MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW

K972117 · Medical Specialty Innovations, Inc. (Msi) · LHI · Aug 26, 1997 · General Hospital

Device Facts

• Record ID: K972117
• Device Name: MSI BOTTLEFLOW, TRANSFLOW, VIALFLOW
• Applicant: Medical Specialty Innovations, Inc. (Msi)
• Product Code: LHI · General Hospital
• Decision Date: Aug 26, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5440
• Device Class: Class 2

Intended Use

The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows > VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container

Device Story

MSI transfer devices are sterile, disposable, one-piece injection-molded transparent hollow tubes with spiked ends; some models include splash guards. Used in clinical settings for aseptic fluid transfer from IV containers (vials, bags, bottles) to other containers. Operation involves manual insertion of the spike into the container port to facilitate fluid flow. Devices benefit patients by maintaining sterility during solution dispensing. No complex processing or electronic components involved.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

One-piece, injection-molded transparent hollow tubes with spiked ends; some models include splash guards. Sterile, disposable. No electronic or software components.

Indications for Use

Indicated for the aseptic dispensing of solutions from IV containers, including glass vials, flexible bags, and large glass IV bottles, or for transferring solutions between containers.

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 Plastic Bag decanter (K811233)
• IV Rigid (Bottle) decanter (K811234)
• Bottle to Bottle decanter (K811268)
• Glass Vial decanter (K811269)

Submission Summary (Full Text)

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K972 117

AUG 26 1997

Attachment 1 510(k) Summary

## Medical Specialty Innovations, Inc. Transfer Devices

## Submitter Information:

Medical Specialty Innovations, Inc. (MSI) 440 Nine McFarland Drive, Suite 100 Alpharetta, GA. 30201

## 510(k) Summary Prepared by:

ﻤﻠﻌﺎﺕ

Carolann Kotula Official Correspondent for MSI c/o mdi Consultants, Inc. 55 Northern Boulevard Great Neck, NY 11021

| Phone: | [phone] |
|--------|----------------|
| Fax: | [phone] |

Date 510(k) Summary Prepared: May 30 , 1997

## Name/Classification of the Device:

IV Container Accessories Classification Name: Transfer device: bottle or bag Common Name: decanter, transfer spike MSI Bottleflow, Transflow, Vialflow Proprietary Name: and Rapidflow

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Classification:

-

These have been classified by the General Hospital Panel as Class II devices.

Identification of the Legally Marketed Device to which the Submitter Claims Equivalence: These devices are substantially equivalent to the transfer devices legally marketed by MediPlast International, Inc. as:

| IV Plastic Bag decanter: | K811233 |
|-----------------------------|---------|
| IV Rigid (Bottle) decanter: | K811234 |
| Bottle to Bottle decanter: | K811268 |
| Glass Vial decanter: | K811269 |

The subject device and predicate are substantially Comparative Information: identical in materials, dimensions, performance, packaging, sterilization and intended use.

Description of the Subject Device: The MSI transfer devices are one piece, injection molded transparent hollow tubes with one or more spiked ends. Some models have a splash guard. They are sterile, disposible devices.

Intended Use of the Subject Device: The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows

> used to dispense fluids from glass vials VialFlow: RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container

Technological Characteristics of the Subject Device: There are no differences in the characteristics of the subject devices and the predicates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 1997

Ms. Carolann Kotula Vice President Medical Specialty Innovations, Incorporated (MSI) . C/O MDI Consultants, Incorporated work 55 Northern Boulevard Great Neck, New York 11021

.. . . .

Re : K972117 MSI Bottleflow, Transflow, Vialflow Trade Name: Requlatory Class: II Product Code: LHI May 30, 1997 Dated: Received: June 5, 1997

Dear Ms. Kotula:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been realer book in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to . comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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.Page 2 - Ms. Kotula

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to
premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski

Timo av A. Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K972117

ATTACHMENT #3

510(k) Number (if known)

Device Name: Medical Specialty Innovations, Inc. Transfer Devices

Indications for Use:

The MSI transfer devices are decanting devices intended for the asceptic dispensing of solutions from IV containers. Each device is used as follows

> VialFlow: used to dispense fluids from glass vials RapidFlow: used to dispense fluids from flexible bags BottleFlow: used to dispense fluids from Large Glass IV Bottles TransFlow: used to dispense fluids from small vial, or to transfer solutions from container to container

(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 Dental, Infection Control,
and General Hospital Devices
510(k) Number K972117

Prescription Use

OR

Over the Counter Use