MEDRAD Imaging Bulk Package Transfer Spike
Device Facts
| Record ID | K200280 |
|---|---|
| Device Name | MEDRAD Imaging Bulk Package Transfer Spike |
| Applicant | Bayer Medical Care, Inc. |
| Product Code | PQH · General Hospital |
| Decision Date | Jul 30, 2020 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5440 |
| Device Class | Class 2 |
Indications for Use
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures. The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.
Device Story
Pre-administration filling device; transfers contrast media from bulk vials to sterile hand syringes or power injector syringes. Device consists of a spike and a swabbable valve; no direct patient contact. Used in MR suites by clinicians. Facilitates controlled, automatic venous administration of contrast agents. Benefits include efficient bulk media transfer while maintaining sterility. Discarded after container depletion, disconnection, or 24 hours post-penetration.
Clinical Evidence
Bench testing only. Testing included microbial ingress (T=0 to 24 hrs), particulate testing per USP <788>, chemical compatibility with Gadavist, and biocompatibility per ISO 10993-1:2018 (cytotoxicity, sensitization, irritation, acute systemic toxicity, hemocompatibility). Sterilization validated per ISO 11137-1/2/3 (SAL 10^-6). Packaging validated per ISO 11607-1/2. Shelf-life verified via accelerated aging (3 years).
Technological Characteristics
Spike and swabbable valve assembly; no tubing. Materials compliant with ISO 10993-1:2018. Sterilization: Gamma radiation. Connectivity: None (mechanical). Conical fittings per ISO 80369-7; infusion equipment standards per ISO 8536-4:2010.
Indications for Use
Indicated for transfer of Gadavist (gadobutrol) contrast media from bulk packages (30mL/65mL) to empty sterile hand syringes or syringes on single-use contrast power injectors for MR 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
- MEDRAD® Imaging Bulk Package Transfer Set (K173913)
Submission Summary (Full Text)
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July 30. 2020
Bayer Medical Care Inc. Leslie O'Nan Director. Regulatory Affairs 1 Bayer Drive Indianola. Pennsylvania 15051
Re: K200280
Trade/Device Name: MEDRAD® Imaging Bulk Package Transfer Spike Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: Class II Product Code: PQH Dated: July 1, 2020 Received: July 2, 2020
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. 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 (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 (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 Ouality Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K200280
Device Name MEDRAD® Imaging Bulk Package Transfer Spike
#### Indications for Use (Describe)
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is indicated for the transfer of Gadavist® (gadobutrol) injection contrast media as supplied in an approved Imaging Bulk package presentation (30 mL or 65mL) to empty, sterile hand syringes and/or empty, sterile syringes on single-use only syringe-based contrast power injection systems indicated for the controlled, automatic venous administration of contrast agents for MR procedures.
The Transfer Spike is to be discarded after one of the following conditions has occurred first: the contrast media container has been depleted, the Transfer Spike has been disconnected from the contrast vial, or after 24 hours has elapsed since the container was penetrated.
Type of Use (Select one or both, as applicable)X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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# K200280
| 510(k) Summary | | |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Date Prepared: | July 24, 2020 | |
| Submitter: | Bayer Medical Care Inc. | Bayer Medical Care Inc. |
| | 1 Bayer Drive<br>Indianola, PA 15051 | 1 Bayer Drive<br>Indianola, PA 15051-0780<br>U.S.A. |
| | | (412) 767-2400 |
| Primary Contact: | Leslie S. O'Nan<br>Director Regulatory Affairs<br>Phone: (412) 406-3165<br>Fax: (412) 767-2451<br>Email: leslie.o’nan@bayer.com | www.bayer.com |
| Device Trade Name: | MEDRAD® Imaging Bulk Package Transfer Spike | |
| Common Name: | Contrast Media Transfer Set | |
