ULTRASITE VALVE

K031923 · B.Braun Medical, Inc. · FPA · Aug 11, 2003 · General Hospital

Device Facts

• Record ID: K031923
• Device Name: ULTRASITE VALVE
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Aug 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.

Device Story

Needle-free, capless positive displacement valve; provides access to IV pump sets, gravity sets, and extension sets. Operates via insertion of standard male luer connector; requires no special accessories. Used in clinical settings for fluid administration/aspiration. Supports power injection up to 300 psi when luer-locked to compatible equipment. Prevents needlestick injuries by replacing needles.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Needle-free, capless positive displacement valve. Mechanical luer-activated design. Compatible with standard male luer connectors. Rated for power injection up to 300 psi.

Indications for Use

Indicated for aspiration, injection, or gravity/pump flow of fluids via male luer fitting connection. Compatible with power injectors up to 300 psi when secured with luer lock. Designed to prevent needlestick injury.

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

• Ultrasite Valve (previously known as V2 Injection Site) (K955585)

Submission Summary (Full Text)

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\$\mathcal{K}_{0}31923\$

AUG 1 1 2003

| 510(k) Summary | |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone]<br>Contact: Sheri L. Musgnung, Manager, Regulatory Affairs |
| DEVICE NAME: | Ultrasite® Valve |
| COMMON OR USUAL<br>NAME: | Needle free Injection Site |
| DEVICE<br>CLASSIFICATION: | Class II per Code of Federal Regulations,<br>Title 21, § 880.5440, Intravascular Administration<br>Sets, product code FPA |
| PREDICATE DEVICE: | B. Braun Medical Inc.'s Ultrasite Valve (previously<br>known as V2 Injection Site (K955585) |
| DESCRIPTION: | B. Braun Medical's Ultrasite® Valve is intended<br>for aspiration, injection or gravity/pump flow of<br>fluids upon insertion of a male luer fitting. |
| | The Ultrasite Valve may also be used with power<br>injectors for which the maximum pressure setting is<br>300 psi. When used with a power injector, the<br>Ultrasite Valve must be secured to other devices<br>with a luer lock connection; other devices must also<br>be rated for 300 psi. The Ultrasite Valve is<br>designed to aid in the prevention of needlestick<br>injury. For more information of the principles of<br>operation, please refer to Attachment I - Proposed<br>Device Labeling and Instructions for Use. |
| B. Braun Medical Inc.<br>510(k) Premarket Notification | The Ultrasite Valve is designed to provide needle-<br>free access on I.V. pump sets, gravity sets, and<br>extension sets. The Ultrasite Valve is a needle-free, |

510(k) Premarket Notification
Ultrasite® Valve SIO(k)

:

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capless positive displacement valve to be used in place of needles for the administration of fluids. The Ultrasite Valve may be accessed with standard male luer connectors and requires no special accessory devices.

#### INTENDED USE:

The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.

### The subject Ultrasite Valve is similar in materials and design to B. Braun Medical's premarket notification, Ultrasite Valve (previously known as V2 Injection site), K955585. Functional testing was performed to support that there are no new issues of safety or effectiveness raised by the expanded indications for use for power injectors.

SUBSTANTIAL EQUIVALENCE:

19. Braun Mudical Inc. 510(2) Premarket Notification Ultrailas Valve 51000

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 1 2003

Ms. Sheri L. Musgnung Regulatory Affairs Manager B. Braun Medical Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109

Re: K031923

Trade/Device Name: Ultrasite® Valve Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 20, 2003 Received: June 23, 2003

Dear Ms. Musgnung:

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. Musgnung

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/dsma/dsmamain.html

Sincerely yours

Patricia Cucenitffa

Susan Runner, DDS, MA Interim 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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031923

# Indications for Use Statement __ of ________________________________________________________________________________________________________________________________________________________________________ Page Page Ca 510(k) Number (if known):

Device Name: Ultrasite® Valve

Indications For Use:

The Ultrasite® Valve is intended for aspiration, injection or gravity/pump flow of fluids upon insertion of a male luer fitting. The Ultrasite Valve may also be used with power injectors for which the maximum pressure setting is 300 psi. When used with a power injector, the Ultrasite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for 300 psi. The Ultrasite Valve is designed to aid in the prevention of needlestick injury.

Palaux Cucenite

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K031923

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

B. Braun Modical Inc. 510(k) Premarket Notification Ultrasited Valva 510(k)

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