The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringes on syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the contrast media container has been emptied or after 12 hours have elapsed since the container has been penetrated, whichever occurs first.

Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

Device Description

The Liebel-Flarsheim™ IBP Transfer Set is a sterile tubing set connection between Optiray® (Ioversol) contrast media imaging bulk packages (hereinafter Optiray IBPs) and empty sterile singleuse syringes on syringe-based automatic contrast injection systems. The Liebel- Flarsheim™ IBP Transfer Set consists of a small bore (1/8" ID) clear polyvinyl chloride (PVC) tube with standard medical component end terminations. Bonded to the proximal end of the PVC tube is a vented IV spike that is used to pierce a rubber stopper belonging to an imaging bulk contrast media container. Distally, a self-sealing Luer type connector (Smiths Medical Nu- Site®) is bonded to the opposite end of the PVC tube. The Liebel-Flarsheim™ IBP Transfer Set, shown in the image below, has an overall length of 19-inches, a protective cap on the IV Spike, and both untethered and tethered protective caps on the Luer end to protect the Nu-Site® Luer Activated fitting between syringe fills. The transfer sets are individually packaged in blister packs with a perimeter heat sealed Tyvek lid. Sealed blister packs are packaged in an outer box containing 50 units (50 units/box) which are terminally sterilized with ethylene oxide.

The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Liebel-Flarsheim™ IBP Transfer Set, based on the provided text:

Important Note: The provided document is a 510(k) summary for a medical device (a transfer set) and does not describe an AI/ML-based device. Therefore, many of the requested fields related to AI/ML studies (like test set size for AI, number of experts for ground truth, MRMC studies, training set size for AI, etc.) are not applicable to this device. The study described is a traditional medical device verification and validation (V&V) study, comparing a new device to a predicate device.

Acceptance Criteria and Device Performance (Verification and Validation)

The document describes various tests performed to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness. The acceptance criteria are generally "compliance with the standards" or "performs as intended."

Acceptance Criteria Category	Acceptance Criteria (Implied)	Reported Device Performance/Verification
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶; EtO residuals comply with ISO 10993-7:2008 limits.	Validated to SAL of 10⁻⁶ in accordance with ISO 11135:2014 and ISO 10993-7:2008. Validation results indicate compliance.
Shelf Life	Maintains integrity of primary package and functional user requirements for 3 years.	Verification and validation testing in accordance with ISO 11607 (framework described, not full conformity) demonstrated maintenance of primary package integrity. Functional user requirements were also verified over the proposed three-year shelf life.
Biocompatibility	Verified in accordance with ISO 10993-1:2018 for cytotoxicity, hemocompatibility, irritation, sensitization, acute systemic toxicity, material mediated pyrogenicity; complies with ISO 10993-18:2005 (chemical characterization), USP <788> (particulate matter), and USP <85> (bacterial endotoxin).	Verification results indicate that the materials comply with the standards listed: ISO 10993-1:2018 (cytotoxicity, hemocompatibility, irritation, sensitization, acute systemic toxicity, material mediated pyrogenicity), ISO 10993-18:2005, USP <788>, and USP <85>.
Bench Performance (General/Functional)	Performance and functional user requirements verified according to product specifications and relevant ISO standards.	Tested for performance and verified in accordance with ISO 8536-4 (infusion sets), ISO 594-2 (Luer taper fittings), and ISO 22413:2010 (transfer sets). Additional testing included Microbial Ingress Testing, Chemical Compatibility (with Optiray®), Extractables and simulation testing for leachable compounds and particulates, and Verification of functional performance according to product specifications. The device "performs as intended."
Microbial Ingress	No microbial ingress (implied good performance).	Performed, implied successful.
Chemical Compatibility	Compatible with Optiray® (Ioversol) Imaging Bulk Package contrast media.	Approved Release Specifications for Optiray® (Ioversol) Imaging Bulk Package.
Extractables/Leachables	Acceptable levels of extractable and leachable compounds and particulates (implied).	Extractables and simulation testing for leachable compounds and particulates was performed.

