GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES

K972158 · Princeton Regulatory Assoc. · MEB · Feb 20, 1998 · General Hospital

Device Facts

• Record ID: K972158
• Device Name: GO MEDICAL PATIENT CONTROLLED ANALGESIA DEVICES
• Applicant: Princeton Regulatory Assoc.
• Product Code: MEB · General Hospital
• Decision Date: Feb 20, 1998
• 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 performed through intravenous (IV) and Epidural routes of administration.

Device Story

GO Medical Patient Controlled Analgesia (PCA) devices are infusion systems designed to deliver analgesic medications to patients. Used in clinical or home settings, these devices allow for controlled administration of pain medication via intravenous or epidural routes. Operated by healthcare professionals or patients (under clinical guidance), the device automates medication delivery to manage acute or chronic pain. By providing a controlled, programmable infusion, the device ensures consistent dosing, potentially improving pain management outcomes and patient comfort compared to manual delivery methods.

Clinical Evidence

No clinical data provided; substantial equivalence based on device design and intended use.

Technological Characteristics

PCA infusion device for intravenous and epidural administration. Operates as a programmable infusion system for analgesic delivery. Technical specifications and materials not detailed in the provided documentation.

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.

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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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 20 1998

Mr. Thomas Becze President Princeton Regulatory Associates 116 Village Boulevard, Suite 200 Princeton, New Jersey 08540-5799

Re : K972158 GO Medical Patient Controlled Analgesia Trade Name: Devices Regulatory Class: II Product Code: MEB February 29, 1998 Dated: February 10, 1998 Received:

Dear Mr. Becze:

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 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 controls provisions The general controls provisions of the Act 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. Allini - 17. substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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. Becze

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

This letter will allow you to begin marketing your device as described in your 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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.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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## Indications For Use Statement

510(k) Number if known): K972158

Device 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 performed through intravenous (IV) and Epidural routes of administration.

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| Division of CDRH, Office of Device Evaluation (ODE) | |
|---------------------------------------------------------------------|---------|
| Division of Dental, Infection Control, and General Hospital Devices | |
| 510(k) Number | K972158 |
| Prescription Use (Per 21 CFR 801.109) | |

OR Over-The-Counter Use

(Optional Format 1-2-96)

(Optional Format 1-2-