The Pronto Pump Tube Set is a part of the Pronto Pump System. This tube set provides peristaltic pump driven fluid transfer that facilities repeatable drug dosage distribution in healthcare environments. The Pronto Pump Tube set provides the fluid path way and pumping mechanism for the pump system.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The ProntoPump Sterile Tube Sets are fluid transfer tube sets used in conjunction with the ProntoPump pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container.

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

Device Description

The ProntoPump sterile tube set is a single channel tube set for use with the ProntoPump pharmacy pump. It consists of clear plastic tubing connected to a silicone tube that functions as a peristaltic pumping chamber. Peristaltic pumps function by a roller compressing the pump tubing and rolling along the length of the tube, squeezing the fluid inside the tube from one end to the other. It has a plastic cassette that holds the pumping chamber in place for insertion into the ProntoPump, which provides the rollers that the force the fluid to move. The proximal and distal ends of the PVC tubing have connectors for various devices and containers. Using the ProntoPump, the tube set is used to deliver specified volumes of liquid into a final dosing container in hospital pharmacies or compounding pharmacies. The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

The cassette is non-fluid-contact and helps hold the tubing in place for loading. It has a machine-readable barcode that can be read by the pharmacy pump. The barcode includes information about the particular tube set item number, lot number, and expiration date, which is used by pharmacy pump to facilitate set up of the tubing.

The tube set is intended to be used by trained healthcare personnel, and is not intended to be used for direct patient contact. Tube sets are packaged individually in a peel pouch and sterilized by radiation.

AI/ML Overview

The provided text describes the regulatory clearance for the "ProntoPump Sterile Tube Set" (K200893) and its substantial equivalence to a predicate device (K062909). However, it does not explicitly state "acceptance criteria" for performance in a table format with specific quantitative goals and reported device performance against those goals for the K200893 device. Instead, it compares the technological characteristics and performance of the subject device to the predicate in a qualitative manner and mentions general ISO and ASTM standards to which the device was tested.

The closest information relating to performance criteria and reported performance is about Volume Accuracy and Minimum Flow Rate, which are compared to the predicate device.

Here's an attempt to create the requested table based on the limited quantitative performance data provided, and then address the other points.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided document, explicit "acceptance criteria" with pass/fail thresholds are not clearly stated for the K200893 device. Instead, the document compares its performance characteristics to the predicate device. The information below is extracted from the "Comparison of Technological Characteristics with The Predicate Device" table and the "Differences Compared to Predicate Device / Substantial Equivalence Discussion" section.

Performance Characteristic	Acceptance Criteria (from predicate/discussion, if explicit)	Reported Device Performance (ProntoPump Sterile Tube Set K200893)
Volume Accuracy	Predicate: +/- 0.02 mL (0.2-2.0 mL), +/- 1% (>2.0 mL)	New Device: +/- 5% (1.0-5.0 mL), +/- 4% (>5 mL)
Minimum Flow Rate at Top Speed	Predicate: At least 11 mL /s	New Device: At least 21 mL /s
Tube Set Maximum Usage	Predicate: Labelled for 200 L maximum use	New Device: Labelled for 40 L maximum use
Sterilization Assurance Level (SAL)	Sterilized by Gamma radiation (10^-6) (Implied standard)	Sterilized by Gamma radiation (10^-6)
Biocompatibility	ISO 10993-1:2018	Compliant with ISO 10993-1:2018
Packaging Integrity	ISO 11607-1 & ISO 11607-2	Compliant with ISO 11607-1, ISO 11607-2
Particulate Matter	USP 788	Compliant with USP 788
General Infusion Equipment Standards	ISO 8536-4:2019	Compliant with ISO 8536-4:2019
Small-bore Connectors Standards	ISO 80369-7:2016	Compliant with ISO 80369-7:2016
Shipping Performance	ASTM D4169-16	Compliant with ASTM D4169-16

Note: The document states "Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness." This indicates that the "reported device performance" for volume accuracy, while different, was deemed acceptable for substantial equivalence.

