HEATER BASE, MODEL PMH7000

K080149 · Pacific Medico Co., Ltd. · BTT · Dec 18, 2008 · Anesthesiology

Device Facts

• Record ID: K080149
• Device Name: HEATER BASE, MODEL PMH7000
• Applicant: Pacific Medico Co., Ltd.
• Product Code: BTT · Anesthesiology
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5450
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gases for administration to a patient. The Humidifier Heater Base, PMH7000 is intended for use on adult at hospital and home.

Device Story

The PMH7000 is a respiratory humidifier heater base used in hospital and home settings to warm and humidify breathing gases for adult patients. It operates by heating distilled water in a humidification chamber placed on the heater base. The device uses a dual servo control system with platinum resistance RTD temperature probes to monitor and regulate gas temperature at both the chamber and patient sides. It supports manual, IPPV, and NPPV modes, with settings adjusted via a front touch panel. The device provides visual LED alarms for temperature deviations or probe/heater wire abnormalities. Compared to the predicate, it utilizes a switching power supply, reducing total weight. It is operated by healthcare providers or patients/caregivers to mitigate airway dryness during ventilation.

Clinical Evidence

No clinical data provided. Substantial equivalence was established through bench testing, comparison of technological characteristics, and reproducibility studies.

Technological Characteristics

Heater base with dual servo control; platinum resistance RTD sensors; switching power supply; front touch panel interface; LED alarm indicators. Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 8185, ISO 10993-1, and ISO 14971.

Indications for Use

Indicated for adult patients in hospital and home settings requiring respiratory gas humidification and warming via a breathing circuit.

Regulatory Classification

Identification

A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.

Predicate Devices

• Pegasus Research PMH5000 (K020700)

Submission Summary (Full Text)

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DEC 1 8 2008

Section 5.

#### 510(k) Summary

SUBMITTER

Pacific Medico Co., Ltd. 2-6-4 Hongo Bunkyo-ku, Tokyo Japan 113-0033 Tel: [phone] Fax: [phone]

OFFICIAL CONTACT

Yukio Tomisawa

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CLASSIFICATION REFERENCE

21 CFR Subpart C 868.5450

PRODUCT CODE TRADE/DEVICE NAME

втт Humidifier Heater Base, PMH7000 K080149

#### CLASSIFICATION

Respiratory Gas Humidifier

NAME

CLASSIFICATION

SUBMISSION DATE

December 16, 2008

Class II

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Image /page/2/Picture/1 description: The image shows a logo with a stylized letter "P" above the word "MEDICO". Below the logo, the text "Description of Device:" is printed in a bold font. The logo and text are black and white, and the image appears to be a scan or photocopy.

The Humidifier Heater Base, PMH7000is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.

Humidifier Heater Base, PMH7000 was designed to comply with applicable portions of the following standards.

| IEC 60601-1 | Medical Electrical Equipment - General Requirements for Safety<br>Requirements for Medical Electrical System |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2 | Medical electrical Equipment-Part 1: General Requirements for<br>Safety-2. Collateral Standard: Electromagnetic Compatibility -<br>Requirements and Tests |
| IEC 60601-1-4 | Medical Electric Equipment Part 1: General Requirements for<br>Safety 4. Collateral Standard:<br>Programmable Electrical Medical Systems |
| ISO 8185 | Humidifiers for Medical Use-General Requirements for<br>Humidification Systems |
| ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation and<br>Testing |
| ISO 14971 | Medical Devices-Application of Risk Management to Medical<br>Devices |

#### Intended Use

The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gases for administration to a patient.

