BRACCO INJEENERING TRANSFER SET

K133147 · Bracco Injeneering S.A. · PQH · Jun 20, 2014 · General Hospital

Device Facts

• Record ID: K133147
• Device Name: BRACCO INJEENERING TRANSFER SET
• Applicant: Bracco Injeneering S.A.
• Product Code: PQH · General Hospital
• Decision Date: Jun 20, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

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).

Device Story

The Bracco Injeneering (BINJ) Transfer Set is a sterile, disposable tubing set (approx. 20 inches long) used to connect an imaging bulk contrast media package to empty sterile syringes on syringe-based contrast delivery systems (injectors). It facilitates the transfer of contrast media for CT procedures. The device is used in clinical settings by healthcare professionals. It is a passive fluid transfer component; it does not contain electronics or software. The device ensures sterile fluid transfer, reducing the risk of contamination during the filling of injector syringes. It is discarded after the contrast container is depleted or 10 hours after initial penetration.

Clinical Evidence

Bench testing only. No clinical data. Testing included microbial ingress, chemical compatibility, leachable compounds, and particulate testing. Sterilization validated to SAL 10^-6 per ISO 11135-1:2007. Packaging validated per ISO 11607-1:2006 and ISO 11607-2:2006. Biocompatibility verified per ISO 10993-1:2009. Mechanical performance verified per ISO 594-2:1998 and ISO 8536-4:2010.

Technological Characteristics

Sterile, disposable tubing set, approx. 20 inches long. Materials are medical grade. Sterilization via Ethylene Oxide (EtO) to SAL 10^-6. Complies with ISO 594-2 (Luer lock fittings), ISO 8536-4 (infusion sets), and ISO 10993-1 (biocompatibility). No energy source, electronics, or software.

Indications for Use

Indicated for the transfer of Isovue (Iopamidol Injection) contrast media from Imaging Bulk Packages to empty sterile syringes on single-use, syringe-based contrast injection systems for venous CT procedures. Discard after container depletion or 10 hours post-penetration.

Regulatory Classification

Identification

An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.

Special Controls

*Classification.* Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.

Predicate Devices

• Empower Transfer Set (K041178)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
| <div> <span> <b> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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 [e-mail]

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# 510(k) Summary

### K133147

.

| Submission Date: | 18 June 2014 | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------|
| Submitter: | Bracco Injeneering S.A. (formerly Swiss Medical Care)<br>Avenue de Sévelin 46<br>1004 Lausanne<br>Switzerland | | |
| Submitter Contact: | Mr. Marc Gingins<br>Phone: [phone]<br>FAX: [phone]<br>Email: [e-mail] | | |
| Trade Name: | Bracco Injeneering Transfer Set | | |
| Common Name: | Intravascular Administration Set | | |
| Classification Name: | Intravascular Administration Set | | |
| Classification<br>Regulation: | 21 CFR §880.5440 | | |
| Product Code: | FPK | | |
| Substantially<br>Equivalent Devices: | BINJ Model | Predicate 510(k)<br>Number | Predicate Manufacturer<br>and Model |
| | BINJ Transfer Set | K041178 | E-Z-EM, Inc. (now ACIST<br>Medical Systems, Inc.)<br>Empower Transfer Set |
| Device Description: | The Bracco Injeneering (BINJ) Transfer Set is a sterile tubing set for<br>connection between an imaging bulk package and empty sterile<br>syringes on single-use-only, syringe based contrast delivery systems<br>(injectors). The BINJ Transfer Set is approximately 20 inches long, and<br>its components are made with medical grade materials.<br>The BINJ Transfer Set is supplied ethylene oxide (EtO) sterilized to a<br>Sterility Assurance Level (SAL) of 10-6, and is individually packaged.<br>At the time of this submission, accelerated aging tests confirm a one (1)<br>year shelf life. The BINJ Transfer Set is disposable, and is to be<br>discarded after the contrast media container has been depleted, or 10<br>hours has elapsed since the container was spiked. | | |
| | | | |

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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.

| Characteristic<br>Comparisons: | E-Z-EM, Inc.<br>(ACIST Medical Systems, Inc.)<br>Empower Transfer Set<br>(K041178) | Bracco Injeneering S.A.<br>BINJ Transfer Set |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The transfer set is intended for the<br>transfer of fluids from bulk containers to<br>empty sterile syringes on syringe based<br>contrast delivery systems (injectors). | Same. |
| Indications for Use | The Empower Transfer Set is intended to<br>deliver fluid (contrast media or saline)<br>from a container into a CT power<br>Injector syringe. | The Bracco Injeneering Transfer Set is a<br>component of a contrast management<br>system and is indicated for the transfer of<br>Isovue (Iopamidol Injection) contrast<br>media as supplied in an Imaging Bulk<br>Package to empty sterile syringes on<br>single-use only syringe-based contrast<br>injection systems indicated for the<br>controlled, automatic administration on<br>the venous side, of contrast agents for CT<br>procedures. The Transfer Set is to be<br>discarded after the contrast media<br>container has been depleted or 10 hours<br>has elapsed since the container was<br>penetrated, 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 media<br>container has been depleted, or 10 hours<br>has elapsed since the container was<br>spiked. |

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| Packaging | Individually packaged in a Tyvek pouch | Individually packaged in a 6" x 10" white<br>Tyvek and clear polyethylene pouch. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Shelf-Life | One (1) year | Same |
| Performance Testing: | | |
| Sterilization | The BINJ Transfer Set is ethylene oxide (EtO) sterilized and was<br>validated to a sterility assurance level of $10^6$ in accordance with the<br>following standard prior to commercial distribution: | |
| | ISO 11135-1: 2007, Sterilization of health care products - Ethylene<br>oxide - Part 1: Requirements for development, validation and<br>routine control of a sterilization process for medical devices.<br>Verification results indicate that the BINJ Transfer Set complies with<br>the standard. | |
| Shelf-Life | The BINJ Transfer Set is sterilized and its packaging was validated in<br>accordance with the following standards: | |
| | ISO 11607-1: 2006 Packaging for terminally sterilized medical<br>devices - Part 1: requirements for materials, sterile barrier systems<br>and packaging systems; and | |
| | ISO 11607-2: 2006 Packaging for terminally sterilized medical<br>devices - Part 2: Validation requirements for forming, sealing and<br>assembly processes. | |
| | Verification results indicate that the BINJ Transfer Set complies with<br>the standards. | |
| Biocompatibility | BINJ Transfer Set indirect patient contact materials were verified in<br>accordance with the following standard: | |
| | ISO 10993-1: 2009, Biological evaluation of medical devices - Part<br>1: 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.