(81 days)
Not Found
No
The description focuses on the physical components and heating mechanism of the device, with no mention of AI or ML terms or functionalities.
No
The device warms irrigation fluids and is not used for treatment or diagnosis of a disease.
No
Explanation: The device is described as warming irrigation fluids and does not mention any function related to diagnosing a disease, condition, or other health-related issue.
No
The device description explicitly states it consists of a "warming device" with electronic control circuitry and aluminum plates, and "irrigation fluid warming disposable sets" which include physical components like a warming cassette, tubing, connectors, etc. These are hardware components, not software.
Based on the provided information, the Ranger Irrigation Fluid Warming System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "warm irrigation fluids." This is a physical process applied to a substance (irrigation fluid) before it is used in or on the body. It does not involve testing or analyzing a sample taken from the body to diagnose a condition, monitor treatment, or screen for diseases.
- Device Description: The description details a system for heating fluids as they pass through a cassette. This aligns with a device used for preparing fluids for medical procedures, not for diagnostic testing.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring analytes
- Providing diagnostic information
- Using reagents or assays
The device is clearly intended for warming fluids used in medical procedures, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Ranger Irrigation Fluid Warming System is intended to warm irrigation fluids.
Product codes
LGZ
Device Description
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.
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
Not Found
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
Not applicable.
Key Metrics
Not Found
Predicate Device(s)
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
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
1
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 (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/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 (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): 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.
ﺍﻟﻤﺴﺎﻋﺪ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘﻮﻯ ﺍﻟﻤﺴﺘ () - ) - ) - )
Section 4: Indications for Use
not most tesiology, General Hospits Jul Conticl. Liental Devices
- Kipt 4424
3
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
4
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
Fluid Warmer | Bair Hugger
Blood/Fluid Warmer | Bair Hugger Patient
Warming System | Level 1 IR-600
Normothermic
Irrigation Set |
|------------------------|---------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Flow rates | KVO-650 mL/min1 | KVO-500 mL/min | KVO-3,000 mL/hr | KVO-650 mL/min1 |
| Method of
operation | Metal plate heated
by electrical
resistance;
disposable
cassette contacts
plates | Metal plate heated by
electrical resistance;
disposable cassette
contacts plates | The warming loop
sits within the Bair
Hugger air hose.
Warm air heated to
43°C flows through
the air hose,
circulating around the
single-lumen
warming loop. | Fluids are warmed
through the use of
a sealed heat
exchanger through
which a
recirculating
solution flows. |
| Electronics | PID-controlled | PID-controlled | Warming unit uses
Bair Hugger Model
500 and 750 series to
provide heat. | Uses water bath
technology and
PID-controlled
electronics |
| Temperature | Electronically | Electronically | Electronically | Electronically |
| Control | Controlled | Controlled | Controlled | Controlled |
| Alarms | Audible and visual
over and under
temperature;
alarms activate
when temperature
is at 33°C and at
49°C. | Audible and visual
over and under
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
53°C. | Audible and visual
over temperature
alarms activate
when temperature
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).