A6 LUER ACCESS DEVICE

K083723 · B.Braun Medical, Inc. · FPA · Jun 5, 2009 · General Hospital

Device Facts

• Record ID: K083723
• Device Name: A6 LUER ACCESS DEVICE
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.

Device Story

A6 Luer Access Device is a 3-piece needle-free valve; features elastomeric piston with pre-slit septum housed in clear, rigid body. Device provides access to IV gravity sets, pump sets, and extension sets. Operation requires manual swabbing for disinfection before inserting male Luer connector. Positive displacement mechanism facilitates fluid administration or aspiration. Supports power injection up to 300 psi and 10 mL/sec. Used in clinical settings by healthcare providers to manage IV access; benefits patient by providing needle-free, sterile, single-use interface for fluid delivery.

Clinical Evidence

Bench testing only. Testing included biocompatibility, package integrity, shipping, microbial ingress challenge, and performance verification for power injector compatibility.

Technological Characteristics

3-piece assembly; elastomeric piston with pre-slit septum; clear, rigid body. Positive displacement valve mechanism. Sterile, single-use, disposable. Compatible with power injectors (max 300 psi, 10 mL/sec).

Indications for Use

Indicated for patients requiring IV therapy, including aspiration, injection, or gravity/pump flow of IV fluids and blood via needle-free access. Compatible with power injectors up to 300 psi and 10 mL/sec.

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 (K031923)
• V2 Injection Site (K955585)

Submission Summary (Full Text)

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K083723

# JUN - 5 2009

Page

## 510(k) SUMMARY

#### APPLICANT/ SUBMITTER:

CONTACT:

B. Braun Medical Inc. 901 Marcon Boulevard Allentown, PA 18109-9341 610-266-0500

Bonnie J. Kincaid, RAC Manager, Regulatory Affairs Phone: [phone] Fax: [phone]

A6 Luer Access Device

DEVICE NAME:

COMMON OR USUAL NAME:

Needle-free Access Device / Injection Site

DEVICE CLASSIFICATION:

PREDICATE DEVICES:

#### DESCRIPTION:

Class II per 21 CFR 8880.5440, Intravascular Administration Set, Product Code: FPA

B. Braun Medical Inc. Ultrasite® Valve [for use with power injectors (K031923), previously known as B. Braun Medical Inc. V2 Injection Site (K955585)]

B. Braun's A6 Luer Access Device is a positive displacement valve intended to provide needle-free access to IV gravity sets, pump sets and extension sets for the administration of IV fluids and blood. The piston/valve assembly of the A6 is a 3-piece assembly containing an elastomeric piston with a pre-slit septum, which is housed within a clear, rigid body. The A6 requires swabbing to disinfect prior to insertion of a male Luer connector.

The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec. The A6 is individually packaged and is supplied as a sterile, non-pyrogenie, single use, disposable device.

Page 58 of 63

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# 510(k) SUMMARY (continued)

## INTENDED USE:

### The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.

Page

## SUBSTANTIAL EQUIVALENCE:

The A6 Luer Access Device has the same intended use and function as the predicate device and is similar to the predicate device in design and materials. Both the proposed and predicate devices are needle-free access devices intended for use in IV therapy. The proposed A6 device and the predicate device are sterile, single use adapters that are used as injection sites when accessed by attaching a male Luer connector to the device. Both the proposed and predicate devices provide needle-free injection sites by means of a positive displacement piston/valve mechanism. Both the proposed and predicate devices may be used with power injectors.

The A6 device was subjected to a variety of tests to demonstrate substantial equivalence with the predicate device, including biocompatibility, package integrity, shipping, microbial ingress challenge and a number of performance tests to verify the safe and effective use of the device. This testing demonstrates that there are no differences between the predicate and the proposed device that raise new issues of safety or effectiveness

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

#### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JUN - 5 2009

Ms. Bonnie J. Kincaid, RAC Manager, Regulatory Affairs B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341

Re: K083723

Trade/Device Name: A6 Luer Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 28, 2009 Received: June 2, 2009

Dear Ms. Kincaid:

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 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. Kincaid

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); 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 go to http://www.fda.gov/cdrh/comp/ for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/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 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.

Antimony V. anakafer

Susan Runner, D.D.S., MA Acting Division 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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K083723

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# INDICATIONS FOR USE STATEMENT

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Indications for Use:

The A6 Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The A6 Luer Access Device may be used with power injectors at a maximum pressure of 300 psi and a maximum flow rate of 10 mL/sec.

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)

Legal Music for Leor. Colburn 06/05/09

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

510(k) Number: K08:3723 :