BIG BAG 3000 PRESSURE INFUSOR

K973133 · Byron Medical · FRN · Sep 12, 1997 · General Hospital

Device Facts

• Record ID: K973133
• Device Name: BIG BAG 3000 PRESSURE INFUSOR
• Applicant: Byron Medical
• Product Code: FRN · General Hospital
• Decision Date: Sep 12, 1997
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

Device Story

The Big Bag 3000 Pressure Infusor is a device designed for general surgical fluid irrigation and infiltration. It operates by using compressed nonflammable gases within a closed, inflatable bladder (cuff) to apply external pressure to a fluid bag. This mechanical pressure facilitates the infusion of fluids during surgical procedures. The device is intended for use in a clinical or surgical setting by healthcare professionals. By providing a controlled, pressurized delivery of irrigation or infiltration fluids, the device assists clinicians in managing fluid administration during surgery, potentially improving procedural efficiency and patient outcomes.

Clinical Evidence

bench testing only

Technological Characteristics

The device consists of an inflatable cuff and a mechanism for applying compressed nonflammable gas. It is a mechanical, non-electronic device. It does not incorporate software or complex algorithms. Materials and specific technical standards are not detailed in the provided documentation.

Indications for Use

Indicated for general surgical fluid irrigation and infiltration in patients requiring pressurized fluid delivery.

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 / MX 820-10 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)

Submission Summary (Full Text)

{0}------------------------------------------------

SEP 1 2 1997

K973133

# Byron Medical Confidential - TRADE SECRET

### 510(k) SUMMARY

This 510(k) summary of safety and effectiveness information is being submitted in This 510(K) Summary of Saloty and Check Chool Chool and 21 CFR § 807.92

The assigned 510(k) number is:________________________________________________________________________________________________________________________________________________

| Submitted by: | Steve Bollinger<br>V.P. Research and Development<br>Byron Medical, Inc.<br>3280 East Hemisphere Loop<br>Tucson, AZ 85706 |
|----------------|--------------------------------------------------------------------------------------------------------------------------|
| | Telephone #: [phone]<br>Facsimile #: [phone] |
| Date Prepared: | 15 August, 1997 |

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.

| Classification Name: | Pressure Infusor for an I.V. bag<br>21 CFR § 880.5420 (1997) |
|----------------------|----------------------------------------------------------------------|
| | Laparoscope, Gynecologic and Accessories<br>21 CFR § 884.1720 (1996) |
| | Jet Lavage<br>21 CFR § 880.5475 (1997) |
| Common/Usual Name: | Pressurized Irrigation/Infiltration Pump |
| Proprietary Name: | Big Bag 3000 Pressure Infusor |
| Indication for Use: | General surgical fluid irrigation and infiltration. |

{1}------------------------------------------------

## Byron Medical Confidential - TRADE SECRET

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

Device Description:

The principles of operation and technology incorporated in the Big Bag 3000 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.

The principles of operation and technology Substantial Equivalence Claim: incorporated in the Byron Medical Big Bag 3000 are similar to other irrigation devices with the function to pressurizing bags of fluid which the FDA has founded to be substantially equivalent to pre-amendment devices as outlined below.

> MX820-5 Pressure Infusor 500cc / MX 820-10 Product: Pressure Infusor 1000cc Manufacturer: Medex. Inc. 510(k) Number: K800560 Substantial Equivalence Date: 29 April 1980

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

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

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

#### end of summary-

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure with three flowing lines forming the head and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 1997

Mr. Steve Bollinger Vice President Research and Development Byron Medical, Incorporated 3280 East Hemisphere Loop Tucson, Arizona 85706

Re : K973133 Big Bag 3000 Pressure Infusor Trade Name: Regulatory Class: II Product Code: FRN Dated: Auqust 15, 1997 Received: August 21, 1997

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 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 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, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, the Food and Drug Administration (FDA) action. may publish further announcements concerning your device in the Federal Register. Please note: 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 Regulations.

{3}------------------------------------------------

Page 2 - Mr. Bollinger

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 immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in anyway represent your device or its labeling as being approved by FDA. If you desire specific advice for your device on our labeling requlation (21 CFR part 801 and additionally 809.10 for in vitro diagnostic devices), promotion, or advertising, please contact the Office of Compliance, Promotion and Advertising Policy Staff (HFZ-302) at [phone]. 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 at [phone].

Sincerely yours,

Clus
Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

{4}------------------------------------------------

510(k) Number (if known): _K973133

Device Name: Big Bag 3000 Pressure Infusor for General Fluid Imgation/Infiltration

Indications for Use:

The Big Bag 3000 Pressure Infusor indications for use are general surgical fluid irrigation and infiltration.

(Please DO NOT WRITE BELOW THIS LINE - Continue on another Page if needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

10

Patrici Cucomite

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Device 510(k) Number

Prescription Use (Per 21 CFR 801.109

Over-The Counter Use

(Optional Format 1-2-96)