Rio™ Drug Reconstitution Transfer Device

K243985 · Icu Medical, Inc. · LHI · Jan 22, 2025 · General Hospital

Device Facts

• Record ID: K243985
• Device Name: Rio™ Drug Reconstitution Transfer Device
• Applicant: Icu Medical, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Jan 22, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Indications for Use

Rio™ Drug Reconstitution Transfer 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 Story

Rio™ is a sterile, single-use, two-way drug transfer device. It connects a drug vial (13mm or 20mm stopper) to an ICU Medical LifeCare IV container system (up to 500 mL) via a drug additive port. The device features a needle-free port spike for the IV bag and a vial spike for the drug vial. A rotating handle (flow director) isolates fluid between the vial and bag until manipulated by a clinician to enable two-way transfer. Used in pharmacy or clinical settings, the device remains attached to the bag and vial until disposal after infusion. It facilitates safe, aseptic drug reconstitution and transfer, reducing manual handling risks for clinicians and ensuring drug delivery to the patient.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence is supported by non-clinical bench testing, including functional performance (leak, flow, retention, fragmentation, insertion force), particulate testing (USP <788>), microbial ingress, biocompatibility (ISO 10993), sterilization validation (ISO 11137), and shelf-life/aging studies.

Technological Characteristics

Two-way fluid transfer device. Materials: Polybutylene (body), HDPE (handle), ABS (bag cap), LDPE (vial cap). Sterilization: E-beam radiation (SAL 10^-6). Connectivity: Mechanical connection to IV bag and drug vial. Standards: ISO 22413, ISO 8536-4, ISO 10993-1, USP <788>, ISO 11137, ISO 11607.

Indications for Use

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. Intended for use in pharmacy settings or patient care areas by trained clinicians.

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

• Rio™ Vial-to-Bag Drug Reconstitution Device (K192154)

Submission Summary (Full Text)

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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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 22, 2025

ICU Medical, Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K243985

Trade/Device Name: Rio™ Drug Reconstitution Transfer Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: LHI Dated: December 23, 2024 Received: December 23, 2024

Dear Prithul Bom:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. 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) K243985

Device Name Rio™ Drug Reconstitution Transfer Device

Indications for Use (Describe)

Rio™ Drug Reconstitution Transfer 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.

| 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/4/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is in blue, with "icu" in a darker shade of blue and "medical" in a lighter shade. Below the logo, in a smaller font, are the words "human connections".

# K243985- 510(k) Summary

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

| Submitter Information | |
|-----------------------------------------|--------------------------------------------------------------------------|
| Name | ICU Medical |
| Address | 951 Calle Amanecer, San Clemente, CA 92673 |
| Phone number | [phone] |
| Fax number | N/A |
| Establishment<br>Registration<br>Number | 2025816 |
| Name of contact<br>person | Remya Krishnan, Senior Global Regulatory Affairs Associate |
| Date prepared | 01/22/2025 |
| Trade or<br>proprietary name | RioTM Drug Reconstitution Transfer Device |
| Common or usual<br>name | Set, I.V. Fluid Transfer |
| Device Class | Class II |
| Regulation Number | 21 CFR 880.5440 |
| Regulation Name | Intravascular Administration Set |
| Review Panel | General Hospital |
| Product Code(s) | LHI |
| Predicate Device | K192154, RioTM Vial-to-Bag Drug Reconstitution Device (ICU Medical Inc.) |
| Predicate Device -<br>Regulation Name | Intravascular Administration Set |
| Predicate Device -<br>Regulation Number | 21 CFR 880.5440 |
| Predicate Device -<br>Product Code | LHI |

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Image /page/5/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is in a sans-serif font, with "icu" in a bold, dark blue and "medical" in a lighter blue. Below the main text, in a smaller, lighter font, are the words "human connections."

#### Rio™Drug Reconstitution Transfer Device Traditional 510(k)

| Traditional 510(k) | |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reason for 510(k)<br>submission | The purpose of this submission is to introduce new design features<br>including the addition of a tamper clip (also known as "wedge") attached<br>to the Rio body, expanded compatibility to the 500 mL ICU Medical<br>LifeCare IV container system (IV bag), and introduction of new model that<br>consists of a vial spike for compatibility with a 13mm drug vial |
| Device description | The Rio™ Drug Reconstitution Transfer Device (Rio) is a single use, sterile,<br>two-way, drug transfer device that is designed to connect an ICU Medical<br>LifeCare IV container system (IV bag)(up to 500 mL) via the drug additive<br>port, to a drug vial having either a 13mm or 20mm stopper closure for<br>reconstituting or mixing and aseptic transfer of the drug from the vial into<br>the solution of the IV bag. Once connected, Rio is not separated from the<br>IV bag or vial and should be disposed of with the IV bag when<br>administration is complete. Rio is intended to be used in a pharmacy<br>setting or patient care area, by trained clinicians.<br>The Rio design consists of a needle-free port spike that connects to the<br>compatible IV bag on one end, and a vial spike on the other end to connect a<br>standard liquid or lyophilized/powdered drug vial. The bag spike and vial<br>spike contain protective caps that maintain the sterility of the device until<br>the caps are removed prior to use. Rio also includes a flow director<br>(rotating handle) that will isolate the fluid between the vial and bag until<br>manipulated by the pharmacist or clinician to allow two-way fluid transfer<br>between the vial and bag. |
| Intended Use of<br>Device/Indication<br>for use | Rio™ Drug Reconstitution Transfer Device is indicated for single-use<br>reconstituting or mixing of liquid or lyophilized drug in a vial, and the<br>aseptic transfer of the reconstituted drug into the multi-port LifeCare IV<br>container system (IV bag) for patient infusion administration. |

