(79 days)
Not Found
No
The description focuses on the physical heating mechanism and temperature control based on electrical resistance, with no mention of AI or ML algorithms for temperature regulation, flow rate adaptation, or other functions.
No.
The device's intended use is to warm blood products and intravenous solutions, which is a supportive function during medical treatment, not a direct therapeutic intervention to treat a disease or condition.
No
The device is an IV fluid/blood warmer designed to warm solutions prior to administration, not to diagnose medical conditions.
No
The device description clearly outlines physical hardware components including a reusable heating unit, controller, on/off switch, and disposable cartridges with aluminum heating plates. This indicates it is a hardware device with potential software control, not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body to analyze biological samples.
- Device Function: The MaxOne™ IV Fluid/Blood Warmer, Model 102, is used to warm fluids before they are administered to a patient. It directly interacts with the fluids being infused into the body, not with samples taken from the body for analysis.
- Intended Use: The intended use clearly states "warming of blood products and intravenous solutions prior to administration." This is a therapeutic or supportive function, not a diagnostic one.
The device is a therapeutic or supportive medical device used in the administration of fluids to a patient.
N/A
Intended Use / Indications for Use
The MaxOne™ IV Fluid/Blood Warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
Product codes
LGZ
Device Description
The MaxOne™ IV Fluid/Blood Warmer consists of a single reusable heating unit with controller containing an on/off switch to be used with disposable MaxOne™ Warmer Cartridges. The device is placed in-line between a standard IV drip set and a standard IV extenstion set and is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 150 mL/min. The MaxOne™ IV Fluid/Blood Warmer will deliver temperatures at 37°C to 41.5°C.
The MaxOne™ IV Fluid/Blood Warmer opens up to reveal the aluminum heating plates. A disposable sterile MaxOne™ Warmer Cartridge is placed on the supporting pins of the aluminum heating plates. Blood, blood products and intravenous solutions travel through channels in the warmer cartridge, which is surrounded by heating channels and heated by means of electrical resistance. The device meets the requirements of UL-2601 and CAN/CSA C22.2360.1.1 M90.
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
healthcare professionals in hospital, clinical and field environments.
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
Results of studies conducted on the sterile disposable MaxOne™ Warmer Cartridge demonstrate the material to be biocompatible for its intended use. In addition, performance data demonstrate the temperature accuracy of the device at different flow rates.
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
Automatic Medical Technologies, Inc. MaxOne™ IV Fluid/Blood Warmer, Model 102 510(k) Notification
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
JAN 1 7 2003
Name of Submitter, Contact Person and Date Summary Prepared: 】.
Michael Mitsunaga Automatic Medical Technologies, Inc. 21250 Hawthorne Blvd., Suite 560 Torrance, California 90503 Phone: (323) 735-3811 Fax: (323) 735-0988
Summary Prepared On: October 29, 2002
-
- Device Name:
| Trade/Proprietary Name: | MaxOne™ IV Fluid/Blood Warmer, Model 102 |
|---|---|
| Common/Usual Name: | Blood, Blood Products and IV Fluid Warmer |
| Classification Name: | Infusion Fluid Thermal Warmer |
| and | |
| Non-electromagnetic Radiation Blood Warmer | |
| and | |
| Blood and Plasma Warming Device |
-
- Legally Marketed Equivalent Device Name:
We are claiming substantial equivalence to the MaxOne™ IV Fluid/Blood Warmer, Model 101, cleared 510(k) K002409.
- Legally Marketed Equivalent Device Name:
-
Description of the Device: 4.
The MaxOne™ IV Fluid/Blood Warmer consists of a single reusable heating unit with controller containing an on/off switch to be used with disposable MaxOne™ Warmer Cartridges. The device is placed in-line between a standard IV drip set and a standard IV extenstion set and is designed to warm blood, blood products and intravenous liquids at flow rates of up to and including 150 mL/min. The MaxOne™ IV Fluid/Blood Warmer will deliver temperatures at 37°C to 41.5°C.