2. Sample Size Used for the Test Set and the Data Provenance

The document refers to "Bench Testing" against various ISO and ASTM standards. However, it does not provide any specific sample sizes for these tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing results, as these are laboratory/bench tests, not clinical studies involving patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts

N/A - This submission is for a medical device (sterile tube set) and relies on bench testing against established engineering and safety standards (ISO, ASTM, USP). There are no human experts involved in establishing a "ground truth" in the context of clinical interpretation or diagnostic accuracy for this type of device. The ground truth is defined by the objective metrics and criteria outlined in the referenced standards.

4. Adjudication Method for the Test Set

N/A - As this is bench testing against objective engineering and safety standards, no adjudication method (like 2+1, 3+1 consensus) is applicable or mentioned. The results are typically measured against the specified tolerances within the standards.

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 document describes a syringe pump accessory (sterile tube set), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC comparative effectiveness study was conducted or is relevant.

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

N/A - This device is a physical medical device (tube set) used in conjunction with a pump, not an algorithm. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the device's performance is established by the requirements and specifications within recognized international standards for medical devices, particularly those related to infusion equipment, sterilization, packaging, and biocompatibility. These include:

ISO 8536-4:2019 (Infusion equipment)
ASTM D4169-16 (Shipping Containers)
ISO 80369-7:2016 (Small-bore connectors)
ISO 10993-1:2018 (Biocompatibility)
USP 788 (Particulate Matter)
ISO 11607-1:2019 & ISO 11607-2:2019 (Packaging)
ISO 11137-1:2006 & ISO 11137-2:2013 (Radiation Sterilization)
The established performance characteristics of the legally marketed predicate device (K062909) also serve as a comparative ground truth for evaluating substantial equivalence.

8. The Sample Size for the Training Set

N/A - This is a physical medical device, not a machine learning or AI algorithm. Therefore, there is no concept of a "training set" for this submission.

9. How the Ground Truth for the Training Set Was Established

N/A - As there is no training set for a physical device, this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".

May 4, 2021

IPAX, Inc Jeff Baldwin CEO 2700 S Raritan St Englewood, Colorado 80110

Re: K200893

Trade/Device Name: ProntoPump Sterile Tube Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI, NEP Dated: April 2, 2021 Received: April 5, 2021

Dear Jeff Baldwin:

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 medical devices and radiation-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,

for Payal Patel Acting 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) K200893

Device Name Pronto Pump Sterile Tube Set

Indications for Use (Describe)

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

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) Summary K200893
Submitted by:	IPAX, INC.2700 S Raritan StEnglewood, CO 80110Registration Number: 1720734
Preparation date:	April 23, 2021
Contact person:	Jeff Baldwin, CEO
Telephone number:	303-975-2444 x 630
Fax number:	N/A
E-mail Address:	jeffb@ipaxinc.com
Manufacturing Site Address:	IPAX, INC.2700 S Raritan StEnglewood, CO 80110
Device Trade or Proprietary Name:	ProntoPump Sterile Tube Set
Common Name:	Set, I.V. Fluid Transfer
Product code:	LHI
Secondary Product Code:	NEP System/Device, Pharmacy Compounding
Regulatory Class:	Class II

Regulation number: 21 CFR 880.5440 Intravascular administration set

Classification Panel: General Hospital

Model number: 3003852 Sterile Tube Set, Universal Spike – Luer Lock 3003854 Sterile Tube Set, Luer Lock to Luer Lock

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Predicate Device:	K062909 Repeater Pump II Tube Sets
Common Name :	Set, I.V. Fluid Transfer
Regulation Number:	21 CFR § 880.5440 Intravascular administration set,
Product Code:	LHI

Device Description:

Indications for Use

The device is for use with IV bags, syringes, elastomeric infusers, and other drug administration containers. Sets are sold sterile.

Comparison of Technological Characteristics with The Predicate Device

The ProntoPump sterile tube set has the same indications for use (to provide a fluid path for the dispensing of fluids using a pharmacy pump), and substantially the same tubing and connections (PVC tubing, ABS spike, ABS fittings) as the predicate device. The tube set uses a silicone tubing to provide peristaltic pump driven fluid transfer, while the predicate device used a high speed syringe pump

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to provide fluid transfer. Both devices are provided as sterile, nonpyrogenic, individually packaged devices to be used with their respective pharmacy pumps.

