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.

Device Description

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,

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (Q2 IV Administration Sets), not a software or AI-based diagnostic device. Therefore, the information requested in points 2 through 9 regarding test sets, ground truth, experts, MRMC studies, and training sets is not applicable to this document. The document describes the substantial equivalence of a physical medical device to a predicate device, focusing on bench and nonclinical performance testing rather than the performance of an algorithm or diagnostic accuracy.

However, I can extract the acceptance criteria and reported device performance from the provided text as it relates to the physical characteristics and functional tests performed on the IV administration sets.

Here's the relevant information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative "acceptance criteria" alongside "reported device performance" in a direct comparison table as one might find for a diagnostic algorithm. Instead, it states that "All necessary bench, nonclinical, and human factors testing was conducted... The subject device met all performance specifications necessary to fulfil its intended use," and "all acceptance criteria were met" for specific tests.

The document lists various nonclinical tests performed to demonstrate safety and effectiveness. For each of these tests, the reported device performance is broadly stated as having met all performance specifications and acceptance criteria. The specific quantitative criteria for each test are not detailed in this summary document, but the conclusion is that the device performed acceptably for its intended use.

Acceptance Criteria (Implied)	Reported Device Performance
Sufficiently low leakage under maximum simulated use conditions.	Met all performance specifications; conducive to intended use.
Acceptable flow rate.	Met all performance specifications; conducive to intended use.
No leakage at high pressure.	Met all performance specifications; conducive to intended use.
No leakage under vacuum pressure.	Met all performance specifications; conducive to intended use.
Proper function of closure piercing device.	Met all performance specifications; conducive to intended use.
Proper function of air inlet device.	Met all performance specifications; conducive to intended use.
Proper function of drip chamber.	Met all performance specifications; conducive to intended use.
Proper function of flow regulator.	Met all performance specifications; conducive to intended use.
Adequate tubing bonding strength.	Met all performance specifications; conducive to intended use.
Correct priming volume.	Met all performance specifications; conducive to intended use.
Adequate spike cap retention.	Met all performance specifications; conducive to intended use.
Compliance with ISO 8536-4 chemical standards.	Met all performance specifications; conducive to intended use.
Compliance with USP <788> particulate standards.	Met all performance specifications; conducive to intended use.
Biocompatibility (absence of cytotoxicity, sensitization, irritation, hemocompatibility, acute systemic toxicity, sub-chronic toxicity, genotoxicity).	Met all performance specifications; conducive to intended use.
Acceptable EO residual levels.	Met all performance specifications; conducive to intended use.
Acceptable bacterial endotoxin levels.	Met all performance specifications; conducive to intended use.
Compliance with ISO 80369-7:2016 for Luer connections.	Met all performance specifications; conducive to intended use.
Acceptable microbial ingress data (for needleless connector, referenced from K002689).	Met all performance specifications; conducive to intended use.
Device maintains performance over 1-year shelf life.	All acceptance criteria were met for 1-year shelf life.

The following points are mostly Not Applicable (N/A) because the provided document concerns a physical device (IV administration set) submission, not an AI/software as a medical device (SaMD).

2. Sample size used for the test set and the data provenance

N/A. The document refers to "nonclinical testing" and "bench tests" rather than a clinical "test set" in the context of an AI/ML algorithm. The specific number of physical units tested for each nonclinical test is not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not relevant for physical device bench testing as described here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Ground truth in the context of diagnostic accuracy (e.g., for an AI algorithm) is not relevant for this physical device's performance testing. The "ground truth" for the device here is whether it meets engineering and safety specifications through defined physical and chemical tests.

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

N/A. Adjudication methods are typically used in clinical studies or for establishing ground truth from expert opinions, which does not apply to the bench testing of a physical device.

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

N/A. This is a physical device, not an AI software. No human reader studies were performed.

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

N/A. This is a physical device, not an algorithm.

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

The "ground truth" implicitly used for this device's acceptance is adherence to established engineering standards, material specifications, and performance criteria for IV administration sets, as defined by relevant ISO, USP, and other medical device standards. This is determined through physical, chemical, and biological testing rather than expert consensus on diagnostic images or outcomes data.

8. The sample size for the training set

N/A. This is a physical device, not an AI/ML algorithm that requires a training set.

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

N/A. As above, this is a physical device.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K213588

Device Name Q2 IV Administration Sets

Indications for Use (Describe)

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) 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

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PREDICATE DEVICE(S) [807.92(a)(3)]

B.Braun Medical IV Administration Sets (K170595)

DEVICE DESCRIPTION [807.92(a)(4)]

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.

