Rio™ Vial-to-Bag Drug Reconstitution Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

Device Description

Rio™ Vial-to-Bag Drug Reconstitution Device (Rio™) is a single use, sterile, two-way, drug transfer device that is designed and indicated to connect an ICU Medical LifeCare IV container system (IV bag)(up to 250 mL) via the drug additive port, to a drug vial having a 20mm stopper closure for reconstituting or mixing and aseptic transfer of the drug from the vial into the solution of the IV bag. Once connected, Rio™ is not separated from the IV bag or vial, and should be disposed of with the IV bag when administration is complete. Rio™ is intended to be used in a pharmacy setting or patient care area, by trained clinicians. RioTM design consists of a port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial having a 20mm closure. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio™ also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag. Rio™ is needlefree and will passively aid in the prevention of needlestick injuries.

AI/ML Overview

The provided document is a 510(k) summary for the Rio™ Vial-to-Bag Drug Reconstitution Device. It describes the device, its intended use, and compares it to a predicate device. It also mentions non-clinical testing performed to support its safety and effectiveness.

However, the document does not contain specific acceptance criteria values or detailed results of a study proving the device meets those criteria in a format that would allow for the construction of the requested table. Specifically, it lacks:

Specific quantitative acceptance criteria: The document lists types of tests (e.g., Positive pressure leak, Fluid flow, Particulate testing) but does not provide numerical thresholds or pass/fail definitions for these tests.
Reported device performance data: While it states "the new device met its design specifications and performs as intended," it does not provide the actual measured performance values from the tests.
Details about sample sizes, data provenance, ground truth establishment, or expert involvement, which are typically associated with studies involving AI or complex diagnostic systems, and are not relevant to this type of mechanical medical device submission which focuses on functional and material testing.

Therefore, I cannot generate the requested table and detailed study information based on the provided text. The submission focuses on demonstrating substantial equivalence through comparison to a predicate device and extensive physical and material testing, rather than a clinical effectiveness study with human readers or AI.

Here's a breakdown of why the requested elements cannot be fulfilled from the provided text:

Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated with quantitative values. The document mentions functional performance per ISO standards (e.g., ISO 8536-4, ISO 22413), particulate testing per ISO 8536-4 and USP<788>, biocompatibility per ISO 10993-1, sterilization per ISO 11137, and packaging per ISO 11607. These standards contain acceptance criteria, but the specific criteria applied (e.g., maximum leakage rate, particle count limits) are not detailed in this summary.
- Reported Device Performance: The document only makes a general statement that "the new device met its design specifications and performs as intended." No specific performance metrics or values are reported.
Sample size used for the test set and the data provenance: Not mentioned. This type of detail is typically included in full test reports, not a 510(k) summary. Data provenance (country of origin, retrospective/prospective) is not relevant for this type of device and testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is a mechanical drug reconstitution device, not an interpretative diagnostic device requiring expert ground truth establishment.
Adjudication method for the test set: Not applicable for this type of device testing.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-assisted diagnostic device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for this device's testing would be defined by the specifications and performance requirements of the relevant ISO and USP standards for mechanical and material properties.
The sample size for the training set: Not applicable. This device does not use machine learning or AI that requires a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

April 20, 2020

ICU Medical, Inc. Sheila Antonio Senior Manager, Regulatory Affairs 951 Calle Amanecer San Clemente, California 92673

Re: K192154

Trade/Device Name: Rio Vial-to-Bag Drug Reconstitution Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: LHI Dated: March 23, 2020 Received: March 24, 2020

Dear Sheila Antonio:

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

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 Tina Kiang 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) K192154

Device Name

Rio™ Vial-to-Bag Drug Reconstitution Device

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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Image /page/3/Picture/0 description: The image shows the ICU Medical logo. The logo is in blue and consists of the letters "icu" in a bold, sans-serif font, followed by the word "medical" in a lighter, thinner font. Below the logo, in smaller letters, are the words "human connections".

K192154 510(k) Summary

A summary of 510(k) substantial equivalence information in accordance with the requirements of 21 CFR 807.92 for the Rio™ Vial-to-Bag Drug Reconstitution Device.

