PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION

K980738 · Byron Medical · FRN · Jun 16, 1998 · General Hospital

Device Facts

• Record ID: K980738
• Device Name: PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
• Applicant: Byron Medical
• Product Code: FRN · General Hospital
• Decision Date: Jun 16, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

Device Story

The Psi-Tec Syringe Infusion Pump is a pneumatically driven device designed for controlled fluid delivery during surgical procedures. It utilizes a disposable syringe cartridge connected to tubing to propel and monitor fluid volumes delivered into a surgical site. The device is intended for use in a clinical/surgical setting by healthcare professionals. By providing precise fluid delivery, the system assists in irrigation and infiltration tasks, potentially improving surgical site management and procedural efficiency.

Clinical Evidence

Bench testing only.

Technological Characteristics

Pneumatically driven infusion pump; utilizes disposable syringe cartridges and tubing for fluid delivery; system includes monitoring capabilities for delivered fluid volumes.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration.

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

• Ackrad Fluid Connecting Set (K820937)
• Big Bag 3000 Pressure Infusor (K973133)
• Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (K953574)

Submission Summary (Full Text)

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JUN 1 6 1998

K980738

## 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

The assigned 510(k) number is: K980738

Submitted by:

Steve Bollinger V.P. Research and Development Byron Medical, Inc. 3280 East Hemisphere Loop Tucson, AZ 85706

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

Date Prepared:

17 February 1998

Establishment Registration Number: Byron Medical is located at 3280 East Hemisphere Loop, Tucson, AZ 85706. We are registered with the Food and Drug Administration as Establishment Number 2025576. Irrigating Syringe Classification Name:

21 CFR § 880.6960 (1997)

Piston Syringe 21 CFR § 880.5860 (1997)

Infusion Pump 21 CFR § 880.5725 (1997)

Jet Lavage 21 CFR § 880.5475 (1997)

Syringe Irrigation/Infiltration Pump

Psi-Tec Syringe Infusion Pump

Common/Usual Name:

Proprietary Name:

Indication for Use:

General surgical fluid irrigation and infiltration.

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## Byron Medical Confidential - TRADE SECRET

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

Device Description: The principles of operation and technology incorporated in the Psi-Tec Svringe Infusion Pump and accessories are to provide controlled fluid delivery by utilizing a disposable, pneumatically driven syringe cartridge attached to tubing, that can propel and monitor fluid volumes delivered into a surgical site by the system.

Substantial Equivalence Claim: The principles of operation and technology incorporated in the Byron Medical Psi-Tec Syringe Infusion Pump and accessories are similar to other irrigation devices, with the function to deliver fluid to a surgical site, which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.

> Product: Ackrad Fluid Connecting Set Manufacturer: Ackrad Laboratories, Inc. 510(k) Number: K820937 Substantial Equivalence Date: 26 April 1982 Substantial Equivalence Letter is presented in Exhibit N.

Product: Big Bag 3000 Pressure Infusor Manufacturer: Byron Medical, Inc. 510(k) Number: K973133 Substantial Equivalence Date: 12 September 1997 Substantial Equivalence Letter is presented as Exhibit O.

Product: Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer Manufacturer: Davol, Inc. 510(k) Number: K953574 Substantial Equivalence Date: 29 September 1995 Substantial Equivalence Letter is presented as Exhibit P.

-end of summary-

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 6 1998

Mr. Steve Bollinger ·V.P. Research and Development Byron Medical 3280 East Hemisphere Loop, Suite 100 Tucson, Arizona 85706

Re: K980738 Psi-Tec Syringe Pump Trade Name: Regulatory Class: II Product Code: FRN March 25, 1998 Dated: Received: March 31, 1998

#### Dear Mr. Bollinger:

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. A 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 regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FD ) 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 - Mr. Bollinger

through 542 of 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 regulation (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 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.qov/cdrh/dsma/dsmamain.html".

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:

Sincerely yours,

Timothy A. Ulatowski

hy A. Ulatowski Timot Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Elling Station Come Comer

Enclosure ... ....

విశ్వవం
లోనూ వైద్యశాల

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510(k) Number (if known): K980738

Device Name: Psi-Tec Syringe Infusion Pump and Accessories Indications for Use:

# The Psi-Tec Syringe Infusion Pump and accessories indications for use are for General Fluid Irrigation/Infiltration.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricio Crescente

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

510(k) Number 4980738

Prescription Use (Per 21 CFR 801.109

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Over-The Counter Use

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