(177 days)
Not Found
No
The device description and performance testing focus on mechanical and material properties for fluid transfer, with no mention of AI/ML algorithms or data processing.
No
The device is described as a "pre-administration filling device" for transferring contrast media, and the description explicitly states, "There is no direct patient contact with the use of this device." It does not provide any therapy or direct medical treatment to a patient.
No
The device is a pre-administration filling device designed to transfer fluid from a bulk package into syringes for contrast power injection systems, not to diagnose a condition.
No
The device description clearly indicates it is a physical device ("spike and a swabbable valve") used for fluid transfer, not a software program. The performance studies also focus on physical properties like sterilization, shelf-life, packaging, biocompatibility, and bench performance.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used to transfer contrast media prior to an MR procedure. It facilitates the delivery of a substance into the patient's body for imaging purposes.
- Device Description: It's described as a "pre-administration filling device" and explicitly states "There is no direct patient contact with the use of this device."
- Lack of In Vitro Testing: The description of the device and its performance studies do not mention any testing of samples outside of the body (in vitro). The performance studies focus on sterilization, shelf-life, packaging, biocompatibility (related to indirect patient contact), and bench performance related to fluid transfer and connections.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis on patient samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
PQH
Device Description
The MEDRAD® Imaging Bulk Package Transfer Spike (Transfer Spike) is a pre-administration filling device that is designed to transfer fluid from an imaging bulk package into multiple sterile syringes via a powered injector system prior to an MR procedure. There is no direct patient contact with the use of this device. It is intended to spike one bulk package of Gadavist® (gadobutrol) injection contrast media only. Each imaging bulk transfer set consists of a spike and a swabbable valve. The transfer spike is provided sterile, individually packaged, and is not intended to be resterilized.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sterilization: Sterilization conditions have been validated on the Transfer Spike in accordance with ISO 11137-1, ISO 11137-2 and ISO 11137-3 to provide a Sterility Assurance Level of 10-6. All testing passed and indicates that the Transfer Spike complies with the standards.
Shelf-Life: Shelf-life testing included verification that the performance was not affected by accelerated aging up to three-years. All testing passed and the demonstrated product performance met all prior established acceptance criteria.
Packaging: The Transfer Spike is sterilized, and its packaging was validated in accordance with ISO 11607-1 and ISO 11607-2. All testing passed and indicates that the Transfer Spike complies with the standards.
Biocompatibility: The Transfer Spike indirect patient contact materials were verified in accordance with the following standard:
- ISO 10993-1: 2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
The following test program was selected for an externally communicating, indirect blood path, limited contact (
- Chemical compatibility
- Through evaluation of conformance to the approved release specifications of Gadavist (gadobutrol).
Verification results indicate that the Transfer Spike complies with its predetermined specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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 | ||
| Indianola, PA 15051 | 1 Bayer Drive | |
| Indianola, PA 15051-0780 | ||
| U.S.A. | ||
| (412) 767-2400 | ||
| Primary Contact: | Leslie S. O'Nan | |
| Director Regulatory Affairs | ||
| Phone: (412) 406-3165 | ||
| Fax: (412) 767-2451 | ||
| 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: | ||
| Regulation Number: | ||
| Product Code: | ||
| Classification: | Intravascular Administration Set | |
| 21 CFR 880.5440 | ||
| PQH | ||
| Class II | ||
| Predicate Device: | MEDRAD® Imaging Bulk Package Transfer Set (IBP | |
| Transfer Set) | ||
| Bayer U.S. LLC | ||
| K173913, May 04, 2018 | ||
| Device Description: | The MEDRAD® Imaging Bulk Package Transfer Spike | |
| (Transfer Spike) is a pre-administration filling device that | ||
| is designed to transfer fluid from an imaging bulk | ||
| package into multiple sterile syringes via a powered | ||
| injector system prior to an MR procedure. There is no | ||
| direct patient contact with the use of this device. It is | ||
| intended to spike one bulk package of Gadavist® | ||