Submitter Information
Company Name	ICU Medical, Inc.
Company Address	951 Calle Amanecer, San Clemente, CA 92673
Establishment Registration	2025816
Application CorrespondentName & Contact	Sheila Antonio, Senior Manager, Regulatory AffairsPhone: (949) 359-5708
Date prepared	March 23, 2020
Device Information
Trade or proprietary name	Rio™ Vial-to-Bag Drug Reconstitution Device
Common or usual name	Binary Connector (Set, I.V. Fluid Transfer)
Regulation name	Intravascular Administration Set
Classification	Class II per 21 CFR 880.5440
Product Code(s)	LHI

Predicate Device - Legally marketed device(s) to which equivalence is claimed

K090905, addEASE Binary Connector (by B. Braun Medical Inc)

Reason for 510(k) submission

The purpose of this submission is to demonstrate substantial equivalence of the new device. Rio™ Vial-to-Bag Drug Reconstitution Device to the legally marketed predicate device.

Device Description

RioTM design consists of a port spike that connects to the compatible IV bag on one end, and a vial spike on the other end to connect a standard liquid or lyophilized/powdered drug vial having a 20mm closure. The bag spike and vial spike contain protective caps that maintain the sterility of the device until the caps are removed prior to use. Rio™ also includes a flow director (rotating handle) that will isolate the fluid between the vial and bag until manipulated by the pharmacist or clinician to allow two-way fluid transfer between the vial and bag. Rio™ is needlefree and will passively aid in the prevention of needlestick injuries.

Indications for use

RioTM Vial-to-Bag Drug Reconstitution Device is indicated for single-use reconstituting or mixing of liquid or lyophilized drug in a vial, and the aseptic transfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) for patient infusion administration.

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Image /page/4/Picture/0 description: The image shows the logo for ICU Medical. The word "icu" is in bold, blue letters, and the word "medical" is in a lighter blue color. Below the company name are the words "human connections" in a smaller font.

Summary of Technological Characteristics and Substantial Equivalence (Subject vs. Predicate)
Feature	Proposed DeviceRio™ Vial-to-Bag DrugReconstitution Device	Predicate DeviceK090905, addEASE Binary Connector(by B. Braun)
Product Code	LHI Class II per 21 CFR 880.5440(Same as predicate)	LHI Class II per 21 CFR 880.5440
Common Name	Set, I.V. Fluid Transfer(Same as predicate)	Set, I.V. Fluid Transfer
Intended Use	Reconstituting or mixing drug in vial withsolution in IV bag(Same as predicate)	Reconstituting or mixing drug in vial withsolution in IV bag
Indications for Use	Rio™ Vial-to-Bag Drug Reconstitution Deviceis indicated for single-use reconstituting ormixing of liquid or lyophilized drug in a vial,and the aseptic transfer of the reconstituteddrug into the multi-port LifeCare IV containersystem (IV bag) for patient infusionadministration.	The addEASE 20 mm Binary Connector with17 Ga. Needle is a double ended transferdevice intended for use in a pharmacy settingto connect a B. Braun 250mL Excel IVsolution bag to a 20 mm drug vial forreconstituting or mixing the drug in the vialwith the solution in the bag.
Principle of Operation	Two-way transfer device to connect drug vialto IV solution bag(Same as predicate)	Two-way transfer device to connect drug vialto IV solution bag
Mechanism of Action	Attaching device to drug vial and IV solutionbag(Same as predicate)	Attaching device to drug vial and IV solutionbag
Use Environment	Pharmacy setting and healthcare facility bytrained clinician.(Same as predicate)	Pharmacy setting and healthcare facility bytrained clinician.
Compatibility –Solution Bag	Multi-port ICU Medical LifeCare IV containersystem (up to 250 mL)(Similar device access as predicate)	B. Braun 250 mL Excel® IV solution bag
Compatibility –Drug Vial	Standard 20 mm closure drug vial (for liquid orpowdered)(Same as predicate)	Standard 20 mm closure drug vial (liquid orpowdered)
Materials ofConstruction	Bag spike – Plastic/ Polycarbonate(Different than predicate)	Bag spike – 17 Ga. Stainless Steel Needle
	Vial spike – Plastic/ Polycarbonate	Vial spike - Plastic (type unknown)
	Body - Polycarbonate(Same base material as predicate)	Body - Polycarbonate
	Handle - Polyethylene	N/A
	Protective Caps –Polyethylene (Bag Spike);PVC Tubing, Non-DEHP (Vial Spike)(Same base material as predicate)	Protective Caps (2) - Polyethylene
Biocompatibility	Per ISO 10993-1(Same as predicate)	Per ISO 10993-1
Sterilization	E-beam radiation; SAL 10-6(Same SAL as predicate)	Gamma radiation; SAL 10-6
Pyrogenicity	Non-pyrogenic(Same as predicate)	Non-pyrogenic
Packaging	Individual, single-use; Sterile barrier packaging(Same as predicate)	Individual, single-use; Sterile barrier packaging

