E-PAIN CARE

K041714 · Breg, Inc. · FRN · Oct 1, 2004 · General Hospital

Device Facts

• Record ID: K041714
• Device Name: E-PAIN CARE
• Applicant: Breg, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Oct 1, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.

Device Story

E-Pain Care is an infusion pump used for post-operative pain management. It delivers local anesthetic directly into an intra-operative site. The device is intended for clinical use by healthcare professionals to manage patient pain following surgery. It functions as a delivery system for medication, aiding in patient recovery by providing localized anesthesia.

Clinical Evidence

No clinical data provided; substantial equivalence based on regulatory classification and device description.

Technological Characteristics

Infusion pump; Class II device; Product Code FRN; Regulation 880.5725.

Indications for Use

Indicated for post-operative pain management via infusion of local anesthetic into an intra-operative site.

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

OCT 1 - 2004

Ms. Kathleen Barber Vice President Quality Assurance/ Regulatory Affairs BREG, Incorporated 2611 Commerce way Vista, California 92081-8309

Re: K041714

Trade/Device Name: E-Pain Care Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: September 2, 2004 Received: September 7, 2004

Dear Ms. Barber:

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 either 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.

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Page 2 - Ms. Barber

Please be advised that FDA's issuance of a substantial equivalence determination does not I lease be actived that 12 a determination that your device complies with other requirements mean that 22 I mar may Federal statutes and regulations administered by other Federal agencies. of the Free of any I vith all the Act's requirements, including, but not limited to: registration 1 od intiles comply was a 807); labeling (21 CFR Part 801); good manufacturing practice alle fisting (21 et read of the quality systems (QS) regulation (21 CFR Part 820); and if requirences as bet form nroduct 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) Frinis for will and in your rinding of substantial equivalence of your device to a premaince notified.com - I 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), rt you dosite spiering and 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 maj South 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,

Chiu Lin, Ph.D.

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

Enclosure

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## Indications for Use

510(k) Number (if known): K041714

Device Name: e-Pain Care

Indications For Use:

BREG's e-PAIN CARETM is intended to provide infusion of a 'local anesthetic into an intra-operative site for the post-operative management of pain.

Srene Reveau for ADW 9/30/04

(Division Sign-C Division of Anesthesion Infection Control. Dent

510(k) Number: K041714

**escription Use** X

AND/OR

Over-The-Counter Use

CFR 801 Subpart D)

(21 CFR 807 Subpart C)

ASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF

Concurrence of CDRH, Office of Device Evaluation (ODE)