(129 days)
The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.
The Arctic Blast Intravenous Fluid Chiller is composed of two main components: a heat exchanger assembly and an adsorption cooling module. The sterile fluid path is incorporated in the heat exchange assembly, which consists of the heat exchanger, a spike with vented drip chamber at the heat exchanger inlet, and a spike receptacle at the heat exchanger outlet. Prior to activation, the heat exchanger assembly inlet (spike) is connected to a liter bag of sterile fluid, and the outlet (spike port) is connected to a standard commercially-available intravenous infusion set. The heat exchanger assembly is constructed of materials and components which are commonly used in the manufacture of commercially-available intravenous infusion sets. The cooling module provides the cooling capability of the device via an adsorption process. The cooling module does not require an external power source. The cooling process is activated by pressing a button on the module. The cooling module is fully sealed and does not come into direct contact with the sterile fluid path.
The provided text does not contain specific acceptance criteria or a study detailing the device's performance against such criteria. The document is a 510(k) summary for the Arctic Blast Intravenous Fluid Chiller, focusing on its substantial equivalence to predicate devices rather than a detailed performance study.
Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given information.
However, based on the provided text, I can state what is available regarding the device's characteristics and the regulatory review process:
1. A table of acceptance criteria and the reported device performance:
- Information not available in the provided text. The document asserts substantial equivalence based on intended use, design, technological characteristics, materials, and system features/functions to predicate devices. It does not provide specific performance metrics or acceptance criteria for the Arctic Blast itself.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Information not available in the provided text. The document does not describe any specific test set or clinical study for performance evaluation.
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):
- Information not available in the provided text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Information not available in the provided text.
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 thermal regulating system, not an AI-assisted diagnostic tool involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a thermal regulating system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information not available in the provided text. As no specific performance study is detailed, the type of ground truth for any such study is also not mentioned. The substantial equivalence relies on comparison to predicate devices, which would have established their own safety and effectiveness.
8. The sample size for the training set:
- Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is not an AI/ML algorithm that requires a training set and associated ground truth.
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KOrorg9
AUG - 7 2008
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
Device Name
Arctic Blast Intravenous Fluid Chiller
Manufacturer Name , Address and Contact Information
Medivance, Inc. 1172 Century Drive, Suite 240 Louisville, CO 80027
Contact: Lynne Aronson, Director RA/QA Phone: 303-926-1917 303-926-1924 Fax:
Common, Classification & Proprietary Names
| Common Name: | thermal regulating system |
|---|---|
| Classification Name: | system, hypothermia, intravenous, cooling |
| Proprietary Name: | Arctic Blast Intravenous (IV) Fluid Chiller |
Device Classification
| Classification: | Class II |
|---|---|
| Classification Panel: | Cardiovascular |
| Classification Regulation: | 870.5900 |
| Product Code: | NCX |
Indications for Use
The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.
Device Description
The Arctic Blast Intravenous Fluid Chiller is composed of two main components: a heat exchanger assembly and an adsorption cooling module.
The sterile fluid path is incorporated in the heat exchange assembly, which consists of the heat exchanger, a spike with vented drip chamber at the heat exchanger inlet, and a spike receptacle at the heat exchanger outlet. Prior to activation, the heat exchanger assembly inlet (spike) is connected to a liter bag of sterile fluid, and the outlet (spike port) is connected to a standard commercially-available intravenous infusion set.
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The heat exchanger assembly is constructed of materials and components which are commonly used in the manufacture of commercially-available intravenous infusion sets.
The cooling module provides the cooling capability of the device via an adsorption process. The cooling module does not require an external power source. The cooling process is activated by pressing a button on the module. The cooling module is fully sealed and does not come into direct contact with the sterile fluid path.
Predicate Devices
| Device Name | Manufacturer |
|---|---|
| IV Fluid Cooler / Warmer | Alsius |
| System 1025 Fast Flow Blood and Fluid Warmer | Level 1 |
| Celsius Control System | InnerCool |
| Thermosuit | Life Recovery System |
Substantial Equivalence
The Arctic Blast Intravenous Fluid Chiller was shown to be substantially equivalent in intended use, design, technological characteristics, materials and system features and functions to the predicate devices.
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Image /page/2/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 2008
Medivance, Inc. % Ms. Lynne Aronson Director, RA/QA 1172 Century Drive, Suite 240 Louisville, Colorado 80027
Re: K080899
Trade/Device Name: Arctic Blast Intravenous Fluid Chiller Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal regulating system Regulatory Class: II Product Code: NCX Dated: July 10, 2008 Received: July 15, 2008
Dear Ms. Aronson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 801); 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.
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Page 2 - Ms. Lynne Aronson
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Petmarket, Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark M. Wilkinson
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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STATEMENT OF INDICATIONS FOR USE (FDA Form)
510(k):
Device:
Arctic Blast Intravenous Fluid Chiller
Indications for Use:
The Arctic Blast® Intravenous Fluid Chiller is intended to cool sterile solutions during intravenous administration where clinically indicated for reduction of patient temperature.
Prescription Use____X Use (Per 21 CFR 801.109) OR
Over-the-Counter
(Per 21 CFR 801.109)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Alvah A. Mellers
(Division Sign-Off) (Division Sign:On)
Division of General, Restorative, Division of Neurological Devices
(Optional Format 1-2-96)
510(k) Number
§ 870.5900 Thermal regulating system.
(a)
Identification. A thermal regulating system is an external system consisting of a device that is placed in contact with the patient and a temperature controller for the device. The system is used to regulate patient temperature.(b)
Classification. Class II (performance standards).