Study Details (Traditional Medical Device V&V)

Sample size used for the test set and the data provenance:
- The document does not specify a "test set" in the context of an AI/ML model where data provenance like country of origin or retrospective/prospective is relevant.
- Instead, for traditional device testing, sample sizes would be determined by statistical methods for each specific test (e.g., sterilization validation, biocompatibility, functional performance). These specific sample sizes are not explicitly stated in this summary for each test, but standard good manufacturing practices and regulatory requirements would apply.
- The data provenance is implicitly from manufacturing and laboratory testing conducted by Liebel-Flarsheim Company LLC (part of Guerbet LLC).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. This is not an AI/ML device, so there is no "ground truth" in the sense of expert annotation for an algorithm. The "ground truth" for this type of device is established through adherence to recognized international standards (ISO, USP) and verified performance against predefined specifications, often evaluated by qualified laboratory personnel and engineers.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Adjudication methods are specific to expert consensus in AI/ML model evaluation. For this device, compliance is assessed against objective technical specifications and performance limits defined by the relevant standards and internal company requirements.
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:
- N/A. This is not an AI/ML device. MRMC studies are for evaluating clinical performance of diagnostic algorithms with human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A (in the AI/ML context). For this device, "ground truth" is based on:
  - Objective physical measurements and chemical analyses: e.g., sterility levels, EtO residuals, particulate matter, leachable compounds.
  - Functional performance tests: verifying fluid transfer, connection integrity (Luer taper), and absence of microbial ingress.
  - Biocompatibility evaluations: ensuring the materials are safe for patient contact according to established biological testing standards.
  - Adherence to recognized industry standards: ISO, USP.
The sample size for the training set:
- N/A. This is not an AI/ML device. There is no "training set."
How the ground truth for the training set was established:
- N/A. This is not an AI/ML device. There is no "training set" or "ground truth" for AI training. The safety and effectiveness of this device are established through direct physical, chemical, and biological testing, manufacturing controls, and adherence to design specifications and regulatory standards.

Summary

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November 18, 2020

Liebel-Flarsheim Company LLC % Matthew Helmi Regulatory Affairs Associate II Guerbet LLC 821 Alexander Road Suite 204 Princeton, New Jersey 08540

Re: K193010

Trade/Device Name: Liebel-Flarsheim™ IBP Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular administration set Regulatory Class: Class II Product Code: PQH Dated: November 16, 2020 Received: November 17, 2020

Dear Matthew Helmi:

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.

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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 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193010

Device Name Liebel-Flarsheim™ IBP Transfer Set

Indications for Use (Describe)

The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (loversol) Imaging Bulk Package contrast media to empty, single-use only, sterile syringe based contrast injection systems indicated for the controlled, automatic intra-vascular administration of radiopaque contrast agents for their indicated procedures. The IBP Transfer Set is to be discarded after the container has been emptied or after 12 hours have elapsed since the container was penetrated, whichever occurs first.

Contra-indications for the use of this device are determined by the prescribing physician at the time of used upon the contrast media package inserts.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Liebel-Flarsheim Company LLC

2111 East Galbraith Road Cincinnati, OH 45237 Tel. +1 513-948-2700 www.guerbet.com

Traditional Premarket Notification Submission - 510(k) Summary Liebel-Flarsheim™ IBP Transfer Set K193010

Submitter

Liebel-Flarsheim Company LLC 2111 East Galbraith Road Cincinnati, OH 45237 Phone: (513)-948-4072

Primary Contact Person

Matthew Helmi Guerbet LLC, Suite 204 821 Alexander Rd Princeton, NJ 08540 matthew.helmi@guerbet.com Phone: (609)-819-5213

Secondary Contact

Ahmed Abdelal, PharmD Guerbet LLC, Suite 204 821 Alexander Rd Princeton, NJ 08540 Ahmed.Abdelal(@guerbet.com Phone: 609-480-7655

Date: November 16, 2020

Device Name and Classification

Trade Name:	Liebel-Flarsheim™ IBP Transfer Set
Common Name:	Iodinated Contrast Media Transfer Tubing
Set Classification:	Class II
Regulation:	21 CFR 880.5440, Intravascular Administration
Set. Review Panel:	General Hospital
Product Code:	PQH (Iodinated Contrast Media Transfer Tubing Set)

Predicate Device

Trade Name:	ulrich Transfer Set
K Number:	K161723
Common Name:	Iodinated Contrast Media Transfer
Set Classification:	Class II
Regulation:	21 CFR 880.5440, Intravascular Administration
Set. Review Panel:	General Hospital
Product Code:	PQH (Iodinated Contrast Media Transfer Tubing Set)

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5.1. Device Information

Device Description and Intended Use

The Liebel-Flarsheim™ IBP Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast injection systems.

Image /page/4/Picture/4 description: The image shows a medical device, specifically an extension set with a needleless connector. The set includes a clear, flexible tube forming a loop, connected to a white connector at one end and a clear connector with a purple valve at the other. Two blue caps are also visible, one attached to the clear connector with a blue tether and the other detached, likely for covering the connector when not in use.

