ALLON 2001 VERSION 5

K024128 · Mtre Advanced Technology , Ltd. · DWJ · Feb 10, 2003 · Cardiovascular

Device Facts

• Record ID: K024128
• Device Name: ALLON 2001 VERSION 5
• Applicant: Mtre Advanced Technology , Ltd.
• Product Code: DWJ · Cardiovascular
• Decision Date: Feb 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.5900
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients.

Device Story

Allon 2001 version 5 is a thermal regulating system for hospital use. System components include a temperature-controlled disposable garment, body sensors, flexible water pipes, and a heating/cooling unit. The unit uses a solid-state thermo-electric device (Peltier effect) to circulate water in a closed loop. Operators select a target core temperature (30-40°C); the system uses a feedback loop from patient sensors (rectal, nasopharyngeal, or esophageal) to automatically maintain the set point. The thermo-electric design provides intrinsic safety by limiting water temperature if coolant flow is interrupted. The device is used by clinicians in ORs, ICUs, recovery, emergency rooms, and burn units to manage patient temperature. Output includes real-time monitoring of water and patient temperatures, with alarms for sensor dislodgement, temperature limits, and water flow/level issues. Benefits include precise, automated thermal regulation for patients.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, technological characteristics, and intended use comparisons to legally marketed predicate devices.

Technological Characteristics

Thermal regulating system using a solid-state thermo-electric (Peltier effect) heat pump. Closed-loop water circulation system with disposable garments. Operates on 120/230V AC. Features include feedback control loop, patient core temperature sensors (rectal/nasopharyngeal/esophageal), and integrated safety alarms for water flow, pressure, and temperature limits. Dimensions: 26cm W x 62.5cm D x 94cm H. Mobile unit with four wheels.

Indications for Use

Indicated for adult and pediatric patients requiring maintenance of pre-set body temperature or maintenance of normal body temperature during surgical procedures. Contraindicated for direct contact with open, widespread skin lesions such as burns or dermatitis. Safety/effectiveness not established for patients with multiple traumas.

Regulatory Classification

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.

Predicate Devices

• M.T.R.E. - Allon 2001 (K003349)
• Cincinnati Subzero - Blanketrol II (preamendment)

Submission Summary (Full Text)

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K024128

Section 2 - Certification and Summaries

Allon 2001 version 5 PG 1 Of 4

M.T.R.E. Advanced Technology, Ltd. POB 26, Or Akiva Industrial Park Or Akiva, Israel 30600 Tel - [972] 4-6108000 Fax - |972| 4-6108001

FEB 1 0 2003

#### Summary of Safety and Effectiveness 2.1

| Non-Confidential Summary of Safety and Effectiveness |
|------------------------------------------------------|
| page 1 of 4 |
| 11-Dec-02 |

| M.T.R.E. Advanced Technology, Ltd.<br>POB 26, Or Akiva Industrial Park<br>Or Akiva, Israel 30600 | Tel - 011-972-4-6108000<br>Fax - 011-972-4-6108001 |
|--------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Official Contact : | Shlomi Deler, QA/RA Manager |
| Proprietary or Trade Name: | Allon 2001 version 5 |
| Common/Usual Name: | Thermal Regulating System |
| Classification Name: | Thermal Regulating System |
| Device: | Allon 2001 version 5 |
| Predicate Devices: | M.T.R.E. - Allon 2001 - K003349<br>Cincinnati Subzero - Blanketrol II - preamendment |

Device Description:

The Allon 2001 vesion 5 system consists of the following elements:

- Temperature controlled disposable garment
- Body sensors ·

.

- . Connecting flexible water pipes
- Heating/Cooling Unit .

The system is operated by circulating water by a pump in a closed loop between the device and a disposable garment worn by the patient. The water circulates through the heating/ cooling unit. Temperature (body) sensors are placed on the patient and in the rectum, nasopharynx or esophageal to measure core temperature. The operator selects the desired patient core temperature and the unit operates in an automatic mode. Patient temperature is controlled and maintained at any set point between 30-40°C using a feedback loop and sensors placed on the patient's body.

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K∅24128

Allon 2001 version 5 HG 200 y

Section 2 - Certification and Summaries

### Non-Confidential Summary of Safety and Effectiveness page 2 of 4 11-Dec-02

The heating/cooling unit is based on a solid-state thermo-electric device, which operates as a heat pump. The system is intrinsically safe, due to the characteristics of the thermo-electric device, heating capacity drops off as the Thermo Electro Cooler (TEC) temperature rises. Hence, if for any reason, flow of coolant is interrupted, the TEC will overheat and the power output will fall, thus limiting water temperature rise.

