CONTRAST MEDIA TRANSFER SETS

K052252 · B.Braun Medical, Inc. · FPA · Nov 16, 2005 · General Hospital

Device Facts

• Record ID: K052252
• Device Name: CONTRAST MEDIA TRANSFER SETS
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Nov 16, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

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.

Device Story

Contrast Media Transfer Sets facilitate transfer of contrast media from primary supply containers to secondary units for multiple-dose dispensing. CT Transfer Set includes vented dual-flow spike and tubing with Ultrasite® luer lock needle-free access valve. Cath Lab Transfer Set includes vented dual-flow spike, burette chamber with stopcock, air inlet filter, auto-shutoff disk to prevent air entry, and tubing to Ultrasite® valve. Cath Lab Extension Set, used for single patient procedures, attaches to Cath Lab Transfer Set via backcheck valves; connects to manifold for dispensing multiple doses to patients. Used in clinical settings (e.g., cath lab) by healthcare professionals. Enables multi-patient use from a single contrast media bottle, improving efficiency in contrast media administration.

Clinical Evidence

Bench testing only. Performance test data and material biocompatibility testing were provided to support substantial equivalence.

Technological Characteristics

Fluid transfer sets featuring vented dual-flow spikes, burette chambers with air inlet filters, auto-shutoff disks, and Ultrasite® luer lock needle-free access valves. Includes backcheck valves on extension sets. Materials evaluated for biocompatibility. Non-powered, mechanical fluid path components.

Indications for Use

Indicated for the transfer of contrast media from a primary supply container to a secondary unit to allow for multiple unit doses from the same primary container in a clinical setting.

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

• Contrast Media Set (K955179)
• NAMIC Contrast Savings Delivery System (K903493)
• Merit Medical Systems, Inc. Contrast Management Systems (K961794)

Submission Summary (Full Text)

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K052252

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page 1 of 2

| 7.0 | 510(k) Summary | NOV 16 2005 |
|--------------|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2367 |
| | | Contact: Christine Ford, Sr. Regulatory Affairs Analyst |
| | DEVICE NAME: | Contrast Media Transfer Sets<br>CT Transfer Set, Cath Lab Transfer Set, Cath Lab<br>Extension Set |
| | COMMON OR USUAL<br>NAME: | Fluid Transfer Set |
| | DEVICE<br>CLASSIFICATION: | Class II per Code of Federal Regulation, Title 21,<br>§892.1600, Angiographic X Ray System, product code<br>IZI and §880.5440, Intravascular administration set,<br>product code LHI. |
| | PREDICATE DEVICE: | B. Braun Medical, Inc.<br>Contrast Media Set, K955179 |
| | | North American Instrument Corporation<br>NAMIC Contrast Savings Delivery System,<br>K903493 |
| | | Merit Medical Systems, Inc.<br>Contrast Management Systems, K961794 |
| DESCRIPTION: | | The Contrast Media Transfer Sets are intended to be used for the transfer<br>of contrast media from a primary supply container to a secondary unit.<br>These sets will allow for multiple unit doses from the same contrast<br>media primary container. The three sets include the CT Transfer Set, the<br>Cath Lab Transfer Set and the Cath Lab Extension Set. |
| | | The CT Transfer Set consists of a vented dual-flow spike at the primary<br>source connection end and tubing that runs from the spike to an<br>Ultrasite® luer lock needle-free access valve. |

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K052252 page 2 of 2

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.

- 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 [phone]. 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 [phone] or [phone] 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:

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.

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)

OR

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:_