The Humidifier Heater Base, PMH7000 is intended for use on adult at hospital and home.

| Prescription Use : | x | Over-The-Counter Use : | |
|-----------------------------|---|------------------------|--|
| (Part 21 CFR 801 Subpart D) | | (21 CFR 801 Subpart C) | |

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Substantial Equivalence to Predicate Device(s) (Part 1)

The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. This is to demonstrate that Pacific Medico PMH7000 Humidifier Heater Base for respiratory therapy (heater base) has no difference from the predicate device that would adversely affect product safety and effectiveness.

| Comparison | Pegasus Research | Pacific Medico |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Parameter | PMH5000 | PMH7000 |
| | K020700 | |
| Intended Use | Respiratory Humidification | Respiratory Humidification |
| General | (1) Humidification:<br>Heat distilled water in the<br>humidification chamber placed on<br>the heater base.<br>(2) Heater Plate:<br>Using heater plate to heat distilled<br>water.<br>(3) Humidified Gas:<br>Humidified gas generated in the<br>chamber led to patient's breathing<br>circuit through inspiratory tube.<br>(4) Inhaling humidified gas:<br>Patient inhale ventilator supplied<br>gas together with humidified gas.<br>(5) Flow per minute:<br>5 liters | (1) Humidification:<br>Heat distilled water in the<br>humidification chamber placed on<br>the heater base.<br>(2) Heater Plate:<br>Using heater plate to heat distilled<br>water.<br>(3) Humidified Gas:<br>Humidified gas generated in the<br>chamber led to patient's<br>breathing circuit through<br>inspiratory tube.<br>(4) Inhaling humidified gas:<br>Patient inhale ventilator supplied<br>gas together with humidified gas.<br>(4) Flow per minute<br>5 liters |
| Mechanism<br>(Setting) Range | (1) Temperature - Heater Plate<br>100°C Thermostat regulated<br>(Normal Operation) | (1) Temperature - Heater Plate<br>100°C Thermostat regulated<br>(Normal Operation) |
| Sensor<br>Technology | 115°C Thermostat limited | 115°C Thermostat limited |

Table 1 Technological Comparison between PMH5000 (predicate device) and PMH7000

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| | (AC power disabled) | (AC power disabled) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Population | Adult | Adult |
| Power Source | AC115V | AC115V |
| Method of | Patient mask through patient | Patient mask through patient |
| Connection to<br>The Patient | breathing circuit | breathing circuit |
| Re-use | (1) Heater Base main unit:<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other applicable<br>regulations.<br>(2) Heater Wire - Inspiratory<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other applicable<br>regulations.<br>(3) Heater Wire - Expiratory<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other applicable<br>regulations.<br>(4) Temperature Probe<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other applicable<br>regulations. | (1) Heater Base main unit:<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other<br>applicable regulations.<br>(2) Heater Wire - Inspiratory<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other<br>applicable regulations.<br>(3) Heater Wire - Expiratory<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other<br>applicable regulations.<br>(4) Temperature Probe<br>Multiple uses with proper care and<br>maintenance in accordance with<br>manual and with all other<br>applicable regulations. |

From the above technological comparison, there is no difference in the technology applied in both PMH5000 and PMH7000 which may which may affect the safety and effectiveness of the subjective devices.

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Image /page/5/Picture/8 description: The image shows a stylized letter "Q" in black, with a decorative flourish on the upper left. To the right of the "Q", there is a vertical arrangement of letters that appear to spell out "MEXICO" in a rotated orientation. The font used for "MEXICO" is a simple, sans-serif typeface, contrasting with the ornate style of the "Q".

## S ubstantial Equivalence to Predicate Device

### (Part 2)

The comparison table is provided as a summary of the technological on the predicate devices. This is to
demonstrate that Pacific Medico PMH7000 has no difference from the pr adversely affect product safety and effectiveness.

