MEDRAD® Imaging Bulk Package Transfer Set
Device Facts
| Record ID | K173913 |
|---|---|
| Device Name | MEDRAD® Imaging Bulk Package Transfer Set |
| Applicant | Bayer U.S., LLC |
| Product Code | PQH · General Hospital |
| Decision Date | May 4, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.
Device Story
Pre-administration filling device; transfers iodinated contrast media from bulk containers to sterile syringes for use with powered CT injectors. Components: spike, flexible tubing, swabbable valve. Used in clinical settings; operated by healthcare personnel. Device spikes bulk container; fluid flows through tubing to syringe. No direct patient contact. Discarded after container depletion, expiration, or 10 hours post-penetration. Facilitates automated contrast delivery; ensures sterility during transfer; supports efficient contrast management in CT imaging.
Clinical Evidence
Bench testing only. Testing included sterility (ISO 11135-1:2014), packaging (ISO 11607-1:2006), biocompatibility (ISO 10993-1:2009), microbial ingress, chemical compatibility, and material compatibility. All results met predetermined specifications.
Technological Characteristics
Components: spike, flexible tubing, swabbable valve. Sterilization: Ethylene Oxide (EtO) to 10^-6 SAL. Standards: ISO 594-2 (Luer lock), ISO 8536-4 (infusion sets), ISO 11135-1 (sterilization), ISO 11607-1 (packaging), ISO 10993-1 (biocompatibility). Non-electronic, mechanical fluid transfer device.
Indications for Use
Indicated for transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media from approved Imaging Bulk Packages to empty sterile syringes on single-use syringe-based contrast power injection systems for controlled, automatic venous administration during CT procedures.
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
- Bracco Injeneering Transfer Set (K133147)
Submission Summary (Full Text)
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May 4, 2018
Bayer U.S. LLC Leslie O'Nan Regulatory Affairs Manager 1 Bayer Drive Indianola, Pennsylvania 15051
Re: K173913
Trade/Device Name: MEDRAD® Imaging Bulk Package Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: POH Dated: April 13, 2018 Received: April 16, 2018
Dear Leslie O'Nan:
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Tina Kiang
-s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K173913
#### Device Name
MEDRAD® Imaging Bulk Package Transfer Set
#### Indications for Use (Describe)
The MEDRAD® Imaging Bulk Package Transfer Set (IBP Transfer Set) is indicated for the transfer of ULTRAVIST® (lopromide), ISOVUE® (lopamidol), and OMNIPAQUE™ (lohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first; the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated.
| Type of Use ( <i>Select one or both, as applicable</i> ) | |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| <span style="font-size: large;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: large;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |
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# K173913 510(k) Summary
| Date Prepared: | April 13, 2018 |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Bayer U.S. LLC<br>1 Bayer Drive<br>Indianola, PA 15051 |
| Primary Contact: | Leslie S. O'Nan<br>Regulatory Affairs Manager<br>Phone: (412) 406-3165<br>Fax: (412) 767-2451<br>Email: leslie.o’nan@bayer.com |
| Device Trade Name: | MEDRAD <sup>®</sup> Imaging Bulk Package Transfer Set |
| Common Name: | Iodinated Contrast Media Transfer Tubing Set |
| Classification Name: | Intravascular Administration Set |
| Regulation Number: | 21 CFR 880.5440 |
| Product Code: | PQH |
| Classification: | Class II |
| Predicate Device: | Bracco Injeneering Transfer Set<br>Bracco Injeneering S.A.<br>K133147, June 20, 2014 |
| Device Description: | The MEDRAD <sup>®</sup> Imaging Bulk Package Transfer Set is a<br>pre-administration filling device that is designed to<br>transfer fluid from an imaging bulk package into multiple<br>sterile syringes via a powered injector system prior to a<br>CT procedure. There is no direct patient contact with |
Bayer U.S. LLC
1 Bayer Drive
Indianola, PA 15051-0780
U.S.A.
(412) 767-2400
www.bayer.com
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the use of this device. It is intended to spike one bulk package of iodinated contrast media only. Each imaging bulk transfer set consists of a spike, flexible tubing, and a swabbable valve. The transfer set is provided sterile, individually packaged, and is not intended to be resterilized. The MEDRAD® Imaging Bulk Package Transfer Set (IBP Indications for Use: Transfer Set) is indicated for the transfer of ULTRAVIST® (Iopromide), ISOVUE® (Iopamidol), and OMNIPAQUE™ (Iohexal) contrast media as supplied in an approved Imaging Bulk Package (IBP) presentation to empty sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for CT procedures. The Transfer Set is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the contrast media use time has expired, or 10 hours has elapsed since the container was penetrated. Performance Testing: The Imaging Bulk Package Transfer Set is ethylene oxide Sterilization: (EtO) sterilized and was validated to a sterility assurance level of 10-6 in accordance with the following standard: ISO 11135-1: 2014, Sterilization of health care . products Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Verification results indicate that the MEDRAD® Imaging Bulk Package Transfer Set complies with the standard.
