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.

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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "MaxOne™ IV Fluid/Blood Warmer, Model 102." It details the device's technical specifications, intended use, and claims substantial equivalence to a previously cleared device. However, it does not contain information about acceptance criteria, a study proving the device meets those criteria, or specific details relevant to the performance evaluation of an AI/ML powered device. This document is for a physical medical device and therefore, the following questions are not applicable.

Here's an explanation that addresses the points you've asked for, based on the provided text, and highlights why much of the requested information is not present:

Responses to your numbered points:

A table of acceptance criteria and the reported device performance:
The document does not explicitly state "acceptance criteria" in the way a performance study for an AI/ML device would. Instead, it describes the device's performance characteristics and uses comparison to a predicate device (Model 101) to demonstrate substantial equivalence.

Performance Characteristic	MaxOne™ Model 102 Reported Performance	Comparison to Predicate (Model 101)
Flow Rate	1 - 150 mL/min	5 - 150 mL/min (improved lower bound)
Infusion Temperature	37°C - 41.5°C	33°C - 39°C (different range)
Alarm Condition	When temperature reaches 44°C	When temperature reaches 40°C (different threshold)

Note: The document only states "performance data demonstrate the temperature accuracy of the device at different flow rates" but does not provide specific temperature accuracy acceptance criteria or detailed results.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document refers to "performance data" but does not detail the specifics of any test set (e.g., number of tests, types of fluids, different flow rates tested). Data provenance is also not mentioned, as this is a physical device and not based on data.
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):
This information is not applicable and therefore not provided. The device warms fluids. Ground truth, in the context of expert consensus, is relevant for diagnostic or AI/ML-powered devices, not for a fluid warmer. The "ground truth" for a fluid warmer would be directly measurable physical properties like temperature and flow rate accuracy, which would be measured by instrumentation, not human experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are used in studies where human interpretation or expert opinion is involved in establishing a ground truth, such as in diagnostic imaging algorithms. For a physical device like a fluid warmer, performance is assessed through objective measurements against technical specifications.
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:
This information is not applicable and not provided. MRMC studies are designed to evaluate the performance of AI-assisted diagnostic tools where human readers interpret cases. This device is a fluid warmer, not a diagnostic tool, and does not involve human "readers" or AI assistance in that context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable and not provided. A standalone performance evaluation is relevant for AI/ML algorithms operating independently. The MaxOne™ IV Fluid/Blood Warmer is a physical device with a "microprocessor control" and thermistors, but it's not an AI/ML algorithm in the sense that would require a separate "standalone" performance study from human-in-the-loop. Its performance is inherent to its physical operation.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this device's performance would be objective physical measurements (e.g., actual fluid temperature, flow rate, alarm activation) compared against predefined engineering specifications. It would not involve expert consensus, pathology, or outcomes data. The document states "performance data demonstrate the temperature accuracy of the device at different flow rates," implying these physical measurements were taken.
The sample size for the training set:
This information is not applicable and not provided. Training sets are used for machine learning algorithms. This device is a physical medical device. It may have firmware or software controlled by a microprocessor, but it's not described as an AI/ML device that undergoes "training."
How the ground truth for the training set was established:
This information is not applicable and not provided for the same reasons as point 8.

Summary

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Automatic Medical Technologies, Inc. MaxOne™ IV Fluid/Blood Warmer, Model 102 510(k) Notification

K023653

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

1. 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 WarmerandNon-electromagnetic Radiation Blood WarmerandBlood and Plasma Warming Device

1. Legally Marketed Equivalent Device Name:
  We are claiming substantial equivalence to the MaxOne™ IV Fluid/Blood Warmer, Model 101, cleared 510(k) K002409.
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.

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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.

1. 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.
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 platesformed to accept warmingcartridge, electrical resistance	Aluminum plates formed toaccept warming cartridge,electrical resistance
Fluid contact product to beused with heating unit	MaxOne™ WarmerCartridge, a sterilepolycarbonate disposablecartridge	MaxOne™ WarmerCartridge, a sterilepolycarbonate disposablecartridge
Temperature controls	3 thermistors	4 thermistors
Alarm	Audio/visual	Audio/visual
Alarm conditions	When temperature reaches40°C	When temperature reaches44°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.

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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.

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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.

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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

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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:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
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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. . - - :

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).