MAXONE IV FLUID/BLOOD WARMER, MODEL 102

K023653 · Automatic Medical Technologies, Inc. · LGZ · Jan 17, 2003 · General Hospital

Device Facts

• Record ID: K023653
• Device Name: MAXONE IV FLUID/BLOOD WARMER, MODEL 102
• Applicant: Automatic Medical Technologies, Inc.
• Product Code: LGZ · General Hospital
• Decision Date: Jan 17, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5725
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

MaxOne™ IV Fluid/Blood Warmer Model 102 is a reusable heating unit used with disposable polycarbonate MaxOne™ Warmer Cartridges. Device placed in-line between standard IV drip set and extension set. Fluid travels through channels in cartridge, heated by electrical resistance via aluminum heating plates. Microprocessor-controlled system uses 4 thermistors to maintain output temperatures between 37°C and 41.5°C at flow rates up to 150 mL/min. Audio/visual alarms trigger if temperature reaches 44°C. Operated by healthcare professionals in hospital, clinical, or field environments. Provides warmed fluids to patients to prevent hypothermia or maintain normothermia during infusion.

Clinical Evidence

Bench testing only. Performance data demonstrated temperature accuracy across specified flow rates. Biocompatibility testing confirmed the safety of the sterile disposable polycarbonate warming cartridge.

Technological Characteristics

Reusable heating unit with aluminum plates; electrical resistance heating; 4 thermistors; microprocessor control; 110v AC power; disposable sterile polycarbonate cartridge; audio/visual alarm system; dimensions 3.25"W x 1.7"L x 9.7"H; weight 2 lbs 10 oz; meets UL-2601 and CAN/CSA C22.2360.1.1 M90 standards.

Indications for Use

Indicated for warming blood products and IV solutions prior to administration in patients requiring fluid therapy. Intended for use by healthcare professionals in hospital, clinical, and field settings.

Regulatory Classification

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.

Predicate Devices

• MaxOne™ IV Fluid/Blood Warmer, Model 101 (K002409)

Submission Summary (Full Text)

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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: [phone] Fax: [phone]

Summary Prepared On: October 29, 2002

- 2. 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<br>and<br>Non-electromagnetic Radiation Blood Warmer<br>and<br>Blood and Plasma Warming Device |

- 3. 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.

- 5. 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™<br>Model 101 | MaxOne™<br>Model 102 |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Heating method | Aluminum heating plates<br>formed to accept warming<br>cartridge, electrical resistance | Aluminum plates formed to<br>accept warming cartridge,<br>electrical resistance |
| Fluid contact product to be<br>used with heating unit | MaxOne™ Warmer<br>Cartridge, a sterile<br>polycarbonate disposable<br>cartridge | MaxOne™ Warmer<br>Cartridge, a sterile<br>polycarbonate disposable<br>cartridge |
| Temperature controls | 3 thermistors | 4 thermistors |
| Alarm | Audio/visual | Audio/visual |
| Alarm conditions | When temperature reaches<br>40°C | When temperature reaches<br>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.

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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 [phone]. 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 [phone] or [phone] 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:

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 |

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