ALPHA INFUSION PUMP AND CATHETERS

K021964 · Advanced Infusion, Inc. · MEB · Aug 12, 2002 · General Hospital

Device Facts

• Record ID: K021964
• Device Name: ALPHA INFUSION PUMP AND CATHETERS
• Applicant: Advanced Infusion, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Aug 12, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Alpha Infusion Pump and associated Catheters are 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 through a catheter containing a flow restriction element. The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are intended for use in the home environment but not limited to use in the home environment.

Device Story

Alpha Infusion Pump is an elastomeric, non-powered ambulatory infusion device. It consists of dual elastomeric chambers within a hard shell case, a luer lock checkvalve for filling, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum. Operation involves filling the chambers with medication via a 60cc syringe, which stretches the elastomeric material; the resulting pressure forces fluid through the filter, pressure regulator, and a micro-bore catheter. The catheter's internal diameter and length act as a flow restrictor to maintain a constant flow rate (0.5 ml/hr to 10 ml/hr). Used in home or clinical settings by patients or healthcare providers to deliver continuous medication. The device provides a passive, mechanical method for controlled drug delivery, benefiting patients requiring ambulatory infusion therapy.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, material, and operational comparisons to the predicate device.

Technological Characteristics

Elastomeric infusion pump; materials include polycarbonate, silicone elastomer, stainless steel, and PVC. Features a 5-micron fluid filter, hydrophobic air vent filter, and spring-operated pressure regulator. Flow rate determined by micro-bore catheter flow restrictor. Non-powered, mechanical operation. Sterilization method not specified.

Indications for Use

Indicated for patients requiring continuous intravenous, intra-arterial, subcutaneous, or epidural infusion of medications or fluids at controlled rates. 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

• Alpha Infusion Pump and Catheters (K992551)

Submission Summary (Full Text)

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AUG 1 2 2002

K021964

#### 19. 510(k) Summary

510(k) SUMMARY - Safety and Effectiveness

## Alpha Infusion Pump

- 1. Submitters Name:
Advanced Infusion, Inc. 6200 South McClintock #6 Tempe, AZ 85283 [phone] (Phone) Contact: Dr. Reese Date Prepared: 8-7-02

2. Name of Device:

Trade Name: Alpha Infusion Pump and Catheters Common Name: Elastomeric Infusion Pump Classification Name: Pump, Infusion, Elastomeric

- 3. Predicate Device:
The proposed device, the revised Alpha Infusion Pump and associated Catheters, claims substantial cquivalence in intended use and is similar in design, construction, and operation to the currently marketed Alpha Infusion Pump and Catheters (K992551).

- 4. Description of Device:
The Alpha Infusion Pump is comprised of dual elastomeric chambers which hold the fluid to be infused under pressure. These chambers are contained within a hard shell case. The infusion pump also contains a luer lock checkvalve used to fill the chambers, a 5-micron fluid filter, a hydrophobic air vent filter, a pressure regulator, and an elastomeric septum for attaching infusion catheter(s) to the pump. The infusion pump is packaged as a kit in a tray containing an insertion needle used for placement of the catheter into the patient, a 60cc syringe used to fill the pump, a fabric belt used for holding the pump onto the patient, patient labels, and an Instructions For Use.

The Alpha Cath Infusion Catheters are micro-bore tubing catheters with a needle attached to one end for insertion of the catheter into the infusion pump septum. The internal diameter and length of the catheter tubing acts as the flow restrictor and determines the flow rate of the fluid through the catheter. The infusion catheters are packaged separately in Tyvek pouches and are contained in cartons along with Tegaderm adhesive dressings and an Instruction For Use.

To fill the Alpha Infusion Pump, a 60cc disposable syringe is filled with medication and connected to the female luer lock of the filling checkvalve which is located on top of the

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infusion pump. As each syringe of medication is emptied into the elastomeric chambers, the chambers are stretched like a balloon and fill the hard shell outer protective case of the pump. The elastomeric chambers pressurize the medication. The hard shell case restricts the maximum volume that can be filled into the pump.

When filling is complete, the elastomeric chambers force the medication contained within the infusion purno through a 5-micron fluid filter to remove any particulates, through a spring-operated pressure regulator which maintains the medication in the outflow chamber at a constant pressure, and into a delivery chamber having an elastomeric septum. A hydrophobic air vent filter allows any air in the fluid to bleed from the outflow chamber. Infusion catheters of the desired flow rate are inserted through the elastomeric septum in order to deliver medication from the outflow chamber of the infusion pump to the patient.

## 5. Statement of Intended Use

The Alpha Infusion Pump and associated Catheters are intended for intravenous, intraarterial, subcutaneous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.

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

| Characteristic | Advanced Infusion Device<br>K992551 | Advanced Infusion Device<br>(revised) |
|---------------------------|---------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Pump Type | Elastomeric | Elastomeric |
| Intended Use | Infusion Pump for delivery of<br>medication or fluid<br>intravenous, intra-arterial,<br>subcutaneous, or epidural | Infusion Pump for delivery of<br>medication or fluid<br>intravenous, intra-arterial,<br>subcutaneous, or epidural |
| Specific Drugs, Biologics | N/A | N/A |
| Labeling | Similar | Similar |
| Components | Infusion Pump<br>5 micron Filter<br>Hydrophobic Filter Vent<br>Pressure Regulator<br>Flow Restrictor<br>PU Catheter | Infusion Pump<br>5 micron Filter<br>Hydrophobic Filter Vent<br>Pressure Regulator<br>Flow Restrictor<br>PVC Catheter |
| Pumping Mechanism | Elastomeric Membrane | Elastomeric Membrane |
| Admin Sets | Catheter with<br>Polyimide Flow Restrictor | Micro-bore Catheter |
| Power Required | N/A | N/A |
| Materials | Polycarbonate | Polycarbonate |

## 6. Comparison to Predicate

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| | Silicone Elastomer | Silicone Elastomer |
|---------------------|---------------------------|-----------------------------|
| | Stainless Steel | Stainless Steel |
| | Nylon Filter | Versapore Filter |
| | PTFE Filter | PTFE Filter |
| | Polyimide Flow Restrictor | Polyvinyl Chloride Catheter |
| | Polyurethane Catheter | |
| Flow Rate & Profile | 0.5 ml/hr to 10 ml/hr | 0.5 ml/hr to 10 ml/hr |
| | Continuous | Continuous |
| Safety/Alarms | N/A | N/A |
| Other Capabilities | N/A | N/A |

:

and the comments of the comments of the comments of

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles three stylized human figures or a triple wave design.

### Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# IG 1 2 2002

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

Re: K021964

Trade/Device Name: Alpha Infusion Pump and Associated Catheters Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: June 12, 2002 Received: June 14, 2002

Dear Mr. Christensen:

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 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can 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.

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice

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Page 2 – Mr. Christensen

requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic 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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 yours,

Timothy A. Ulatowski

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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K021964

#### Statement of Indications for Use 20.

# INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________ Alpha Infusion Pump and associated Catheters

Indications for Use:

The Alpha Infusion Pump and associated Catheters are intended for intravenous, intra-arterial, subcutancous, or epidural infusion of medications or fluids requiring continuous delivery at controlled infusion rates. Medications or fluids are intended to be delivered through a catheter containing a flow restriction element.

The Alpha Infusion Pump and associated Catheters are suitable for use as an ambulatory device and are 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

OR Over-The-Counter Use
Patrici Cucinata

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

510(k) Number: K021964