MSI PRESSURE INFUSOR

K973843 · Smith Assoc. · KZD · Oct 29, 1997 · General Hospital

Device Facts

• Record ID: K973843
• Device Name: MSI PRESSURE INFUSOR
• Applicant: Smith Assoc.
• Product Code: KZD · General Hospital
• Decision Date: Oct 29, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid. Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

Device Story

The MSI Pressure Infusor is a reusable, inflatable cuff designed to wrap around standard intravenous (I.V.) fluid bags. Operated by clinical staff in hospital or clinical settings, the device is manually inflated to apply external pressure to the fluid bag, thereby increasing the flow rate of the I.V. fluid into the patient. This mechanical assistance facilitates rapid fluid administration when required. The device functions as a simple pneumatic pressure delivery system; it does not involve electronic components, software, or automated algorithms. It provides a mechanical benefit by overcoming resistance in the infusion line to ensure timely fluid delivery.

Clinical Evidence

No clinical data provided; device is a mechanical accessory for I.V. fluid administration.

Technological Characteristics

Reusable inflatable cuff; mechanical pressure application; manual inflation mechanism; non-electronic; no software; no energy source.

Indications for Use

Indicated for use in clinical settings to assist the infusion of intravenous fluids by applying external pressure to an I.V. bag. Restricted to prescription use by or on the order of a physician.

Regulatory Classification

Identification

A pressure infusor for an I.V. bag is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of the fluid.

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with a double-stranded snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 29 1997

Mr. E.J. Smith ·Smith Associates P.O. Box 4343 Crofton, Maryland 21114-4341

Re: K973843 MSI Pressure Infusor Trade Name: Regulatory Class: I Product Code: KZD Dated: October 8, 1997 Received: October 8, 1997 --

Dear Mr. Smith:

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 reclassified in accordance with the provisions of the Federal Food, Druq, 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 reqistration, 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. ಗಳ 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 requlation 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 - Mr. Smith

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic 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 requlation 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):K973843

Device Name: MPI Pressure Infusor

Classification Panel: 80KZD General Hospital

Indications for Use:

The Medical Solutions, Inc.'s Reusable Pressure Infusor is a device consisting of an inflatable cuff which is placed around an I.V. bag. When the device is inflated, it increases the pressure on the I.V. bag to assist the infusion of fluid.

Caution: Federal (U.S.A) law restricts this device to sale by or on the order of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | <span style="text-decoration: overline;">✓</span> | or | Over-the-Counter Use |
|------------------|---------------------------------------------------|----|----------------------|
|------------------|---------------------------------------------------|----|----------------------|

(Division Sign-Off) Patricia Crucente
Division of Dental, Infection Control,
and General Hospital Devices

| 510(k) Number | K973843 |
|---------------|---------|
|---------------|---------|