ALPHA INFUSION PUMP, MODEL A200, A450

K071532 · Advanced Infusion, Inc. · MEB · Feb 19, 2008 · General Hospital

Device Facts

• Record ID: K071532
• Device Name: ALPHA INFUSION PUMP, MODEL A200, A450
• Applicant: Advanced Infusion, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Feb 19, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively. for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

Device Story

Elastomeric infusion pump; consists of two elastomeric silicone chambers within plastic housing; one-way check valve for filling; 5-micron filter; internal pressure regulator maintains 6 psi in outflow chamber. Provides constant flow rate through catheter with flow restriction element. Used in hospital or by ambulatory patients for post-operative local anesthetic delivery. Device provides continuous medication infusion to manage pain; benefits patient by enabling controlled, consistent analgesic delivery post-surgery.

Clinical Evidence

No clinical data. Substantial equivalence based on technological characteristics and material comparison.

Technological Characteristics

Elastomeric infusion pump. Materials: medical grade silicone elastomer chambers, plastic housing. Sensing/actuation: internal pressure regulator (6 psi), one-way check valve, 5-micron filter. Connectivity: none. Sterilization: not specified. Software: none.

Indications for Use

Indicated for post-operative pain relief via infusion of local anesthetic into surgical sites or body cavities. Intended for hospital or ambulatory patient use.

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 (K021964)
• Accufuser and Accufuser Plus (K003915)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows a logo for "Advanced Infusion". The logo features a stylized letter "A" with an orbit-like shape encircling it. Below the symbol, the words "Advanced" and "Infusion" are printed in a simple, sans-serif font, with "Infusion" in a smaller font size.

466 W. Arrow Hwy. • Unit H • San Dimas, California 91773 909.394.4916 • fax: [phone] www.advancedinfusion.com

K07,532

# 510(k) SUMMARY – Safety and Effectiveness

### Alpha Infusion Pump

| Owner: | Advanced Infusion, Inc.<br>920 E. University Drive. Suite D202<br>Tempe, Arizona 85281<br>[phone]<br>[phone] fax | FEB | 19 2008 |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---------|
| Contact: | James Christensen<br>Vice President Operations<br>[phone] | | |
| Date Prepared: | February 12, 2008 | | |
| Trade Name:<br>Common Name:<br>Classification Name: | Alpha Infusion Pump<br>Infusion Pump<br>Elastomeric Infusion Pump<br>(21 CFR 880.5725, Product Code MEB) | | |
| Predicate Devices: | K021964 - Alpha Infusion Pump and Catheters<br>K003915 - Accufuser and Accufuser Plus | | |
| Device Description: | The Alpha Infusion Pump consists of two elastomeric chambers,<br>which pressurize the medication. These chambers are protected<br>in a plastic housing. A one-way check valve is provided to fill<br>these chambers. Medication delivered from the elastomeric<br>chambers is filtered through a 5-micron filter and held in an<br>outflow chamber. An internal pressure regulator maintains the<br>pressure of the medication in the outflow chamber at 6 psi in<br>order to provide a constant flow rate through each infusion<br>catheter inserted through the septum into the outflow chamber of<br>the pump. | | |
| Intended Use: | The Alpha Infusion Pump is intended for the infusion of a local<br>anesthetic into a surgical site or body cavity, post-operatively. for<br>the relief of pain. Medication is intended to be delivered through<br>a catheter containing a flow restriction element. The Alpha<br>Infusion Pump is intended for use in the hospital or by an<br>ambulatory patient. | | Page 1 |

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Image /page/1/Picture/0 description: The image shows a logo with the letter A at the top. A ring encircles the letter A. Below the letter A, the words "Advanced Infusion" are written in a sans-serif font. The word "Advanced" is on the top line, and the word "Infusion" is on the bottom line.

466 W. Arrow Hwy. • Unit H • San Dimas, California 91773 909.394.4916 • fax: [phone] www.advancedinfusion.com

## 510(k) SUMMARY – Safety and Effectiveness

| Technological<br>Comparison: | The elastomeric chamber material for the Alpha Infusion Pump is<br>being changed from medical grade polyisoprene to medical grade<br>silicone. The silicone elastomer chosen has substantially the<br>same material properties as the previous used polyisoprene<br>elastomer. |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Silicone is already used elsewhere in the pump for the septum, in<br>the pressure regulator, and in the check valve. Polyisoprene will<br>no longer be used in the Alpha Infusion Pump. Silicone<br>elastomer chambers are also used in Accufuser and Accufuser<br>Plus infusion pumps marketed by McKinley. |
| Conclusion: | The Alpha Infusion Pump with the silicone elastomer chambers<br>is substantially equivalent to the current Alpha Infusion Pump<br>with the polyisoprene chambers. |

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

FEB 19 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. James Christensen Vice President Operations Advanced Infusion, Incorporated 466 West Arrow Highway, Unit H San Dimas, California 91773

Re: K071532

Trade/Device Name: Alpha Infusion Pump Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB Dated: February 6, 2008 Received: February 7, 2008

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.

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Page 2 - Mr. Christensen

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 practicerequirements 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), please contact the Office of Compliance 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

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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#### 4. INDICATIONS FOR USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

The Alpha Infusion Pump is intended for the infusion of a local anesthetic into a surgical site or body cavity, post-operatively, for the relief of pain. Medication is intended to be delivered through a catheter containing a flow restriction element. The Alpha Infusion Pump is intended for use in the hospital or by an ambulatory patient.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

E. R. Ziemer, M.D.

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

510(k) Number:

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