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 Description

The Alpha Infusion Pump consists of two elastomeric chambers, which pressurize the medication. These chambers are protected in a plastic housing. A one-way check valve is provided to fill these chambers. Medication delivered from the elastomeric chambers is filtered through a 5-micron filter and held in an outflow chamber. An internal pressure regulator maintains the pressure of the medication in the outflow chamber at 6 psi in order to provide a constant flow rate through each infusion catheter inserted through the septum into the outflow chamber of the pump.

AI/ML Overview

This document is a 510(k) summary for the Alpha Infusion Pump and describes a change to the device, not a study evaluating acceptance criteria of a device's performance. Therefore, most of the requested information cannot be extracted from the provided text.

The primary purpose of this 510(k) submission is to demonstrate substantial equivalence of a modified Alpha Infusion Pump by changing the elastomeric chamber material. As such, it does not contain a study presenting acceptance criteria and device performance in the manner typically associated with clinical or standalone performance studies for AI/ML-based medical devices.

Here's a breakdown of what can be extracted based on the input text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not Applicable. The document describes a change in material for a component of an infusion pump and asserts substantial equivalence to a predicate device. It does not present specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity) or report device performance against such criteria for a new feature or algorithm. The "performance" being assessed here is the functional equivalence of the new material, not a clinical outcome or diagnostic accuracy.

2. Sample size used for the test set and the data provenance:

Not Applicable. This document does not describe a test set or data provenance for evaluating an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. Ground truth establishment by experts is not relevant to this type of device modification submission.

4. Adjudication method for the test set:

Not Applicable. Adjudication methods are not described as there is no test set in the context of an AI/ML performance evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not Applicable. This is not an AI/ML device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

Not Applicable. Ground truth is not relevant to this device modification. The "truth" being established is the functional equivalence of the new material to the old.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no training set mentioned.

9. How the ground truth for the training set was established:

Not Applicable. Not an AI/ML device.

Key Information from the Document:

Device Name: Alpha Infusion Pump
Modification: The elastomeric chamber material is being changed from medical grade polyisoprene to medical grade silicone.
Reason for Change: Silicone is already used elsewhere in the pump (septum, pressure regulator, check valve), and polyisoprene will no longer be used. Silicone elastomer chambers are also used in predicate devices (Accufuser and Accufuser Plus).
Conclusion of the Manufacturer: The Alpha Infusion Pump with silicone elastomer chambers is "substantially equivalent" to the current Alpha Infusion Pump with polyisoprene chambers.
FDA Decision: The FDA determined the device is "substantially equivalent" based on the provided information.

Summary

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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: 909.305.0895 www.advancedinfusion.com

K07,532

510(k) SUMMARY – Safety and Effectiveness

Alpha Infusion Pump

Owner:	Advanced Infusion, Inc.920 E. University Drive. Suite D202Tempe, Arizona 85281(480) 768-9747(480) 894-5288 fax	19 2008
Contact:	James ChristensenVice President Operations(909) 394-4916
Date Prepared:	February 12, 2008
Trade Name:Common Name:Classification Name:	Alpha Infusion PumpInfusion PumpElastomeric Infusion Pump(21 CFR 880.5725, Product Code MEB)
Predicate Devices:	K021964 - Alpha Infusion Pump and CathetersK003915 - Accufuser and Accufuser Plus
Device Description:	The Alpha Infusion Pump consists of two elastomeric chambers,which pressurize the medication. These chambers are protectedin a plastic housing. A one-way check valve is provided to fillthese chambers. Medication delivered from the elastomericchambers is filtered through a 5-micron filter and held in anoutflow chamber. An internal pressure regulator maintains thepressure of the medication in the outflow chamber at 6 psi inorder to provide a constant flow rate through each infusioncatheter inserted through the septum into the outflow chamber ofthe pump.
Intended Use:	The Alpha Infusion Pump is intended for the infusion of a localanesthetic into a surgical site or body cavity, post-operatively. forthe relief of pain. Medication is intended to be delivered througha catheter containing a flow restriction element. The AlphaInfusion Pump is intended for use in the hospital or by anambulatory 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: 909.305.0895 www.advancedinfusion.com

510(k) SUMMARY – Safety and Effectiveness

TechnologicalComparison:	The elastomeric chamber material for the Alpha Infusion Pump isbeing changed from medical grade polyisoprene to medical gradesilicone. The silicone elastomer chosen has substantially thesame material properties as the previous used polyisopreneelastomer.
	Silicone is already used elsewhere in the pump for the septum, inthe pressure regulator, and in the check valve. Polyisoprene willno longer be used in the Alpha Infusion Pump. Siliconeelastomer chambers are also used in Accufuser and AccufuserPlus infusion pumps marketed by McKinley.
Conclusion:	The Alpha Infusion Pump with the silicone elastomer chambersis substantially equivalent to the current Alpha Infusion Pumpwith 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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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:

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

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

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

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:

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
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.(b)
Classification. Class II (performance standards).