Who is the manufacturer of ProntoPump Sterile Tube Set?

Ipax, Inc. filed the 510(k) submission for ProntoPump Sterile Tube Set (K200893).

What is the FDA product code for ProntoPump Sterile Tube Set?

LHI. It is classified under 21 CFR 880.5440 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for ProntoPump Sterile Tube Set?

510(k) clearance (submission type: Traditional).

What are the predicate devices for ProntoPump Sterile Tube Set?

Repeater Pump II Tube Sets (K062909).

Who can help prepare an FDA 510(k) submission like ProntoPump Sterile Tube Set?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ProntoPump Sterile Tube Set

K200893 · Ipax, Inc. · LHI · May 4, 2021 · General Hospital

Device Facts

Record ID	K200893
Device Name	ProntoPump Sterile Tube Set
Applicant	Ipax, Inc.
Product Code	LHI · General Hospital
Decision Date	May 4, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5440
Device Class	Class 2

Intended Use

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 Story

Single-channel sterile tube set for use with ProntoPump pharmacy pump; facilitates fluid transfer between containers (IV bags, syringes, elastomeric infusers). Consists of PVC tubing with silicone peristaltic pumping chamber; plastic cassette holds chamber for pump insertion. Cassette includes machine-readable barcode for pump setup (item number, lot, expiration). Operated by pharmacists/technicians in pharmacy environments. Peristaltic rollers compress silicone tubing to move fluid. Output is precise volume of liquid in final dosing container. Benefits include repeatable drug dosage distribution in pharmacy compounding workflows.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence supported by bench testing, including ISO 8536-4 (infusion equipment), ASTM D4169-16 (shipping containers), ISO 80369-7 (connectors), ISO 10993-1 (biocompatibility), USP 788 (particulate matter), and sterilization/packaging validation (ISO 11607, ISO 11137).

Technological Characteristics

Materials: PVC (DEHP-free), medical-grade platinum-cured silicone, ABS. Peristaltic pumping principle. Single-use, sterile (Gamma radiation). Includes machine-readable barcode for pump interface. Complies with ISO 10993-1, ISO 8536-4, ISO 80369-7, ISO 11607, and ISO 11137.

Indications for Use

Indicated for use by trained healthcare personnel (pharmacists, pharmacy technicians) in hospital and compounding pharmacies for fluid transfer between containers (IV bags, syringes, elastomeric infusers). Not for direct patient contact.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

Repeater Pump II Tube Sets (K062909)

Related Devices

K212530 — IVX Fluid Transfer Set · Omnicell, Inc. · Apr 24, 2022
K062909 — REPEATER PUMP II TUBE SETS · Baxa Corp. · Mar 9, 2007
K203674 — B Dispensing Line · Aea Srl · Sep 27, 2021
K162216 — GRI-FILL PERISTALTIC SET · Laboratorios Grifols, S.A. · Oct 19, 2017
K022523 — RAPID-FILL TUBESET, MODEL 90005 · Baxa Corp. · Aug 12, 2002

