K Number
K080149
Device Name
HEATER BASE, MODEL PMH7000
Date Cleared
2008-12-18

(331 days)

Product Code
Regulation Number
868.5450
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 Description
The Humidifier Heater Base, PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.
More Information

Not Found

No
The summary describes a humidifier heater base and does not mention any AI or ML capabilities.

No.
The device facilitates the humidification and warming of breathing gases, which supports patient respiration, but it does not directly treat a disease or condition itself. It's an accessory to a ventilator, which is a therapeutic device.

No
Explanation: The device description states its purpose is to add moisture and warm breathing gases for administration to a patient, functioning as a humidifier. It does not mention any diagnostic capabilities such as detecting, monitoring, or analyzing physiological parameters or conditions.

No

The device description clearly states it is a "Humidifier Heater Base," which is a physical hardware component used in conjunction with a ventilator. It is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is to "add moisture and to warm the breathing gases for administration to a patient." This is a therapeutic function, directly interacting with the patient's breathing circuit.
  • Device Description: The description reinforces this by stating it "provides respiratory humidification through patient breathing circuit."
  • Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.

Therefore, the Humidifier Heater Base PMH7000 is a medical device used for respiratory support, not an in vitro diagnostic device.

N/A

Intended Use / Indications 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.

Product codes (comma separated list FDA assigned to the subject device)

BTT

Device Description

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

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

Adult

Intended User / Care Setting

Hospital and home

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K020700

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 868.5450 Respiratory gas humidifier.

(a)
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.(b)
Classification. Class II (performance standards).

0

Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'P' at the top and the word 'MEDICO' at the bottom. The letter 'P' is large and ornate, with thick and thin lines creating a sense of elegance. The word 'MEDICO' is in a simple, sans-serif font, and it is placed directly below the left side of the 'P'.

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: +81 3-3818-6127 Fax: +81 3-3818-6128

OFFICIAL CONTACT

Yukio Tomisawa

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Image /page/1/Picture/1 description: The image shows the text "510(k) Summary" in a large, bold font. Above the text is a logo that includes the word "MEDICO" in a smaller font. The logo also features a stylized letter "P" in a decorative font. The image appears to be a title or heading for a document related to a 510(k) submission, which is a type of premarket submission to the FDA.

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

ComparisonPegasus ResearchPacific Medico
ParameterPMH5000PMH7000
K020700
Intended UseRespiratory HumidificationRespiratory Humidification
General(1) Humidification:
Heat distilled water in the
humidification chamber placed on
the heater base.
(2) Heater Plate:
Using heater plate to heat distilled
water.
(3) Humidified Gas:
Humidified gas generated in the
chamber led to patient's breathing
circuit through inspiratory tube.
(4) Inhaling humidified gas:
Patient inhale ventilator supplied
gas together with humidified gas.
(5) Flow per minute:
5 liters(1) Humidification:
Heat distilled water in the
humidification chamber placed on
the heater base.
(2) Heater Plate:
Using heater plate to heat distilled
water.
(3) Humidified Gas:
Humidified gas generated in the
chamber led to patient's
breathing circuit through
inspiratory tube.
(4) Inhaling humidified gas:
Patient inhale ventilator supplied
gas together with humidified gas.
(4) Flow per minute
5 liters
Mechanism
(Setting) Range(1) Temperature - Heater Plate
100°C Thermostat regulated
(Normal Operation)(1) Temperature - Heater Plate
100°C Thermostat regulated
(Normal Operation)
Sensor
Technology115°C Thermostat limited115°C Thermostat limited

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

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(AC power disabled)(AC power disabled)
PopulationAdultAdult
Power SourceAC115VAC115V
Method ofPatient mask through patientPatient mask through patient
Connection to
The Patientbreathing circuitbreathing circuit
Re-use(1) Heater Base main unit:
Multiple uses with proper care and
maintenance in accordance with
manual and with all other applicable
regulations.
(2) Heater Wire - Inspiratory
Multiple uses with proper care and
maintenance in accordance with
manual and with all other applicable
regulations.
(3) Heater Wire - Expiratory
Multiple uses with proper care and
maintenance in accordance with
manual and with all other applicable
regulations.
(4) Temperature Probe
Multiple uses with proper care and
maintenance in accordance with
manual and with all other applicable
regulations.(1) Heater Base main unit:
Multiple uses with proper care and
maintenance in accordance with
manual and with all other
applicable regulations.
(2) Heater Wire - Inspiratory
Multiple uses with proper care and
maintenance in accordance with
manual and with all other
applicable regulations.
(3) Heater Wire - Expiratory
Multiple uses with proper care and
maintenance in accordance with
manual and with all other
applicable regulations.
(4) Temperature Probe
Multiple uses with proper care and
maintenance in accordance with
manual and with all other
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.

5

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
Probe | Temperature
Control | Control Panel | Setting Function | Alarm | Humidity Control | Population | Power Source | Method of
Connection to |
|------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|-------------------------|------------------------|---------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|-------------------|---------------|---------------|---------------------------------|
| Comparison
Parameter | Pegasus Research
PMH5000
K020700 | Pacific Medico
PMH7000 | Discussion of
Differences and
Similarities | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode:
Temperature can be set
manually. | All alarms : displayed by LED | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
| Intended Use | The Humidifier Heater Base
PMH5000 is intended to add
moisture and to warm the
breathing gases for
administration to a patient.
The humidifier is intended for
use with flows of 5 liters per
Minute or more through the
humidifier. | 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. | No difference | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode: same as in PMH5000
IPPV Mode: Patient side & Chamber side
temperature can be pre-set.
Patient side: 40°C
Chamber side: 37°C
NPPV Mode: Patient side & Chamber side
temperature can be pre-set.
Patient side: 34°C
Chamber side: 37°C
Both IPPV and NPPV mode are controlled on
front touch panel. | All alarms: displayed by LED at the illustrated
portion on the front touch panel.

  • Refer below note for alarm details | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
    | Temperature
    Setting | Patient Side : 30 to 40 °C
    Chamber Side: 23 to 34°C | Patient Side : 30 to 40 °C
    Chamber Side: 23 to 34°C | No difference | No difference | No Difference | No difference | Differences do
    not affect safety
    or effectiveness | Differences do
    not affect safety
    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

7

Marrier

The Patient
Re-useMultiple UseMultiple UseNo difference
Heater WireControlled by an internalControlled by Switching Power SupplyDifferences do
Control PowerControlled by an
transformerTotal weight reduced almost half.not affect safety
Supplyor 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.
    1. 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.
    1. It is determined that the Performance Testing Clinical is not required because of the above comparison.

9

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.

10

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 (240) 276-0120. 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 (800) 638-2041 or (240) 276-3150 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

11

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