| (gadobutrol) injection contrast media only. Each | ||
| imaging bulk transfer set consists of a spike and a | ||
| swabbable valve. The transfer spike is provided sterile, | ||
| individually packaged, and is not intended to be | ||
| resterilized. | ||
| 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 | ||
| 65 mL) 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. | ||
| Performance Testing: | ||
| Sterilization: | Sterilization conditions have been validated on the | |
| Transfer Spike in accordance with ISO 11137-1, ISO | ||
| 11137-2 and ISO 11137-3 to provide a Sterility Assurance | ||
| Level of 106. All testing passed and indicates that the | ||
| Transfer Spike complies with the standards. | ||
| Shelf-Life: | Shelf-life testing included verification that the | |
| performance was not affected by accelerated aging up | ||
| to three-years. All testing passed and the demonstrated | ||
| product performance met all prior established | ||
| acceptance criteria. | ||
| Packaging: | The Transfer Spike is sterilized, and its packaging was | |
| validated in accordance with ISO 11607-1 and ISO | ||
| 11607-2. All testing passed and indicates that the | ||
| Transfer Spike complies with the standards. | ||
| Biocompatibility: | The Transfer Spike indirect patient contact materials | |
| were verified in accordance with the following standard: | ||
| • ISO 10993-1: 2018 Biological evaluation of medical | ||
| devices Part 1: Evaluation and testing within a risk | ||
| management process | ||
| The following test program was selected for an | ||
| externally communicating, indirect blood path, | ||
| limited contact ( ● |
- 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:
K173913
MEDRAD® Imaging Bulk Package
Transfer Set | Proposed Device:
K200280
MEDRAD® Imaging Bulk Package
Transfer Spike | Comparison |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulatory
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.
Testing demonstrated that the differences do not raise new questions of safety and effectiveness. |
| Item | Predicate Device:
K173913
MEDRAD® Imaging Bulk Package
Transfer Set | Proposed Device:
K200280
MEDRAD® Imaging Bulk Package
Transfer Spike | Comparison | |
| Indications for Use | The MEDRAD® Imaging Bulk
Package Transfer Set (IBP Transfer
Set) is indicated for the transfer of
ULTRAVIST® (lopromide), ISOVUE®
(Iopamidol), and OMNIPAQUE™
(Iohexol) 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. | 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 65 mL) 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. | The proposed device has been
tested with the listed contrast
agent. Chemical
compatibility testing including
particulate testing as per USP
has
demonstrated that the
differences do not raise new
questions of safety and
effectiveness. | |
| Item | Predicate Device:
K173913
MEDRAD® Imaging Bulk Package
Transfer Set | Proposed Device:
K200280
MEDRAD® Imaging Bulk Package
Transfer Spike | Comparison | |
| Construction | Spike
Vented Spike | Spike
Vented Spike | Same | |
| | Tubing Length
20" | Tubing Length
N/A | No tubing in the Transfer Spike | |
| | Valve
Swabable | Valve
Swabable | Same | |
| Packaging | Type
Individually packaged in a
Tyvek pouch | Type
Individually packaged in a
Tyvek pouch | Same | |
| | Shelf Life
5 years at release | Shelf Life
3 years at release | Shelf life testing has been
completed and demonstrated
that the differences do not
raise new
questions of safety and
effectiveness. | |
| Biological | Biocompatibility
Compliant to applicable sections of
ISO/AAMI 10993-1:2009 | Biocompatibility
Compliant to applicable sections of
ISO/AAMI 10993-1:2018 | Same
(tested to newest version of
the standard) | |
| | Pyrogenicity
Non-pyrogenic | Pyrogenicity
Non-pyrogenic | Same | |
| | Latex content
This device is not made with
natural rubber latex | Latex content
This device is not made with natural
rubber latex | Same | |
| | Sterilization Type
Ethylene Oxide (EtO) | Sterilization Type
Radiation (Gamma) | Change to sterilization method.
SAL remains 10-6 | |
| | Sterilization Assurance
Level (SAL) | 10-6 | 10-6 | |
| Item | Predicate Device:
K173913
MEDRAD® Imaging Bulk Package
Transfer Set | Proposed Device:
K200280
MEDRAD® Imaging Bulk Package
Transfer Spike | Comparison | |
| Performance | Fill (Load) Rate | 10 mL/sec for manual fill
4 mL/sec for autoload | 10 mL/sec for manual fill
4 mL/sec for autoload | Same |
| | Use Environment | Ambient (CT Suite) | Ambient (MR Suite) | Same - Ambient environment
of radiology suite |
| | Use Time | 10 hours | 24 hours | Use time aligns with the use
time of Gadavist contrast
media. Testing has been
completed and demonstrated
that the differences do not
raise new
questions of safety and
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.