ResQ Administration Set

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. January 3, 2024 Q for Plastic Industries % Abdel Halim President Global Quality and Regulatory Services 10 Scenic Way Monroe, New Jersey 08831 Re: K231707 Trade/Device Name: ResQ Administration Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: FPA Dated: December 3, 2023 Received: December 4, 2023 Dear Abdel Halim: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. David Walloschek David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, {2}------------------------------------------------ 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K231707 Device Name ResO Administration Set #### Indications for Use (Describe) ResO Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings. | 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." {4}------------------------------------------------ # K231707 - 510(k) Summary | Date: | Dec. 22, 2023 | |-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter (Owner): | Islam Nazeih Mohamed Ali<br>Chief Executive Officer<br>Islam Nazeih Mohamed Ali and Partner<br>Land plot #25,27 first industrial zone, Badr city ,11829Cairo,<br>Egypt<br>Phone: +20 1146626663<br>E-mail ID: i.aly@qmedicaldevices.com | | 510(k) Contact Person: | Yasmeen Fawzy<br>Quality manager of Q for plastic industries<br>Land plot #25,27 first industrial zone, Badr city ,11829Cairo,<br>Egypt<br>Phone: +20 1019670495<br>E-mail ID: yasmeen.fawzy@qmedicaldevices.com | | Device Trade Name: | ResQ Administration Set | | Common name: | Intravascular administration Set | | Regulation Number: | 21 CFR 880.5440 | | Regulation classification<br>Description: | Intravascular Administration Set | | Review Panel: | General Hospital | | Device Class: | Class II | | Product Code: | FPA | | Predicate Device: | 510(k) Number: K112204<br>Product Name: KDL Disposable Infusion Set<br>Manufacturer: Shanghai Kindly Enterprise Development<br>Group Co., Ltd. | ### Device Description ResO Administration set is a single use, gravity feed, sterile device sterilized with Ethylene Oxide Gas. ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings. ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications. The proposed device consists of protective cap, air filtration membrane, closure-piercing device, drip chamber, medicine fluid filter, roller clamp, tubing, flow regulator, injection sites (needle access - needleless access), in-line filter &two-part luer lock connector. {5}------------------------------------------------ The protective cap is intended to maintain sterility and to protect the closure piercing device that used to pierce the container, the drip chamber is transparent so that the user can observe the dropping condition of the medical solution, it has an air filtration membrane which can filter the air into the container and an air-inlet set which can control the air into the container and a medicine fluid filter which can filter the medical solution, the roller clamp is used to control the flow of the medicine solution, the tubing is used to connect various components, the flow regulator is used to adjust the flow rate from zero to maximum, there are two injection sites one is needleless and the other is needle access, which are used to inject solution into the tubing, the in-line filter used for retention of particles, bacteria and fungi, also it used for elimination of the air, two-part luer lock connector is used to connect the infusion needle or catheter with the tubing. - It is single use device, sterilized by EO sterilization. ● - . Environment of Use: healthcare facility/hospital # Indications for Use ResQ Administration set is intended to administer fluids from a container to a patient's venous system through a needle or catheter inserted into the vein. The set is a sterile, disposable for a single use. The ResQ Administration Set should be used no more frequently than at 96-hour intervals. It can be used on patients of all age groups under the supervision of a qualified physicians or nurses in hospital or clinical settings. # Contraindications - Some patients have anatomy that poses a risk for fluid extravasation or inadequate flow and peripheral IVs should be avoided in these situations. - . Include extremities that have massive edema, burns or injury. - · For the patient with severe abdominal trauma, it is preferable to start the IV in an upper extremity because of the potential for injury to vessels between the lower extremities and the heart. - For the patient with cellulitis of an extremity, the area of infection should be avoided when starting . an IV because of the risk of