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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the MEDRAD® Imaging Bulk Package Transfer Spike:

The document is a 510(k) Premarket Notification from the FDA for the MEDRAD® Imaging Bulk Package Transfer Spike. This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device, rather than proving absolute safety and effectiveness through extensive clinical trials. Therefore, the "studies" are primarily bench and verification tests to show compliance with standards and functional specifications.

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a dedicated "acceptance criteria" table with specific quantitative thresholds. Instead, it lists various performance tests and states that "All testing passed" or "Verification results indicate that the Transfer Spike complies with the standards" or "Verification results indicate that the Transfer Spike complies with its predetermined specifications."

Here's a table summarizing the tests performed and the reported outcomes, essentially inferring the acceptance criteria as "compliance with the standard" or "meeting predetermined specifications":

Performance Aspect	Acceptance Criteria (Inferred)	Reported Device Performance
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶ in accordance with ISO 11137-1, 11137-2, 11137-3	All testing passed; complies with standards.
Shelf-Life	Performance not affected by accelerated aging up to three years; meet all established acceptance criteria.	All testing passed; demonstrated product performance met all prior established acceptance criteria.
Packaging	Validated in accordance with ISO 11607-1 and ISO 11607-2.	All testing passed; complies with standards.
Biocompatibility	Compliant with ISO 10993-1:2018 (Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Hemocompatibility).	Verification results indicated materials comply with the standard.
Bench Performance (General)	Compliant with ISO 80369-7 and ISO 8536-4:2010.	Verification results indicate compliance with standards.
Microbial Ingress	Maintain integrity at specified time points (0, 7, 11, 15, 20, 24 hr, and bottle depletion) for various components.	Complies with predetermined specifications.
Injectable Particulate	Conformance to USP <788>.	Complies with predetermined specifications.
Chemical Compatibility	Conformance to approved release specifications of Gadavist (gadobutrol).	Demonstrated that differences do not raise new questions of safety and effectiveness. (Implies compliance during testing)
Pyrogenicity	Non-pyrogenic.	Non-pyrogenic.
Latex Content	Not made with natural rubber latex.	Not made with natural rubber latex.
Fill (Load) Rate	10 mL/sec for manual fill, 4 mL/sec for autoload.	Same as predicate (implied compliance). See Predicate Comparison.
Use Environment	Ambient conditions (MR Suite).	Same as predicate (Ambient environment of radiology suite). See Predicate Comparison.
Use Time	24 hours (aligned with Gadavist contrast media).	Testing demonstrated the differences do not raise new questions of safety and effectiveness. See Predicate Comparison.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify general "sample sizes" for the test sets in a clinical study sense, as the testing described is primarily bench validation. For validation tests like sterilization, shelf-life, packaging, and biocompatibility, sample sizes would be determined by the relevant ISO standards and internal validation protocols, but these specifics are not provided in the summary.

Sample Size: Not explicitly stated for each test, but implied to be sufficient for compliance with the cited ISO standards and internal protocols.
Data Provenance: The studies are prospective bench and laboratory testing conducted by or for Bayer Medical Care Inc. The location of the test facilities is not explicitly stated beyond Bayer's address in Indianola, Pennsylvania, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to this submission. The device is a medical accessory (transfer spike) and the studies are technical engineering verifications (sterilization, shelf-life, biocompatibility, etc.), not diagnostic or treatment efficacy studies that would require expert consensus for ground truth. The "ground truth" is established by adherence to recognized national and international standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert readers interpret medical images or data to establish a consensus ground truth. The tests performed for this device are objective measurements and validations against predefined technical standards, not subjective interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is not an AI algorithm or an imaging device that would involve human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm performance study was not done. This device is a mechanical accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the various tests performed is the compliance with established national and international standards and predetermined specifications for medical devices and their components. Examples include:

ISO 11137-1, 11137-2, 11137-3 for sterilization.
ISO 11607-1 and ISO 11607-2 for packaging.
ISO 10993-1:2018 for biocompatibility.
ISO 80369-7 and ISO 8536-4:2010 for bench performance.
USP <788> for injectable particulate matter.
Approved release specifications for chemical compatibility with Gadavist.

These standards and specifications are the "ground truth" against which the device's technical performance is measured.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this device is not an AI algorithm.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for this device.

Summary

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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)