Feature	ProntoPumpSterile Tube Set(K200893)	RepeaterPump II TubeSet(K062909)	Discussion/Justification
Indicationsfor use	The ProntoPumpSterile Tube Sets arefluid transfer tubesets used inconjunction with theProntoPumppharmacy pump inhospital andcompoundingpharmacies toprovide a pathwaythrough which fluid istransferred from onesource container intoanother suitablecontainer.The device is for usewith IV bags,syringes, elastomericinfusers, and otherdrug administrationcontainers. Sets aresold sterile.	The Repeater Pump IItube sets are fluidtransfer tube sets usedin conjunction with theRepeater Pump IIpharmacy pump inhospital andcompoundingpharmacies to provide apathway through whichfluid is transferred fromone source containerinto another suitablecontainer.	Same
Intended Use	The ProntoPumpSterile Tube Setsare fluid transfertube sets used inconjunction with theProntoPumppharmacy pump inhospital andcompoundingpharmacies toprovide a pathwaythrough which fluid istransferred from onesource container into	The Repeater PumpII tube sets are fluidtransfer tube setsused in conjunctionwith the ProntoPumppharmacy pump inhospital andcompoundingpharmacies toprovide a pathwaythrough which fluid istransferred from onesource container intoanother suitable	Same
Feature	ProntoPumpSterile Tube Set(K200893)	RepeaterPump II TubeSet(K062909)	Discussion/Justification
	another suitablecontainer.	container.
Usage	Single use. Rx Only	Single Use. Rx Only	Same
TargetPopulation	Customers for thetube sets areProntoPumppharmacy pumpusers, includinghospital and homecare pharmacist andpharmacytechnicians. Thesetube sets are usedby trained personnel,and do not havedirect contact withany patient.	Customers for thetube sets are BaxaRepeater Pump 2™pump users, includinghospital and homecare pharmacist andpharmacytechnicians. Thesetube sets are used bytrained personnel,and do not havedirect contact withany patient.	Same
Anatomical	Not intended forpatient contact	Not intended forpatient contact	Same
Where Used	This product is usedby Pharmacists andPharmacytechnicians bothinside and outside offlow hoods	This product is usedby Pharmacists andPharmacytechnicians bothinside and outside offlow hoods	Same
Connections	Luer fittings, spikesfor IV bags, andother standard IV, ororal/ topicalconnections.Different sets willhave differentconnectionsdepending on thesource and finalcontainers.	Luer fittings, spikesfor IV bags, and otherstandard IV, or oral/topical connections.Different sets willhave differentconnectionsdepending on thesource and finalcontainers.	Same
Feature	ProntoPumpSterile Tube Set(K200893)	RepeaterPump II TubeSet(K062909)	Discussion/Justification
Biocompatibility	ISO 10993-1,ExternallyCommunicating,Indirect	ISO 10993-1,ExternallyCommunicating,Indirect	Same
Inlet andOutletMaterials	Polyvinyl Chloride(PVC): tubing with noDi (2-ethylhexyl)phthalate (DEHP)added.	PVC tubing with noDEHP added.	Same
PumpingMechanism	Uses a silicone tubeto provide peristalticpumping.	Uses a custom moldedsyringe as a pumpingchamber.	Both methods achievethe intended use oftransferring fluid from asource container intoanother container safelyand effectively.
PumpingChamberMaterial	Medical gradeplatinum curedSilicone tubing	Clear plastic cylindercontaining a maximumof 10 mL, non-latexrubber piston, and anon-latex rubber valveto control direction offlow.	Different:The predicate deviceuses a high-speedsyringe pump to transferfluids from a sourcecontainer into anothersuitable container. TheProntoPump uses asilicone tube to providea peristaltic pumpingaction to transfer intoanother suitablecontainer. The methodsof transfer aresubstantially equivalentin terms of safety andeffectiveness ofachieving the intendeduse
Spike Material	AcrylonitrileButadiene Styrene(ABS)	ABS	Same
LuerConnectorMaterials	ABS	ABS	Same
Sterilization	Sterilized by Gammaradiation ( $10 ^ -6$ )	Sterilized by Gammaradiation ( $10 ^ -6$ )
Feature	ProntoPumpSterile Tube Set(K200893)	RepeaterPump II TubeSet(K062909)	Discussion/Justification
Tube setmaximumusage	Labelled for 40 Lmaximum use	Labelled for 200 Lmaximum use	DifferentSterile sets in criticalcare pharmacies areonly used for 24 hours,and most doses arebelow 250 mL, the 24hour limit is identified inthe ProntoPump SterileTube Set Instructionsfor Use.The 40L limit will meetthe needs of almost allusers. The 40L limit isidentified in theProntoPump device[510(k) exempt]instructions for use
Minimum FlowRate at TopSpeed	At least 21 mL /s attop speed	At least 11 mL /s	DifferentMost doses in criticalcare pharmacies arebelow 250 mL, and thehigher flow rate of thepredicate device doesnot provide significantvalue to the user. Theflow rate of filling thedose container has noknown impact on thesafety or efficacy of thedose to the patient.
Feature	ProntoPump Sterile Tube Set (K200893)	Repeater Pump II Tube Set (K062909)	Discussion/Justification
Volume Accuracy	+/- 5% from 1.0 mL to 5.0 mL+/- 4% above 5 mL	labelled as+/1 0.02 mL from 0.2 ml to 2.0 mL+/- 1% above 2.0 mL	DifferentThe predicate device used a fixed sized, high speed syringe pump to achieve the stated accuracy of the volume transferred from source container to the final container.The ProntoPump tube sets use the silicone tubing in conjunction with the ProntoPump pharmacy pump to achieve the stated accuracy of the volume transferred from source container to the final container.Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container have substantially equivalent safety