inoculating the circulation with bacteria. As well, extremities on the side of a mastectomy or that have an indwelling fistula should be avoided because of concerns about adequate flow. - . Administration of highly viscous fluids like human albumin, Dextrans, Etherified Starch, Plasma Protein Fraction & Gelatin. - Blood transfusion: the device isn't designed to be used for blood transfusion. - # Working Principle Closure piercing device inserted into ResQ Administration set. Container and roller clamp is opened and permitted chamber to fill to required level, squeeze drip chamber to fill half full and open roller clamp again to refill to required level. Close roller clamp and make sure there is solution in the drip chamber that way it enables precise volume and slow Administration of infusion or injectable medicine. A micro regulator is integrated into ResQ Administration set for precise flow control to regulate the flow of IV fluid from an infusion set into an IV catheter. A filter serves as security barrier, its membrane has symmetrical diameter ensuring no medium to fall off or deform with the function of removing contaminations including bacteria, fungi and endotoxins from the tubing, it guarantees high-precision filtration. {6}------------------------------------------------ # Comparison to Predicate Device One predicate device is selected in this submission for ResQ Administration set. Predicate device: KDL Disposable Infusion Set and the details of the substantial equivalence between the subject device and predicate device is explained below: | Comparable<br>Properties | Subject Device (K231707) | Predicate Device (K112204) | Comparison<br>Results | |---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | ResQ Administration set | KDL Disposable Infusion Set | N/A | | Regulation<br>Number | 21 CFR 880.5440 | 21 CFR 880.5440 | Identical | | Product Code | FPA | FPA | Identical | | Product Class | II | II | Identical | | Intended Use /<br>Indications for Use | The device is intended to administer<br>fluids from a container to a patient's<br>venous system through a needle or<br>catheter inserted into the vein. The<br>set is a sterile, disposable for a single<br>use. The ResQ Administration Set<br>should be used no more frequently<br>than at 96-hour intervals. It can be<br>used on patients of all age groups<br>under the supervision of a qualified<br>physicians or nurses in hospital or<br>clinical settings. | Disposable Infusion Set is<br>intended to administer fluids<br>from a container to a patient's<br>vascular system through a needle<br>or catheter inserted into the vein.<br>It can be used on patients of all<br>age groups under the supervision<br>of a qualified physician or health<br>care professionals in hospital or<br>clinical settings. | Different<br>Only we<br>mentioned in<br>the<br>indication<br>for use of<br>our device<br>that it should<br>be used no<br>more<br>frequently<br>than at 96-<br>hour<br>intervals<br>And we state<br>that the<br>solution will<br>be<br>administered<br>in to the<br>patients<br>venous<br>system and<br>the predicate<br>states that it<br>is<br>administered<br>into the<br>patients<br>vascular<br>system | | Mode of Fluid<br>Delivery | Gravity | Gravity | Identical | # Table 1: Comparison to Predicate Devices {7}------------------------------------------------ | Comparable<br>Properties | Subject Device (K231707) | | Predicate Device (K112204) | | Comparison<br>Results | |-------------------------------|-------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------|----------|-----------------------| | Single-Use | Yes | | Yes | | Identical | | Prescription<br>only | Yes | | Yes | | Identical | | Disposable | Yes | | Yes | | Identical | | Configuration and<br>material | Configuration | material | Configuration | material | Different 1 | | | Protective Cap of<br>Closure-piercing<br>Device (Spike) | HDPE | Protective Cap of<br>Closure-piercing<br>Device | | | | | Closure-piercing<br>Device (Spike) | ABS | Closure-piercing<br>Device | Unknown | | | | Air Vent | PVC | Air Vent | | | | | Drip Chamber | PVC | Drip Chamber | | | | | Fluid Filter | ABS | Fluid Filter | | | | | Flexible Tube | PVC | Flexible Tube | | | | | Roller Clamp | HDPE | Roller Clamp | | | | | needleless port | Synthetic Silicone | needleless port | | | | | Y-Injection site | Synthetic Silicone | Y-Injection site | | | | | Luer Lock<br>Connector | PVC | Luer Lock<br>Connector | | | | | Protector Cap of | HDPE | Protector Cap of | | | | | Luer Lock<br>Connector | PVC | Luer Lock<br>Connector | | | | | In-Line Filter | PVC | In-Line Filter | | | | | Flow regulator | ABS | Flow