The Precision Delivery Infusion Sets are intended to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

Device Description

Ouest Medical's Precision Delivery Infusion Sets are single use, disposable, extension sets used to deliver fluids to a patient. The Precision Delivery Sets consist of various configurations, which includes tubing, filter, clamp, needleless connector and luers.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device (infusion sets). It does not describe an AI/ML medical device, therefore, the requested information about acceptance criteria and study proving the device meets the criteria in the context of AI/ML performance is not present.

The document discusses substantial equivalence to a predicate device based on non-clinical performance testing. It explicitly states that clinical testing was not performed to support this 510(k) submission and that no human-in-the-loop, multi-reader multi-case (MRMC) comparative effectiveness study, or standalone algorithm performance study was conducted.

Therefore, I cannot provide the requested information regarding:

Table of acceptance criteria and reported device performance (in the context of AI/ML metrics). The acceptance criteria mentioned are related to physical and chemical properties of the infusion set (e.g., priming volume, flow rate, bond strength, filter efficiency, biocompatibility, sterilization) rather than AI/ML performance metrics.
Sample size for the test set and data provenance. No such test set for AI/ML performance is described.
Number of experts and their qualifications for ground truth. No ground truth establishment related to AI/ML is mentioned.
Adjudication method. Not applicable.
MRMC comparative effectiveness study and effect size. Stated as "Not applicable. Clinical testing was not performed."
Standalone (algorithm only) performance. Not applicable.
Type of ground truth used. Not applicable in the AI/ML context.
Sample size for the training set. Not applicable.
How ground truth for the training set was established. Not applicable.

The document focuses on demonstrating that the "Precision Delivery Infusion Sets" are substantially equivalent to a previously cleared predicate device by comparing their indications for use, design features, materials, and non-clinical performance data.

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 21, 2021

Quest Medical, Inc. Tosan Eweka Regulatory Affairs Supervisor One Allentown Parkway Allen, Texas 75002

Re: K202672

Trade/Device Name: Precision Delivery Infusion Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: FPA Dated: December 17, 2020 Received: December 18, 2020

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,

CAPT Alan M. Stevens Director (acting) 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) K202672

Device Name Precision Delivery Infusion 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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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 Supervisor 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: September 17, 2020

DEVICE INFORMATION [807.92(a)(2)]

Trade Name:

Precision Delivery Infusion 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)]

Extension Sets with BD Q-Syte Luer Access Split Septum (K142527)

DEVICE DESCRIPTION [807.92(a)(4)]

INDICATIONS FOR USE [807.92(a)(5)]

The Precision Delivery Infusion Sets are intended to be used to administer or aspirate fluids. These devices may be used with any patient population with consideration given to the procedure being performed and fluids being infused.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE [807.92(a)(6)]

The Precision Delivery Infusion Set has the same intended use, indications for use, and principles of operation and similar design features and technological characteristics as the predicate device. The differences in the technological characteristics between the Precision Delivery Infusion Set and the predicate device do not raise different questions of safety or effectiveness. Thus, the Precision Delivery Infusion Set is substantially equivalent to the predicate device. An analysis of the differences in technological characteristics is provided in the table below.