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Image /page/5/Picture/0 description: The image shows the logo for ICU Medical. The logo is in blue and consists of the word "icumedical" in lowercase letters. Below the word "icumedical" are the words "human connections" in a smaller font size and a lighter shade of blue. The logo is simple and modern, and the use of blue gives it a clean and professional look.

Comparison Summary

Rio™ utilizes the same fundamental drug transfer device technology as the predicate device. addEASE (K090905), to include equivalency in:

intended use
principles of operation ●
mechanism of action ●
intended use environments ●
biocompatibility
sterility
pyrogenicity
sterile barrier packaging ●

The main technological differences between Rio™ and the predicate device, addEASE (K090905), are as follows:

Rio™ is needlefree and addEASE contains a stainless steel needle on bag spike end.
. Rio™ contains a directional turn handle to open and/or close fluid flow ("On" or "Off") once assembled to a vial and bag, and addEASE has no flow director feature that allows for an 'Off' position. Rio™ and addEASE starts in an "Off" state. Once assembled and ready to use, Rio™ can be turned "On/Off" with the turn handle. The addEASE is actuated "On" and remains "On".
Rio™ and addEASE are compatible with company specific brands of IV solution bags.
. Rio™ is E-beam sterilized and addEASE is gamma sterilized. Each are radiation sterilized with the device provided in individual sterile barrier packaging.

These differences do not raise new questions of safety or effectiveness.

By design, Rio™ incorporates the existing ICU Medical vial spike and a modified bag (port) spike (cleared under K173477) to produce a two-way transfer device for directly connecting the drug vial to the IV solution bag. Modifications in the design composition and material of construction were made to the existing cleared components to integrate the body and turn handle with the bag and vial spikes into a single unit transfer device. Functionally, the Rio™ bag and vial spike features are equivalent to the reference device components cleared under K173477.

Performance Data: Non-Clinical Testing Summary

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Image /page/6/Picture/0 description: The image contains the logo for ICU Medical. The logo is in blue and consists of the text "icu medical" in a sans-serif font. Below the company name is the tagline "human connections" in a smaller, lighter font. The logo is simple and modern, and the colors are clean and professional.

Non-clinical tests were conducted to support the safety of the device and demonstrates that the new device met its design specifications and performs as intended. The new device was subjected to the following functional and performance tests to demonstrate the device performs as intended:

. Functional Performance (per ISO 8536-4 and ISO 22413) including:
- o Positive pressure leak - dye solution tightness/air under water/pressure decay
- Negative pressure leak O
- Fluid flow O
- Fragmentation/Coring O
- Insertion & Removal force O
- o Retention Testing (Bag, Vial, & Fluid)
- Vapor Barrier Test O
Particulate testing (per ISO 8536-4 and USP<788>) ●
Chemical Compatibility ●
Biocompatibility (per ISO 10993-1 for Externally Communicating Device with Blood Path, Indirect, Contact for a Prolonged Duration (> 24 hours to 30 days))
- Hemocompatibility O
- Cytotoxicity O
- Sensitization O
- Irritation/Intracutaneous irritation O
- Acute Systemic Toxicity O
- Pyrogenicity O
- Subacute/Sub-Chronic Toxicity (Extractables per ISO 10993-18 with O Toxicological Risk Assessment ISO 10993-17)
- Sterilization Validation (per ISO 11137)
. Packaging (per ISO 11607)
Shelf life/Aging

Conclusion

●

RioTM Vial-to-Bag Drug Reconstitution Device utilizes the same fundamental technology as the predicate device. The non-clinical testing and risk management demonstrates that the new device meets all design requirements and performance specifications, and does not raise new issues of safety or effectiveness when used as intended. Based on these data, Rio™ is deemed substantially equivalent (SE) 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.