regulator | | | | | — | — | Infusion needle | | | | Tubing Diameter | 4mm | | 3.9 mm | | Different 3 | | Filter<br>Characteristics | 0.2 µm for in line filter and 15µm for<br>fluid filter | | 0.2 µm for in line filter and 15 µmfor<br>fluid filter | | Identical | | Infusion Set<br>Performance | Conform with ISO 8536-4:2019 | | Conform with ISO 8536-4:2010 | | Identical | | Flow rate of<br>regulator | 5 to 250 ml/hour | | 20 to 250 ml/hour | | Different 4 | | Sterility | ETO sterilization | | ETO sterilization | | Identical | | Biocompatibility | ISO 10993-1<br>ISO 10993-4<br>ISO 10993-5<br>ISO 10993-10<br>ISO 10993-11<br>ISO 10993-23 | | Conform with ISO 10993 series<br>standards | | Identical | {8}------------------------------------------------ | Comparable<br>Properties | Subject Device (K231707) | Predicate Device (K112204) | Comparison<br>Results | |--------------------------|---------------------------------------------|---------------------------------------------|-----------------------| | Labeling | Meet the requirements of 21 CFR Part<br>801 | Meet the requirements of 21 CFR Part<br>801 | Identical | | Note 1 | The subject device Configurations and materials are not contained needle where the KDL Disposable infusion set configuration with infusion needle. The performance and biocompatibility testing on the subject device demonstrate substantial equivalence. All the performance testing of the device as mentioned below in table 2 in this summary and they were done as per product standard and FDA guidance for this device indicate that the subject device testing results were all accepted as per acceptance criteria for the tests and the biocompatibility testing as mentioned below in table 3 in this summary also done as per ISO10993-1 and all the results was accepted for the subject device and their testing results was accepted as per testing ISO standard requirements. | |--------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Note 2 | The subject device configuration and material not contain needle but contain the male luer lock with its cover which comply with ISO 80369 where the KDL Disposable infusion set configuration with infusion needle so it complies with ISO 594-1, ISO 594-2. The performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. | | Note 3 | The Subject device tube diameter is 4mm. The performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. We did for the subject device flow rate testing and tensile strength testing as per (ISO 8536-4 Sixth edition 2019-09 Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.) and the results were accepted as per acceptance criteria for the test and the tube diameter was not raise any new question for safety or performance of the device | | Note 4 | The subject device Flow rate limit from 5 to 250mm, the performance testing on the subject device demonstrates substantial equivalence without raising any new questions of safety and effectiveness. As the flow rate of the predicate device limit is from 20 to 250 and the subject device limit is from 5 to 250 so all the predicate device range is within the range of the subject device and we did the flow rate testing for the subject device and all results were accepted as per test acceptance criteria. | {9}------------------------------------------------ # Performance Data The following tests according to the identified standards / guidance were conducted on ResQ Administration set to verify the performance of the device: # Table 2: Bench Testing of ResQ Administration set Inner Diameter of PVC Tube: 3.0 ± 0.1mm as per ISO 8536-4:2019 Outer Diameter of PVC Tube: 4.1 ± 0.1 mm as per ISO 8536-4:2019 | S.<br>No. | Test Description | Standard/Guideline | |-----------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 1. | Leakage test of Infusion set. | ISO 8536-4 Sixth edition 2019-09 Infusion<br>equipment for medical use - Part 4: Infusion sets<br>for single use, gravity feed. | | 2. | Tensile strength. | | | 3. | Leakage of the IV injection site. | | | 4. | Efficiency of the IV set fluid filter. | | | 5. | Particulate contamination test. | | | 6. | Test for titration acidity or alkalinity | | | 7. | Test for Reducing (oxidizing matters). | | | 8. | Test for non- volatile residue. | | | 9. | UV Absorption of extract solution. | | | 10. | Determination of Fluid Flow Rate for IV<br>Administration Set with Integral Air Inlet Device. | | | 11. | Flow rate for graduate flow regulator. | ISO 8536-13 First edition 2016-10 Infusion<br>equipment for medical use - Part 13: Graduated<br>flow regulators for single use with fluid contact. | | 12. | Determination of Graduated Flow