CARESITE LUER ACCESS DEVICE

K140311 · B.Braun Medical, Inc. · FPA · May 7, 2014 · General Hospital

Device Facts

• Record ID: K140311
• Device Name: CARESITE LUER ACCESS DEVICE
• Applicant: B.Braun Medical, Inc.
• Product Code: FPA · General Hospital
• Decision Date: May 7, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Caresite 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 Caresite Luer Access Device may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

Device Story

Caresite Luer Access Device (LAD) is a 3-piece positive displacement needleless connector; provides needle-free access to IV gravity sets, extension sets, and catheters. Input: male luer connector insertion. Operation: elastomeric piston with slit septum housed in clear rigid body; allows fluid/blood aspiration, injection, or flow. Used in clinical settings; operated by healthcare professionals. Compatible with power injectors (max 400 psi, 15 mL/sec). Requires swabbing for disinfection. Benefits: enables safe, needle-free vascular access for fluid administration.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1. Performance testing conducted to demonstrate safety and effectiveness for intended use, including power injector compatibility.

Technological Characteristics

3-piece assembly; elastomeric piston with slit septum; clear rigid body; luer nut. Sterile, non-pyrogenic, single-use disposable. Compatible with power injectors (400 psi, 15 mL/sec). Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for aspiration, injection, or gravity/pump flow of IV fluids and blood via male luer connector insertion. Compatible with power injectors up to 400 psi and 15 mL/sec. Prescription use only.

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

• A6 Luer Access Device (K083723)

Submission Summary (Full Text)

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#### 5. 510(k) SUMMARY

DATE:

February 7, 2014

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>610-266-0500 |
|------------|-------------------------------------------------------------------------------------------|
|------------|-------------------------------------------------------------------------------------------|

| Contact: | Kimberly Smith, Regulatory Affairs Specialist<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |
|----------|-------------------------------------------------------------------------------------------------------------------------------|
|----------|-------------------------------------------------------------------------------------------------------------------------------|

| DEVICE NAME: | Caresite Luer Access Device |
|--------------|----------------------------------------------------------------------------------|
| COMMON NAME: | Needle-free Injection Site; Needle-free Luer Access Device; Needleless Connector |

| DEVICE<br>CLASSIFICATION: | 21 CFR §880.5440, Class II<br>Intravascular Administration Set<br>Classification Product Code: FPA |
|---------------------------|----------------------------------------------------------------------------------------------------|
|---------------------------|----------------------------------------------------------------------------------------------------|

| PREDICATE DEVICE: | 510(k) Number: K083723<br>Device Name: A6 Luer Access Device<br>Classification Product Code: FPA |
|-------------------|--------------------------------------------------------------------------------------------------|
|-------------------|--------------------------------------------------------------------------------------------------|

# Applicant: B. Braun Medical Inc.

# DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

The Caresite Luer Access Device (LAD) is a positive displacement needleless connector intended to provide needle-free access to IV gravity sets, extension sets and catheters for the administration of IV fluids and blood. The Caresite Luer Access Device (LAD) is a 3-piece assembly containing an elastomeric piston with a slit septum, which is housed within a clear, rigid body. The Caresite Luer Access Device (LAD) requires swabbing to disinfect prior to insertion of a male luer connector. The Caresite Luer Access Device (LAD) does not require a specific clamping sequence or technique in order to be used safely.

Regulation Number: \$880.5440. Class II

The Caresite Luer Access Device (LAD) may be used with power injectors with a maximum pressure rating of 400 psi and a maximum flow rate of 15mL/sec. The Caresite Luer Access Device (LAD) is individually packaged and is supplied as a sterile, non-pyrogenic, single use, disposable device.

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B. Braun Medical Inc. 510(k) Premarket Notification Caresite Luer Access Device

## INDICATIONS FOR USE

The Caresite Luer Access Device (LAD) is a needleless connector intended for the aspiration, injection or gravity/pump flow of IV fluids and blood upon insertion of a male luer connector. The Caresite Luer Access Device (LAD) may be used with power injectors at a maximum pressure of 400 psi and a maximum flow rate of 15 mL/sec.

# SUBSTANTIAL EQUIVALENCE

The B. Braun Medical Inc. Caresite Luer Access Device (LAD) is substantially equivalent to the predicate device having similar indications for use, technological properties and performance.

### Technical Characteristics

The Caresite Luer Access Device (LAD) has similar physical and technical characteristics to the predicate device. Both the Caresite Luer Access Device (LAD) and the predicate device are comprised of a body, piston and luer nut. Both devices are comprised of similar materials and components.

### Performance Data

Biocompatibility and performance testing was performed on the Caresite Luer Access Device (LAD) to support substantial equivalence to the predicate device. Biocompatibility testing was performed in accordance with ISO 10993-1. Performance testing was performed to demonstrate safety and effectiveness.

## CONCLUSION

Based on the results of biocompatibility and performance testing, the proposed B. Braun Medical Caresite Luer Access Device (LAD) is considered substantially equivalent to the predicate device and is safe and effective for its intended use.

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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 & Human Services. The logo is circular and contains the department's name around the perimeter. In the center is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design. The symbol consists of a series of curved lines that form a shape reminiscent of a human figure.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 7, 2014

B. Braun Medical Incorporated Ms. Kimberly Smith Regulatory Affairs Specialist 901 Marcon Boulevard Allentown, PA 18109

Re: K140311

Trade/Device Name: Caresite Luer Access Device Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: February 7, 2014 Received: February 7, 2014

Dear Ms. Smith:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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. Smith

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) (2) 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 contact the Division of Industry and Consumer Education at its toll-lice number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Mary S. Runner -S

Erin 1. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known)

#### Device Name

Caresite Luer Access Device

#### Indications for Use (Describe)

The Caresite Luer Access Device is a valve intended for the aspiration, injection or gravity/pump flow of V fluids and blood upon insection of a male luer connector. The Carest Luer Access Device may be used with power injectors at a maximum presure of 400 psi and a maximum flow rate of 15 mL/sec.

Type of Use (Select one or both, as applicable)

[x] Prescription Use (Parl 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

| FOR FDA USE ONLY | | | | | |
|------------------------------------------------------------------------------|--|--|---------------------|--|-------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | | | | | |
| | | | Digitally signed by | | |
| | | | Richard C. Chapman | | |
| | | | Date: 2014.05.06 | | |
| | | | 14:53:58 -04'00' | | |
| FORM FDA 3881 (1/14) | | | | | Page 1 of 2 |