Comparison of Technological Characteristics with the Predicate

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Differences Compared to Predicate Device / Substantial Equivalence Discussion

The devices are similar in intended use, function, sterility, and packaging. The most notable physical difference is the predicate device uses a custom molded syringe as a pumping chamber. The ProntoPump sterile tube set uses a silicone tube to provide peristaltic pumping. Both methods achieve the intended use safely and effectively.

While the predicate device is labelled for deliveries as small as 0.2 mL, it is not for use on syringes smaller than 3mL. The ProntoPump sterile tube set is labelled for use down to 1.0 mL. This is since for practical reasons that is the smallest delivery users would be likely to put into a 3 mL syringe.

The volume accuracy claim of the predicate device was +/- 0.02 mL from 0.2 mL to 2.0 mL, and +/- 1% above 2.0 mL. The ProntoPump Tube Set provides accuracy of +/- 5% from 1.0 mL to 5.0 mL and +/- 4% above 5 mL. Although the accuracy of the ProntoPump tube sets is not as precise as the predicate device, in the context of doses prepared in Hospital and Compounding Pharmacies the accuracy of the volume delivered to the final container is substantially equivalent in terms of safety and effectiveness.

The technological and performance differences between the devices have been analyzed and it has been concluded no new issues of safety and effectiveness are presented in the new device compared to the predicate device. The results of the bench testing conducted demonstrate the subject device is substantially equivalent to the predicate device in the intended use, indications for use and functionality.

Summary of Performance Testing

Bench Testing

ISO 8536-4:2019, Infusion equipment for-medical use- Part 4: Infusion . sets for single use, gravity feed.
ASTM D4169-16:2016 Standard Practice for Performance Testing of . Shipping Containers and Systems
ISO 80369-7:2016 Small-bore connectors for liguids and gases in . healthcare applications - Part 7: Connectors for intravascular or hypodermic applications

Biocompatibility

ISO 10993-1:2018 Biological evaluation of medical .
devices Part 1: Evaluation and testing within a risk management . process

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USP 788, Particulate Matter in Injections .

Sterilization and Packaging

ISO 11607-1:2019 Packaging for terminally sterilized medical devices . - Part 1: Requirements for materials, sterile barrier systems and packaging systems
ISO 11607-2:2019 Packaging for terminally sterilized medical devices -. Part 2: Validation requirements for forming, sealing and assembly processes
ISO 11137-1:2006 Sterilization of health care products Radiation -. Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
. ISO 11137-2:2013 - Sterilization of health care products - Radiation -Part 2: Establishing the sterilization dose

Clinical or Animal Testing

N/A - No animal or clinical testing.

Substantial Equivalence Conclusion:

Based on the indication for use, the technological and performance characteristics, and results of performance testing, the subject device Pronto Pump Sterile tube sets have been demonstrated to be substantially equivalent to the legally marketed predicate device, K062909.

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.