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200893 Device Name Pronto Pump Sterile Tube Set #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ | | 510(K) Summary K200893 | |-----------------------------------|----------------------------------------------------------------------------------------| | Submitted by: | IPAX, INC. 2700 S Raritan St Englewood, CO 80110 Registration 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 St Englewood, 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 {4}------------------------------------------------ | 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: 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. ### Indications for Use 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. ### 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 {5}------------------------------------------------ to provide fluid transfer. Both devices are provided as sterile, nonpyrogenic, individually packaged devices to be used with their respective pharmacy pumps. | Feature | ProntoPump Sterile Tube Set (K200893) | Repeater Pump II Tube Set (K062909) | Discussion/ Justification | |--------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | 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. | The Repeater Pump II tube sets are fluid transfer tube sets used in conjunction with the Repeater Pump II pharmacy pump in hospital and compounding pharmacies to provide a pathway through which fluid is transferred from one source container into another suitable container. | Same | | Intended Use | 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 | The Repeater Pump II 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 | Same | | Feature | ProntoPump Sterile Tube Set (K200893) | Repeater Pump II Tube Set (K062909) | Discussion/ Justification | | | another suitable container. | container. | | | Usage | Single use. Rx Only | Single Use. Rx Only | Same | | Target Population | Customers for the tube sets are ProntoPump pharmacy pump users, including hospital and home care pharmacist and pharmacy technicians. These tube sets are used by trained personnel, and do not have direct contact with any patient. | Customers for the tube sets are Baxa Repeater Pump 2™ pump users, including hospital and home care pharmacist and pharmacy technicians. These tube sets are used by trained personnel, and do not have direct contact with any patient. | Same | | Anatomical | Not intended for patient contact | Not intended for patient contact | Same | | Where Used | This product is used by Pharmacists and Pharmacy technicians both inside and outside of flow hoods | This product is used by Pharmacists and Pharmacy technicians both inside and outside of flow hoods | Same | | Connections | Luer fittings, spikes for IV bags, and other standard IV, or oral/ topical connections. Different sets will have different connections depending on the source and final containers. | Luer fittings, spikes for IV bags, and other standard IV, or oral/ topical connections. Different sets will have different connections depending on the source and final containers. | Same | | Feature | ProntoPump Sterile Tube Set (K200893) | Repeater Pump II Tube Set (K062909) | Discussion/ Justification | | Biocompatibility | ISO 10993-1, Externally Communicating, Indirect | ISO 10993-1, Externally Communicating, Indirect | Same | | Inlet and Outlet Materials | Polyvinyl Chloride (PVC): tubing with no Di (2-ethylhexyl) phthalate (DEHP) added. | PVC tubing with no DEHP added. | Same | | Pumping Mechanism | Uses a silicone tube to provide peristaltic pumping. | Uses a custom molded syringe as a pumping chamber. | Both methods achieve the intended use of transferring fluid from a source container into another container safely and effectively. | | Pumping Chamber Material | Medical grade platinum cured Silicone tubing | Clear plastic cylinder containing a maximum of 10 mL, non-latex rubber piston, and a non-latex rubber valve to control direction of flow. | Different: The predicate device uses a high-speed syringe pump to transfer fluids from a source container into another suitable container. The ProntoPump uses a silicone tube to provide a peristaltic pumping action to transfer into another suitable container. The methods of transfer are substantially equivalent in terms of safety and effectiveness of achieving the intended use | | Spike Material | Acrylonitrile Butadiene Styrene (ABS) | ABS | Same | | Luer Connector Materials | ABS | ABS | Same | | Sterilization | Sterilized by Gamma radiation ( $10 ^ -6$ ) | Sterilized by Gamma radiation ( $10 ^ -6$ ) | | | Feature | ProntoPump Sterile Tube Set (K200893) | Repeater Pump II Tube Set (K062909) | Discussion/ Justification | | Tube set maximum usage | Labelled for 40 L maximum use | Labelled for 200 L maximum use | Different Sterile sets in critical care pharmacies are only used for 24 hours, and most doses are below 250 mL, the 24 hour limit is identified in the ProntoPump Sterile Tube Set Instructions for Use. The 40L limit will meet the needs of almost all users. The 40L limit is identified in the ProntoPump device [510(k) exempt] instructions for use | | Minimum Flow Rate at Top Speed | At least 21 mL /s at top speed | At least 11 mL /s | Different Most doses in critical care pharmacies are below 250 mL, and the higher flow rate of the predicate device does not provide significant value to the user. The flow rate of filling the dose container has no known impact on the safety or efficacy of the dose 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 | Different The 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 {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ ## 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 {11}------------------------------------------------ - 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.

ProntoPump Sterile Tube Set

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Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

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Device Story

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