1
The MaxOne™ IV Fluid/Blood Warmer opens up to reveal the aluminum heating plates. A disposable sterile MaxOne™ Warmer Cartridge is placed on the supporting pins of the aluminum heating plates. Blood, blood products and intravenous solutions travel through channels in the warmer cartridge, which is surrounded by heating channels and heated by means of electrical resistance. The device meets the requirements of UL-2601 and CAN/CSA C22.2360.1.1 M90.
-
- Intended Use of the Device
The MaxOne™ IV Fluid/Blood Warmer is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
- Intended Use of the Device
-
Comparison of technological characteristics With Predicate Device 6.
The MaxOne™ IV Fluid/Blood Warmer, Model 102, is substantially equivalent to the MaxOne™ IV Fluid/Blood Warmer, Model 101, cleared 510(k) K002409.
| Features | MaxOne™
Model 101 | MaxOne™
Model 102 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Heating method | Aluminum heating plates
formed to accept warming
cartridge, electrical resistance | Aluminum plates formed to
accept warming cartridge,
electrical resistance |
| Fluid contact product to be
used with heating unit | MaxOne™ Warmer
Cartridge, a sterile
polycarbonate disposable
cartridge | MaxOne™ Warmer
Cartridge, a sterile
polycarbonate disposable
cartridge |
| Temperature controls | 3 thermistors | 4 thermistors |
| Alarm | Audio/visual | Audio/visual |
| Alarm conditions | When temperature reaches
40°C | When temperature reaches
44°C |
| Electronics | Microprocessor control | Microprocessor control |
| Operation | 110v AC | 110v AC |
| Flow | 5 - 150 mL/min | 1 - 150 mL/min |
| Infusion Temp | 33°C - 39°C | 37°C - 41.5°C |
| Dimensions | 3.25"W x 1.7"L x 9.7"H | 3.25"W x 1.7"L x 9.7"H |
| Weight | 2 lbs. 10 oz. | 2 lbs. 10. oz. |
rison of Technological Features
7. Discussion of Non-clinical Studies
Results of studies conducted on the sterile disposable MaxOne™ Warmer Cartridge demonstrate the material to be biocompatible for its intended use. In addition, performance data demonstrate the temperature accuracy of the device at different flow rates.
2
Automatic Medical Technologies, Inc. MaxOne™ IV Fluid/Blood Warmer, Model 102 510(k) Notification
8. Conclusion
The MaxOne™ IV Fluid/Blood Warmer, Model 102, has the same technological characteristics and intended use as the Model 101. Therefore, the Model 102 does not raise any new safety or effectiveness issues.
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three heads, representing the department's focus on health and human services. The figure is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 1 7 2003
Automatic Medical Technologies, Incorporated C/O Ms. Cindy Martin The Regulatory Consultants 1711 North Bush Street Santa Ana, California 92706
Re: K023653
Trade/Device Name: MaxOne™ IV Fluid/Blood Warmer, Model 102 Regulation Number: 864.9205 Regulation Name: Blood and Plasma Warming Device Regulatory Class: II Product Code: LGZ Dated: October 29, 2002 Received: October 30, 2002
Dear Ms. Martin:
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 Fecleral Register.
4
Page 2 - Ms. Martin
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807,97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Les Lilienthal
Timothy A. Ulatowski Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
4.0 Indications For Use Statement
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name: MaxOne™ IV Fluid/Blood Warmer, Model 102
Indications For Use:
The MaxOne™ IV Fluid/Blood Warmer, Model 102, is indicated for the warming of blood products and intravenous solutions prior to administration. It is intended to be used by healthcare professionals in hospital, clinical and field environments.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -- | -------------------------------------------------------- |
| Prescription Use ( | OR | Over-The-Counter Use ( ) | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | ||
| (Division Sign-Off) |
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| Traditional 510(k) October 2002 | |
|---|---|
| 510(k) Number: | K023653 |
6n (ODD) ACDDU OFG en с . 1. . - - :