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.

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.

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

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "ResQ Administration Set". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving novel clinical effectiveness through comparative studies with human readers. Therefore, several of the requested sections related to AI performance, multi-reader multi-case studies, and human reader improvement are not applicable to this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

The document provides a list of standards and guidelines used for performance testing (bench testing) and biocompatibility testing. It states that "the subject device testing results were all accepted as per acceptance criteria for the tests" and "all the results was accepted for the subject device and their testing results was accepted as per testing ISO standard requirements." However, specific quantitative acceptance criteria and detailed reported performance values (e.g., exact leakage rates, precise flow rates achieved vs. target range) are not explicitly listed in the summaries provided. Instead, the document generally affirms compliance with the standards.

Acceptance Criteria (Standard/Guideline)	Reported Device Performance
ISO 8536-4:2019 (Leakage test, Tensile strength, IV injection site leakage, fluid filter efficiency, particulate contamination, titration acidity/alkalinity, reducing matters, non-volatile residue, UV Absorption, Fluid Flow Rate)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 8536-13:2016 (Flow rate for graduate flow regulator, Leakage Test of Graduated Flow Regulator)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 80369-7:2021 (Falling drop positive pressure liquid leakage for male luer connector, Resistance to overriding for male luer connector, Resistance to overriding for needle free connector)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 80369-20:2015 (Resistance from separation from axial load for male luer connector, Resistance from separation from axial load for LAV of Needle Free Connector, Resistance to separation from unscrewing for needle free)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ANSI AAMI CN27:2021 (Sub atmospheric pressure air leakage (activated) for Needle Free)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 1135-4:2015 (Test for IPA Exposure for Needle Free, Needleless Access Port Activation Time Test)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 8536-11:2015 (Test for air/water leakage for infusion set in line filter)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 11135:2014 (Ethylene oxide sterilization validation and routine control)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ASTM F1980-16 (Shelf-life study by accelerated aging)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ASTM F1929-15 (Device packaging integrity testing - Dye Penetration)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ASTM D3078-02 (Device packaging integrity testing - Bubble emission)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ASTM F1140/F1140M-13 (Device packaging integrity testing - Internal Pressurization Failure Resistance)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 11737-1:2018 (Bio-burden Of Finished Product)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
USP 41 chapter 71 (Sterility Test for Sterile Product)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 11737-2:2019 (Test Method of Pyrogen Test)	All results accepted as per acceptance criteria of the standard. Specific quantitative results are not detailed.
ISO 10993-5:2009 (Cytotoxicity)	Safe and elicited no reactions in test animals.
ISO 10993-10:2021 (Sensitization)	Safe and elicited no reactions in test animals.
ISO 10993-23:2021 (Irritation)	Safe and elicited no reactions in test animals.
ISO 10993-11:2017 (Acute toxicity, Subacute toxicity, Hemolysis)	Safe and elicited no reactions in test animals.
ISO 10993-4:2017 (Hemocompatibility)	Safe and elicited no reactions in test animals.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document primarily refers to bench testing and biocompatibility testing against established international standards. For these types of tests, specific "samples" are devices or materials, not patient data. The sample sizes for each specific test are not enumerated in this summary. The tests were performed to verify the performance of the device against the referenced standards. The provenance of the data in terms of "country of origin for testing" or "retrospective/prospective" is not detailed in the provided excerpt, though the submitter's address is listed as Egypt.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of device and submission. The "ground truth" for this device's performance is established by adherence to recognized international standards and bench testing protocols, not by expert consensus on clinical imagery or diagnostic interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This device is an intravenous administration set, and its evaluation involves
bench testing and biocompatibility against established standards, not expert adjudication of clinical outcomes or images.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is not an AI-assisted diagnostic tool. No MRMC comparative effectiveness study was conducted or is relevant for this type of medical device submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical medical device (an intravenous administration set), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the performance of the ResQ Administration Set is defined by the acceptance criteria within the international standards and guidelines referenced in Table 2 (Bench Testing) and Table 3 (Biocompatibility Evaluation). This includes:

Engineering specifications and performance limits defined by standards like ISO 8536-4, ISO 80369-7, ASTM F1980-16, etc., for aspects like leakage, flow rate, tensile strength, and packaging integrity.
Biological safety endpoints determined by biocompatibility standards like ISO 10993-5, ISO 10993-10, etc., assessed for cytotoxicity, sensitization, irritation, and systemic toxicity.
Sterility assurance levels confirmed by standards like ISO 11135 for EO sterilization and USP 41 chapter 71 for sterility testing.

8. The sample size for the training set

Not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI models.

9. How the ground truth for the training set was established

Not applicable, as no training set is relevant for this device.

