PAIN CARE 2000

K983454 · Breg, Inc. · MEB · Dec 16, 1998 · General Hospital

Device Facts

• Record ID: K983454
• Device Name: PAIN CARE 2000
• Applicant: Breg, Inc.
• Product Code: MEB · General Hospital
• Decision Date: Dec 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

Device Story

Pain Care 2000 is a patient-controlled infusion device for local anesthetic delivery. It functions as a delivery mechanism for maintenance doses of anesthetic to sustain pain relief established by an initial intra-operative bolus. Used in clinical settings for post-operative pain management; operated by patients under physician guidance. Device provides continuous or intermittent infusion to the surgical site, aiming to extend analgesic effects and improve patient comfort post-surgery.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Infusion device for local anesthetic delivery; mechanical delivery mechanism for maintenance dosing; intended for intra-operative site administration.

Indications for Use

Indicated for post-operative pain management via patient-controlled intermittent infusion of local anesthetic into an intra-operative site following an initial intra-operative loading dose.

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

DEC 1 6 1998

Ms. Kathleen Barber Vice President of Regulatory Affairs BREG®, Incorporated 2611 Commerce Way Vista, California 92083

K983454 Re : PAIN CARE 2000 Trade Name: Regulatory Class: Unclassified Product Code: MEB September 29, 1998 Dated: Received: September 30, 1998

Dear Ms. Barber:

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 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 (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. ਸ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, 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 Reqister. 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 - Ms. Barber

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 and 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" (21CFR 807.97). Other qeneral 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/dsma/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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## STATEMENT OF INDICATIONS FOR USE

## Intended Use

BREG's Pain Care 2000 is intended to provide patient controlled intermittent infusion of a local anesthetic into an intra-operative site for the post-operative management of pain. BREG's Pain Care 2000 provides a delivery mechanism of local anesthetic maintenance doses in order to sustain pain relief that is initially established by the bolus of local anesthetic that is injected intra-operatively (loading dose).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

OR

Over-The-Counter Use

Patricia Cucenbe
(Division Sign Off)
(Optional Format 1-2-96)

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device

510(k) Number K983454