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 DriveIndianola, PA 15051	1 Bayer DriveIndianola, PA 15051-0780U.S.A.
		(412) 767-2400
Primary Contact:	Leslie S. O'NanDirector Regulatory AffairsPhone: (412) 406-3165Fax: (412) 767-2451Email: 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 Set21 CFR 880.5440PQHClass II
Predicate Device:	MEDRAD® Imaging Bulk Package Transfer Set (IBPTransfer Set)Bayer U.S. LLCK173913, May 04, 2018
Device Description:	The MEDRAD® Imaging Bulk Package Transfer Spike(Transfer Spike) is a pre-administration filling device thatis designed to transfer fluid from an imaging bulkpackage into multiple sterile syringes via a powered
	injector system prior to an MR procedure. There is nodirect patient contact with the use of this device. It isintended to spike one bulk package of Gadavist®(gadobutrol) injection contrast media only. Eachimaging bulk transfer set consists of a spike and aswabbable valve. The transfer spike is provided sterile,individually packaged, and is not intended to beresterilized.
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 anapproved Imaging Bulk Package presentation (30 mL or65 mL) to empty, sterile hand syringes and/or empty,sterile syringes on single-use only syringe-based contrastpower injection systems indicated for the controlled,automatic venous administration of contrast agents forMR procedures.
	The Transfer Spike is to be discarded after one of thefollowing conditions has occurred first: the contrastmedia container has been depleted, the Transfer Spikehas been disconnected from the contrast vial, or after 24hours has elapsed since the container was penetrated.
Performance Testing:
Sterilization:	Sterilization conditions have been validated on theTransfer Spike in accordance with ISO 11137-1, ISO11137-2 and ISO 11137-3 to provide a Sterility AssuranceLevel of 106. All testing passed and indicates that theTransfer Spike complies with the standards.
Shelf-Life:	Shelf-life testing included verification that theperformance was not affected by accelerated aging upto three-years. All testing passed and the demonstratedproduct performance met all prior establishedacceptance criteria.
Packaging:	The Transfer Spike is sterilized, and its packaging wasvalidated in accordance with ISO 11607-1 and ISO11607-2. All testing passed and indicates that theTransfer Spike complies with the standards.
Biocompatibility:	The Transfer Spike indirect patient contact materialswere verified in accordance with the following standard:• ISO 10993-1: 2018 Biological evaluation of medicaldevices Part 1: Evaluation and testing within a riskmanagement processThe following test program was selected for anexternally communicating, indirect blood path,limited contact (< 24 h) device:• Cytotoxicity• Sensitization• Irritation / Intracutaneous Reactivity• Acute Systemic Toxicityo Acute Systemic Injectiono Materials Mediated Pyrogen• HemocompatibilityVerification results indicated that the materials complywith the standard.
Performance — Bench:	The Transfer Spike was tested for performance andverified 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:K173913MEDRAD® Imaging Bulk PackageTransfer Set	Proposed Device:K200280MEDRAD® Imaging Bulk PackageTransfer Spike	Comparison
RegulatoryClassification	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:K173913MEDRAD® Imaging Bulk PackageTransfer Set	Proposed Device:K200280MEDRAD® Imaging Bulk PackageTransfer Spike	Comparison
Indications for Use	The MEDRAD® Imaging BulkPackage Transfer Set (IBP TransferSet) is indicated for the transfer ofULTRAVIST® (lopromide), ISOVUE®(Iopamidol), and OMNIPAQUE™(Iohexol) contrast media assupplied in an approved ImagingBulk Package (IBP) presentation toempty sterile syringes on single-use only syringe-based contrastpower injection systems indicatedfor the controlled, automaticvenous administration of contrastagents for CT procedures.The Transfer Set is to be discardedafter one of the followingconditions has occurred first: thecontrast media container has beendepleted, the contrast media usetime has expired, or 10 hours haselapsed since the container waspenetrated.	The MEDRAD® Imaging BulkPackage Transfer Spike (TransferSpike) is indicated for the transferof Gadavist® (gadobutrol) Injectioncontrast media as supplied in anapproved Imaging Bulk Packagepresentation (30 mL or 65 mL) toempty, sterile hand syringes and/orempty, sterile syringes on single-useonly syringe-based contrast powerinjection systems indicated for thecontrolled, automatic venousadministration of contrast agentsfor MR procedures.The Transfer Spike is to bediscarded after one of the followingconditions has occurred first: thecontrast media container has beendepleted, the Transfer Spike hasbeen disconnected from thecontrast vial, or after 24 hours haselapsed since the container waspenetrated.	The proposed device has beentested with the listed contrastagent. Chemicalcompatibility testing includingparticulate testing as per USP<788> hasdemonstrated that thedifferences do not raise newquestions of safety andeffectiveness.
Item	Predicate Device:K173913MEDRAD® Imaging Bulk PackageTransfer Set	Proposed Device:K200280MEDRAD® Imaging Bulk PackageTransfer Spike	Comparison
Construction	SpikeVented Spike	SpikeVented Spike	Same
	Tubing Length20"	Tubing LengthN/A	No tubing in the Transfer Spike
	ValveSwabable	ValveSwabable	Same
Packaging	TypeIndividually packaged in aTyvek pouch	TypeIndividually packaged in aTyvek pouch	Same
	Shelf Life5 years at release	Shelf Life3 years at release	Shelf life testing has beencompleted and demonstratedthat the differences do notraise newquestions of safety andeffectiveness.
Biological	BiocompatibilityCompliant to applicable sections ofISO/AAMI 10993-1:2009	BiocompatibilityCompliant to applicable sections ofISO/AAMI 10993-1:2018	Same(tested to newest version ofthe standard)
	PyrogenicityNon-pyrogenic	PyrogenicityNon-pyrogenic	Same
	Latex contentThis device is not made withnatural rubber latex	Latex contentThis device is not made with naturalrubber latex	Same
	Sterilization TypeEthylene Oxide (EtO)	Sterilization TypeRadiation (Gamma)	Change to sterilization method.SAL remains 10-6
	Sterilization AssuranceLevel (SAL)	10-6	10-6
Item	Predicate Device:K173913MEDRAD® Imaging Bulk PackageTransfer Set	Proposed Device:K200280MEDRAD® Imaging Bulk PackageTransfer Spike	Comparison
Performance	Fill (Load) Rate	10 mL/sec for manual fill4 mL/sec for autoload	10 mL/sec for manual fill4 mL/sec for autoload	Same
	Use Environment	Ambient (CT Suite)	Ambient (MR Suite)	Same - Ambient environmentof radiology suite
	Use Time	10 hours	24 hours	Use time aligns with the usetime of Gadavist contrastmedia. Testing has beencompleted and demonstratedthat the differences do notraise newquestions of safety andeffectiveness.

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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.

Regulation Number and Section

§ 880.5440 Intravascular administration set.

(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.