Summary

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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"

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(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,

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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

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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)

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K231707 - 510(k) Summary

Date:	Dec. 22, 2023
Submitter (Owner):	Islam Nazeih Mohamed AliChief Executive OfficerIslam Nazeih Mohamed Ali and PartnerLand plot #25,27 first industrial zone, Badr city ,11829Cairo,EgyptPhone: +20 1146626663E-mail ID: i.aly@qmedicaldevices.com
510(k) Contact Person:	Yasmeen FawzyQuality manager of Q for plastic industriesLand plot #25,27 first industrial zone, Badr city ,11829Cairo,EgyptPhone: +20 1019670495E-mail ID: yasmeen.fawzy@qmedicaldevices.com
Device Trade Name:	ResQ Administration Set
Common name:	Intravascular administration Set
Regulation Number:	21 CFR 880.5440
Regulation classificationDescription:	Intravascular Administration Set
Review Panel:	General Hospital
Device Class:	Class II
Product Code:	FPA
Predicate Device:	510(k) Number: K112204Product Name: KDL Disposable Infusion SetManufacturer: Shanghai Kindly Enterprise DevelopmentGroup Co., Ltd.

Device Description

ResQ Administration set is compatible with various cannula or catheters models and can be used for most low viscosity fluids or medications.

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It is single use device, sterilized by EO sterilization. ●
. Environment of Use: healthcare facility/hospital

Indications for Use

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.

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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:

ComparableProperties	Subject Device (K231707)	Predicate Device (K112204)	ComparisonResults
Device Name	ResQ Administration set	KDL Disposable Infusion Set	N/A
RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Identical
Product Code	FPA	FPA	Identical
Product Class	II	II	Identical
Intended Use /Indications for Use	The device is intended to administerfluids from a container to a patient'svenous system through a needle orcatheter inserted into the vein. Theset is a sterile, disposable for a singleuse. The ResQ Administration Setshould be used no more frequentlythan at 96-hour intervals. It can beused on patients of all age groupsunder the supervision of a qualifiedphysicians or nurses in hospital orclinical settings.	Disposable Infusion Set isintended to administer fluidsfrom a container to a patient'svascular system through a needleor catheter inserted into the vein.It can be used on patients of allage groups under the supervisionof a qualified physician or healthcare professionals in hospital orclinical settings.	DifferentOnly wementioned intheindicationfor use ofour devicethat it shouldbe used nomorefrequentlythan at 96-hourintervalsAnd we statethat thesolution willbeadministeredin to thepatientsvenoussystem andthe predicatestates that itisadministeredinto thepatientsvascularsystem
Mode of FluidDelivery	Gravity	Gravity	Identical

Table 1: Comparison to Predicate Devices

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ComparableProperties	Subject Device (K231707)		Predicate Device (K112204)		ComparisonResults
Single-Use	Yes		Yes		Identical
Prescriptiononly	Yes		Yes		Identical
Disposable	Yes		Yes		Identical
Configuration andmaterial	Configuration	material	Configuration	material	Different 1
	Protective Cap ofClosure-piercingDevice (Spike)	HDPE	Protective Cap ofClosure-piercingDevice
	Closure-piercingDevice (Spike)	ABS	Closure-piercingDevice	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 LockConnector	PVC	Luer LockConnector
	Protector Cap of	HDPE	Protector Cap of
	Luer LockConnector	PVC	Luer LockConnector
	In-Line Filter	PVC	In-Line Filter
	Flow regulator	ABS	Flow regulator
	—	—	Infusion needle
Tubing Diameter	4mm		3.9 mm		Different 3
FilterCharacteristics	0.2 µm for in line filter and 15µm forfluid filter		0.2 µm for in line filter and 15 µmforfluid filter		Identical
Infusion SetPerformance	Conform with ISO 8536-4:2019		Conform with ISO 8536-4:2010		Identical
Flow rate ofregulator	5 to 250 ml/hour		20 to 250 ml/hour		Different 4
Sterility	ETO sterilization		ETO sterilization		Identical
Biocompatibility	ISO 10993-1ISO 10993-4ISO 10993-5ISO 10993-10ISO 10993-11ISO 10993-23		Conform with ISO 10993 seriesstandards		Identical

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ComparableProperties	Subject Device (K231707)	Predicate Device (K112204)	ComparisonResults
Labeling	Meet the requirements of 21 CFR Part801	Meet the requirements of 21 CFR Part801	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.

