(61 days)
K973741, BK020043
K973741, BK020043
No
The summary describes a system for warming fluids and controlling flow, with no mention of AI, ML, or related concepts.
No.
The device's intended use is to deliver warm blood, blood products, and liquids to patients, which is a supportive function rather than a direct therapeutic intervention that treats or cures a disease or condition. It facilitates a medical procedure but is not itself a therapy.
No
The device is a blood/fluid warming system, designed to deliver warm fluids to patients, not to diagnose a medical condition.
No
The device description explicitly lists hardware components such as warming plates, fluid detection, valve control, pressure infusors, and a fluid warming disposable set, indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided information, the Ranger Rapid Flow blood/fluid warming system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver warm blood, blood products, and liquids to adult and pediatric patients." This describes a device used on a patient for therapeutic purposes (warming fluids before infusion), not a device used to test samples from a patient to diagnose or monitor a condition.
- Device Description: The description focuses on warming fluid, detecting fluid levels, controlling a valve, and delivering fluid under pressure. These are all functions related to the physical delivery of fluids to a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Ranger Rapid Flow system does not fit this description.
N/A
Intended Use / 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.
Product codes
LGZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Clinical tests were not necessary regarding the use of the Rangor Rapid Flow blood/fluid warming system.
Key Metrics
Not Found
Predicate Device(s)
K973741, BK020043
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5725 Infusion pump.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the side. The image is simple and iconic, and is likely used to represent the department in official communications and documents.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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
3
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.
4
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.
5
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
Blood/Fluid Warming
System | Bair Hugger
Blood/Fluid Warmer | Level 1 H-1028 Fluid
Warming System |
|-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Features | | | |
| Flow rates | KVO-1200 mL/min | KVO-500 mL/min | KVO-1400 mL/min |
| Method of
operation | Aluminum plate heated
by electrical resistance;
disposable cassette
contacts plates | Aluminum plate heated
by electrical resistance;
disposable cassette
contacts plates | Fluids are warmed through
the use of a sealed heat
exchanger through which a
recirculating solution flows.
Uses water bath technology
controlled electronics |
| Electronics | PID-controlled | PID-controlled | Uses water bath technology
controlled electronics |
| Temperature
Control | Electronically Controlled | Electronically Controlled | Electronically Controlled |
| Alarms | Audible and visual under
and over temperature;
alarms activate when
temperature is at 25°C, at
45.5°C, and at 46°C. | Audible and visual under
and over temperature;
alarms activate when
temperature is at 33°C, at
43°C, and at 46°C. | Audible and visual over
temperature alarms activate
when temperature is at
43.9°C. |
| Tubing | • 144" long,
0.185" min ID,
0.273 max OD.
• Patient Line: 84" long,
0.185" min ID,
0.273 max OD. | • 144" long,
0.185" min ID,
0.273 max OD.
• Patient Line: 84" long,
0.185" min ID,
0.273 max OD. | • 68" long, 0.185" max ID,
0.273" min ID.
• Patient Line: 87" long,
0.185" min ID, 0.273 max
OD. |
| Sterilization
method | 100% Ethylene Oxide,
reference Isomedix Soft
Cycle. | 100% Ethylene Oxide,
reference Isomedix Soft
Cycle. | 100% Ethylene Oxide,
reference Isomedix Soft
Cycle. |
| Disposable
packaging | The disposable set will be
manufactured and
assemble in a filtered air
environment. Prior to
exiting the filtered air
environment, each
disposable set will be
placed in a box and then
sealed within a pouch.
The pouch is made of
polyethylene and tyvek
header which have been
proven to resist tearing or
puncturing. | The disposable set is
manufactured and
assemble in a filtered air
environment. Prior to
exiting the filtered air
environment, each
disposable set will be
placed in a box or sealed
within a pouch. The
pouch is made of
polyethylene and tyvek
header which have been
proven to resist tearing or
puncturing. | The disposable set is placed
within a box. |
Comparison of Technological Features
Arizant Healthcare Inc.
6
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.