Element ofComparison	Predicate Device –Extension Sets with BDQ-Syte Luer AccessSplit Septum(K142527)	Subject Device	Analysis ofDifferences
Indications for Use	Extension Sets with anattached BD Q-SyteLuer Access SplitSeptum are intended tobe used withintravascular catheters toaspirate blood oradminister fluids,including medicationsand blood or bloodproducts. These devicesmay be used with anypatient population withconsideration given tothe procedure beingperformed and fluidsbeing infused.	The Precision DeliveryInfusion Sets areintended to be used toadminister or aspiratefluids. These devicesmay be used with anypatient population withconsideration given tothe procedure beingperformed and fluidsbeing infused.	The main differenceis the indications foruse of the predicate isbroader than theindications for use ofthe subject device.The predicate isindicated foraspiration andadministration ofblood, blood productsand fluids while thesubject device isindicated foradministration oraspiration of fluids.The indications forthe subject devicefalls within theindications for thepredicate device. Thedifference in the
Element ofComparison	Predicate Device -Extension Sets with BDQ-Syte Luer AccessSplit Septum(K142527)	Subject Device	Analysis ofDifferences
			indications for usetherefore does notalter the intended useof the predicatedevice and the subjectdevice, which is toprovide a conduit forthe administration offluids.
DesignFeatures/Components	Tubing with Slideclamp, Needlelessconnector, Luers andCaps. Extension Sets areprovided in singletubing, bifurcated tubingor trifurcated tubingconfigurations withlengths ranging from 5"-21".	Tubing with Slideclamp, Needlelessconnector, Luers, Capsand Filter. ExtensionSets are provided insingle tubing andtrifurcated tubingconfigurations withlengths ranging from 7"-62".	The predicate deviceand subject device areboth offered in singleand trifurcated tubingconfigurations. Thepredicate deviceadditionally has abifurcated tubingconfiguration. Thesubject device is notoffered in bifurcatedmodels. The predicatedevice and subjectdevice are comprisedof the samecomponent types withthe exception of afilter componentincluded in thesubject device. Thefluid filter in thesubject device isintended to filterparticulates. Fluidfilter efficiency testwas conducted on thesubject device and allacceptance criteriawas met. Theminimum/maximumlength configurationof the subject deviceis shorter/longer thanthe predicate device.The results fromperformance testingconducted on thesubject devicedemonstrates that the
Element ofComparison	Predicate Device -Extension Sets with BDQ-Syte Luer AccessSplit Septum(K142527)	Subject Device	Analysis ofDifferences
			difference in designfeatures andcomponents betweenthe subject device andpredicate device donot raise differentquestions of safetyand effectiveness. Thesubject device met allperformancespecificationsnecessary to fulfil itsintended use.
Mode of FluidDelivery	Gravity	Same	No difference
Device Materials	Tubing• Non-DEHPPVCSlide clamp• UnknownLuer Cap• UnknownNeedleless Connector• UnknownLuers• Unknown	Tubing• Non-DEHPPVCSlide clamp• HDPELuer Cap• HDPEFilter• Acrylic/PTFE/PESNeedleless Connector• Polycarbonate/SiliconeLuers• ABS/Co-Polyester	The subject devicetubing and predicatedevice tubing aremade from Non-DEHP PVC. Thematerials used onother components ofthe predicate device isunknown. Resultsfrom biocompatibilitytesting conducted onthe subject devicedemonstrate thatdifferences (if any) inthe materials used inthe subject device andpredicate device donot raise differentquestions of safetyand effectiveness.
Patient ContactCategory/Duration	ExternallyCommunicating, BloodPath Indirect, Prolongedcontact	Same	No difference
Sterilization	SAL 10-6	Same	No difference

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PERFORMANCE DATA [807.92(b)]

All necessary testing was conducted on the Precision Delivery Infusion 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 Precision Delivery Infusion Sets in this submission included:

Priming Volume
Backpressure Leak ●
Flow Rate ●
Simulated Maximum Use ●
o Tubing Bond Strength
Multiple Clamping
Prolonged Clamping ●
o Tubing Kink Resistance
Aspiration Test ●
ISO 8536-4 Chemical and Particulate Tests ●
ISO 8536-4 Filter Efficiency Test
ISO 80369-7:2016 Luer compliance
USP <788> Particulate Test
Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation, Pyrogenicity, o Hemocompatibility, Acute Systemic Toxicity, Sub-Chronic Toxicity)
Sterilization validation per ISO 11135:2014 ●
Bacterial Endotoxin Tests ●

Microbial ingress data for the needleless connector component 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 Precision Delivery Infusion Sets meets the established specifications necessary for consistent performance during its intended use. In addition, the collective performance testing demonstrate that the Precision Delivery Infusion 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 Precision Delivery Infusion Sets is substantially equivalent to the predicate device.

SUMMARY

The Precision Delivery Infusion 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.