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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.No.	Test Description	Standard/Guideline
1.	Leakage test of Infusion set.	ISO 8536-4 Sixth edition 2019-09 Infusionequipment for medical use - Part 4: Infusion setsfor 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 IVAdministration Set with Integral Air Inlet Device.
11.	Flow rate for graduate flow regulator.	ISO 8536-13 First edition 2016-10 Infusionequipment for medical use - Part 13: Graduatedflow regulators for single use with fluid contact.
12.	Determination of Graduated Flow Regulator LeakageTest.
13.	Test for falling drop positive pressure liquid leakagefor male luer connector.	ISO 80369-7 Secondedition 2021-05 Small- bore connectors forliquids and gases in healthcare applications -Part 7: Connectors for intravascular orhypodermic applications.
14.	Test for Resistance to overriding for male luer connector.
15.	Test for Resistance from separation from axial load formale luer connector.	ISO 80369-20 Firstedition 2015-05-15 Small-bore connectors forliquids and gases in healthcare applications -Part 20: Common test methods.
16.	Test for Resistance to overriding for needle free connectorwith LAV.	ISO 80369-7 Secondedition 2021-05 Small- bore connectors forliquids and gases in healthcare applications -Part 7: Connectors for intravascular orhypodermic applications.
17.	Test for Resistance from separation from axial load forLuer Activated Valve (LAV) of Needle Free Connector.
18.	Resistance to separation from unscrewing for needle free.	ISO 80369-20 Firstedition 2015-05-15 Small-bore connectors forliquids and gases in healthcare applications -Part 20: Common test methods.
19.	Positive Pressure Liquid Leakage (activated) for NeedleFree.
20.	Sub atmospheric pressure air leakage (activated) forNeedle Free.	ANSI AAMICN27:2021 General requirements for Lueractivated valves (LAVs) incorporated intomedical devices for intravascular applications.
21.	Test for IPA Exposure for Needle Free.	ISO 1135-4:2015Transfusion equipment for medical use – Part 4:Transfusion sets for single use, gravity feed.
22.	Test for Priming Volume forNeedle Free.
23.	Test for ResidualVolume for Needle Free.
24.	Test Method ofFlow 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(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 andY- injection port
31.	Needleless Access Port Activation Time Test.	ISO 1135-4:2015Transfusion equipment for medical use – Part 4:Transfusion sets for single use, gravity feed.
32.	Needleless Access Port Leakage Test DuringAspiration.There are 6 models of our device 2 of whichcontaining 1 check valve only, one model containingno any check valve and the other 3 models containing3 check valves The microbial ingress test isconcerned with only the check valves (injection portsand needless ports) So, we should do the test on theworst case model that contain 2 check valves Weperformed the microbial ingress test for the testarticle (IVQ49) as we consider this model as theworst case model (in this test) which contains 2 checkvalves (1 injection port, and one needless port) also itcontains the most number of device othercomponents.
33.	Needleless Access Port Leakage Test.

34.	Test for air/water leakage for infusion set in line filter.	ISO 8536-11 SecondEdition 2015-06-15 Infusion Equipment forMedical Use - Part 11: Infusion Filters for SingleUse with Pressure Infusion Equipment.
35.	Ethylene oxide sterilization validation and routinecontrol.	ISO 11135:2014Sterilization of health- care products - Ethyleneoxide - Requirements for the development,validation and routine control of a sterilizationprocess for medical devices [Including:Amendment 1 (2018)].
36.	Shelf-life study by accelerated aging studies.	ASTM F1980-16Standard Guide for Accelerated Aging of SterileBarrier Systems for Medical Devices.
37.	Device packaging integrity testing (Dye PenetrationTest).	ASTM F1929-15Standard Test Method for Detecting Seal Leaksin Porous Medical Packaging by Dye Penetration.
38.	Device packaging integrity testing (Bubble emission).	ASTM D3078-02(Reapproved 2013) Standard Test Method forDetermination of Leaks in Flexible Packaging byBubble Emission.
39.	Device packaging integrity testing.	ASTM F1140/F1140M-13Standard Test Methods for Internal PressurizationFailure 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.	- ISO 11737-2: 2019.

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Based on the tests performed and information provided on predicate devices, it can be concluded that the subject device is substantially equivalent to the predicate devices and raises of safety and performance.

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Biocompatibility Data

Product name: ResQ Administration set.

Category: external communication device.

Contact: blood path indirect.

Contact duration: prolonged (24 h to 30 days)

And are under category of external communication device blood path indirect to ensure safety of ResQ Administration set during use in patients, testing and risk assessment as per ISO 10993-1 were performed. Testing included the following assessments:

Table 3: Biological Evaluation of ResQ Administration set

S. No.	Test Name	Reference guidance document /standard
1.	Cytotoxicity	ISO 10993-5:2009
2.	Sensitization guinea pig maximization test	ISO 10993-10:2021
3.	(GPMT)	ISO 10993-23:2021
4.	Irritation	ISO 10993-11:2017
5.	Acute toxicity	ISO 10993-11:2017
6.	Subacute toxicity	ISO 10993-4:2017
7.	Hemocompatibility	ISO 10993-4:2017
8.	Hemolysis	ISO 10993-11:2017

Testing results and risk assessment demonstrated that materials used in the construction of ResQ Administration set were safe and elicited no reactions in test animals.

Clinical Performance Summary

Not applicable. No clinical tests were conducted for this submission.

Conclusion

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The ResQ Administration set manufactured by Q for Plastic Industries is substantially equivalent to the KDL Disposable Infusion Set and is as safe and effective when used as intended.

Regulation Number and Section

§ 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.