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| Shelf-Life: | The Imaging Bulk Package Transfer Set is sterilized and<br>its packaging was validated in accordance with the<br>following standard:<br>ISO 11607-1: 2006 Packaging for terminally<br>sterilized medical devices - Part 1: requirements<br>for materials, sterile barrier systems and<br>packaging systems; and<br>Verification results indicate that the MEDRAD® Imaging<br>Bulk Package Transfer Set complies with the standard. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | The MEDRAD® Imaging Bulk Package Transfer Set<br>indirect patient contact materials were verified in<br>accordance with the following standard:<br>ISO 10993-1: 2009 (R2013) Biological evaluation of<br>medical devices Part 1: Evaluation and testing<br>within a risk management process<br>The following test program was selected for an<br>externally communicating, indirect blood path,<br>limited contact (≤ 24 h) device: Cytotoxicity Sensitization Irritation / Intracutaneous Reactivity Acute Systemic Toxicity Acute Systemic Injection Materials Mediated Pyrogen Hemocompatibility Hemolysis Partial Thromboplastin Time Platelet and LeukocyteVerification results indicated that the materials comply<br>with the standard. |
| Performance - Bench: | The MEDRAD® Imaging Bulk Package Transfer Set was<br>tested for performance and verified in accordance with<br>the following standards: |
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- ISO 594-2:1998, Conical fittings with 6 % (Luer) . taper for syringes, needles and certain other medical equipment -- Part 2: Lock fittings
- . ISO 8536-4:2007, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
Verification results indicate that the MEDRAD® Imaging Bulk Package Transfer Set complies with the standards.
Additional testing included:
- Microbial ingress testing conducted at time . points, T = 0 hr, 4 hr, 10 hr, 14 hr, and bottle depletion for the following components:
- Swabbable Valve
- . Bottle Septum
- Spike
- Syringe
- Chemical compatibility and injectable particulate ● – Through evaluation of conformance to the approved release specifications of ULTRAVIST® and USP monographs for ISOVUE® and OMNIPAQUE™
- Material compatibility Through evaluation of the . transfer set under worst-case conditions and simulated use with ULTRAVIST® 370 as solvent for leachable compounds.
Verification results indicate that the MEDRAD® Imaging Bulk Package Transfer Set complies with its predetermined specifications
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# Predicate Device Comparison:
| Item | Predicate Device:<br>Bracco Injeneering Transfer<br>Set | Subject Device:<br>MEDRAD® Imaging Bulk<br>Package Transfer Set | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The transfer set is intended for the<br>transfer of fluids from bulk<br>containers to empty sterile syringes<br>on syringe based contrast delivery<br>systems (injectors). | The MEDRAD® Imaging Bulk Package<br>Transfer Set is intended for the transfer<br>of fluids from bulk containers to empty<br>sterile syringes on syringe based<br>contrast delivery systems (injectors). | Same |
| | The Bracco Injeneering Transfer Set<br>is a component of a contrast<br>management system and is<br>indicated for the transfer of Isovue®<br>(Iopamidol Injection) contrast media<br>as supplied in an Imaging Bulk<br>Package to empty sterile syringes on<br>single-use only syringe-based<br>contrast injection systems indicated<br>for the controlled, automatic<br>administration on the venous side,<br>of contrast agents for CT<br>procedures. The Transfer Set is to be<br>discarded after the contrast media<br>container has been depleted or 10<br>hours has elapsed since the<br>container was penetrated,<br>whichever occurs first. | The MEDRAD® Imaging Bulk Package<br>Transfer Set (IBP Transfer Set) is<br>indicated for the transfer of<br>ULTRAVIST® (Iopromide), ISOVUE®<br>(Iopamidol), and OMNIPAQUE™<br>(Iohexal) contrast media as supplied in<br>an approved Imaging Bulk Package (IBP)<br>presentation to empty sterile syringes<br>on single-use only syringe-based<br>contrast power injection systems<br>indicated for the controlled, automatic<br>venous administration of contrast<br>agents for CT procedures.<br>The Transfer Set is to be discarded after<br>one of the following conditions has<br>occurred first: the contrast media<br>container has been depleted, the<br>contrast media use time has expired, or<br>10 hours has elapsed since the<br>container was penetrated. | The predicate device is indicated<br>for use with ISOVUE® (Iopamidol)<br>contrast media as supplied in an<br>Imaging Bulk Package; whereas,<br>the subject device is indicated for<br>use with ULTRAVIST®<br>(Iopromide), ISOVUE®<br>(Iopamidol), and OMNIPAQUE™<br>(Iohexal) contrast media as<br>supplied in an Imaging Bulk<br>Package. The MEDRAD® Imaging<br>Bulk Package Transfer Set has<br>been tested with each of the<br>listed contrast agents and testing<br>has demonstrated that the<br>differences do not raise new<br>questions of safety and efficacy. |
| Indications for<br>Use | | | |
| Item | Predicate Device:<br>Bracco Injeneering Transfer<br>Set | Subject Device:<br>MEDRAD® Imaging Bulk<br>Package Transfer Set | Comparison |
| Tubing Length | 20" | 20" | Same |
| Single Use | Yes | Yes | Same |
| Biocompatible | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterility<br>Assurance Level | 10-6 | 10-6 | Same |
| Sterilization<br>Method | Ethylene Oxide (EtO) | Ethylene Oxide (EtO) | Same |
| Disposable | Yes | Yes | Same |
| Shelf Life | one (1) year shelf life | five (5) year shelf life | Shelf life testing has<br>demonstrated that the difference<br>does not raise new questions of<br>safety and efficacy. |
| Packaging | Individually packaged in a Tyvek<br>pouch | Individually packaged in a Tyvek pouch | Same |
| Microbial Ingress<br>Testing | Yes | Yes | Same |
| Chemical<br>Compatibility<br>Testing | Yes | Yes | Same |
| Material<br>Compatibility<br>Testing | Yes | Yes | Same |
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Bayer U.S., LLC
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## Conclusion:
Bayer considers the MEDRAD® Imaging Bulk Package Transfer Set to be substantially equivalent to the predicate device listed above. This conclusion is based upon device similarities in indications for use, functional design, the technological characteristics comparison and testing that demonstrates that the MEDRAD® Imaging Bulk Package Transfer Set is substantially equivalent to the predicate device.