Liebel-Flarsheim™ IBP Transfer Set Image 1:

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Indications for Use

Contra-indications for the use of this device are determined by the prescribing physician at the time of use based upon the contrast media package inserts.

Risk Analysis Method

The Liebel-Flarsheim™ IBP Transfer Set was assessed for risks to health associated with the use of intravascular administration sets and accessories. Risks including but not limited to device malfunctions, bio-incompatibility risks, infection risks, and improper use were assessed. This device risk analysis was conducted in accordance with ISO 14971:2012 Medical Devices – Application of Risk Management to Medical Devices.

5.2. Substantial Equivalence

The Liebel-Flarsheim™ IBP Transfer Set is substantially equivalent to the ulrich Transfer Set (K161723) predicate device, currently legally marketed in the United States of America. The Liebel-Flarsheim™ IBP Transfer Set has the same intended use and substantially equivalent indications for use as the ulrich Transfer Set. The Liebel-Flarsheim™ IBP Transfer Set is indicated for the transfer of Optiray® (Ioversol) Imaging Bulk Package contrast media while the ulrich Transfer Set is indicated for the transfer of Omnipaque™ (Iohexol) Imaging Bulk Package contrast media. The Liebel-Flarsheim™ IBP Transfer Set uses equivalent overall design and operating principals to the ulrich Transfer Set. The materials of the components are comparable to the predicates.

Similar tests and test methods performed in accordance with the same standards were used with the transfer set and the predicate device to validate the design. Safety questions have been evaluated for the transfer set through extensive design verification and validation testing. The above described differences do not adversely affect the safety or effectiveness of the transfer set as compared to the predicate device for the following reasons:

a. Biocompatibility: An evaluation of biocompatibility was performed in compliance with ISO 10993-1:2018.
b. Performance Testing (Bench): Bench testing, including but not limited to functional testing, chemical compatibility, and microbial ingress testing, was performed to verify the device for its intended use. The acceptance criteria were chosen to ensure that the device performs in an equivalent than the predicate device.

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5.2.1 Summary Comparison of Subject and Predicate Device

Item	Subject DeviceLiebel-Flarsheim™ IBPTransfer SetK193010	Predicate Deviceulrich Transfer SetK161723	Comparison
Intended Use	The Liebel-Flarsheim™ IBPTransfer Set is intended for thetransfer of fluids from bulkcontainers to empty sterilesyringes on syringe-basedcontrast injection systems.	The transfer set is intended forthe transfer of fluids from bulkcontainers to empty sterilesyringes on syringe basedcontrast delivery systems(injectors).	Identical to thepredicatedevice.
Indications forUse	The Liebel-Flarsheim™ IBPTransfer Set is indicated for thetransfer of Optiray® (Ioversol)Imaging Bulk Package contrastmedia to empty, single-useonly, sterile syringes on syringebased contrast injection systemsindicated for the controlled,automatic intra-vascularadministration of radiopaquecontrast agents for theirindicated procedures. The IBPTransfer Set is to be discardedafter the contrast mediacontainer has been emptied orafter 12 hours have elapsedsince the container waspenetrated, whichever occursfirst.	The ulrich Transfer Set isindicated for the transfer ofOmnipaque™ (Iohexol)contrast media as supplied inan Imaging Bulk Package tonon pre-filled single-use onlysterile syringes on syringe-based contrast injectionsystems indicated for thecontrolled, automaticadministration on the venousside of contrast media for CTprocedures. The Transfer Set isto be discarded after thecontrast media container hasbeen depleted or 8 hours haveelapsed since the container waspenetrated, whichever occursfirst.	Substantiallyequivalent to thepredicate device.
Item	Subject DeviceLiebel-Flarsheim™ IBPTransfer SetK193010	Predicate Deviceulrich Transfer SetK161723	Comparison
Tubing Length	19 inches	20 inches	Substantiallyequivalent to thepredicate device.Does not impactperformance
Single Use	Yes	Yes	Identical to thepredicate device.
Biocompatible	Yes - ISO 10993-1	Yes - ISO 10993-1	Substantiallyequivalent to thepredicate device.
Sterile	Yes	Yes	Identical to thepredicate device.
SterilityAssuranceLevel	$10^{-6}$	$10^{-6}$	Identical to thepredicate device.
SterilizationMethod	Ethylene Oxide (EtO)	Ethylene Oxide (EtO)	Identical to thepredicate device.
Shelf Life	Three (3) year shelf life.	One (1) year shelf life.	Substantiallyequivalent to thepredicate device.Shelf life testinghas been completedand demonstratedthat the differencesdo not raise newquestions of safetyand effectiveness.
Item	Subject DeviceLiebel-Flarsheim™ IBPTransfer SetK193010	Predicate Deviceulrich Transfer SetK161723	Comparison
Packaging	Individually packaged in aTyvek pouch.	Individually packaged in aTyvek pouch.	Substantiallyequivalent to thepredicate device.
MicrobialIngress Testing	Yes	Yes	Substantiallyequivalent to thepredicate device.
ChemicalCompatibilityTesting	Yes - Optiray® (Ioversol)Imaging Bulk Package	Yes - Omnipaque™(Iohexol) Contrast Media	Substantiallyequivalent to thepredicate device.
Design-Protective Capfor LuerConnection	Yes - Tethered Cap withSmiths Medical Nu-Site®Luer Actuated Connector	Yes - With Halkey-RobertsSwabbable Valve	Substantiallyequivalent to thepredicate device.
Design- Spike	Protected IV Spike with Vent	Spike with Protected Capand Integrated Air Filter	Substantiallyequivalent to thepredicate.
Use Life (AfterpuncturingIBP)	12 Hours or disconnectionfrom IBP (whichever occursfirst)	8 Hours or disconnectionfrom IBP (whichever occursfirst)	Substantiallyequivalent to thepredicate.
MaterialDifferences	Fluid Contacting TubingNon DEHP PVCSpikeABSLuerPolyurethane HosingSilicone SealAcetal Actuator	Unknown	Substantiallyequivalent to thepredicate.

