INFUSION DYNAMICS POWER INFUSER MODEL M100B

K992044 · Infusion Dynamics, Inc. · FRN · Sep 8, 1999 · General Hospital

Device Facts

• Record ID: K992044
• Device Name: INFUSION DYNAMICS POWER INFUSER MODEL M100B
• Applicant: Infusion Dynamics, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Sep 8, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ID Power Infuser™ Model M100B 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™ Model M100B 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 Model M100B is a portable infusion device designed for rapid intravenous fluid resuscitation. Operated by medical, paramedical, or EMT personnel in field or hospital settings, it delivers crystalloid and colloid fluids to restore intravascular volume and blood pressure in shock states. Device functions as a mechanical pump to accelerate fluid administration compared to gravity-fed systems. Output is controlled fluid delivery to the patient's venous access site. Benefits include rapid stabilization of hemodynamically unstable patients. Device is restricted to non-blood and non-medication fluid delivery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical infusion pump for crystalloid and colloid fluids. Portable form factor for field and hospital use. Does not include software or electronic processing components.

Indications for Use

Indicated for patients experiencing clinical shock, hypotension, and hypoperfusion due to hemorrhagic blood loss, occult hemorrhage, neurogenic shock, or septic shock. Used by medical, paramedical, and EMT personnel in field, pre-hospital, and hospital settings. Contraindicated for blood, blood products, and pharmaceutical/medication delivery.

Regulatory Classification

Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP | 8 1999

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

Re: K992044 Infusion Dynamics Power Infuser Model M100B Trade Name: Requlatory Class: II Product Code: FRN Dated: June 10, 1999 Received: June 17, 1999

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 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 (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. ਉ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in requlatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Becze

the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

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

19992044 510(k) Number if known): TO BE ASSIGNED

Device Name: ID Power Infuser™ Model M100B

Indications For Use:

The ID Power Infuser™ Model M100B 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™ Model M100B 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.

Talinza Creciente

ion Sion-Off of Dental, Infection Control, and Ge, cral Hospital Devic

510(k) Number K972044/

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)