ALPHA INFUSION PUMP

K992551 · Advanced Infusion, Inc. · MEB · Oct 27, 1999 · General Hospital

Device Facts

• Record ID: K992551
• Device Name: ALPHA INFUSION PUMP
• Applicant: Advanced Infusion, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Oct 27, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter. The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

Device Story

Alpha Infusion Pump is an ambulatory, external, disposable infusion device. It delivers medications or fluids percutaneously via catheter. Principle of operation involves an elastomeric chamber and flow restrictor to control infusion rates. Device supports continuous delivery and bolus administration on patient demand. Used in home and clinical environments; operated by patients or healthcare providers. Output is the controlled infusion of fluids/medications. Benefits include portable, patient-controlled drug delivery for pain management or fluid therapy.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Ambulatory, disposable, external infusion pump. Utilizes an elastomeric chamber for fluid storage and a flow restrictor for rate control. Percutaneous delivery via catheter. Mechanical operation; no electronic or software components.

Indications for Use

Indicated for patients requiring continuous intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids via percutaneous catheter. Suitable for ambulatory use in home or clinical settings.

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

• Baxter Intermate LV Elastomeric Infusion Device (K922382)
• I-Flow PainBuster Infusion System (K980558)
• Burron Ambulatory Drug Delivery System (K896422)
• Sgarlato Laboratories Pain Control Infusion Pump (K990101)
• McKinley Medical OutBound Disposable Syringe Infusor (K982256)
• McKinley Medical OutBound PCA Pain Management System (K982256)
• Breg Pain Care 2000 (K983454)

Submission Summary (Full Text)

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### Statement of Indications for Use 20.

## INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Alpha Infusion Pump is intended for intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered percutaneously through a catheter.

The Alpha Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ X

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR alle

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 5100k) Number Kergels

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K 992551/

#### 510(k) Summary 19.

# 510(k) SUMMARY - Safety and Effectiveness

## Alpha Infusion Pump

The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use and operation to the Baxter Intermate LV Elastomeric Infusion Device (K922382) and the I-Flow PainBuster Infusion System (K980558). Both are elastomeric chamber infusion pump intended to deliver medications or fluids to a patient by an intravenous, intra-arterial, subcutaneous, or epidural route. These pumps are ambulatory, external. disposable infusion pumps which deliver medication or fluids percutaneously to the patient via a catheter. They control flow rate using a flow restrictor.

The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use to the Burron Ambulatory Drug Delivery System (K896422), the Sgarlato Laboratories Pain Control Infusion Pump (K990101), and the McKinley Medical OutBound Disposable Syringe Infusor (K982256). These infusion pumps differ from the Alpha Infusion Pump only in the method used to pressurize the medication or fluid contained within the pump.

The proposed device, the Alpha Infusion Pump, claims substantial equivalence in intended use to the McKinley Medical OutBound PCA Pain Management System (K982256) and the Breg Pain Care 2000 (K983454). These infusion systems provide for the delivery of a bolus of medication on patient demand through a percutaneous catheter.

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Public Health Service

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 7 1999

Mr. James Christensen Advanced Infusion, Incorporated 6200 South McClintock #6 Tempe, Arizona 85283

DEPARTMENT OF HEALTH & HUMAN SERVICES

Re: K992551 Alpha Infusion Pump Trade Name: Requlatory Class: II Product Code: FPA Dated: July 27, 1999 Received: July 30, 1999

Dear Mr. Christensen:

We have reviewed your Section 510(k) notification of intent to We have reviewed your Section 310, move have determined the market the device referenced above (for the indications for device is substantially equivacio (ces marketed in interstate use stated in the encreases, so the enactment date of the commerce prior to hay as , or to devices that have been Medical Device Amendments, or o actives of the Federal reclassified in accordance #15Act). You may, therefore, Food, Drug, and Cosmetic nee (iso, eneral controls provisions
market the device, subject to the general on of the Agt The general controls provisions of the Act of the Act. of the Act. The general conual registration, listing of Include requiremenfacturing practice, labeling, and devices, good manast misbranding and adulteration.

If your device is classified (see above) into either class II II your device is class III (Premarket Approval), it may (Special Controls) of Srabled Controls. Exisling major be subject to back addroms device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A rederal Regulations, frees === "baation assumes compliance with substantlarly equivalent acture for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic (GMP) regulacion (Dr Sood and Drug Administration (PDA) will om Inbpections, onlons. Failure to comply with the GMP vertify such abbampens. regulation may resure in regulate concerning your device in may publish farcher announcement. this response to your the reactal negion submission does not affect any

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Page 2 - Mr. Christensen

obligation you might have under sections 531 through 542 of 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 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 oblained 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