PAIN CONTROL INFUSION PUMP

K990101 · Sgarlato Laboratories, Inc. · FRN · Mar 19, 1999 · General Hospital

Device Facts

• Record ID: K990101
• Device Name: PAIN CONTROL INFUSION PUMP
• Applicant: Sgarlato Laboratories, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 19, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter. The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment. The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

Device Story

Single-use ambulatory infusion pump; delivers local anesthetic percutaneously to surgical sites for postoperative pain management. Device operates as a mechanical infusion system; intended for home or clinical use. Provides continuous medication delivery; assists in pain control. Identical in design and manufacture to predicate device.

Clinical Evidence

No clinical data; substantial equivalence based on identical design and manufacturing to the predicate device.

Technological Characteristics

Single-use ambulatory infusion pump. Mechanical delivery system. Identical materials and design to predicate device.

Indications for Use

Indicated for postoperative pain management via continuous percutaneous infusion of local anesthetic into intraoperative sites. Suitable for ambulatory use in home or clinical settings. Contraindicated for epidural, subcutaneous, or vascular delivery; not for blood, blood products, or TPN.

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.

Predicate Devices

• Burron Ambulatory Drug Delivery System (K896422)

Submission Summary (Full Text)

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3/19/99

#### 19. 510(k) Summary

# 510(k) SUMMARY - Safety and Effectiveness

K990101

## Pain Control Infusion Pump

The proposed device, the Sgarlato Laboratories Pain Control Infusion Pump, claims substantial equivalence to a currently marketed device, the Burron Ambulatory Drug Delivery System (K896422). The Pain Control Infusion Pump is identical in design to the Burron device and will be manufactured for Sgarlato Laboratories by Burron, a division of B. Braun, Inc. The Pain Control Infusion Pump is used for the same intended purpose as the Burron Ambulatory Drug Delivery System. There is no change in design, materials, method of manufacture, or intended use and only minor name changes in the labeling from the Burron device.

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Image /page/1/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 1999

Thomas Sgarlato, DPM Sgarlato Laboratories, Incorporated 250 Almendra Avenue Los Gatos, California 95030

Re : K990101 Pain Control Infusion Pump Trade Name: Requlatory Class: II Product Code: FRN February 8, 1999 Dated: January 12, 1999 Received:

Dear Mr. Sgarlato

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. ਜੋ substantially equivalent determination assumes compliance with the Good Manufacturinq Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements 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 through 542 of

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Page 2 - Mr. Sgarlato

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 requlation entitled, "Misbranding by reference to ene regaration Choroson" (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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### Statement of Indications for Use 20.

## INDICATIONS FOR USE

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________ ______________________________________________________________________________________________________________________________________________________________________________

Device Name:__________________________________________________________________________________________________________________________________________________________________ Pain Control Infusion Pump ...................................................................................................................................................

Indications for Use:

The Pain Control Infusion Pump is a single use device intended to provide continuous infusion of a local anesthetic directly into the intraoperative site for postoperative management of pain following surgery. Medication is intended to be delivered percutaneously through a catheter.

The Pain Control Infusion Pump is suitable for use as an ambulatory device and is intended for use in the home environment but not limited to use in the home environment.

The Pain Control Infusion Pump is not intended for epidural, subcutaneous or vascular drug delivery. It is not intended for the delivery of blood, blood products or TPN.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Paloux Cassente

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

2 99101 510(k) Number ________________________________________________________________________________________________________________________________________________________________

Prescription Use______________________________________________________________________________________________________________________________________________________________

OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________