CONTRAST MEDIA TRANSFER SETS by B. BRAUN MEDICAL, INC.

The Contrast Media Transfer Sets are intended to be used for the transfer of contrast media from a primary source container to a secondary unit. These sets are intended to allow for multiple unit doses from the same Contrast Media primary container.

Device Description

The Contrast Media Transfer Sets are intended to be used for the transfer of contrast media from a primary supply container to a secondary unit. These sets will allow for multiple unit doses from the same contrast media primary container. The three sets include the CT Transfer Set, the Cath Lab Transfer Set and the Cath Lab Extension Set.

The CT Transfer Set consists of a vented dual-flow spike at the primary source connection end and tubing that runs from the spike to an Ultrasite® luer lock needle-free access valve.

The Cath Lab Transfer Set consists of a vented dual-flow spike at the primary source connection end, a burette chamber which is designed with a stopcock and air inlet filter that allows for priming of the burette, and a second tubing segment that leads from the burette chamber to an Ultrasite® valve. The burette is designed with an auto-shutoff disk which inhibits air from entering the set when the primary contrast media container is depleted.

A Cath Lab Extension Set, which is available as a single patient use extension device, is attached to the Cath Lab Transfer Set at the Ultrasite The Cath Lab Extension Set is equipped with two backcheck valve. In a clinical setting, following connection to the Cath Lab valves. Transfer Set, the extension set is connected to a manifold which allows for the dispensing of multiple doses of contrast media to the patient during the cath lab procedure. Attachment of a new Cath Lab Extension Set to the Cath Lab Transfer Set for each patient allows for dispensing from the same bottle of contrast media to multiple patients.

AI/ML Overview

Here's a breakdown of the requested information based on the provided text. It's important to note that this document is a 510(k) summary, which often provides high-level information. Therefore, detailed specifics about the study design, acceptance criteria, and performance results might be limited.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for K052252 does not explicitly list specific acceptance criteria in a table format with corresponding performance results for the Contrast Media Transfer Sets. The submission focuses on demonstrating "substantial equivalence" to predicate devices. The "Performance Test Data" is listed as an attachment (Attachment V), but the details are not included in the summary itself.

However, based on the description and the nature of the device, implied performance aspects would include:

Acceptance Criteria (Implied)	Reported Device Performance (Implied from substantial equivalence)
Maintenance of sterile barrier	Similar to predicate devices, K955179, K903493, K961794.
Prevention of air entrainment	Burette with auto-shutoff disk designed to inhibit air entry.
Compatibility with contrast media	Materials are biocompatible (Attachment III).
Functionality of luer locks, spikes, valves	Operates as intended, similar to predicate devices.
Ability to deliver multiple unit doses from primary container	Explicitly stated as intended use and design feature.

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance testing. It only mentions "Performance Test Data" as an attachment without detailing the studies themselves.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not available in the provided 510(k) summary. For devices like the Contrast Media Transfer Sets, the "ground truth" often relates to objective physical and chemical testing (e.g., sterility, flow rates, material integrity) rather than expert interpretation of diagnostic images. Therefore, the concept of "experts establishing ground truth" in the diagnostic imaging sense might not apply directly here.

4. Adjudication Method (for the test set)

The 510(k) summary does not mention any adjudication method. This is generally relevant for studies involving human interpretation or subjective assessments, which are not explicitly detailed in this summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this 510(k) summary. MRMC studies are typically performed for diagnostic imaging devices to assess the impact of AI on human reader performance. This device is a medical accessory for fluid transfer, not an imaging diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study for an algorithm was not conducted in this context. The device is a physical medical accessory, not an AI algorithm. Therefore, "algorithm only performance" is not applicable.

7. Type of Ground Truth Used

Based on the device type and typical testing for such accessories, the ground truth would likely be established through:

Objective physical testing: Measurable parameters like flow rates, leak integrity, connection strength, and air elimination.
Chemical testing: Compatibility with contrast media, extractables.
Sterility testing: Confirmation of the sterile barrier.
Biocompatibility testing: As listed in Attachment III.

This information is derived from the common requirements for fluid transfer sets and is implied, as the specific methodologies are not detailed in the summary.

8. Sample Size for the Training Set

This information is not applicable as the Contrast Media Transfer Sets are physical medical devices, not AI-powered systems that require a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device does not involve a training set.

Summary

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K052252

page 1 of 2

7.0	510(k) Summary	NOV 16 2005
	SUBMITTER:	B. Braun Medical Inc.901 Marcon BoulevardAllentown, PA 18109-9341(610) 266-0500, ext. 2367
		Contact: Christine Ford, Sr. Regulatory Affairs Analyst
	DEVICE NAME:	Contrast Media Transfer SetsCT Transfer Set, Cath Lab Transfer Set, Cath LabExtension Set
	COMMON OR USUALNAME:	Fluid Transfer Set
	DEVICECLASSIFICATION:	Class II per Code of Federal Regulation, Title 21,§892.1600, Angiographic X Ray System, product codeIZI and §880.5440, Intravascular administration set,product code LHI.
	PREDICATE DEVICE:	B. Braun Medical, Inc.Contrast Media Set, K955179
		North American Instrument CorporationNAMIC Contrast Savings Delivery System,K903493
		Merit Medical Systems, Inc.Contrast Management Systems, K961794
DESCRIPTION:		The Contrast Media Transfer Sets are intended to be used for the transferof contrast media from a primary supply container to a secondary unit.These sets will allow for multiple unit doses from the same contrastmedia primary container. The three sets include the CT Transfer Set, theCath Lab Transfer Set and the Cath Lab Extension Set.
		The CT Transfer Set consists of a vented dual-flow spike at the primarysource connection end and tubing that runs from the spike to anUltrasite® luer lock needle-free access valve.

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K052252 page 2 of 2

The Contrast Media Transfer Sets are intended to be used for the transfer INTENDED USE: of contrast media from a primary supply container to a secondary unit. These sets will allow for multiple unit doses from the same contrast media primary container.

SUBSTANTIAL

The Contrast Media Transfer Sets have the same intended use, operation EQUIVALENCE: and function as stated for the Contrast Media Set distributed by B. Braun Medical, Inc., K955179, Contrast Savings Delivery System distributed by NAMIC, K903493, and Contrast Management System distributed by Merit Medical Systems, Inc., K961794. There are no differences that raise new issues of safety and effectiveness.

8.0 Attachments

Attachment I:	Proposed Device Labeling
Attachment II:	Device Drawings
Attachment III:	Material Biocompatibility
Attachment IV:	Predicate Device Labeling and Information
Attachment V:	Performance Test Data
Attachment VI:	Risk Analysis
Attachment VII:	Samples

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Image /page/2/Picture/1 description: The image is a black and white circular logo. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the circumference of the circle, with the bird figure positioned in the center.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 6 2005

Ms. Christine Ford Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K052252

Trade/Device Name: Contrast Media Transfer Sets Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: August 16, 2005 Received: August 18, 2005

Dear Ms. Ford:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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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Page 2 - Ms. Ford

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Snyite y. Michael Davis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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K052252

2.0 Indications for Use Statement

Page __________ of ___________________________________________________________________________________________________________________________________________________________

052732 510(k) Number (if known):

Device Name:

Contrast Media Transfer Sets

Indications For Use:

Prescription Use _ X (Per 21 CFR 801.109)

. : :

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cen

i /sion Sign-Off) rision of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number:_

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.