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Element ofComparison	Predicate Device – ExtensionSets with B.Braun Medical IVAdministrationSets(K170595)	Subject Device	Analysis of Differences
Product Code	FPA	FPA	Same
RegulationNumber	21 CFR 880.5440	21 CFR 880.5440	Same
Regulation Name	Intravascular Administration Set	Intravascular Administration Set	Same
Class	II	II	Same
Indications forUse	The IV Administration Sets areintravenous administration setsintended for delivery of fluidsfrom a container into a patient'svascular system. These devicesmay be used for any patientpopulation with considerationgiven to adequacy of vascularanatomy and appropriateness forthe solution being infused andduration of therapy.	The IV Administration Setsare intended for delivery offluids from a container intoa patient's vascular system.These devices may be usedfor any patient populationwith consideration given toadequacy of vascularanatomy andappropriateness for thesolution being infused andduration of therapy.	Removed "intravenousadministration sets" from thesubject device indications to avoidrepetition. There is no differencein the actual indications for use.The indications for use for thesubject device and predicatedevice are therefore substantiallyequivalent.
Components	Insertion spikedrip chambertubingluerconnectionsmanifoldneedleless connectorstopcocksclampscheckvalve	Insertion spikedrip chambertubingluer connectionsneedleless connectorstopcocksclampscheckvalve	The predicate device andsubject device are comprised ofthe same components with theexception of a manifold in someconfigurations of the predicatedevice, which is not included inthe subject device.Configurations of the predicatedevice without the manifold aretherefore substantiallyequivalent to the subject device.The results from performancetesting conducted on the subjectdevice demonstrates that thedifference in componentsbetween the subject device andpredicate device do not raisedifferent questions of safety andeffectiveness. The subjectdevice met all performancespecifications necessary to fulfilits intended use.
Mode of FluidDelivery	Gravity	Gravity	Same
ControlMechanism	Clamps and Stopcock	Clamps and Stopcock	Same
Compatibilitywith Blood andBlood Products	Not intended for use with blood orblood products per IFU	The subject device is notintended to be used with bloodor blood products	Same
Sterilization	Ethylene Oxide, SAL 10-6	Ethylene Oxide, SAL 10-6	Same
Element ofComparison	Predicate Device –Extension Sets with B.BraunMedical IV AdministrationSets(K170595)	Subject Device	Analysis of Differences
Device Materials	Unknown	Tubing - Alpha Gary 2235L-78PVC not made with DEHPVented drip chamber• Alpha Gary 2235L-78PVC not made withDEHP• ABS• HDPE• LDPE• Lexan polycarbonate and304 stainless steel.Check valve - Plexiglas DR100,DR6602, SiliconeNeedless Connector y-site-Makrolon RX 1805-451118Polycarbonate, LR3003/40SiliconePinch clamp –Polypropylene Roller clamp– ABSMale luer - Eastman TritanMX-731 CopolyesterFemale luer - Eastman DN003CopolyesterMale Luer - ABSTerlux PP PurellHP317PStopcock - Makrolon RX1805- 451118 Polycarbonate,LR3003/40 Silicone, HDPESolvent 20/80 Code R –Cyclohexanone, Methyl EthylKetone	The materials used on components ofthe predicate device is unknown.Materials used in the subject deviceare identical to those used in currentlymarketed Quest IV AdministrationSets. Results from biocompatibilitytesting conducted on the subjectdevice demonstrate that differences (ifany) in the materials used in thesubject device and predicate device donot raise different questions of safetyand effectiveness.
Patient ContactCategory/Duration	Externally Communicating,BloodPath Indirect, Prolonged contact	Externally Communicating,BloodPath Indirect, Prolonged contact	Same
Shelf-Life	Unknown	1 year	The shelf life of the predicate device isunknown. The subject device wasqualified with 1 year shelf life and allacceptance criteria were met. Resultsfrom shelf life testing conducted on thesubject device demonstrate thatdifferences (if any) between the shelflife of the predicate device and thesubject device shelf life do not raisedifferent questions of safety andeffectiveness.
Tubing length	Unknown	102"- 118"	The tubing length of the predicate deviceis unknown. Results from productperformance qualification testingconducted on the subject devicedemonstrate that differences (if any)between the tubing length of thepredicate device and the subject devicedo not raise different questions ofsafety and effectiveness.

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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 ●

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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.

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.