Regulator Leakage<br>Test. | | | 13. | Test for falling drop positive pressure liquid leakage<br>for male luer connector. | ISO 80369-7 Second<br>edition 2021-05 Small- bore connectors for<br>liquids and gases in healthcare applications -<br>Part 7: Connectors for intravascular or<br>hypodermic applications. | | 14. | Test for Resistance to overriding for male luer connector. | | | 15. | Test for Resistance from separation from axial load for<br>male luer connector. | ISO 80369-20 First<br>edition 2015-05-15 Small-bore connectors for<br>liquids and gases in healthcare applications -<br>Part 20: Common test methods. | | 16. | Test for Resistance to overriding for needle free connector<br>with LAV. | ISO 80369-7 Second<br>edition 2021-05 Small- bore connectors for<br>liquids and gases in healthcare applications -<br>Part 7: Connectors for intravascular or<br>hypodermic applications. | | 17. | Test for Resistance from separation from axial load for<br>Luer Activated Valve (LAV) of Needle Free Connector. | | | 18. | Resistance to separation from unscrewing for needle free. | ISO 80369-20 First<br>edition 2015-05-15 Small-bore connectors for<br>liquids and gases in healthcare applications -<br>Part 20: Common test methods. | | 19. | Positive Pressure Liquid Leakage (activated) for Needle<br>Free. | | | 20. | Sub atmospheric pressure air leakage (activated) for<br>Needle Free. | ANSI AAMI<br>CN27:2021 General requirements for Luer<br>activated valves (LAVs) incorporated into<br>medical devices for intravascular applications. | | 21. | Test for IPA Exposure for Needle Free. | ISO 1135-4:2015<br>Transfusion equipment for medical use – Part 4:<br>Transfusion sets for single use, gravity feed. | | 22. | Test for Priming Volume for<br>Needle Free. | | | 23. | Test for Residual<br>Volume for Needle Free. | | | 24. | Test Method of<br>Flow rate for needle free. | | | 25. | Test for Backpressure (unactivated) for Needle Free. | | | 26. | Test for Displacement for Needle Free. | | | 27. | Test for sub atmospheric pressure air leakage<br>(Unactivated) for Needle Free. | | | 28. | Test of Number of Activations for Needle free. | | | 29. | Test for Infusate compatibility. | | | 30. | microbial ingress of check valve, needle less port and<br>Y- injection port | | | 31. | Needleless Access Port Activation Time Test. | ISO 1135-4:2015<br>Transfusion equipment for medical use – Part 4:<br>Transfusion sets for single use, gravity feed. | | 32. | Needleless Access Port Leakage Test During<br>Aspiration.<br>There are 6 models of our device 2 of which<br>containing 1 check valve only, one model containing<br>no any check valve and the other 3 models containing<br>3 check valves The microbial ingress test is<br>concerned with only the check valves (injection ports<br>and needless ports) So, we should do the test on the<br>worst case model that contain 2 check valves We<br>performed the microbial ingress test for the test<br>article (IVQ49) as we consider this model as the<br>worst case model (in this test) which contains 2 check<br>valves (1 injection port, and one needless port) also it<br>contains the most number of device other<br>components. | | | 33. | Needleless Access Port Leakage Test. | | | | | | | 34. | Test for air/water leakage for infusion set in line filter. | ISO 8536-11 Second<br>Edition 2015-06-15 Infusion Equipment for<br>Medical Use - Part 11: Infusion Filters for Single<br>Use with Pressure Infusion Equipment. | | 35. | Ethylene oxide sterilization validation and routine<br>control. | ISO 11135:2014<br>Sterilization of health- care products - Ethylene<br>oxide - Requirements for the development,<br>validation and routine control of a sterilization<br>process for medical devices [Including:<br>Amendment 1 (2018)]. | | 36. | Shelf-life study by accelerated aging studies. | ASTM F1980-16<br>Standard Guide for Accelerated Aging of Sterile<br>Barrier Systems for Medical Devices. | | 37. | Device packaging integrity testing (Dye Penetration<br>Test). | ASTM F1929-15<br>Standard Test Method for Detecting Seal Leaks<br>in Porous Medical Packaging by Dye Penetration. | | 38. | Device packaging integrity testing (Bubble emission). | ASTM D3078-02<br>(Reapproved 2013) Standard Test Method for<br>Determination of Leaks in Flexible Packaging by<br>Bubble Emission. | | 39. | Device packaging integrity testing. | ASTM F1140/F1140M-13<br>Standard Test Methods for Internal Pressurization<br>Failure Resistance of Unrestrained Packages. | | 40. | Bio-burden Of Finished Product. | ISO 11737-1:2018. | | 41. | Sterility Test for Sterile Product. | -USP 41 chapter 71. | | 42. | Test Method of Pyrogen Test.…