Comparison of Subject and Predicate Device Table 1:

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5.2.2 Summary of substantial equivalence discussion

In summary, the subject device's principle of operation, intended use, functional performance, and similar technological characteristics are substantially equivalent to those of the predicate device. Any differences in characteristics between the subject device and predicate device do not raise questions of safety or effectiveness. The subject device is substantially equivalent to the legally marketed predicate device.

5.3 Testing

5.3.1 Sterilization

The Liebel-Flarsheim™ IBP Transfer Set is ethylene oxide (EtO) sterilized and was validated to a sterility assurance level (SAL) of 10-6 in accordance with the following standards:

ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the . development, validation and routine control of a sterilization process for medical devices.
ISO 10993-7:2008 Biological evaluation of medical devices -- Part 7: Ethylene oxide sterilization . residuals

EtO residuals are tested to ISO 10993-7:2008 limits. Validation results indicate that the Liebel-Flarsheim™ IBP Transfer Set complies with the standards.

5.3.2 Shelf Life

The proposed labeled shelf life of the Liebel-Flarsheim™ IBP Transfer Set is three years. Verification and validation testing in accordance with the framework described in (but not in full conformity with) ISO 11607 has been conducted, validated the process, and verified that the primary package (sterile barrier) maintains its integrity throughout the course of the labeled three year shelf life as further described in Section 12 - Sterilization and Shelf Life. Maintenance of functional user requirements over the proposed three year shelf life was also verified as described in Section 16 - Performance Testing - Bench.

5.3.3 Biocompatibility

The Liebel-Flarsheim™ IBP Transfer Set indirect patient contact materials were verified in accordance with the following standards:

. ISO 10993-1:2018 Biological evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process.
- Cytotoxicity o
- Hemocompatibility O
- Irritation o
- Sensitization o
- Acute Systemic Toxicity o
- Material Mediated Pyrogenicity Test o

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ISO 10993-18:2005 Biological Evaluation of Medical Devices – Part 18: Chemical Characterization of Medical Device Materials Within a Risk Management Process
USP <788> Particulate Matter in Injections
USP <85> Bacterial Endotoxin Test ●

Verification results indicate that the materials comply with the standards.

5.3.4 Performance - Bench

The Liebel-Flarsheim™ IBP Transfer Set was tested for performance and verified in accordance with the following standards:

ISO 8536-4 - 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.
. ISO 594-2, Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings.
ISO 22413:2010, Transfer sets for pharmaceutical preparations -- Requirements and test methods.

Additional testing included:

Microbial Ingress Testing ●
Chemical Compatibility through Approved Release Specifications for Optiray® (Ioversol) Imaging Bulk ● Package
Extractables and simulation testing for leachable compounds and particulates
Verification of functional performance according to product specifications

5.4 Conclusions

The transfer set has the same intended use as the predicate device, differing only in the claimed compatible contrast media and access duration. The principle features of the device that were described, as well as the testing provided, show that the minor differences in device characteristics between the subject device and predicate devices do not raise any new questions of safety or effectiveness. Performance data, including Bench Testing and Biocompatibility, have established that the transfer set performs as intended. The subject device is substantially equivalent to the legally marketed 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.