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 syringe-based contrast injection systems included 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 deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.

Device Description

The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for connection between an imaging bulk package and empty sterile syringes on single-use-only, syringe based contrast delivery systems (injectors). The BINJ Transfer Set is approximately 20 inches long, and its components are made with medical grade materials. The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a Sterility Assurance Level (SAL) of 10-6, and is individually packaged. At the time of this submission, accelerated aging tests confirm a one (1) year shelf life. The BINJ Transfer Set is disposable, and is to be discarded after the contrast media container has been depleted, or 10 hours has elapsed since the container was spiked.

AI/ML Overview

This document is a 510(k) Summary for the Bracco Injeneering Transfer Set, indicating substantial equivalence to a predicate device. It primarily details the device's intended use, technological characteristics, and performance testing related to safety and manufacturing standards, rather than providing a study comparing device performance against specific clinical acceptance criteria in terms of diagnostic accuracy or reader improvement.

Based on the provided text, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily related to safety, sterility, shelf-life, and material compatibility, demonstrating that the device meets established medical device standards. No specific performance metrics like sensitivity, specificity, or accuracy (as one might find for an AI diagnostic device) are provided, as this is a medical device for fluid transfer, not a diagnostic tool.

Acceptance Criteria Category	Specific Standard/Test	Reported Device Performance
Sterilization	ISO 11135-1: 2007, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. Validation for a Sterility Assurance Level (SAL) of 10-6.	Verification results indicate that the BINJ Transfer Set complies with the standard and was validated to a SAL of 10-6.
Shelf-Life & Packaging	ISO 11607-1: 2006 Packaging for terminally sterilized medical devices - Part 1: requirements for materials, sterile barrier systems and packaging systems. ISO 11607-2: 2006 Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes. Accelerated aging tests confirm a one (1) year shelf life.	Verification results indicate that the BINJ Transfer Set complies with the standards. Accelerated aging tests confirmed a one-year shelf life.
Biocompatibility	ISO 10993-1: 2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.	Verification results indicated that the materials comply with the standard.
Performance (Bench Testing)	- IEC 62366: 2007, Medical devices Application of usability engineering to medical devices - ISO 594-2: 1998, Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Part 2: Lock fittings - ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed. - Microbial ingress testing - Chemical compatibility, leachable compounds, and particulates testing.	Test and verification results indicate that the BINJ Transfer Set complies with its predetermined specifications and the standards.
Substantial Equivalence (Overall)	Demonstrated equivalence to predicate device (E-Z-EM, Inc. Empower Transfer Set, K041178) in intended use, indications for use, and technological characteristics.	The BINJ Transfer Set is considered substantially equivalent to the predicate device, being safe and effective when used in accordance with its intended use and labeling.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of diagnostic accuracy, as this is a device for fluid transfer. The testing described (sterilization, shelf-life, biocompatibility, and bench performance) involves specific samples of the device and its components, but the sample sizes for these engineering tests are not explicitly stated. The data provenance is internal testing conducted by Bracco Injeneering S.A.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The device is a transfer set, and the "ground truth" for its performance is assessed through compliance with engineering and safety standards, not through expert consensus on diagnostic interpretations.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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 such study was conducted or is relevant for this type of medical device (a fluid transfer set). This is not an AI diagnostic or assistive device.

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

This information is not applicable. The device is a physical medical component, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance is adherence to established international and national standards for medical devices, including:

Sterility: Sterility Assurance Level (SAL) of 10-6 per ISO 11135-1.
Packet integrity and Shelf-life: Compliance with ISO 11607-1 and ISO 11607-2, and confirmed 1-year shelf life via accelerated aging.
Biocompatibility: Compliance with ISO 10993-1.
Functional Performance: Compliance with IEC 62366, ISO 594-2, ISO 8536-4, and specific testing for microbial ingress, chemical compatibility, leachable compounds, and particulates.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of device development for a fluid transfer set.

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

This information is not applicable for the reasons stated above.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 25, 2017

Bracco Injeneering S.A. % Mr. Thomas Kroenke Speed to Market, Inc P.O. Box 3018 Nederland, Colorado, 80466

Re: K133147

Trade/Device Name: Bracco Injeneering Transfer Set Regulation Number: 21 CFR 880.5440 Regulation Name: Regulatory Class: II Product Code: PQH Dated: June 13, 2014 Received: June 16, 2014

Dear Mr. Thomas Kroenke:

This letter corrects our substantially equivalent letter of June 20, 2014

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 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.

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

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Page 2 - Mr. Thomas Kroenke

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, .

Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT Acting Division Director Science and Policy Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on lest page.

