1000 PRESSURE INFUSION SIGMACON 1000

K990447 · Valley West, Inc. · FRN · May 12, 1999 · General Hospital

Device Facts

• Record ID: K990447
• Device Name: 1000 PRESSURE INFUSION SIGMACON 1000
• Applicant: Valley West, Inc.
• Product Code: FRN · General Hospital
• Decision Date: May 12, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

General surgical fluid irrigation and infiltration.

Device Story

1000 Pressure Infusor is a device for general surgical fluid irrigation and infiltration. It utilizes a closed bladder (inflatable cuff) to apply direct pressure externally to a bag of fluid. This mechanical pressure forces the fluid out of the bag for infusion. The device is intended for use in a surgical setting by healthcare professionals. By providing a controlled, pressurized flow of irrigation fluid, it assists surgeons during procedures requiring fluid delivery. The device operates via compressed nonflammable gases to inflate the cuff, requiring no complex electronic or software-based control systems.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical pressure infusor; utilizes an inflatable cuff/bladder system; powered by compressed nonflammable gas; designed for external application to standard IV fluid bags; non-electronic, non-software device.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration in patients requiring such procedures.

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 (K922286)
• Niagara Pump, 3.0 Liter High Volume (K924530)
• Big Bag 3000 (K973133)
• Lapro Flow 3000 (K980089)

Submission Summary (Full Text)

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K990447

## 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: _______________________________________________________________________________________________________________________________________________

| Submitted by: | C. Kenneth French<br>President<br>Valley West, Inc.<br>Hwy 6, North<br>Meridian, Texas 76665<br>Telephone #: [phone]<br>Facsimile #: [phone] |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | 19 November 1998 |
| Establishment Registration Number: | Valley West, Inc. is located at Hwy 6, North, Meridian, Texas 76665.<br>We are registered with the Food and Drug Administration as<br>Establishment Number 1645369. |
| Classification Name: | Pressure Infusor for an IV bag<br>21 CFR § 880.5420 (1997)<br>Laparoscope, Gynecologic and Accessories<br>21 CFR § 884.1720 (1996)<br>Jet Lavage<br>21 CFR § 880.5475 (1997) |
| Common/Usual Name: | Pressurized Irrigation/Infiltration Pump |
| Proprietary Name: | 1000 Pressure Infusor |
| Indication for Use: | General surgical fluid irrigation and infiltration. |
| Device Description: | The principles of operation and technology incorporated in the 1000<br>Pressure Infusor are equivalent to pressurized irrigation systems, which<br>use compressed nonflammable gases within a closed bladder (inflatable<br>cuff to apply direct pressure externally to a bag of fluid for infusion of<br>fluids). |

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Valley West, Inc.

Substantial Equivalence Claim:

The principles of operation and technology incorporated in the Valley West, Inc. 1000 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.

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

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

Automatic Surgical Irrigation Pump/Autocuff Product: Manufacturer: Alton Dean Medical. Inc./Spartamed, Inc. 510(k) Number: K922286 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

Product: Lapro Flow 3000 Manufacturer: ASSC 510(k) Number: K980089 Substantial Equivalence Date:

-end of summary-

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1999

Mr. C. Kenneth French Valley West, Incorporated Highway 6, North Meridian, Texas 76665

K990447 Re : 1000 Pressure Infusion Sigmacon 1000 Trade Name: Regulatory Class: II Product Code: FRN 1998 Dated: November 19, February 12, 1999 Received:

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, 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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug 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 Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. French

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/dsmamain.html".

Sincerely yours,

Susan Runner

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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Image /page/4/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 than "Inc.". The font appears to be a serif font with a slight italic slant, giving it a formal and professional look.

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: 1000 Pressure Infusor for General Fluid Irrigation/Infiltration

Indications for Use:

The 1000 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)

Prescription Use (Per 21 CFR 801.109)

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

Patricio Ciceretti

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

510(k) Number K990447