RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM

K082217 · Arizant Healthcare, Inc. · LGZ · Oct 6, 2008 · General Hospital

Device Facts

• Record ID: K082217
• Device Name: RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM
• Applicant: Arizant Healthcare, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Oct 6, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

Device Story

Ranger Rapid Flow is a stand-alone blood/fluid warming system for clinical use. It accepts blood/fluid bags (250cc-1000cc) and delivers them under pressure (300 mmHg) to achieve high flow rates. The system comprises a warming unit with aluminum plates (dry-heat) and a disposable set with a heat exchanger, bubble trap, and patient line. Operation involves PID-controlled heating (42°C setpoint) and automated fluid management; sensors in the bubble trap detect fluid levels to control a patient valve. If fluid levels are inadequate, the valve closes and pressure is exhausted from the infusors to prevent air delivery. The system provides continuous temperature monitoring and audible/visual alarms for unsafe conditions. It benefits patients by preventing hypothermia during high-volume fluid resuscitation.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dry-heat aluminum plate warming system; PID-controlled electronics; 300 mmHg pressure infusors; disposable set includes heat exchanger, bubble trap, and patient line; sterilization via 100% Ethylene Oxide; flow rates up to 1200 mL/min.

Indications for Use

Indicated for adult and pediatric patients requiring delivery of warmed blood, blood products, and liquids.

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)
• Level 1 H-1028 Fluid Warming System (BK020043)

Submission Summary (Full Text)

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

Mr. David Westlin Chief Compliance Officer Senior Director of Regulatory Affairs Arizant Healthcare Incorporated 10393 West 70th Street Eden Prairie, Minnesota 55344

JAN 1 0 2017

Re: K082217

Trade/Device Name: Ranger Rapid Flow Blood/Fluid Warming System Regulation Number: 21 CFR 880.5725 Regulation Name: Infusion Pump Regulatory Class: Class II Product Code: LGZ Dated: October 1, 2008 Received: October 2, 2008

Dear Mr. Westlin:

This letter corrects our substantially equivalent letter of October 6, 2008.

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

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Page 2 - Mr. David Westlin

CFR Part 807); labeling (21 CFR Parts 801 and 809 ); medical device reporting (reporting of 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 809]), 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/ReportalProblem/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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# Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name:

Ranger Rapid Flow Blood/Fluid Warming System

Indications For Use:

The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

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)

Ad Er-chun Lin

Page 1 of

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K

Arizant Healthcare Inc.

1

Section 4: Indications for Use

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## OCT 0 6 2008

# 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® Rapid Flow™ blood/fluid warming system.

#### Submitter

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

### Date Prepared

July 31, 2008

# Trade/Proprietary Name

Ranger® Rapid Flow™ blood/fluid warming system

#### Common/Usual Name Blood/Fluid Warmer with Pressure Infusor

Classification Name Warmer, Thermal, Infusion Fluid

#### Predicate Devices

Arizant Healthcare Inc. Bair Hugger blood/fluid warmer (K973741) Level 1 0 H-1028 Fluid Warming System (BK020043)

#### Intended Use

The Ranger Rapid Flow blood/fluid warming system is intended to deliver warm blood, blood products, and liquids to adult and pediatric patients.

Arizant Healthcare Inc.

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#### Description of Device

The Ranger Rapid Flow blood/fluid warming system is a stand-alone system that warms fluid, detects fluid level within the bubble trap, controls a patient valve, and delivers high volumes of fluid under pressure. The warming system consists of warming plates, fluid detection, valve control, pressure infusors and a fluid warming disposable set.

#### Ranger Rapid Flow blood/fluid warming unit

The warming unit consists of the clectronic control circuitry and aluminum plates contacted by heating elements, also known as dry-heat. With a setpoint of 42°C that is PID controlled, the displayed temperature is an avcrage of the fluid and plate temperature.

The air detection has two sensors that detect the fluid level (absence of air) and controls a patient valve. If the fluid level is not adequate, the patient valve closes and stops flow to the patient. When the fluid level is adcquate the patient valve opens, allowing the flow of fluid to the patient. This functionality is also tied to the operation of the pressure infusors. If the patient valve closes, the pressure is exhausted from the pressure infusors. Only if the fluid level is adequate and the valve is open can the pressure infusors be pressurized. The pressure infusor interface provides feedback to the user.

The pressure infusors accept solution bags ranging from 250cc to 1000cc. Each side of the pressure infusor is controlled independently. The pressure infusors are set to 300 mmHg and provide fluid under pressure to achieve a higher flow.

