GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

K020421 · Hennig Enterprises Europe Srl · MEA · Apr 29, 2003 · General Hospital

Device Facts

• Record ID: K020421
• Device Name: GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
• Applicant: Hennig Enterprises Europe Srl
• Product Code: MEA · General Hospital
• Decision Date: Apr 29, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))

Device Story

Go Medical Patient Controlled Analgesia (PCA) devices deliver analgesic medications to patients. Administration occurs via intravenous (IV) or epidural routes. Used for both acute and chronic pain management in clinical or home settings. Operated by healthcare professionals or patients under physician supervision. Device provides controlled medication delivery to manage pain levels, aiming to improve patient comfort and therapeutic outcomes.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion pump (Regulation 880.5725, Product Code MEA). Designed for IV and epidural analgesic delivery. Class II device.

Indications for Use

Indicated for in-patients and out-patients requiring analgesic medication delivery via intravenous (IV) or epidural routes for acute or chronic pain management. Prescription use only.

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.

Submission Summary (Full Text)

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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 features a stylized caduceus, which is a symbol of medicine, with three lines representing the staff and two snakes intertwined around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

APR 2 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dr. George O'Neal Henning Enterprises Europe S.R.L. 25 Shann Street Floreat Park Perth AUSTRALIA 6014

Re: K020421

Trade/Device Name: Go Medical Patient Controlled Analgesia Devices (PCA) Devices Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEA Dated: February 12, 2003 Received: February 24, 2003

Dear Dr. O' Neil:

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 vour 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 vour 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 - Dr. O' Neil

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 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), 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/dsma/dsmamain.html

Sincerely yours,

Susan Rumer

Susan Runner, DDS, MA Interim 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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## INDICATIONS FOR USE STATEMENT

510 (k) Number:

wmo RU20421 To be Assoned

Trade Name:

Go Medical PCA Devices

Indications For Use:

Go Medical Patient Controlled Analgesia Devices, if properly used, are intended to provide a safe and effective means of delivering various analgesic medications to in-patients and out-patients, on both an acute and/or chronic basis. This can be peformed through intravenous (IV) and epidural routes of administration. The device will be available only by prescription and will carry the following legend: "Caution : Federal Law restricts this device to sale by or on the order of a physician". (21 CFR 801.109(b)(1))

Patricia Quixote
(Division Sign Off)

Division of Anesthesiology, General Hospital, Infection Control, Dental De

510(k) Number: K220421