The disposable garment is provided in a variety of shapes and sizes, which are manufactured of the same materials and by the same process as those already cleared under K001546, K992386 and K003349.

| Intended Use: | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use-- | The Allon 2001 version 5 is intended to maintain pre-set body<br>temperature as determined by the physician. It can also be utilized<br>to maintain normal body temperature during surgical procedures.<br>This system can be used with adult and pediatric patients. |
| Environment of Use -- | Hospital, invasive and coronary care units, in operating, recovery<br>and emergency rooms, in burn units, and on medical / surgical<br>floors |
| Contraindications-- | The Allon 2001 version 5 system should not be in direct contact<br>with open, widespread skin lesions such as burns or dermatitis. The<br>safety and effectiveness of use of the Allon2001 version 5<br>on patients with multiple traumas has not been established. |

Comparison to Predicate Devices:

| | Allon 2001 / CSZ - Blanketrol<br>K003349 Preamendment | Allon 2001 version 5 |
|---------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|
| Equipment Design | | |
| Dimensions | 26cm X 53cm X 52cm | 26cm W X 62.5cm D<br>X 94cm H |
| Weight | 33 Kg (without water in the<br>reservoir) | The same |
| Mobility | Mobile with four wheels. | The same |
| Power max. | 500 W max. | The same |
| Input power | 120/230 V ac with isolation<br>transformer | The same |
| Water tank | 6 liter | The same |
| page 3 of 4<br>11-Dec-02 | | |
| | Allon 2001 / CSZ - Blanketrol<br>K003349<br>Preamendment | Allon 2001 version 5 |
| HCU | Thermo Electro Cooler based on<br>Peltier effect. | The same |
| Control System | | |
| Water out temp' | 13-40.8 °C | The same |
| Set Point temp' | 30-40 °C | The same |
| Flow rate | 0.2-1.25Lpm | The same |
| Pressure rate | 0.1-1.3 bar | The same |
| Safety System | | |
| High primary | 41°C / CSZ - 45 °C | 42 °C |
| High secondary | 42°C / CSZ - 46 °C | 44 °C |
| High third | 44°C / CSZ - N/A | N/A |
| Low primary | 10 °C | The same |
| Pressure valve | Yes | The same |
| Safety Alert / Alarms | | |
| Dislodged sensor | Yes | The same |
| Incorrect Patient temp' setting | Yes | The same |
| High/Low patient temp' limit. | Yes | The same |
| Out of normothermia | Yes | The same |
| High/Low water temp' limit | Yes | The same |
| Low water | Yes | The same |
| Low water flow | Yes | The same |
| Water blocking | Yes | The same |
| Non - Operating Pump | Yes | The same |
| Monitoring/indicators | | |
| Water out temp' | Yes | The same |
| Not enough water in tank | Yes | The same |
| Water in temp' | Yes | The same |
| Patient Surface Temp. | Yes | The same |
| Patient core Temp. | Yes | The same |
| Water pressure | Yes | The same |
| Graphic presentation. | Yes | Modified , after changing<br>machine interface lay-out<br>display |
| Patient temp During treatment | | |
| | <i>Allon 2001 / CSZ - Blanketrol</i> | <i>Allon 2001- modified</i> |
| | <i>K003349</i><br><i>Preamendment</i> | |
| Operating Buttons | | |
| Set Point temp' | Yes | The same |
| Silence Alarm | Yes | The same |

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Section 2 - Certification and Summaries

K024128 Allon 2001 version 5 PG 3 of Y

## Non-Confidential Summary of Safety and Effectiveness

t d

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Section 2 - Certification and Summaries

# K024128 Allon 2001 version 5

PG-YOF Y

### Non-Confidential Summary of Safety and Effectiveness

page 4 of 4 11-Dec-02

### Discussion of Substantial Equivalence to Legally Marketed Predicate Devices

The Allon 2001 version 5 system is viewed as substantially equivalent to the following predicate devices - Allon 2001 system cleared under K003349, and Cincinnati Subzero - Blanketrol preamendment.

There are no significant differences between the Allon 2001 version 5 and the Allon 2001 and Cincinnati Subzero - Blanketrol, the predicate devices, that affect the safety or effectiveness of the intended device as compared to the predicate devices. Allon 2001 version 5 is viewed as substantially equivalent to the predicate devices since they:

1. Have the same intended use

- Maintain pre-set body temperature as determined by the physician. 1.1
- 1.2 Maintain normal body temperature during surgical procedures.

2. Have the same environment for use

- Are used in hospitals, invasive and coronary care units, in operating, recovery and 2.1 emergency rooms, in burn units, and on medical / surgical floors,
- 2.2 Have been designed for stationary and intra-institution transport only.
- 3. Are similar in design
- 4. Employ the same technology
- 5. Are made of identical materials

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 2003

M.T.R.E. Advanced Technology, Ltd. c/o Mr. Douglas Rash President M.T.R.E. North America, Inc. 6052 Wilmington Pick #225 Centerville, OH 45459

Re: K024128

Trade Name: Allon 2001 Version 5 Regulation Number: 21 CFR 870.5900 Regulation Name: Thermal Regulation System Regulatory Class: Class II (two) Product Code: DWJ Dated: January 20, 2003 Received: January 27, 2003

Dear Mr. Rash:

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.

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Page 2 – Mr. Douglas Rash

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,

[signature]

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### 2.3 Indications for Use

Page 1 of 1

Pursuant to the Notice of February 6, 1996 regarding listing of Indications for Use on a separate sheet, the following is per that request.

| 510(k) Number: | KΦ24128 (To be assigned) |
|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Allon 2001 version 5 |
| Intended Use | The Allon 2001 version 5 is intended to maintain pre- set body temperature as determined by the physician. It can also be utilized to maintain normal body temperature during surgical procedures. It is indicated for use in hospital invasive and coronary care units, in operating, recovery and emergency rooms, in burn units, and on medical / surgical floors. This system can be used with adult and pediatric patients. |

Concurrence of CDRH, Office of Device Evaluation (ODE)

K. De La Torre

510(k) Number K024128

Prescription Use
(Per CFR 801.109) X

or

Over-the-counter use _