SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K090917 · Baxa Corp. · LHI · Feb 19, 2010 · General Hospital

Device Facts

• Record ID: K090917
• Device Name: SURECONNECT CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM
• Applicant: Baxa Corp.
• Product Code: LHI · General Hospital
• Decision Date: Feb 19, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.

Device Story

SureConnect is a closed system for drug reconstitution and transfer. Used by pharmacists and healthcare professionals in clinical settings to prepare and administer medications, including cytotoxic drugs, for IV infusion or injection. The system maintains a closed environment during the transfer process, protecting the user from exposure to hazardous drugs and maintaining sterility of the medication. It functions as a mechanical transfer interface between drug vials and IV containers/administration sets. No electronic components, software, or algorithms are involved.

Clinical Evidence

Bench testing only.

Technological Characteristics

Mechanical closed system transfer device. Materials and design facilitate sterile drug reconstitution and transfer. No energy source, software, or connectivity features.

Indications for Use

Indicated for pharmacists or healthcare professionals to prepare and administer drugs, including cytotoxic agents, via intravenous infusion or injection.

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 Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Jim Morgan Regulatory Affairs Contractor Baxa Corporation 14445 Grasslands Drive Englewood, Colorado 80112-7062

FEB 1 9 2010

Re: K090917

Trade/Device Name: SureConnect® Closed Drug Reconstitution and Transfer System Regulation Number: 21CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: January 18, 2010 Received: January 19, 2010

Dear Mr. Morgan:

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. Morgan

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/ReportalProblem/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,
Susan Runover

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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## SECTION 4: INDICATIONS FOR USE

510(k) Number:

Device Name: SureConnect® Closed Drug Reconstitution and Transfer System

## Indications for use:

The SureConnect Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare and administer drugs, including cytotoxic drugs, for intravenous infusion or injection.

Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)

Over the Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Concurrence of CDRH, O

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Division Sign-Off livision of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: K910917

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