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 Description

The Rio™ Drug Reconstitution Transfer Device (Rio) is a single use, sterile, two-way, drug transfer device that is designed to connect an ICU Medical LifeCare IV container system (IV bag)(up to 500 mL) via the drug additive port, to a drug vial having either a 13mm or 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.
The Rio design consists of a needle-free 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. 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.

AI/ML Overview

The provided text is a 510(k) summary for the Rio™ Drug Reconstitution Transfer Device. This document focuses on demonstrating substantial equivalence to a predicate device (K192154), rather than providing detailed acceptance criteria and study results for de novo device performance validation.

Therefore, the document does not contain the specific information required to answer most of your questions about:

A table of acceptance criteria and reported device performance.
Sample sizes for test sets or their provenance.
Number of experts, their qualifications, or adjudication methods for ground truth.
MRMC or standalone comparative effectiveness studies.
Types of ground truth used.
Sample size or methods for establishing ground truth for training sets.

The document indicates that clinical data was not needed to support the substantial equivalence determination, which means there are no clinical studies of the type you're asking about (e.g., MRMC studies).

However, I can extract the information that is present regarding non-clinical testing and how it supports the device's conformance:

Summary of Non-Clinical Testing and Conformance:

The manufacturer states that "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."

The document generally states that "Test results from the performance testing conducted demonstrate the subject device met all acceptance criteria requirements." However, it does not explicitly list the quantitative acceptance criteria or the specific numerical results obtained for each test.

Here's what can be gleaned about the non-clinical testing performed:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria: While specific numerical criteria are not provided, the testing aimed to meet various ISO and USP standards. For example, for particulates, the device had to "meet USP <788> requirements." For sterility, it had to meet a "SAL 1x 10-6."
Reported Device Performance: The summary states that the device "met all acceptance criteria requirements" for the listed tests. No specific numerical performance values are given.

Test Type	Relevant Standard (if mentioned)	General Performance Description (Acceptance Criteria Implicit)	Reported Device Performance
Functional Performance			Met all requirements
Positive pressure leak	ISO 22413	Device maintains seal under positive air pressure	Met requirements
Negative pressure leak	ISO 8536-4	Device maintains seal under negative pressure	Met requirements
Fluid flow	ISO 22413	Fluid flows as intended through the device	Met requirements
Retention Testing	ISO 8536-4	Device retains components as designed	Met requirements
Fragmentation/Coring	ISO 22413	Device does not shed particulates or core	Met requirements
Vapor Barrier Test	Not Specified	Device maintains vapor barrier	Met requirements
Dye Leak Test	ISO 8871-5	No dye leakage detected	Met requirements
Bag Insertion force	Not Specified	Insertion into IV bag requires acceptable force	Met requirements
Tamper Clip Performance			Met all requirements
Engagement force	Not Specified	Tamper clip engages with appropriate force	Met requirements
Removal force	Not Specified	Tamper clip removes with appropriate force	Met requirements
Particulate Testing	USP <788>	Particulate levels must be below specified USP limits	Meets USP <788> requirements
Microbial Ingress	Not Specified	Device prevents microbial entry	Met requirements
Biocompatibility	ISO 10993-1, FDA Guidance (Sept. 2023)	Device material is biologically compatible with human contact	Met requirements
Sterilization Validation	ISO 11137	Device is effectively sterilized to SAL 1x10^-6	Met requirements (SAL 1x10^-6)
Packaging	ISO 11607	Packaging maintains sterility and integrity	Met requirements
Shelf life/Aging	Not Specified	Device maintains performance over its 5-year shelf life	Met requirements (5 years)

2. Sample sized used for the test set and the data provenance:

Not specified in the provided text.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not specified. This is not a study involving expert readers or ground truth establishment in the context of diagnostic AI.

4. Adjudication method for the test set:

Not applicable/Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. The document explicitly states: "Clinical data was not needed to support a substantial equivalence determination." This is not an AI device or a diagnostic device.

