MEDLINE VIAL DECANTER

K111577 · Medline Industries, Inc. · LHI · Sep 8, 2011 · General Hospital

Device Facts

• Record ID: K111577
• Device Name: MEDLINE VIAL DECANTER
• Applicant: Medline Industries, Inc.
• Product Code: LHI · General Hospital
• Decision Date: Sep 8, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

Decanting device intended for the aseptic dispensing of solutions from IV containers. For use in Docalining at 100 minumedication from a vial to an IV fluid administration device.

Device Story

Medline Vial Decanter is a manual decanting device used for aseptic transfer of medication from vials to IV fluid administration sets. Operated by clinicians in clinical settings; facilitates fluid transfer; ensures aseptic conditions during medication preparation. Benefits include reduced risk of contamination during IV fluid preparation.

Clinical Evidence

Bench testing only.

Technological Characteristics

Manual decanting device for IV fluid transfer. No electronic components, software, or complex materials specified.

Indications for Use

Indicated for the aseptic dispensing of medication from a 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.

Submission Summary (Full Text)

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

Mr. Matt Clausen Regulatory Affairs Specialist Medline Industries Incorporated One Medline Place Mundelein. Illinois 60060

SEP - 8 2011

Re: K111577

Trade/Device Name: Medline Vial Decanter Regulation Number: 21 CFR 880.5440 Regulation Name: I.V. Fluid Transfer Set Regulatory Class: Class II Product Code: LHI Dated: August 18, 2011 Received: August 19, 2011

Dear Mr. Clausen:

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.

ff 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. Clausen

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 (2) CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If vou 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 (CDRHis) 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.lda.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 yours.

Anthony D. Matson

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

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## Indications for Use

510(k) Number (if known):

Device Name:

## Medline Vial Decanter

Indications For Use:

Decanting device intended for the aseptic dispensing of solutions from IV containers. For use in Docalining at 100 minumedication from a vial to an IV fluid administration device.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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(Division Sign-Off)

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RUBPRD COOPMAN

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: