(133 days)
Not Found
No
The device description and performance studies focus on the physical and material properties of a fluid transfer set, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No.
The device is described as a "pre-administration filling device" designed for transferring contrast media to syringes, and it states there is "no direct patient contact with the use of this device." It facilitates the preparation of contrast agents for imaging but does not directly diagnose, cure, mitigate, or treat a disease or condition.
No
This device is a transfer set for moving contrast media from a bulk package to syringes for CT procedures. It is a pre-administration filling device and does not diagnose any condition.
No
The device description clearly outlines physical components (spike, flexible tubing, swabbable valve) and the performance studies focus on sterilization, shelf-life, biocompatibility, and bench testing of these physical components. There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the transfer of contrast media from a bulk package to syringes for administration to a patient during a CT procedure. This is a pre-administration step and involves handling substances that will be introduced into the body, not analyzing samples from the body.
- Device Description: The device is described as a "pre-administration filling device" designed to transfer fluid. It explicitly states "There is no direct patient contact with the use of this device." IVDs are typically used to examine specimens obtained from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or functions associated with IVD devices (e.g., reagents, assays, detection methods).
- Performance Studies: The performance studies focus on sterility, shelf-life, biocompatibility (related to indirect patient contact), and bench performance related to fluid transfer and compatibility with the contrast media. These are typical tests for medical devices that handle fluids for administration, not for devices that analyze biological samples.
In summary, the MEDRAD® Imaging Bulk Package Transfer Set is a medical device used in the preparation for a medical procedure (CT with contrast), but it does not perform any diagnostic testing on biological samples.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
POH
Device Description
The MEDRAD® Imaging Bulk Package Transfer Set 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 a CT procedure. There is no direct patient contact with 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.
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)
Performance Testing: The Imaging Bulk Package Transfer Set is ethylene oxide (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.
Shelf-Life: The Imaging Bulk Package Transfer Set is sterilized and its packaging was validated in accordance with the following standard: ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems; and Verification results indicate that the MEDRAD® Imaging Bulk Package Transfer Set complies with the standard.
Biocompatibility: The MEDRAD® Imaging Bulk Package Transfer Set indirect patient contact materials were verified in accordance with the following standard: ISO 10993-1: 2009 (R2013) 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 (≤ 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 with the standard.
Performance - Bench: The MEDRAD® Imaging Bulk Package Transfer Set was tested for performance and verified in accordance with the following standards:
- 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
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.
0
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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.
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); 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
2
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 ( Select one or both, as applicable ) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Image /page/3/Picture/0 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" stacked vertically, with each letter in a bold, sans-serif font. The letters are gray and outlined in black. The wordmark is encircled by a ring that transitions from green at the top to blue at the bottom, creating a gradient effect.
K173913 510(k) Summary
| Date Prepared: | April 13, 2018 |
|---|---|
| Submitter: | Bayer U.S. LLC |
| 1 Bayer Drive | |
| Indianola, PA 15051 | |
| Primary Contact: | Leslie S. O'Nan |
| Regulatory Affairs Manager | |
| Phone: (412) 406-3165 | |
| Fax: (412) 767-2451 | |
| Email: leslie.o’nan@bayer.com | |
| Device Trade Name: | MEDRAD ® 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 |
| Bracco Injeneering S.A. | |
| K133147, June 20, 2014 | |
| Device Description: | The MEDRAD ® Imaging Bulk Package Transfer Set 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 a | |
| 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
4
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.
5
| Shelf-Life: | The Imaging Bulk Package Transfer Set is sterilized and
its packaging was validated in accordance with the
following standard:
ISO 11607-1: 2006 Packaging for terminally
sterilized medical devices - Part 1: requirements
for materials, sterile barrier systems and
packaging systems; and
Verification results indicate that the MEDRAD® Imaging
Bulk Package Transfer Set complies with the standard. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility: | The MEDRAD® Imaging Bulk Package Transfer Set
indirect patient contact materials were verified in
accordance with the following standard:
ISO 10993-1: 2009 (R2013) 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 (≤ 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
with the standard. |
| Performance - Bench: | The MEDRAD® Imaging Bulk Package Transfer Set was
tested for performance and verified in accordance with
the following standards: |
6
- 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
7
Predicate Device Comparison:
| Item | Predicate Device:
Bracco Injeneering Transfer
Set | Subject Device:
MEDRAD® Imaging Bulk
Package Transfer Set | Comparison |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The 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 Set is intended for the transfer
of fluids from bulk containers to empty
sterile syringes on syringe based
contrast delivery systems (injectors). | Same |
| | The Bracco Injeneering Transfer Set
is a component of a contrast
management system and is
indicated for the transfer of Isovue®
(Iopamidol Injection) contrast media
as supplied in an Imaging Bulk
Package to empty sterile syringes on
single-use only syringe-based
contrast injection systems indicated
for the controlled, automatic
administration on the venous side,
of contrast agents for CT
procedures. The Transfer Set is to be
discarded after the contrast media
container has been depleted or 10
hours has elapsed since the
container was penetrated,
whichever occurs first. | 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. | The predicate device is indicated
for use with ISOVUE® (Iopamidol)
contrast media as supplied in an
Imaging Bulk Package; whereas,
the subject device is indicated for
use with ULTRAVIST®
(Iopromide), ISOVUE®
(Iopamidol), and OMNIPAQUE™
(Iohexal) contrast media as
supplied in an Imaging Bulk
Package. The MEDRAD® Imaging
Bulk Package Transfer Set has
been tested with each of the
listed contrast agents and testing
has demonstrated that the
differences do not raise new
questions of safety and efficacy. |
| Indications for
Use | | | |
| Item | Predicate Device:
Bracco Injeneering Transfer
Set | Subject Device:
MEDRAD® Imaging Bulk
Package Transfer Set | Comparison |
| Tubing Length | 20" | 20" | Same |
| Single Use | Yes | Yes | Same |
| Biocompatible | Yes | Yes | Same |
| Sterile | Yes | Yes | Same |
| Sterility
Assurance Level | 10-6 | 10-6 | Same |
| Sterilization
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
demonstrated that the difference
does not raise new questions of
safety and efficacy. |
| Packaging | Individually packaged in a Tyvek
pouch | Individually packaged in a Tyvek pouch | Same |
| Microbial Ingress
Testing | Yes | Yes | Same |
| Chemical
Compatibility
Testing | Yes | Yes | Same |
| Material
Compatibility
Testing | Yes | Yes | Same |
8
Bayer U.S., LLC
9
Image /page/9/Picture/0 description: The image shows the Bayer company logo. The logo consists of the word "BAYER" arranged vertically in a circle. The circle has a gradient, transitioning from green at the top to blue at the bottom. The letters are in a sans-serif font and are colored gray.
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.