DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM

K072921 · Symbios Medical Products, LLC · MEB · Nov 26, 2007 · General Hospital

Device Facts

• Record ID: K072921
• Device Name: DISPOSABLE INFUSION PUMP KIT, GO PUMP RAPID RECOVERY SYSTEM
• Applicant: Symbios Medical Products, LLC
• Product Code: MEB · General Hospital
• Decision Date: Nov 26, 2007
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

Device Story

GOPump Rapid Recovery System is a disposable, self-contained infusion pump; utilizes inflatable elastomeric reservoir to provide mechanical infusion of prescribed solutions; intended for post-operative pain management; operated by healthcare professionals in clinical settings; provides continuous delivery of medication to patient; benefits include simplified pain management administration.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Disposable, self-contained infusion system; utilizes inflatable elastomeric reservoir for mechanical fluid delivery; percutaneous administration; non-electronic/mechanical operation.

Indications for Use

Indicated for post-operative pain management via percutaneous infusion of prescribed solutions.

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)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows a black and white seal for the Department of Health and Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the edge. In the center of the seal is a stylized image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 6 2007

Mr. Jeffrey Alholm President, Chief Executive Officer Symbios medical Products, LLC 7301 Georgetown road, Suite 150 Indianapolis, Indiana 46268

Re: K072921

: «ﺍﻟﺘﻲ ﺍﻟﻤﺮﺍﺟﻊ

. ''. '.•

Trade/Device Name: GOPump Rapid Recovery System, Disposable Infusion Pump Kit Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: MEB, KGZ,BSO Dated: October 12, 2007 Received: October 15, 2007

Dear Mr. Alholm:

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 cither 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.

{1}------------------------------------------------

## Page 2 - Mr. Alholm

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/industry/support/index.html.

Sincerely yours.

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

2

## Enclosure

{2}------------------------------------------------

## ATTACHMENT 2

## Indications for Use

510(k) Number: K072921.

Device Name(s): GOPump Rapid Recovery System (or) Disposable Infusion Pump Kit

Indications for Use:

The Disposable Infusion Pump is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a presely for post-operative pain management.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Condon D. In

. Division Sign-Off)

Oivision of Anesthesiology, General Hospital nfection Control, Dental Devices

10(k) Number: _ K 472991

Page 1 of *_*_

Page 15 of 19