510(k) Number (if known) K133147

Device Name Bracco Injeneering Transfer Set

Indications for Use (Describe)

The Bracco Injeneering Transfer Set is a component of a contrast management system and is indicated for the transfer of Isovue (loganido) Injection) contrast media as supplied in an Imaging Bulk Package to empty sterile syringebased contrast injection systems included 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 deplected or 10 hours has elapsed since the container was penetrated, whichever occurs first.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR STORE FOR FOR FOR FOR FOR FOR FOR FOR FOR THE CONTRACT CONTRACTOR CONTRACTOR ・・・・・ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Digitally signed by Richard C. Chapman -S Date: 2014.06.20 12:18:43 -04'00'

FORM FDA 3881 (9/13)

PSC Proticipa Sgrvisco (101) 4434740

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This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of Information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paparwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." •

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510(k) Summary

K133147

Submission Date:	18 June 2014
Submitter:	Bracco Injeneering S.A. (formerly Swiss Medical Care)Avenue de Sévelin 461004 LausanneSwitzerland
Submitter Contact:	Mr. Marc GinginsPhone: +011 41 21 621 74 00FAX: +011 41 21 621 74 51Email: marc.gingins@bracco.com
Trade Name:	Bracco Injeneering Transfer Set
Common Name:	Intravascular Administration Set
Classification Name:	Intravascular Administration Set
ClassificationRegulation:	21 CFR §880.5440
Product Code:	FPK
SubstantiallyEquivalent Devices:	BINJ Model	Predicate 510(k)Number	Predicate Manufacturerand Model
	BINJ Transfer Set	K041178	E-Z-EM, Inc. (now ACISTMedical Systems, Inc.)Empower Transfer Set
Device Description:	The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set forconnection between an imaging bulk package and empty sterilesyringes on single-use-only, syringe based contrast delivery systems(injectors). The BINJ Transfer Set is approximately 20 inches long, andits components are made with medical grade materials.The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to aSterility Assurance Level (SAL) of 10-6, and is individually packaged.At the time of this submission, accelerated aging tests confirm a one (1)year shelf life. The BINJ Transfer Set is disposable, and is to bediscarded after the contrast media container has been depleted, or 10hours has elapsed since the container was spiked.

Page 1 of 4

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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).

Indications for Use 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.

Technology Comparison: The BINJ Transfer Set employs the same technological characteristics as the predicate device.

CharacteristicComparisons:	E-Z-EM, Inc.(ACIST Medical Systems, Inc.)Empower Transfer Set(K041178)	Bracco Injeneering S.A.BINJ Transfer Set
Intended Use	The transfer set is intended for thetransfer of fluids from bulk containers toempty sterile syringes on syringe basedcontrast delivery systems (injectors).	Same.
Indications for Use	The Empower Transfer Set is intended todeliver fluid (contrast media or saline)from a container into a CT powerInjector syringe.	The Bracco Injeneering Transfer Set is acomponent of a contrast managementsystem and is indicated for the transfer ofIsovue (Iopamidol Injection) contrastmedia as supplied in an Imaging BulkPackage to empty sterile syringes onsingle-use only syringe-based contrastinjection systems indicated for thecontrolled, automatic administration onthe venous side, of contrast agents for CTprocedures. The Transfer Set is to bediscarded after the contrast mediacontainer has been depleted or 10 hourshas elapsed since the container waspenetrated, whichever occurs first.
Tubing Length, Nominal	6 "	20 "
Sterility Method	Ethylene Oxide (EtO)	Same
Sterility Assurance Level	$10^6$	Same
Disposable or Reusable	Disposable	Disposable after the contrast mediacontainer has been depleted, or 10 hourshas elapsed since the container wasspiked.

Page 2 of 4

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Packaging	Individually packaged in a Tyvek pouch	Individually packaged in a 6" x 10" whiteTyvek and clear polyethylene pouch.
Shelf-Life	One (1) year	Same
Performance Testing:
Sterilization	The BINJ Transfer Set is ethylene oxide (EtO) sterilized and wasvalidated to a sterility assurance level of $10^6$ in accordance with thefollowing standard prior to commercial distribution:
	ISO 11135-1: 2007, Sterilization of health care products - Ethyleneoxide - Part 1: Requirements for development, validation androutine control of a sterilization process for medical devices.Verification results indicate that the BINJ Transfer Set complies withthe standard.
Shelf-Life	The BINJ Transfer Set is sterilized and its packaging was validated inaccordance with the following standards:
	ISO 11607-1: 2006 Packaging for terminally sterilized medicaldevices - Part 1: requirements for materials, sterile barrier systemsand packaging systems; and
	ISO 11607-2: 2006 Packaging for terminally sterilized medicaldevices - Part 2: Validation requirements for forming, sealing andassembly processes.
	Verification results indicate that the BINJ Transfer Set complies withthe standards.
Biocompatibility	BINJ Transfer Set indirect patient contact materials were verified inaccordance with the following standard:
	ISO 10993-1: 2009, Biological evaluation of medical devices - Part1: Evaluation and testing within a risk management process.
	Verification results indicated that the materials comply with the

standard.

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Performance Testing - Bench

The BINJ Transfer Set was tested for performance in accordance with its predetermined specifications as specificd in Section 11, Device Description - Performance Specifications, of this submission, and verified in accordance with the following standards:

IEC 62366: 2007, Medical devices Application of usability . engineering to medical devices
ISO 594-2: 1998. Conical fittings with a 6 % (Luer) taper for . syringes, needles and certain other medical equipment – Part 2: Lock fittings
. ISO 8536-4: 2010, Infusion equipment for medical use - Part 4: Infusion sets for single use, gravity feed.

Specific, predetermined specifications testing of note included:

Microbial ingress testing; and �
Chemical compatibility, leachable compounds and particulates . testing.

Test and verification results indicate that the BINJ Transfer Set complies with its predetermined specifications and the standards.

Conclusion Verification and validation activities were conducted to establish the performance and safety characteristics of the BINJ Transfer Set. The results of these activities demonstrate that the BINJ Transfer Set is safe and effective when used in accordance with its intended use and labeling.

Therefore, the BINJ Transfer Set is considered 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.