Indications: The system is indicated for the relief of pain in patients following surgery by the continuous administration of medication into the incision site.

Device Description

AVIA Pain Medication Delivery System

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the "AVIA Pain Medication Delivery System." It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) clearance process focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study as might be required for a PMA (Premarket Approval) or de novo submission for novel devices.

Therefore, I cannot provide the requested information based on the provided text. The document primarily outlines:

Device: AVIA Pain Medication Delivery System
Applicant: AMTEC Medical, Incorporated
Regulatory Class: II
Product Code: MEA
Date of Clearance: April 22, 1999
Indications for Use: Relief of pain in patients following surgery by the continuous administration of medication into the incision site.
Contraindications: Not intended for intravenous or intra-vascular infusion.
Warnings: Disposable, do not refill or resterilize, do not overfill, follow drug manufacturer's instructions.
Caution: Federal (USA) Law restricts this device to use or sale only by or on the order of a physician.

Summary

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Image /page/0/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 an eagle or bird in flight, with three stylized human profiles incorporated into the design.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1999

Terrell L. Friedrich, R.R.T. Vice President, Sales & Marketing AMTEC Medical, Incorporated 9119 Metric Boulevard 78758 Austin, Texas

Re : K990312 AVIA Pain Medication Delivery System Trade Name: Regulatory Class: II Product Code: MEA Dated: February 26, 1999 Received: March 3, 1999

Dear Mr. Friedrich:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general The general controls controls provisions of the Act. 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Friedrich

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA acberroom in your sia will puivalence 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamajn.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

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Page _ 1 of

510 (k) NUMBER (IF KNOWN) :

DEVICE NAME: AVIA Pain Medication Delivery System

INDICATIONS FOR USE:

Indications:

The system is indicated for the relief of pain in patients following surgery by the continuous administration of medication into the incision site.

Contraindications :

This system is not intended for intravenous or intra-vascular infusion.

Warnings :

DISPOSABLE - Destroy after single patient use. Do not refill or resterilize. Do not overfill medication container. Follow drug manufacturers instructions for the medication being used.

Caution:

Federal (USA) Law restricts this device to use or sale only by or on the order of a physician.

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

CONCURRANCE OF CDRH, OFFICE of DEVICE EVALUATION (ODE)

Prescription Use (Per 21 CFR 801.109)

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Over-The Counter-Use (Optional Format 1-2)

Palocen Cassinik

··al, Infection Control,

510(k) Number K990312

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).