INFPUMP INFILTRATION PUMP

K050324 · Carolina Medical, Inc. · FRN · Apr 27, 2005 · General Hospital

Device Facts

• Record ID: K050324
• Device Name: INFPUMP INFILTRATION PUMP
• Applicant: Carolina Medical, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.

Device Story

Peristaltic pump for tumescent infiltration; moves fluid from IV bag to infiltration site via mechanical roller-based tubing compression. Device contacts only external tubing; maintains fluid sterility. Used in clinical settings for body contouring procedures. Output is controlled fluid delivery to surgical site; assists clinicians in managing infiltration volume during lipoplasty. Benefits include consistent fluid delivery for tumescent anesthesia.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use compared to predicate devices.

Technological Characteristics

Peristaltic pump; mechanical roller-based fluid displacement; non-patient-contacting tubing interface; standalone unit; manual operation.

Indications for Use

Indicated for lipoplasty general tumescent infiltration including body contouring. Not for intravenous use.

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

• PSI-TEC Peristaltic Infiltration Pump (K040149)
• Klein Surgical Infiltration Pump, Model KIP-II (K031432)

Submission Summary (Full Text)

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### APR 2 7 2005

# 510(k) Summary of Safety and Effectiveness

| Submitted by: | B. Leon Wilson<br>Quality Manager<br>Carolina Medical, Inc.<br>157 Industrial Drive<br>King, NC 27021 USA |
|----------------------|-----------------------------------------------------------------------------------------------------------|
| | Telephone #: [phone]<br>Facsimile #: [phone] |
| Date Prepared: | January 28, 2005 |
| Trade Name: | Infiltration Pump |
| Common Name: | Infiltration Pump |
| Classification Name: | Infusion Pump<br>21 CFR 880.5725 (2004), Product Code FRM |

#### Establishment Registration Number:

Carolina Medical, Inc. is located at 157 Industrial Drive. We are registered with the Food and Drug Administration as Establishment Number 1017913.

#### Indications for Use:

The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.

#### Device Description:

The principles of operation and technology incorporated in the Infiltration Pump are equivalent to peristaltic infiltration/irrigation devices, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller.

The Infiltration Pump uses a multiple roller pump and a mechanical tubing clamp to squeeze and hold tubing and assist in moving fluid from an IV fluid bag to the infiltration site. As with all peristaltic pumps, the Infiltration Pump contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

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### Substantial Equivalence Claim:

Substantial Equivaloroo Claimic and technology incorporated in the Carolina The principles of operation and technology infiltration/irrigation devices with Medical innitration i amp ad with a roller, which the FDA has found to be substantially equivalent to devices as listed below:

| Product: | PSI-TEC Peristaltic |
|---------------------------------|---------------------|
| | Infiltration Pump |
| Manufacturer: | Byron Medical, Inc. |
| 510(k) Number: | K040149 |
| Substantial Equivalence Date: | June 3, 2004 |
| Substantial Equivalence Letter: | See Appendix A |

Product:

Manufacturer: 510(k) Number: Substantial Equivalence Date: Substantial Equivalence Letter: Klein Surgical Infiltration Pump, Model KIP-II HK Surgical, Inc. K031432 August 7, 2003 See Appendix A

-end of summary-

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 7 2005

Mr. Leon Wilson Quality Manager California Medical, Incorporated 157 Industrial Drive P.O. Box 307 King, North Carolina 27021-0307

Re: K050324

Trade/Device Name: Infiltration Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: February 7, 2005 Received: February 9, 2005

Dear Mr. Wilson:

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 mureations for ass barror to May 28, 1976, the enactment date of the Medical Device micrate conmiseres press that have been reclassified in accordance with the provisions of Amendinens, or to do roug, and Cosmetic Act (Act) that do not require approval of a premarket the rederal 1 000; Drug, and one may, therefore, market the device, subject to the general approvin application (the Act. The general controls provisions of the Act include confirements 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 If your device is olasbirou (soo as additional controls. Existing major regulations affecting (1 MA), it may of subject to tack and of Federal Regulations, Title 21, Parts 800 to 898. In your device ear be fourther announcements concerning your device in the Federal Register.

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Page 2 - Mr. Wilson

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 moan that I Dr mas made statutes and regulations administered by other Federal agencies. of the Act of uny 1 oderal bands and survey and submitted to: registration r ou must comply with and 807); labeling (21 CFR Part 801); good manufacturing practice alle nisting (21 et rears of ); equality systems (QS) regulation (21 CFR Part 820); and if requirements as set form in als quadis ion 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) This letter whil anon yourse organ.
The Forest notification. The FDA finding of substantial equivalence of your device to a premarket notification. - I sults 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), rf you deente spleeting af 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 may obtain 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 vours,

Smitte Michiend ms.

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):K050324

Device Name:

Infiltration Pump

Indications for Use:

The Infiltration Pump indications for use are lipoplasty general tumescent infiltration to include body contouring. The Infiltration Pump is not intended for intravenous use.

2 Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

N/A 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)

Antin Vm

( Division Sign-Off) of vision of Anesthesiology, General Hospital, Intection Control, Dental Devices

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