3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000

K980089 · Valley West, Inc. · FRN · Mar 24, 1998 · General Hospital

Device Facts

• Record ID: K980089
• Device Name: 3600 PRESURE INFUSOR, SIGMACON 3600, LAPRO FLOW 3000
• Applicant: Valley West, Inc.
• Product Code: FRN · General Hospital
• Decision Date: Mar 24, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

Device Story

3600 Pressure Infusor is a device for general surgical fluid irrigation and infiltration. It utilizes an inflatable cuff containing a closed bladder; compressed nonflammable gas is used to inflate the bladder, which applies direct external pressure to a fluid bag to facilitate infusion. The device is intended for use in a surgical setting by healthcare professionals. By providing controlled pressure to irrigation fluids, it assists in the delivery of fluids during surgical procedures, potentially benefiting the patient by maintaining consistent irrigation flow.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device consists of an inflatable cuff and a closed bladder system. It operates via pneumatic pressure using compressed nonflammable gases to exert force on fluid bags. It is a mechanical, non-electronic device.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration. Patient population not specified.

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

• MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc (K800560)
• Nezhat-Dorsey Hydro-Dissection Universal Bag Squeezer (K953574)
• Automatic Surgical Irrigation Pump/Autocuff (K92286)
• Niagara Pump, 3.0 Liter High Volume (K924530)
• Big Bag 3000 (K973133)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the text "Valley West, Inc." in a stylized font. The words are arranged horizontally, with "Valley" and "West" being larger and bolder than "Inc.". The text is black and appears to be printed on a white background.

K980089

MAR 2 4 1998

## 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:_139 8 00 89

Submitted by:

C. Kenneth French President Valley West. Inc. Hwy 6, North Meridian, Texas 76665

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

Date Prepared:

06 January 1998

Establishment Registration Number: Valley West, Inc. is located at Hwy 6, North, Meridian, Texas 76665. We are registered with the Food and Drug Administration as Establishment Number 1645369

Classification Name:

Pressure Infusor for an IV bag 21 CFR § 880.5420 (1997)

Laparoscope, Gynecologic and Accessories 21 CFR § 884.1720 (1996)

Pressurized Irrigation/Infiltration Pump

Jet Lavage 21 CFR § 880.5475 (1997)

3600 Pressure Infusor

Common/Usual Name:

Proprietary Name:

Indication for Use:

General surgical fluid irrigation and infiltration.

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Valley West, Inc.

## TRADE SECRET

## 510(k) SUMMARY (cont.)

Device Description:

The principles of operation and technology incorporated in the 3600 Pressure Infusor are equivalent to pressurized irrigation systems, which use compressed nonflammable gases within a closed bladder (inflatable cuff to apply direct pressure externally to a bag of fluid for infusion of fluids.

Substantial Equivalence Claim:

The principles of operation and technology incorporated in the Valley West, Inc. 3600 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has found to be substantially equivalent to pre-amendment devices as outlined below.

Product: MX820-5 Pressure Infusor 500cc / MX820-10 Pressure Infusor 1000cc Manufacturer: Medex, Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980

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

Product: Automatic Surgical Irrigation Pump/Autocuff Manufacturer: Alton Dean Medical, Inc./Spartamed, Inc. 510(k) Number: K92286 Substantial Equivalence Date: Unknown

Product: Niagara Pump, 3.0 Liter High Volume Manufacturer: Cabot Medical Systems 510(k) Number: K924530 Substantial Equivalence Date: 05 February 1993

Product: Big Bag 3000 Manufacturer: Byron Medical 510(k) Number: K973133 Substantial Equivalence Date: 10 September 1997 -end of summary-

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three human profiles facing right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 4 1998

Mr. C. Kenneth French ·President Valley West, Incorporated Hwy. 6, North Meridian, Texas 76665

Re : K980089 3600 Pressure Infusor, Sigmacon 3600, Lapro Trade Name: Flow 3000 Regulatory Class: II Product Code: FRN Dated: January 6, 1998 Received: January 9, 1998

Dear Mr. French:

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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

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Page 2 - Mr. French

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the regulation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

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" (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/dsma/dsmamain.html" .

Sincerely yours,

Timothy A. Ulatowski

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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Valley West, Inc.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 3600 Pressure Infusor for General Fluid Irrigation/Infiltration

Indications for Use:

The 3600 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Palacia Cuente

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

510(k) Number K980089

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use (Optional format 1-2-96)