RANGER IRRIGATION FLUID WARMING SYSTEM

K060939 · Arizant Healthcare, Inc. · LGZ · Jun 26, 2006 · General Hospital

Device Facts

• Record ID: K060939
• Device Name: RANGER IRRIGATION FLUID WARMING SYSTEM
• Applicant: Arizant Healthcare, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Jun 26, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

Device Story

Ranger Irrigation Fluid Warming System warms irrigation fluids for clinical use. System comprises electronic warming unit and disposable irrigation set. Disposable set includes warming cassette (heat exchanger), tubing, connectors, flow chamber with float, and clamps. Warming cassette inserts into slot in warming unit; aluminum plates heated by electrical resistance transfer heat to fluid as it passes through cassette. PID-controlled electronics manage temperature. Device provides audible and visual alarms for over/under temperature conditions. Used in clinical settings to maintain fluid temperature, potentially benefiting patients by preventing hypothermia during irrigation procedures.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Warming unit features aluminum plates heated by electrical resistance. Disposable set includes heat exchanger cassette, tubing, connectors, flow chamber, and float. System uses PID-controlled electronics for temperature regulation. Provides audible and visual alarms for temperature deviations (33°C and 49°C).

Indications for Use

Indicated for warming irrigation fluids for patients requiring such therapy.

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

• Bair Hugger Blood/Fluid Warmer (K973741)
• Bair Hugger Patient Warming System (K933726)
• Smiths Level 1 IR-600 Normothermic Irrigating Set (K873435)

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized design featuring a symbol that resembles a human figure embracing or protecting another figure, representing the department's mission of promoting health and well-being.

#### Public Health Service

## JAN 1 0 2017

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Mr. David Westlin Senior Director. Regulatory Affairs and Quality Assurance Arizant Healthcare, Incorporated 10393 West 70th Street Eden Prairie, Minnesota 55344

Re: K060939

Trade/Device Name: Ranger Irrigation Fluid Warming System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: April 3, 2006 Received: April 6, 2006

#### Dear Mr. Westlin:

This letter corrects our substantially equivalent letter of June 26, 2006.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 8091 ), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Erin I. Keith -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K060939

## Indications for Use

510(k) Number (if known): K060939

Device Name:

Ranger Irrigation Fluid Warming System

Indications For Use:

The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

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)

Page 1 of __

Arizant Healthcare Inc.

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Section 4: Indications for Use

not most tesiology, General Hospits Jul Conticl. Liental Devices

- Kipt 4424

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K060939

Page 1 of 2

JUN 26 2006

## 510(k) Summary of Safety & Effectiveness

This 510(k) Summary of Safety & Effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92. The device is a Class II device called the Ranger Irrigation Fluid Warming System.

#### Submitter

Arizant Healthcare Inc. 10393 West 70th Street, Eden Prairic, MN 55344

## Date Prepared

April 3, 2006

#### Trade/Proprietary Name Ranger® Irrigation Fluid Warming System

#### Common/Usual Name

Irrigation Fluid Warmer

Classification Name Warmer, Irrigation Solution

#### Predicate Devices

Arizant Healthcare Inc. Bair Hugger Blood/Fluid Warmer (K973741) Arizant Healthcare Inc. Bair Hugger Patient Warming System (K933726) Smiths Level 1 IR-600 Normothermic Irrigating Set (K873435)

#### Description of Device

The Ranger Irrigation Fluid Warming System consists of a warming device and an irrigation fluid warming disposable set. The warming device consists of the electronic control circuitry and aluminum plates contacted by heating elements. The irrigation disposable sets are an integral component of the total fluid warming system.

One standard irrigation fluid warming disposable set is available. The irrigation sets include a warming cassette (heat exchanger), tubing, connectors, flow chamber with float, and clamps. The warming cassette fits inside a slot in the warming device; liquids are warmed as they pass through it.

#### Intended Use

The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.

Arizant Healthcare Inc.

Section 5: 510(k) Summary of Safety & Effectiveness 1

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K060939 page 2 of 2

### Comparison of the Technological Characteristics of the New Device and Predicate Devices

The Ranger® Irrigation Fluid Warming System is substantially equivalent to the Bair Hugger Blood/Fluid Warmer (K973741), Bair Hugger Patient Warming System (K933726), and Level 1 IR-600 Normothermic Irrigating Set (K873435).

| Features | Ranger Irrigation<br>Fluid Warmer | Bair Hugger<br>Blood/Fluid Warmer | Bair Hugger Patient<br>Warming System | Level 1 IR-600<br>Normothermic<br>Irrigation Set |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Flow rates | KVO-650 mL/min1 | KVO-500 mL/min | KVO-3,000 mL/hr | KVO-650 mL/min1 |
| Method of<br>operation | Metal plate heated<br>by electrical<br>resistance;<br>disposable<br>cassette contacts<br>plates | Metal plate heated by<br>electrical resistance;<br>disposable cassette<br>contacts plates | The warming loop<br>sits within the Bair<br>Hugger air hose.<br>Warm air heated to<br>43°C flows through<br>the air hose,<br>circulating around the<br>single-lumen<br>warming loop. | Fluids are warmed<br>through the use of<br>a sealed heat<br>exchanger through<br>which a<br>recirculating<br>solution flows. |
| Electronics | PID-controlled | PID-controlled | Warming unit uses<br>Bair Hugger Model<br>500 and 750 series to<br>provide heat. | Uses water bath<br>technology and<br>PID-controlled<br>electronics |
| Temperature | Electronically | Electronically | Electronically | Electronically |
| Control | Controlled | Controlled | Controlled | Controlled |
| Alarms | Audible and visual<br>over and under<br>temperature;<br>alarms activate<br>when temperature<br>is at 33°C and at<br>49°C. | Audible and visual<br>over and under<br>temperature; alarms<br>activate when<br>temperature is at<br>33°C, at 43°C, and at<br>46°C. | Audible and visual<br>over temperature<br>alarms activate when<br>temperature is at<br>53°C. | Audible and visual<br>over temperature<br>alarms activate<br>when temperature<br>is at 43.9°C. |

#### Comparison of Technological Features

## Discussion of Nonclinical Studies and Clinical Tests

Not applicable.

#### Conclusion

The Ranger Irrigation Fluid Warming System has similar technological characteristics, components, and materials, and the same intended use as devices currently on the market. Therefore, because of the similarities to the predicate devices, Arizant Healthcare this new device does not raise any new safety or effectiveness issues.

#### Contact

David Westlin Senior Director, Regulatory Affairs and Quality Assurance, Arizant Healthcare Inc.

Arizant Healthcare Inc.

Section 5: 510(k) Summary of Safety & Effectiveness 2

¹ With scope attached (flow rates may vary due to bag height and brand of scope).