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

No. This is a physical, mechanical device, not an algorithm.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is established by adherence to recognized standards (ISO, USP) and engineering specifications for mechanical and material performance. For example, for particulate testing, the USP <788> limits define the "ground truth" for acceptable particulate levels. For sterility, the SAL 1x10^-6 is the "ground truth" for validated sterility.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device.

9. 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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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	(949) 370-3962
Fax number	N/A
EstablishmentRegistrationNumber	2025816
Name of contactperson	Remya Krishnan, Senior Global Regulatory Affairs Associate
Date prepared	01/22/2025
Trade orproprietary name	RioTM Drug Reconstitution Transfer Device
Common or usualname	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 -Regulation Name	Intravascular Administration Set
Predicate Device -Regulation Number	21 CFR 880.5440
Predicate Device -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)submission	The purpose of this submission is to introduce new design featuresincluding the addition of a tamper clip (also known as "wedge") attachedto the Rio body, expanded compatibility to the 500 mL ICU MedicalLifeCare IV container system (IV bag), and introduction of new model thatconsists 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,two-way, drug transfer device that is designed to connect an ICU MedicalLifeCare IV container system (IV bag)(up to 500 mL) via the drug additiveport, to a drug vial having either a 13mm or 20mm stopper closure forreconstituting or mixing and aseptic transfer of the drug from the vial intothe solution of the IV bag. Once connected, Rio is not separated from theIV bag or vial and should be disposed of with the IV bag whenadministration is complete. Rio is intended to be used in a pharmacysetting or patient care area, by trained clinicians.The Rio design consists of a needle-free port spike that connects to thecompatible IV bag on one end, and a vial spike on the other end to connect astandard liquid or lyophilized/powdered drug vial. The bag spike and vialspike contain protective caps that maintain the sterility of the device untilthe caps are removed prior to use. Rio also includes a flow director(rotating handle) that will isolate the fluid between the vial and bag untilmanipulated by the pharmacist or clinician to allow two-way fluid transferbetween the vial and bag.
Intended Use ofDevice/Indicationfor use	Rio™ Drug Reconstitution Transfer Device is indicated for single-usereconstituting or mixing of liquid or lyophilized drug in a vial, and theaseptic transfer of the reconstituted drug into the multi-port LifeCare IVcontainer 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 solutionin IV bag	Reconstituting or mixing drug in vial withsolution in IV bag	Same
Indications forUse	Rio™ Drug Reconstitution Transfer Device isindicated for single-use reconstituting or mixing ofliquid or lyophilized drug in a vial, and the aseptictransfer of the reconstituted drug into the multi-port LifeCare IV container system (IV bag) forpatient infusion administration	Rio™ Vial-to-Bag Drug Reconstitution Device isindicated for single-use reconstituting or mixingof liquid or lyophilized drug in a vial, and theaseptic transfer of the reconstituted drug intothe multi-port LifeCare IV container system (IVbag) for patient infusion administration.	Same
Principle ofOperation	Two-way transfer device to connect drug vial to IVsolution bag.	Two-way transfer device to connect drug vial toIV solution bag	Same
Mechanism ofAction	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 -Plastic/ Polycarbonate	Not applicable*	Different,Not applicable**New design featurefor the subjectdevices
	13mm Adapter –Plastic/ Polycarbonate	Not applicable*	Different,Not applicable**New design featurefor the subjectdevice- VB-13TE only
	Rio Bag Side Protective Cap-Acrylonitrile Butadiene Styrene (ABS)	Rio Bag Side Protective Cap-Polyethylene	Different
	Rio Vial Spike Protective CapLDPE Low Density Polyethylene	Rio Vial Spike endPVC Tubing (Non-DEHP)	Different
Pyrogenicity	Non-pyrogenic	Non-pyrogenic	Same
SterilizationMethod	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.

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.