20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500

K100640 · B.Braun Medical, Inc. · LHI · Jul 22, 2010 · General Hospital

Device Facts

• Record ID: K100640
• Device Name: 20 MMVIAL FLUID TRANSFER ADAPTER, MODEL 7E2500
• Applicant: B.Braun Medical, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Jul 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The 20 mm Vial Fluid Transfer Adapter is intended for use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.

Device Story

The 20 mm Vial Fluid Transfer Adapter is a sterile, single-use device designed to facilitate the transfer of fluids or medications from a 20 mm drug vial into an IV administration set. The device consists of a flexible PVC twist-off cap, PVC tubing, a polycarbonate large bore male luer lock, a polycarbonate/LDPE piercing pin, and an inline air filter assembly. In operation, the piercing pin is inserted into the drug vial, allowing the fluid to be drawn through the tubing and luer lock connection into the administration device. The device is intended for use by healthcare professionals in clinical settings. It provides a closed or controlled pathway for fluid transfer, reducing the risk of contamination during the preparation of IV medications.

Clinical Evidence

Bench testing only. Functional performance testing included visual inspection, occlusion, pressure, pull, insertion, and retention testing. Material safety was verified through biocompatibility and chemical testing. All testing met acceptance criteria.

Technological Characteristics

Materials: PVC (DEHP-free), polycarbonate, LDPE. Components are solvent bonded. Features: flexible twist-off cap, large bore male luer lock, piercing pin, inline air filter. Sterile, single-use. No electronic or software components.

Indications for Use

Indicated for transferring IV fluids or medication from a 20 mm drug vial to an IV fluid administration device.

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

• IV Fluid Transfer Pin, B. Braun Medical Inc, K925401

Submission Summary (Full Text)

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# K 100640

## 5. 510(k) SUMMARY

| SUBMITTER: | B. Braun Medical Inc.<br>901 Marcon Boulevard<br>Allentown, PA 18109-9341<br>[phone] |
|------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Matthew J. Homa<br>Sr. Regulatory Affairs Analyst<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] |

JUL 22 2010

| DATE: | May 17, 2010 |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | 20 mm Vial Fluid Transfer Adapter |
| COMMON OR<br>USUAL NAME: | Set, I.V. Fluid Transfer |
| DEVICE<br>CLASSIFICATION: | Class II, Product Code LHI, 21 CFR \$880.5440 |
| PREDICATE DEVICE: | IV Fluid Transfer Pin, B. Braun Medical Inc, K925401, Class<br>II, LHI and 21 CFR §880.5440. |
| DESCRIPTION: | The 20 mm Vial Fluid Transfer Adapter is a sterile, single use<br>fluid transfer device. The 20 mm Vial Fluid Transfer Adapter<br>is composed of a flexible PVC twist-off cap, PVC tubing, a<br>polycarbonate large bore male luer lock, polycarbonate/LDPE<br>piercing pin, and an inline air filter assembly. The PVC<br>components do not contain DEHP. Components will be<br>solvent bonded to assemble the device. The finished device<br>will be packed and sterilized. |
| INTENDED USE: | The 20 mm Vial Fluid Transfer Adapter is intended for use in<br>transferring IV fluids/medication from a 20 mm drug vial to an<br>IV fluid administration device. |
| SUBSTANTIAL<br>EQUIVALENCE: | The 20 mm Vial Fluid Transfer Adapter has a similar intended<br>use and is comprised of components similar to the IV Fluid<br>Transfer Pin (K925401). Both products have a plastic spike<br>used to access the source container and withdraw IV fluid.<br>Biocompatibility, chemical and functional testing have been<br>completed to verify that there are no differences between the |

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proposed device and the predicate device which raise new issues of safety or effectiveness.

Transfer Adapter is both safe and effective and performs

#### NONCLINICAL Non clinical testing of the proposed device was conducted to TESTING: demonstrate safety and effective and substantial equivalence to the predicate device. To verify that the design characteristics and input requirements of the 20 mm Vial Fluid Transfer Adapter are appropriate for the intended use and user requirements, functional performance testing has been executed in the test laboratory. This testing demonstrates that the 20 mm Vial Fluid Transfer Adapter functions as intended. Testing conducted included visual inspection, occlusion, pressure, pull, insertion and retention. The safety of the subject device materials of composition was verified through biocompatibility and chemical testing. All functional performance testing, biological and chemical testing of the materials met the acceptance criteria. CONCLUSION: Functional performance testing and material biocompatibility and chemical testing demonstrate that the 20 mm Vial Fluid

similarly to the predicate device.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

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

Mr. Matthew J. Homa Senior Regulatory Affairs Analyst B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18196-3941

JUL 2-2 2010

Re: K100640

Trade/Device Name: 20 mm Vial Fluid Transfer Adapter Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: July 16, 2010 Received: July 19, 2010

Dear Mr. Homa:

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 - Mr. Homa

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/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm 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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

hh for

Anthony D. Watson, B.S., M.S., M.B.A. 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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B. Braun Medical Inc. 510(k) Premarket Notification 20 mm Vial Fluid Transfer Adapter

### 4. INDICATIONS FOR USE STATEMENT

Page _________ of ____________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):

Device Name:

20 mm Vial Fluid Transfer Adapter

Indications For Use:

For use in transferring IV fluids/medication from a 20 mm drug vial to an IV fluid administration device.

Prescription Use X (Per 21 CFR 801.109)

OR

Over-The-Counter Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

:10(k) Number: _______________________________________________________________________________________________________________________________________________________________