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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Ranger Rapid Flow Blood/Fluid Warming System." This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for a new AI/diagnostic device.

Therefore, many of the requested categories (such as acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable or cannot be extracted from this type of regulatory submission.

The document emphasizes that clinical tests were not necessary for the Ranger Rapid Flow blood/fluid warming system to demonstrate substantial equivalence, which further confirms the absence of the specific types of studies you've inquired about.

Here's an attempt to fill in what information is available, and explicitly state what is not applicable or not provided:

1. A table of acceptance criteria and the reported device performance

The document does not specify "acceptance criteria" in the typical sense of a diagnostic device's performance metrics (e.g., sensitivity, specificity). Instead, the comparison is based on technological characteristics and intended use to demonstrate substantial equivalence to predicate devices. The table provided compares features of the new device to two predicate devices.

Feature	Ranger Rapid Flow Blood/Fluid Warming System	Bair Hugger Blood/Fluid Warmer	Level 1 H-1028 Fluid Warming System
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 warmed through a sealed heat exchanger with recirculating solution; uses water bath technology
Electronics	PID-controlled	PID-controlled	Uses water bath technology controlled electronics
Temperature Control	Electronically Controlled	Electronically Controlled	Electronically Controlled
Alarms	Audible & visual under/over temperature; activate at 25°C, 45.5°C, 46°C	Audible & visual under/over temperature; activate at 33°C, 43°C, 46°C	Audible & visual over temperature; activate 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	Manufactured/assembled in filtered air; each set placed in box then sealed in polyethylene/tyvek pouch	Manufactured/assembled in filtered air; each set placed in box or sealed in polyethylene/tyvek pouch	Disposable set placed within a box

The general "acceptance criterion" for this 510(k) submission is that the device demonstrates substantial equivalence to existing legally marketed predicate devices, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. The conclusion states: "The Ranger Rapid Flow blood/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."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document explicitly states: "Clinical tests were not necessary regarding the use of the Ranger Rapid Flow blood/fluid warming system." This implies no formal clinical test set or data was used in the context of human patient data for this submission. The comparison is based on engineering specifications and intended use.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No ground truth establishment by experts for a test set is described, as clinical testing was deemed unnecessary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set and thus no adjudication method is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a blood/fluid warming system, not an AI or diagnostic imaging device. An MRMC study is irrelevant for this product type.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an algorithm-based device requiring standalone performance evaluation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. No ground truth in this context was established or used, as no clinical studies with human data were performed for this submission. The "truth" for this submission is based on the functional specifications and performance characteristics of the device being sufficiently similar to predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a training set.

9. How the ground truth for the training set was established

Not applicable. As there's no training set, there's no ground truth establishment for it.

Summary

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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

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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 (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

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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.

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

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 FlowBlood/Fluid WarmingSystem	Bair HuggerBlood/Fluid Warmer	Level 1 H-1028 FluidWarming System
Features
Flow rates	KVO-1200 mL/min	KVO-500 mL/min	KVO-1400 mL/min
Method ofoperation	Aluminum plate heatedby electrical resistance;disposable cassettecontacts plates	Aluminum plate heatedby electrical resistance;disposable cassettecontacts plates	Fluids are warmed throughthe use of a sealed heatexchanger through which arecirculating solution flows.Uses water bath technologycontrolled electronics
Electronics	PID-controlled	PID-controlled	Uses water bath technologycontrolled electronics
TemperatureControl	Electronically Controlled	Electronically Controlled	Electronically Controlled
Alarms	Audible and visual underand over temperature;alarms activate whentemperature is at 25°C, at45.5°C, and at 46°C.	Audible and visual underand over temperature;alarms activate whentemperature is at 33°C, at43°C, and at 46°C.	Audible and visual overtemperature alarms activatewhen temperature is at43.9°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 maxOD.
Sterilizationmethod	100% Ethylene Oxide,reference Isomedix SoftCycle.	100% Ethylene Oxide,reference Isomedix SoftCycle.	100% Ethylene Oxide,reference Isomedix SoftCycle.
Disposablepackaging	The disposable set will bemanufactured andassemble in a filtered airenvironment. Prior toexiting the filtered airenvironment, eachdisposable set will beplaced in a box and thensealed within a pouch.The pouch is made ofpolyethylene and tyvekheader which have beenproven to resist tearing orpuncturing.	The disposable set ismanufactured andassemble in a filtered airenvironment. Prior toexiting the filtered airenvironment, eachdisposable set will beplaced in a box or sealedwithin a pouch. Thepouch is made ofpolyethylene and tyvekheader which have beenproven to resist tearing orpuncturing.	The disposable set is placedwithin 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.

Regulation Number and Section

§ 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).