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Image /page/6/Picture/0 description: The image shows the logo for ICU Medical. The text "icu medical" is in a blue sans-serif font. Below that, in a smaller font, is the text "human connections".

| Characteristic | Subject Device | Predicate (cleared under K192154) | Comparison |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| | (Rio™ Drug Reconstitution Transfer Device) | (Rio™ Vial-to-Bag Drug Reconstitution Device) | |
| Product Code | LHI | LHI | Same |
| Common Name | Set, I.V. Fluid Transfer | Set, I.V. Fluid Transfer | Same |
| Intended Use | Reconstituting or mixing drug in vial with solution<br>in IV bag | Reconstituting or mixing drug in vial with<br>solution in IV bag | Same |
| Indications for<br>Use | Rio™ Drug Reconstitution Transfer Device is<br>indicated for single-use reconstituting or mixing of<br>liquid or lyophilized drug in a vial, and the aseptic<br>transfer of the reconstituted drug into the multi-<br>port LifeCare IV container system (IV bag) for<br>patient infusion administration | Rio™ Vial-to-Bag Drug Reconstitution Device is<br>indicated for single-use reconstituting or mixing<br>of liquid or lyophilized drug in a vial, and the<br>aseptic transfer of the reconstituted drug into<br>the multi-port LifeCare IV container system (IV<br>bag) for patient infusion administration. | Same |
| Principle of<br>Operation | Two-way transfer device to connect drug vial to IV<br>solution bag. | Two-way transfer device to connect drug vial to<br>IV solution bag | Same |
| Mechanism of<br>Action | Attaching device to drug vial and IV solution bag | Attaching device to drug vial and IV solution bag | Same |
| Use Environment | Pharmacy setting and healthcare facility by trained clinician | Pharmacy setting and healthcare facility by trained clinician | Same |
| Compatibility – Solution Bag | Multi-port ICU Medical LifeCare IV container system (IV bag)(up to 500 mL*) | Multi-port ICU Medical LifeCare IV container system (IV bag)(up to 250 mL) | Different, *Expanded compatibility to the 500ml IV Bag |
| Compatibility – Drug Vials | Rio 20mm: Standard 20mm closure drug vial (for liquid or powdered drug) | Standard 20 mm closure drug vial (for liquid or powdered drug) | Same |
| | Rio 13mm: Standard 13mm closure drug vial (for liquid or powdered drug) (expanded compatibility with 13mm drug vials) | Not Applicable | Different, New design for compatibility to 13mm vial closure size |
| Materials of Construction | Rio Body (including vial spike and bag spike) - Polybutylene | Rio Body (including vial spike and bag spike)- Polycarbonate | Different |

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Image /page/7/Picture/0 description: The image shows the logo for ICU Medical. The text "icumedical" is written in a sans-serif font, with "icu" in a bold blue and "medical" in a lighter blue. Below the main text, in a smaller font, are the words "human connections" also in a light blue color.

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Image /page/8/Picture/0 description: The image shows the ICU Medical logo. The text "icumedical" is displayed in a combination of blue and light blue colors. Below the main text, the words "human connections" are written in a smaller, light blue font.

| | Handle - HDPE (High Density Polyethylene) | Handle -Polyethylene | Same |
|-------------------------|-----------------------------------------------------------------------|----------------------------------------------|-------------------------------------------------------------------------------------------------|
| | Tamper Clip/ Wedge -<br>Plastic/ Polycarbonate | Not applicable* | Different,<br>Not applicable*<br>*New design feature<br>for the subject<br>devices |
| | 13mm Adapter –<br>Plastic/ Polycarbonate | Not applicable* | Different,<br>Not applicable*<br>*New design feature<br>for the subject<br>device- VB-13TE only |
| | Rio Bag Side Protective Cap-<br>Acrylonitrile Butadiene Styrene (ABS) | Rio Bag Side Protective Cap-<br>Polyethylene | Different |
| | Rio Vial Spike Protective Cap<br>LDPE Low Density Polyethylene | Rio Vial Spike end<br>PVC Tubing (Non-DEHP) | Different |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Same |
| Sterilization<br>Method | E-beam radiation | E-beam radiation | Same |
| SAL | SAL 1x 10-6 | SAL 1x 10-6 | Same |
| Shelf Life | 5 years | 5 years | Same |

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Image /page/9/Picture/1 description: The image shows the ICU Medical logo. The logo is in blue and consists of the words "icu medical" in a sans-serif font. Below the company name are the words "human connections" in a smaller, lighter font. The logo is simple and modern.

