INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE

K030739 · Infusion Dynamics, Inc. · FRN · Jan 14, 2004 · General Hospital

Device Facts

• Record ID: K030739
• Device Name: INFUSION DYNAMICS (ID) POWER INFUSER, MODEL M100B-3A WITH BLOOD CARTRIDGE
• Applicant: Infusion Dynamics, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Jan 14, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The ID Power Infuser® Model M100B-3A is intended to support primary intravenous fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in patients with Clinical Shock, hypovolemic shock, and septic shock. The device is intended for use by medical, paramedical, and EMT personnel in the field and in pre-hospital and hospital environments. When used with the Crystalloid/Colloid Cartridge (K992044), the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid resuscitative fluids and is not intended to support the infusion of blood or blood products. When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is intended to deliver crystalloid and colloid resuscitative fluids, whole blood and packed red blood cells. The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.

Device Story

The ID Power Infuser® Model M100B-3A is a portable infusion device designed for rapid fluid resuscitation. It accepts either a Crystalloid/Colloid Cartridge or a Blood Cartridge to deliver fluids, whole blood, or packed red blood cells. Operated by medical, paramedical, or EMT personnel in field or hospital environments, the device provides rapid volume expansion to treat shock. It does not deliver medications. The device assists clinicians in stabilizing patients by restoring intravascular volume and blood pressure during emergency resuscitation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and design comparison.

Technological Characteristics

Portable infusion pump system; utilizes interchangeable cartridges (Crystalloid/Colloid or Blood) for fluid delivery. Mechanical infusion principle. Designed for field and hospital use by trained personnel.

Indications for Use

Indicated for patients in clinical, hypovolemic, or septic shock requiring rapid intravenous fluid resuscitation to restore intravascular volume and blood pressure. Intended for use by medical, paramedical, and EMT personnel in field, pre-hospital, and hospital settings. Contraindicated for the delivery of pharmaceutical or other medications.

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.

Predicate Devices

• Crystalloid/Colloid Cartridge (K992044)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes extending from its back, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 4 2004

Infusion Dynamics, Incorporated Mr. Thomas Becze Director, Consulting Services Science Applications International Corporation 5340 Spectrum Drive, Suite N Frederick, Maryland 21703

Re: K030739

Trade/Device Name: Infusion Dynamics (ID) Power Infuser® Model M100B-3A with Blood Cartridge Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: October 27, 2003 Received: October 29, 2003

Dear Mr. Becze:

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 controls provided be a 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 (111) 1) and 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. Becze

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. or the Act of ally I ederal the Act a 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 requirements as bet roring 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), 11 you decire speember 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 your,

Chiu Lin, Ph.D.

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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## Indications For Use Statement

510(k) Number (if known): K030739

Device Name: ID Power Infuser® Model M100B-3A

## Indications For Use:

The ID Power Infuser® Model M100B-3A is intended to support primary intravenous The ID Power Infuser® Model MT600 of to intenescular volume and blood pressure in
fluid resuscitation therapy to rapidly restore intravascular volume and blood pressure in fillid resuscitation therapy to rapidly routers in the poperfusion states as a result of patients with Cilifical Shock, hypotonenic shock, and septic shock, and septic shock.

The device is intended for use by medical, paramedical, and EMT personnel in the field and in pre-hospital and hospital environments.

When used with the Crystalloid/Colloid Cartridge (K992044), the lD Power When used with the Oryetalloid to deliver crystalloid and colloid musel® Model MTOOD of to interior is not intended to support the infusion of blood or blood products.

When used with the Blood Cartridge, the ID Power Infuser® Model M100B-3A is When used with the Drood Cartings, it resuscitative fluids, whole blood and packed red blood cells.

The ID Power Infuser® Model M100B-3A is not intended to support the delivery of any pharmaceutical or other medications.

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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)

Pattana Cucenote

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

510(k) Number: K030739