IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING

K041490 · B.Braun Medical, Inc. · FPA · Oct 29, 2004 · General Hospital

Device Facts

• Record ID: K041490
• Device Name: IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Oct 29, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

Device Story

IV Administration Sets with Ultrablock UV-Resistant Tubing are single-use, sterile, non-pyrogenic devices designed to deliver light-sensitive IV fluids from a container to a patient's vascular system. The device consists of UV-resistant tubing and may incorporate components such as a universal chamber assembly, injection site, male luer lock, slide clamp, 0.2-micron air-eliminating filter, flow clip assembly, and pump cassette. Used in clinical settings, the device is operated by healthcare professionals to facilitate controlled fluid administration via gravity or infusion pump. The primary benefit is the protection of light-sensitive medications from degradation during delivery, ensuring therapeutic efficacy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Single-use, sterile, non-pyrogenic IV administration set. Features UV-resistant tubing to protect light-sensitive solutions. Components include universal chamber, injection site, male luer lock, slide clamp, 0.2-micron air-eliminating filter, and pump cassette. Mechanical fluid delivery system; no electronic or software components.

Indications for Use

Indicated for the pump or gravity administration of IV fluids involving light sensitive solutions in patients requiring intravenous therapy.

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

• Codan US Corporation Light-Safe Extension Set (K021480)
• Abbott LifeShield® Primary Microbore Device Set

Submission Summary (Full Text)

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K04/490

:

OCT 2 9 2004

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| 510(k) Summary | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone], ext. 2376<br>Contact: Scott Pease, Manager, Regulatory Affairs |
| DEVICE NAME: | IV Administration Sets with Ultrablock UV-Resistant<br>Tubing |
| COMMON OR USUAL<br>NAME: | Set, Administration Intravascular |
| DEVICE<br>CLASSIFICATION: | Class II, 21 CFR §880.5440,<br>Product Code: FPA |
| PREDICATE DEVICE: | K021480 Codan US Corporation Light-Safe Extension Set<br>(BC565) and<br>Abbott LifeShield® Primary Microbore Device Set |
| DESCRIPTION: | The IV Administration Sets with Ultrablock UV-Resistant<br>Tubing are a single-use, sterile, non-pyrogenic tubing set<br>intended for the administration of light sensitive solutions<br>from a container to a patient's vascular system. The device<br>is composed of UV-Resistant IV tubing and may include<br>one or more of the following: universal chamber assembly,<br>injection site, male luer lock, slide clamp, 0.2 micron air<br>eliminating filter, flow clip assembly, and pump cassette. |
| INTENDED USE: | The IV Administration Sets with Ultrablock UV-Resistant<br>Tubing are intended for the pump or gravity administration<br>of IV fluids involving light sensitive solutions. |
| SUBSTANTIAL<br>EQUIVALENCE: | The B. Braun Medical Inc. IV Administration Sets with<br>Ultrablock UV-Resistant Tubing are similar in indications<br>for use to the Codan US Corporation Light-Safe Extension<br>Set marketed by Codan under their 510(k) Premarket<br>Notification K021480 and the Abbott LifeShield Microbore<br>Device Sets marketed by Abbott Healthcare. |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 9 2004

Mr. Scott Pease Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K041490

Trade/Device Name: IV Administration Set with Ultrablock UV-Resistant Tubing Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: September 9, 2004 Received: September 10, 2004

Dear Mr. Pease:

.

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 - Mr. Pease

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 vour 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/dsma/dsmamain.html

Sincerely yours,

C. Shin Lin, Ph.D.

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

Enclosure

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## 2.0 Indications for Use Statement

Page

510(k) Number (if known): K041490

IV Administration Sets with Ultrablock UV-Resistant Tubing Device Name:

Indications For Use:

The IV Administration Sets with Ultrablock UV-Resistant Tubing are intended for the pump or gravity administration of IV fluids involving light sensitive solutions.

Arton V, m

(Division Sign-Off) (Division Sign-on)
Division of Anesthesiology, General Hospital, Division of Anton Dental Devices

510(k) Number: k941490

Prescription Use
(Per 21 CFR 801.109)

OR

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)