MIX2VIAL TRANSFER DEVICE

K031861 · Medimop Medical Projects, Ltd. · LHI · Jul 29, 2003 · General Hospital

Device Facts

• Record ID: K031861
• Device Name: MIX2VIAL TRANSFER DEVICE
• Applicant: Medimop Medical Projects, Ltd.
• Product Code: LHI · General Hospital
• Decision Date: Jul 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.

Device Story

Mix2vial Transfer Device is a mechanical accessory used for drug reconstitution; facilitates fluid transfer between two vials. Device consists of a double-ended spike system; allows connection of a drug vial and a diluent vial. Operation involves manual attachment to vials; enables closed-system fluid transfer for mixing. Used in clinical or home settings by healthcare providers or patients. Simplifies drug preparation; reduces risk of contamination during transfer; ensures accurate mixing of multi-vial medications.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Mechanical transfer device; double-ended spike configuration; plastic construction; non-powered; manual operation; sterile.

Indications for Use

Indicated for the transfer and reconstitution of drugs contained in two separate vials.

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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Public Health Service

JUL 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MEDIOP MEDICAL PROJECT LIMITED C/O Mr. Benny Arazy Mintzpe Aviv, Industrial Park 13 M.P Misgav 20187 ISRAEL

Re: K031861

Trade/Device Name: Mix2vial Transfer Device Regulation Number: 880. 5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: LHI Dated: June 12, 2003 Received: June 16, 2003

Dear Mr. Arazy

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 such additional controls. Existing major regulations affecting vour 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. Arazy

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/dsma/dsmamain.html

Sincerely yours.

Patricio Caceres ffa

Susan Runner, DDS, MA Interim 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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## IX. C: INDICATION FOR USE STATEMENT

The Mix2vial Transfer Device is intended for transferring and mixing drugs contained in two vials.

Freddy Zinger f.z

General Manager (Name & Signature)

13|6|2003
Date

(Premarket Notification [510(k)] Number)

Paloria Crescenti
(Division Sign Off)

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

510(k) Number: K031861