(255 days)
No
The device description and performance studies focus on mechanical and fluid transfer properties, with no mention of AI or ML.
No.
The device is described as a drug reconstitution and transfer device, not a device that directly treats a medical condition. It prepares drugs for infusion, which is a therapeutic process, but the device itself is not a therapeutic device.
No
Explanation: The device is a drug reconstitution and transfer device, designed to facilitate the mixing and transfer of drugs from a vial to an IV bag for patient infusion. It is not used to diagnose any medical condition or disease.
No
The device description clearly outlines a physical, single-use hardware device with components like spikes, caps, and a flow director, designed for the physical transfer of drugs. The performance studies also focus on physical and chemical properties of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the reconstitution and transfer of drugs for patient infusion. This is a therapeutic process, not a diagnostic one.
- Device Description: The device is described as a drug transfer device designed to connect a drug vial to an IV bag. Its function is to facilitate the mixing and transfer of medication.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
- Performance Studies: The performance studies focus on the device's functional performance, safety (biocompatibility, sterilization), and packaging, which are typical for medical devices used in drug administration, not IVDs.
- Predicate Device: The predicate device (addEASE Binary Connector) is also a drug transfer device, further supporting that this device falls under the category of drug delivery/administration devices, not IVDs.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not perform any such function.
N/A
Intended Use / Indications for Use
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.
Product codes
LHI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Rio™ is intended to be used in a pharmacy setting or patient care area, by trained clinicians.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical tests were conducted to support the safety of the device and demonstrate 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:
- Positive pressure leak - dye solution tightness/air under water/pressure decay
- Negative pressure leak
- Fluid flow
- Fragmentation/Coring
- Insertion & Removal force
- Retention Testing (Bag, Vial, & Fluid)
- Vapor Barrier Test
- Particulate testing (per ISO 8536-4 and USP)
- 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
- Cytotoxicity
- Sensitization
- Irritation/Intracutaneous irritation
- Acute Systemic Toxicity
- Pyrogenicity
- Subacute/Sub-Chronic Toxicity (Extractables per ISO 10993-18 with Toxicological Risk Assessment ISO 10993-17)
- Sterilization Validation (per ISO 11137)
- Packaging (per ISO 11607)
- Shelf life/Aging
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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
2
Indications for Use
510(k) Number (if known) K192154
Device Name
Rio™ Vial-to-Bag Drug Reconstitution Device
Indications for Use (Describe)
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.
| 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 Correspondent | |
| Name & Contact | Sheila Antonio, Senior Manager, Regulatory Affairs |
| Phone: (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
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.
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 Device | |
| Rio™ Vial-to-Bag Drug | ||
| Reconstitution Device | Predicate Device | |
| K090905, 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 with | |
| solution in IV bag | ||
| (Same as predicate) | Reconstituting or mixing drug in vial with | |
| solution in IV bag | ||
| Indications for Use | 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. | The addEASE 20 mm Binary Connector with | |
| 17 Ga. Needle is a double ended transfer | ||
| device intended for use in a pharmacy setting | ||
| to connect a B. Braun 250mL Excel IV | ||
| solution bag to a 20 mm drug vial for | ||
| reconstituting or mixing the drug in the vial | ||
| with the solution in the bag. | ||
| Principle of Operation | Two-way transfer device to connect drug vial | |
| to IV solution bag | ||
| (Same as predicate) | Two-way transfer device to connect drug vial | |
| to IV solution bag | ||
| Mechanism of Action | Attaching device to drug vial and IV solution | |
| bag | ||
| (Same as predicate) | Attaching device to drug vial and IV solution | |
| bag | ||
| Use Environment | Pharmacy setting and healthcare facility by | |
| trained clinician. | ||
| (Same as predicate) | Pharmacy setting and healthcare facility by | |
| trained clinician. | ||
| Compatibility – | ||
| Solution Bag | Multi-port ICU Medical LifeCare IV container | |
| system (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 or | |
| powdered) | ||
| (Same as predicate) | Standard 20 mm closure drug vial (liquid or | |
| powdered) | ||
| Materials of | ||
| Construction | 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) ●
- 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.