The system continuously monitors temperature and detects air in the fluid path to ensure safe operation and alarms at all unsafe conditions. The main panel on the front of the unit displays the temperature and status of the warming unit.

#### Ranger Rapid Flow disposable set

The disposable set is an integral component to the Ranger Rapid Flow blood/fluid warming system. The set has spike/filter drip chambers, heat exchanger, bubble trap, patient line with injection ports, tubing, luer locks, and other standard administration set components. The spike/drip chambers can be casily replaced during a procedure. There is an option for dual or triple spike disposable sets. The heat exchanger makes contact with the heating plates to warm the fluid. The bubble trap captures and vents air from the system. Sensors monitor the fluid level within the bubble trap and control a valve on the disposable to stop or allow flow to the patient.

Arizant Healthcare Inc.

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

The Ranger® Rapid Flow blood/fluid warning system is substantially equivalent to the Bair Hugger blood/fluid warmer (K973741) and Level 1® H-1028 Fluid Warming System (BK020043).

| | Ranger Rapid Flow<br>Blood/Fluid Warming<br>System | Bair Hugger<br>Blood/Fluid Warmer | Level 1 H-1028 Fluid<br>Warming System |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | | | |
| Flow rates | KVO-1200 mL/min | KVO-500 mL/min | KVO-1400 mL/min |
| Method of<br>operation | Aluminum plate heated<br>by electrical resistance;<br>disposable cassette<br>contacts plates | Aluminum plate heated<br>by electrical resistance;<br>disposable cassette<br>contacts plates | Fluids are warmed through<br>the use of a sealed heat<br>exchanger through which a<br>recirculating solution flows.<br>Uses water bath technology<br>controlled electronics |
| Electronics | PID-controlled | PID-controlled | Uses water bath technology<br>controlled electronics |
| Temperature<br>Control | Electronically Controlled | Electronically Controlled | Electronically Controlled |
| Alarms | Audible and visual under<br>and over temperature;<br>alarms activate when<br>temperature is at 25°C, at<br>45.5°C, and at 46°C. | Audible and visual under<br>and over temperature;<br>alarms activate when<br>temperature is at 33°C, at<br>43°C, and at 46°C. | Audible and visual over<br>temperature alarms activate<br>when temperature is at<br>43.9°C. |
| Tubing | • 144" long,<br>0.185" min ID,<br>0.273 max OD.<br>• Patient Line: 84" long,<br>0.185" min ID,<br>0.273 max OD. | • 144" long,<br>0.185" min ID,<br>0.273 max OD.<br>• Patient Line: 84" long,<br>0.185" min ID,<br>0.273 max OD. | • 68" long, 0.185" max ID,<br>0.273" min ID.<br>• Patient Line: 87" long,<br>0.185" min ID, 0.273 max<br>OD. |
| Sterilization<br>method | 100% Ethylene Oxide,<br>reference Isomedix Soft<br>Cycle. | 100% Ethylene Oxide,<br>reference Isomedix Soft<br>Cycle. | 100% Ethylene Oxide,<br>reference Isomedix Soft<br>Cycle. |
| Disposable<br>packaging | The disposable set will be<br>manufactured and<br>assemble in a filtered air<br>environment. Prior to<br>exiting the filtered air<br>environment, each<br>disposable set will be<br>placed in a box and then<br>sealed within a pouch.<br>The pouch is made of<br>polyethylene and tyvek<br>header which have been<br>proven to resist tearing or<br>puncturing. | The disposable set is<br>manufactured and<br>assemble in a filtered air<br>environment. Prior to<br>exiting the filtered air<br>environment, each<br>disposable set will be<br>placed in a box or sealed<br>within a pouch. The<br>pouch is made of<br>polyethylene and tyvek<br>header which have been<br>proven to resist tearing or<br>puncturing. | The disposable set is placed<br>within a box. |

# Comparison of Technological Features

Arizant Healthcare Inc.

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## Discussion of Nonclinical Studies and Clinical Tests

Clinical tests were not necessary regarding the use of the Rangor Rapid Flow blood/fluid warming system.

#### Conclusion

The Ranger Rapid Flow blood/fluid warming system has similar technological characteristics, components, and materials, and the same intended use as devices contently on the market. Therefore, because of the similarities to the predicate devices, Arizant Healthcare this new device does not raise any new safety or effectivencss issues.

#### Contact

David Westlin Chief Compliance Officer and Senior Director of Regulatory Affairs, Arizant Healthcare Inc.

Arizant Healthcare Inc.