PSI-TEC PERISTALTIC INFILTRATION PUMP

K040149 · Byron Medical · FRN · Jun 3, 2004 · General Hospital

Device Facts

• Record ID: K040149
• Device Name: PSI-TEC PERISTALTIC INFILTRATION PUMP
• Applicant: Byron Medical
• Product Code: FRN · General Hospital
• Decision Date: Jun 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

The PSI TEC III Peristaltic Infiltration Pump is a peristaltic irrigation system used for lipoplasty and body contouring. It utilizes a single-cam roller and grooved channel to mechanically squeeze fluid-filled tubing, moving fluid from an I.V. bag to the infiltration site. The device contacts only the external surface of the tubing, ensuring the pumping mechanism remains isolated from the fluid to maintain sterility. It is intended for use by clinicians in a surgical or clinical setting. The device assists in the delivery of tumescent fluid, facilitating the lipoplasty procedure. It is not intended for intravenous administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Peristaltic pump mechanism; single-cam roller and grooved channel design; non-contact fluid delivery; standalone device; mechanical 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

• Bi-Phasic Infiltrator (K012044)
• Autofuse V Infiltration Pump (K980394)
• Wells-Johnson Infusion System (K991437)

Submission Summary (Full Text)

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K040149

# Byron Medical Confidential - TRADE SECRET

#### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92

Submitted by:

Regina S. Harris Quality & Regulatory Affairs Manager Byron Medical, Inc. 602 W. Rillito St Tucson, AZ 85705

Telephone #: [phone] Facsimile #: [phone]

Date Prepared:

December 05, 2003

## Establishment Registration Number:

Byron Medical is located at 602 W Rillito St. We are registered with the Food and Drug Administration as Establishment Number 2025576.

| Classification Name: | Irrigating Syringe<br>21 CFR § 880.6960 (1997) |
|----------------------|-----------------------------------------------------------------------------|
| | Infusion Pump<br>21 CFR § 880.5725 (1997) |
| | Jet Lavage<br>21 CFR § 880.5475 (1997) |
| Common/Usual Name: | Syringe Irrigation/Infiltration Pump |
| Proprietary Name: | Psi-Tec Syringe Infusion Pump |
| Indication for Use: | Lipoplasty general tumescent to include liposuction and<br>body contouring. |

PROPRIETARY & CONFIDENTIAL

This document is the property of Byron Medical, Inc. in Tucson, AZ. This document may not without witten consent of executive or designated management representative.

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### 510(k) SUMMARY (cont.)

#### Device Description:

The principles of operation and technology incorporated in the PT-PINF III pump are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller

The PT-PINF III uses a single-cam roller and a grooved channel to squeeze and hold tubing and assist in moving fluid from an I.V. fluid bag to the infiltration site. As with all peristaltic pumps, the PT-PINF III contacts only the tubing/tractor and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action.

#### Substantial Equivalence Claim:

The principles of operation and technology incorporated in the Byron Medical PT-PINF III Pump and accessories are similar to other irrigation devices with the function to deliver fluid with a roller, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below:

| Product: | Bi-Phasic Infiltrator |
|---------------------------------|-------------------------------|
| Manufacturer: | Reliance Medical |
| 510(k) Number: | K012044 |
| Substantial Equivalence Date: | August 28th, 2001 |
| Substantial Equivalence Letter: | Exhibit O.I |
| Product: | Autofuse V Infiltration Pump |
| Manufacturer: | Randolph- Austin |
| 510(k) Number: | K980394 |
| Substantial Equivalence Date: | March 25th, 1998 |
| Substantial Equivalence Letter: | Exhibit O.II |
| Product: | Wells-Johnson Infusion System |
| Manufacturer: | Wells-Johnson |
| 510(k) Number: | K991437 |
| Substantial Equivalence Date: | August 30th, 1999 |
| Substantial Equivalence Letter: | Exhibit O.III |

#### -end of summary-

#### PROPRIETARY & CONFIDENTIAL

This document is the property of Byron Medical, Inc. in Tucson, AZ. This document may rot be oppied in whole or part without written consent of executive or designated management representative.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three stripes extending from its wing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

UN - 3 2004

Ms. Regina S. Harris Regulatory Affairs Manager Byron Medical, Incorporated 602 W. Rillito St. Tucson, Arizona 85705

Re: K040149

Ro40117
Trade/Device Name: The PSI TEC III Peristaltic Infiltration Pump Regulation Number: 880.5725 Regulation Name: Infusion Pump Regulatory Class: II Product Code: FRN Dated: May 3, 2004 Received: May 5, 2004

Dear Ms. Harris:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have teviewed your becatermined 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 Interstate commerce prior to that have been reclassified in accordance with the provisions of Amendinents, or to do roug, and Cosmetic Act (Act) that do not require approval of a premarket the roderal 1 004, Drag, and Coommay, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls provisions of the Fist - Insting 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 II your device is classified (000 a001 additional controls. Existing major regulations affecting (FMA), it may be subject to tass ade of Federal Regulations, Title 21, Parts 800 to 898. In your device can be found in firsher announcements concerning your device in the Federal Register.

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#### Page 2 - Ms. Harris

Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that I DA 3 issualled of a basetan and many of the with other requirements mean that IDA has made a decembers and regulations administered by other Federal agencies. of the Act of ally rederal states and regarments, including, but not limited to: registration You must comply with an the Fee s required to reart 801); good manufacturing practice and listing (21 CFR Part 807), labeling (21 cm (QS) regulation (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); a requirements as set form in the quality Systems (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 will anow you to obgin mained of your device of your device to a premits in the results in the PDF millions 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), IT you desire specific at 7.0 2019 594-4618. 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 Division [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Carl

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

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510(k) Number (if known):

K040149

Device Name:

The PSI TEC III Peristaltic Infiltration Pump

Indications For Use:

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

Prescription Use
(Part 21 CFR 801 Subpart D)

AND/OR

N/A Over-The-Counter Use _ (21 CFR 807 Subpart C)

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cathy Turner

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

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