| Classification Name:<br>Regulation Number:<br>Product Code:<br>Classification: | Intravascular Administration Set<br>21 CFR 880.5440<br>PQH<br>Class II | |
| Predicate Device: | MEDRAD® Imaging Bulk Package Transfer Set (IBP<br>Transfer Set)<br>Bayer U.S. LLC<br>K173913, May 04, 2018 | |
| Device Description: | The MEDRAD® Imaging Bulk Package Transfer Spike<br>(Transfer Spike) is a pre-administration filling device that<br>is designed to transfer fluid from an imaging bulk<br>package into multiple sterile syringes via a powered | |
| | injector system prior to an MR procedure. There is no<br>direct patient contact with the use of this device. It is<br>intended to spike one bulk package of Gadavist®<br>(gadobutrol) injection contrast media only. Each<br>imaging bulk transfer set consists of a spike and a<br>swabbable valve. The transfer spike is provided sterile,<br>individually packaged, and is not intended to be<br>resterilized. | |
| Indications for Use: | The MEDRAD® Imaging Bulk Package Transfer Spike<br>(Transfer Spike) is indicated for the transfer of Gadavist®<br>(gadobutrol) injection contrast media as supplied in an<br>approved Imaging Bulk Package presentation (30 mL or<br>65 mL) to empty, sterile hand syringes and/or empty,<br>sterile syringes on single-use only syringe-based contrast<br>power injection systems indicated for the controlled,<br>automatic venous administration of contrast agents for<br>MR procedures. | |
| | The Transfer Spike is to be discarded after one of the<br>following conditions has occurred first: the contrast<br>media container has been depleted, the Transfer Spike<br>has been disconnected from the contrast vial, or after 24<br>hours has elapsed since the container was penetrated. | |
| Performance Testing: | | |
| Sterilization: | Sterilization conditions have been validated on the<br>Transfer Spike in accordance with ISO 11137-1, ISO<br>11137-2 and ISO 11137-3 to provide a Sterility Assurance<br>Level of 106. All testing passed and indicates that the<br>Transfer Spike complies with the standards. | |
| Shelf-Life: | Shelf-life testing included verification that the<br>performance was not affected by accelerated aging up<br>to three-years. All testing passed and the demonstrated<br>product performance met all prior established<br>acceptance criteria. | |
| Packaging: | The Transfer Spike is sterilized, and its packaging was<br>validated in accordance with ISO 11607-1 and ISO<br>11607-2. All testing passed and indicates that the<br>Transfer Spike complies with the standards. | |
| Biocompatibility: | The Transfer Spike indirect patient contact materials<br>were verified in accordance with the following standard:<br>• ISO 10993-1: 2018 Biological evaluation of medical<br>devices Part 1: Evaluation and testing within a risk<br>management process<br>The following test program was selected for an<br>externally communicating, indirect blood path,<br>limited contact (< 24 h) device:<br>• Cytotoxicity<br>• Sensitization<br>• Irritation / Intracutaneous Reactivity<br>• Acute Systemic Toxicity<br>o Acute Systemic Injection<br>o Materials Mediated Pyrogen<br>• Hemocompatibility<br>Verification results indicated that the materials comply<br>with the standard. | |
| Performance — Bench: | The Transfer Spike was tested for performance and<br>verified in accordance with the following standards: | |
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- ISO 80369-7 Conical Fittings with 6% (Luer) taper . for syringes, needles, and other medical equipment
- ISO 8536-4:2010, Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed
Verification results indicate that the Transfer Spike complies with the standards.
## Additional testing included:
- . Microbial ingress testing conducted at time points, T = 0 hr, 7 hr, 11 hr, 15 hr, 20 hr, 24 hr, and bottle depletion for the following components:
- . Swabbable Valve
- . Bottle Septum
- . Spike
- Syringe ●
- Injectable particulate Per USP <788> ●
- Chemical compatibility .
- o Through evaluation of conformance to the approved release specifications of Gadavist (gadobutrol).
Verification results indicate that the Transfer Spike complies with its predetermined specifications.
