber<br>tubing<br>luer<br>connections<br>manifold<br>needleless connector<br>stopcocks<br>clamps<br>check<br>valve | Insertion spike<br>drip chamber<br>tubing<br>luer connections<br>needleless connector<br>stopcocks<br>clamps<br>check<br>valve | The predicate device and<br>subject device are comprised of<br>the same components with the<br>exception of a manifold in some<br>configurations of the predicate<br>device, which is not included in<br>the subject device.<br>Configurations of the predicate<br>device without the manifold are<br>therefore substantially<br>equivalent to the subject device.<br>The results from performance<br>testing conducted on the subject<br>device demonstrates that the<br>difference in components<br>between the subject device and<br>predicate device do not raise<br>different questions of safety and<br>effectiveness. The subject<br>device met all performance<br>specifications necessary to fulfil<br>its intended use. | | Mode of Fluid<br>Delivery | Gravity | Gravity | Same | | Control<br>Mechanism | Clamps and Stopcock | Clamps and Stopcock | Same | | Compatibility<br>with Blood and<br>Blood Products | Not intended for use with blood or<br>blood products per IFU | The subject device is not<br>intended to be used with blood<br>or blood products | Same | | Sterilization | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 | Same | | Element of<br>Comparison | Predicate Device –<br>Extension Sets with B.Braun<br>Medical IV Administration<br>Sets(K170595) | Subject Device | Analysis of Differences | | Device Materials | Unknown | Tubing - Alpha Gary 2235L-78<br>PVC not made with DEHP<br>Vented drip chamber<br>• Alpha Gary 2235L-78<br>PVC not made withDEHP<br>• ABS<br>• HDPE<br>• LDPE<br>• Lexan polycarbonate and<br>304 stainless steel.<br>Check valve - Plexiglas DR100,<br>DR6602, Silicone<br>Needless Connector y-site-<br>Makrolon RX 1805-451118<br>Polycarbonate, LR3003/40<br>Silicone<br>Pinch clamp –<br>Polypropylene Roller clamp<br>– ABS<br>Male luer - Eastman Tritan<br>MX-<br>731 Copolyester<br>Female luer - Eastman DN003<br>Copolyester<br>Male Luer - ABS<br>Terlux PP Purell<br>HP317P<br>Stopcock - Makrolon RX<br>1805- 451118 Polycarbonate,<br>LR3003/40 Silicone, HDPE<br>Solvent 20/80 Code R –<br>Cyclohexanone, Methyl Ethyl<br>Ketone | The materials used on components of<br>the predicate device is unknown.<br>Materials used in the subject device<br>are identical to those used in currently<br>marketed Quest IV Administration<br>Sets. Results from biocompatibility<br>testing conducted on the subject<br>device demonstrate that differences (if<br>any) in the materials used in the<br>subject device and predicate device do<br>not raise different questions of safety<br>and effectiveness. | | Patient Contact<br>Category/Duration | Externally Communicating,<br>Blood<br>Path Indirect, Prolonged contact | Externally Communicating,<br>Blood<br>Path Indirect, Prolonged contact | Same | | Shelf-Life | Unknown | 1 year | The shelf life of the predicate device is<br>unknown. The subject device was<br>qualified with 1 year shelf life and all<br>acceptance criteria were met. Results<br>from shelf life testing conducted on the<br>subject device demonstrate that<br>differences (if any) between the shelf<br>life of the predicate device and the<br>subject device shelf life do not raise<br>different questions of safety and<br>effectiveness. | | Tubing length | Unknown | 102"- 118" | The tubing length of the predicate device<br>is unknown. Results from product<br>performance qualification testing<br>conducted on the subject device<br>demonstrate that differences (if any)<br>between the tubing length of the<br>predicate device and the subject device<br>do not raise different questions of<br>safety and effectiveness. | {6}------------------------------------------------ {7}------------------------------------------------ # Discussions of differences in Components The component used in the various configurations of the predicate device and subject device are similar. The main difference between the components used on the predicate device and those used on the subject device is the inclusion of manifold in some configurations of the predicate device, which is not included in the subject device. Configurations of the predicate device without the manifold are therefore substantially equivalent to the subject device. The results from performance qualification testing conducted on the subject device demonstrates that the difference in components between the subject device and predicate device do not raise different questions of safety and effectiveness. The subject device met all performance specifications necessary to fulfil its intended use. # Discussions of differences in Materials The materials used on the predicate device is unknown. Materials used in the subject device are identical to those used in currently marketed Quest IV Administration Sets. Additionally, results from biocompatibility testing conducted on the subject device demonstrate that differences (if any) between the materials used in the subject device and those used in the predicate device do not raise different questions of safety and effectiveness. # Discussions of differences in Shelf Life The shelf life of the predicate device is unknown. The subject device was qualified with 1 year shelf life and all acceptance criteria were met. Results from shelf life testing conducted on the subject device demonstrate that differences (if any) between the shelf life of the predicate device and the subject device shelf life do not raise different questions of safety and effectiveness. # Discussions of differences in Tubing Length The tubing length of the predicate device is unknown. The tubing length of the subject device ranges from 102"- 118". Results from performance qualification testing conducted on the subject device demonstrate that differences (if any) between the tubing length of the predicate device and the subject device do not raise different questions of safety and effectiveness as all acceptance criteria were met. ## PERFORMANCE DATA [807.92(b)] All necessary bench, nonclinical, and human factors testing was conducted on the Q2 IV Administration Sets to support a determination of substantial equivalence to the predicate device. # Nonclinical Testing Summary [807.92(b)(1)] The bench and nonclinical tests conducted on the Q2 IV Administration Sets in this submission included: - Maximum Simulated Use Test ● {8}------------------------------------------------ - Flow Rate Test ● - High Pressure Leak Test 0 - Vacuum Pressure Leak Test ● - Closure Piercing Device Test - Air Inlet Device Test 0 - 0 Drip Chamber Test - Flow Regulator Test - Tubing Bonding Strength Test ● - Priming Volume Test ● - Spike Cap Retention Test ● - ISO 8536-4 Chemical Test . - USP <788> Particulate Test - Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, 0 Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity, Genotoxicity) - EO Residual Test ● - Bacterial Endotoxin Test ● - ISO 80369-7:2016 Luer compliance ● Microbial ingress data for the needleless connector component used on the Q2 IV Admin Sets was referenced to the previously cleared K002689. # Clinical Testing Summary [807.92(b)(2)| Not applicable. Clinical testing was not performed to support this 510(k) submission. # CONCLUSIONS [807.92(b)(3)] The collective results of the performance testing demonstrate that the Q2 IV Administration Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Q2 IV Administration Sets does not raise different questions of safety or effectiveness when compared to the predicate device. The results from the performance testing support the conclusion that the Q2 IV Administration Sets is substantially equivalent to the predicate device. # SUMMARY The Q2 IV Administration Sets is substantially equivalent to the predicate device.