| Table 2 Discussions on Substantial Equivalence | | | | Temperature<br>Probe | Temperature<br>Control | Control Panel | Setting Function | Alarm | Humidity Control | Population | Power Source | Method of<br>Connection to |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------|------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------|---------------|---------------------------------|
| Comparison<br>Parameter | Pegasus Research<br>PMH5000<br>K020700 | Pacific Medico<br>PMH7000 | Discussion of<br>Differences and<br>Similarities | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode:<br>Temperature can be set<br>manually. | All alarms : displayed by LED | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
| Intended Use | The Humidifier Heater Base<br>PMH5000 is intended to add<br>moisture and to warm the<br>breathing gases for<br>administration to a patient.<br>The humidifier is intended for<br>use with flows of 5 liters per<br>Minute or more through the<br>humidifier. | The Humidifier Heater Base PMH7000 is<br>intended to add moisture and to warm the<br>breathing gases for administration to a patient.<br>The Humidifier Heater Base, PMH7000 is<br>intended for use on adult at hospital and home. | No difference | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode: same as in PMH5000<br>IPPV Mode: Patient side & Chamber side<br>temperature can be pre-set.<br>Patient side: 40°C<br>Chamber side: 37°C<br>NPPV Mode: Patient side & Chamber side<br>temperature can be pre-set.<br>Patient side: 34°C<br>Chamber side: 37°C<br>Both IPPV and NPPV mode are controlled on<br>front touch panel. | All alarms: displayed by LED at the illustrated<br>portion on the front touch panel.<br>* Refer below note for alarm details | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
| Temperature<br>Setting | Patient Side : 30 to 40 °C<br>Chamber Side: 23 to 34°C | Patient Side : 30 to 40 °C<br>Chamber Side: 23 to 34°C | No difference | No difference | No Difference | No difference | Differences do<br>not affect safety<br>or effectiveness | Differences do<br>not affect safety<br>or effectiveness | No difference | No difference | No difference | No difference |

F

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Image /page/6/Picture/3 description: The image shows a black and white logo. The logo features a stylized letter "Q" with a flourish at the bottom. To the right of the "Q", the word "MEDICO" is written vertically, with the letters stacked on top of each other.

KOBONA
KOBOTY

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Marrier

| The Patient | | | |
|---------------|---------------------------------|--------------------------------------|-------------------|
| Re-use | Multiple Use | Multiple Use | No difference |
| Heater Wire | Controlled by an internal | Controlled by Switching Power Supply | Differences do |
| Control Power | Controlled by an<br>transformer | Total weight reduced almost half. | not affect safety |
| Supply | | | or effectiveness |

# NOTE: * Details of alarm display on PMH7000 front touch panel at the illustrated porti

Chamber side temperature over-decreasing: color of LED becomes Orange Patient side temperature over-decreasing: color of LED becomes Orange Chamber side temperature over-increasing; color of LED becomes Red Abnormal temperature of Thermo-probe: color of LED becomes Red Patient side temperature over-increasing: color of LED becomes Re Abnormal temperature of Heater Wire: color of LED becomes Red

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Image /page/8/Picture/1 description: The image shows a stylized letter P in a bold, serif font. The letter is large and dominates the image. Below the letter, in a smaller font size, is the word "MEDICO". The overall impression is that of a logo or emblem, possibly for a medical-related entity.

#### Conclusion:

- 1) Based on the results of the comparison and reproducibility studies described in this 510(k) submission, it is concluded that the Humidifier Heater Base, PMH7000 is as safe and effective (therefore substantially equivalent) as the predicate device as an aid for mitigation of dryness of airway.
- 2) Under the above technological comparison, discussion on substantial equivalence, it is demonstrated that the subjective device is as safe and effective, performs as well as the predicate device.
- 3) It is determined that the Performance Testing Clinical is not required because of the above comparison.

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Image /page/9/Picture/1 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a bird-like figure, which is the department's emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### DEC 1 8 2008

Mr. Yoshio Toyama Manager of Regulatory Affairs Pacific Medico Company, Limited 2-6-4 Hongo, Bunkyo-ku Tokyo JAPAN 113-0033

Re: K080149

Trade/Device Name: Humidifier Heater Base: PMH7000 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: II Product Code: BTT Dated: November 26, 2008 Received: December 1, 2008

Dear Mr. Toyama:

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 ffor 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. Toyama

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. 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 [phone]. 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 Postmarket 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Sautge Y. Michels OMD.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Indications for Use

K080149 510(k) Number : Humidifier Heater Base: PMH7000 Device Name :

#### Indication for Use:

The Humidifier Heater Base PMH7000 is intended to add moisture and to warm the breathing gases for administration to a patient.

The Humidifier Heater Base, PMH7000 is intended for use on adult at hospital and home.

Prescription Use : × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use : (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smitty J. Michie Dmd

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: 长 080149