The key differences between the subject and predicate are as follows:

- Compatibility to LifeCare IV container system (IV Bag) is different between the subject and predicated . the expanded compatibility to the LifeCare N container system from 250ml does not raise new questions of safety and effectiveness.
- The subject device Rio™Drug Reconstitution Transfer Device compatibility to the 13mm vial closure size in comparison to . the predicate Rio device that is compatible with 20mm vial closure size. Performance testing demonstibility to vial closure sizes does not raise new questions of safety and effectiveness.
- The Rio Body (including vial spike) consist of a different material between the subject and predicate device. Biocompatibility and performance testing demonstrated the difference in material does not raise new questions of safety and effectiveness.
- · The subject Rio design incorporates a tamper clip (wedge) that is different from the predicate device design and material composition. Biocompatibility and performance testing demonstrated the new subject material does not raise new effectiveness.
- . The subject device Rio™Drug Reconstitution Transfer Device (for use with 13mm vial closure sizes) incorporates a 13mm adapter that is different from the predicate device design. Biocomatibility and performance the new subject material does not raise new questions of safety and effectiveness.
- · The Rio bag side protective cap and vial spike protective cap consist of a different material between the subject and predicate device. Biocompatibility and performance testing demonstrated the difference in material does not raise new effectiveness.

# Summary of Technological Characteristics:

The subject device (Rio™ Drug Reconstitution Transfer Devicetions for Use and is also technologically equivalent to the predicate device (Rio") Vial-to-Bag Drug Reconstitution Device - K192154). They use similar functional specifications, materials and design (with minor modifications). They have the same sterility assurance level of 10°. A comparison between the subject device and the predicate was performed to support a substantial equivalence comparison includence comparison included the device's indications for use, design, technological characterilization method. The conclusion of the comparison analysis is that the subject device is substantially equivalent to the predicate device cleared under K192154.

# Summary of Non-Clinical Testing

Non-clinical verification has been conducted to evaluate the safety, performance and functionality. The results of these test have demonstrated the overall safety of the subject device and ultimately supports a substantial equivalence device. A summary of the testing conducted is presented below.

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Image /page/10/Picture/1 description: The image shows the logo for ICU Medical. The logo is in blue and white. The words "icu medical" are in blue, with "icu" in a bold font. Below the company name are the words "human connections" in a smaller, lighter font.

# Biocompatibility Testing

Biocompatibility testing was conducted in accordance with ISO 10993-1 and FDA's September, 2023 Guidance titled, "Use of International Standard ISO 1099-1, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process," as recognized by FDA. Testing included for Externally Communicating Device with Blood Path, Indirect, Contact for a Prolonged Duration (>24hours to 30 days).

#### Performance Data

The following performance data was provided in support of the substantial equivalence:

- . Functional Performance - tests for body, handle, caps:
- O Positive pressure leak – air under water/pressure decay (ISO 22413)
- o Negative pressure leak (ISO 8536-4)
- о Fluid flow (ISO 22413)
- Retention Testing (ISO 8536-4) O
- Fragmentation/ Coring (ISO 22413) o
- o Vapor Barrier Test
- Dye Leak Test (ISO 8871-5) O
- Bag Insertion force o
- Functional Performance tests for tamper clip: .
- Engagement force O
- o Removal force
- Particulate testing (ISO 8536-4 and USP<788>) .
- Microbial Ingress ●
- Biocompatibility (ISO 10993) .
- Sterilization Validation (ISO 11137) ●
- Packaging (ISO 11607) ●
- Shelf life/Aging .

# Particulates

Particulate contamination testing was performed by following USP <788> to demonstrate particulate levice that meets USP <788> requirements.

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Rio™Drug Reconstitution Transfer Device Traditional 510(k)

Image /page/11/Picture/1 description: The image shows the logo for ICU Medical. The text "icumedical" is in a sans-serif font, with "icu" in a bold, dark blue and "medical" in a lighter blue. Below the company name, in a smaller, lighter blue font, are the words "human connections."

# Clinical Testing

Clinical data was not needed to support a substantial equivalence determination.

#### Conclusion

The subject device meets the functional claims and intended in the product labeling. Test results from the performance testing conducted demonstrate the subject device met all acceptance criteria requirements. Therefore, is substantially equivalent to the predicate device cleared under K192154. The changes outined above do not affectiveness of the device and do not alter the intended use of the device.