INFUSION DYNAMICS POWER INFUSER

K974074 · Infusion Dynamics, Inc. · KZD · Feb 17, 1998 · General Hospital

Device Facts

• Record ID: K974074
• Device Name: INFUSION DYNAMICS POWER INFUSER
• Applicant: Infusion Dynamics, Inc.
• Product Code: KZD · General Hospital
• Decision Date: Feb 17, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5420
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock. The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments. The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

Device Story

ID Power Infuser is a portable device designed for rapid delivery of crystalloid and colloid resuscitative fluids. Operated by medical, paramedical, and EMT personnel in field, pre-hospital, and hospital settings. Device supports primary IV fluid resuscitation to restore intravascular volume and blood pressure in shock states. Output is controlled fluid infusion; healthcare providers use this to stabilize patients experiencing hypoperfusion. Benefits include rapid volume replacement in emergency scenarios. Device is restricted to non-blood, non-medication fluid delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable infusion device for crystalloid/colloid fluids. Mechanical/electromechanical design for fluid delivery. No software or electronic processing described.

Indications for Use

Indicated for patients with clinical shock, hypotension, and hypoperfusion due to hemorrhagic blood loss, occult hemorrhage, neurogenic shock, or septic shock requiring rapid intravascular volume and blood pressure restoration. Contraindicated for blood, blood products, or medication delivery.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 7 1998

Infusion Dynamics, Incorporated C/O Mr. Thomas Becze President Princeton Regulatory Associates 116 Village Boulevard, Suite 200 Princeton, New Jersey 08540-5799

K974074 Re: Infusion Dynamics Power Infuser Trade Name: Regulatory Class: I Product Code: KZD February 3, 1998 Dated: February 6, 1998 Received:

Dear Mr. Becze:

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, 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 Existing major be subject to such additional controls. 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 General regulation (21 CFR Part 820) and that, Devices: 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 Reqister. 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. Becze

through 542 of the Act for devices under the Electronic enroduct 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 acberrood in your alence of your device to a legally Finang of babbandaaiice results in a classification for your marketed predicate and the 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 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,

Timoth A. Ulatowski

v A. Ulatowski Timo 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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## Indications For Use Statement

510(k) Number if known): TO BE ASSIGNED

Device Name: ID Power Infuser™

Indications For Use:

The ID Power Infuser™ is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with clinical shock, hypotension, and hypoperfusion states as a result of hemorrhagic blood loss, occult hemorrhage, neurogenic shock, and septic shock.

The device is intended to be used by medical, paramedical, and EMT personnel in the field, and in pre-hospital and hospital environments.

The ID Power Infuser™ is intended to deliver crystalloid and colloid resuscitative fluids only. It is NOT intended to support the infusion of blood or blood products, nor is it intended for the delivery of any pharmaceutical or other medications.

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| | Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|--------------------------------------------------------|--------------------------|
| (Division Sign-Off) | Patricia Cuceide | |
| Division of Dental, Infection Control, and General Hospital Devices | | |
| 510(k) Number | K974074 | |
| Prescription Use | OR | Over-The-Counter Use |
| (Per 21 CFR 801.109) | | (Optional Format 1-2-96) |