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## Predicate Device Comparison:
| | Item | Predicate Device:<br>K173913<br>MEDRAD® Imaging Bulk Package<br>Transfer Set | Proposed Device:<br>K200280<br>MEDRAD® Imaging Bulk Package<br>Transfer Spike | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory<br>Classification | Class | II | II | Same |
| | FDA Regulation Number | 880.5440 | 880.5440 | Same |
| | Classification Product Code | PQH | PQH | Same |
| Labeling | Intended Use | The MEDRAD® Imaging Bulk Package Transfer Set is intended for the transfer of fluids from bulk containers to empty sterile syringes on syringe-based contrast delivery systems (injectors). | The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is intended for the transfer of fluid from bulk containers to sterile, empty hand syringes and/or sterile, empty syringes on syringe-based contrast delivery systems (injectors). | Adds use with sterile hand syringes.<br>Testing demonstrated that the differences do not raise new questions of safety and effectiveness. |
| Item | Predicate Device:<br>K173913<br>MEDRAD® Imaging Bulk Package<br>Transfer Set | Proposed Device:<br>K200280<br>MEDRAD® Imaging Bulk Package<br>Transfer Spike | Comparison | |
| Indications for Use | The MEDRAD® Imaging Bulk<br>Package Transfer Set (IBP Transfer<br>Set) is indicated for the transfer of<br>ULTRAVIST® (lopromide), ISOVUE®<br>(Iopamidol), and OMNIPAQUE™<br>(Iohexol) contrast media as<br>supplied in an approved Imaging<br>Bulk Package (IBP) presentation to<br>empty sterile syringes on single-<br>use only syringe-based contrast<br>power injection systems indicated<br>for the controlled, automatic<br>venous administration of contrast<br>agents for CT procedures.<br>The Transfer Set is to be discarded<br>after one of the following<br>conditions has occurred first: the<br>contrast media container has been<br>depleted, the contrast media use<br>time has expired, or 10 hours has<br>elapsed since the container was<br>penetrated. | The MEDRAD® Imaging Bulk<br>Package Transfer Spike (Transfer<br>Spike) is indicated for the transfer<br>of Gadavist® (gadobutrol) Injection<br>contrast media as supplied in an<br>approved Imaging Bulk Package<br>presentation (30 mL or 65 mL) to<br>empty, sterile hand syringes and/or<br>empty, sterile syringes on single-use<br>only syringe-based contrast power<br>injection systems indicated for the<br>controlled, automatic venous<br>administration of contrast agents<br>for MR procedures.<br>The Transfer Spike is to be<br>discarded after one of the following<br>conditions has occurred first: the<br>contrast media container has been<br>depleted, the Transfer Spike has<br>been disconnected from the<br>contrast vial, or after 24 hours has<br>elapsed since the container was<br>penetrated. | The proposed device has been<br>tested with the listed contrast<br>agent. Chemical<br>compatibility testing including<br>particulate testing as per USP<br><788> has<br>demonstrated that the<br>differences do not raise new<br>questions of safety and<br>effectiveness. | |
| Item | Predicate Device:<br>K173913<br>MEDRAD® Imaging Bulk Package<br>Transfer Set | Proposed Device:<br>K200280<br>MEDRAD® Imaging Bulk Package<br>Transfer Spike | Comparison | |
| Construction | Spike<br>Vented Spike | Spike<br>Vented Spike | Same | |
| | Tubing Length<br>20" | Tubing Length<br>N/A | No tubing in the Transfer Spike | |
| | Valve<br>Swabable | Valve<br>Swabable | Same | |
| Packaging | Type<br>Individually packaged in a<br>Tyvek pouch | Type<br>Individually packaged in a<br>Tyvek pouch | Same | |
| | Shelf Life<br>5 years at release | Shelf Life<br>3 years at release | Shelf life testing has been<br>completed and demonstrated<br>that the differences do not<br>raise new<br>questions of safety and<br>effectiveness. | |
| Biological | Biocompatibility<br>Compliant to applicable sections of<br>ISO/AAMI 10993-1:2009 | Biocompatibility<br>Compliant to applicable sections of<br>ISO/AAMI 10993-1:2018 | Same<br>(tested to newest version of<br>the standard) | |
| | Pyrogenicity<br>Non-pyrogenic | Pyrogenicity<br>Non-pyrogenic | Same | |
| | Latex content<br>This device is not made with<br>natural rubber latex | Latex content<br>This device is not made with natural<br>rubber latex | Same | |
| | Sterilization Type<br>Ethylene Oxide (EtO) | Sterilization Type<br>Radiation (Gamma) | Change to sterilization method.<br>SAL remains 10-6 | |
| | Sterilization Assurance<br>Level (SAL) | 10-6 | 10-6 | |
| Item | Predicate Device:<br>K173913<br>MEDRAD® Imaging Bulk Package<br>Transfer Set | Proposed Device:<br>K200280<br>MEDRAD® Imaging Bulk Package<br>Transfer Spike | Comparison | |
| Performance | Fill (Load) Rate | 10 mL/sec for manual fill<br>4 mL/sec for autoload | 10 mL/sec for manual fill<br>4 mL/sec for autoload | Same |
| | Use Environment | Ambient (CT Suite) | Ambient (MR Suite) | Same - Ambient environment<br>of radiology suite |
| | Use Time | 10 hours | 24 hours | Use time aligns with the use<br>time of Gadavist contrast<br>media. Testing has been<br>completed and demonstrated<br>that the differences do not<br>raise new<br>questions of safety and<br>effectiveness. |
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### Conclusion:
All test results demonstrate that the design and materials of the MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) meet the established performance criteria and will perform as intended. Bayer considers the Transfer Spike 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 Transfer Spike is substantially equivalent to the predicate device.
