(231 days)
Not Found
No
The description focuses on standard servo control systems, temperature monitoring, and safety features, with no mention of AI or ML algorithms for control, prediction, or analysis.
Yes.
The device is intended to warm and add moisture to breathing gases administered to a patient, which directly contributes to the treatment and management of respiratory conditions.
No
This device is a humidifier heater base intended to add moisture and warm breathing gases for patient administration. Its function is therapeutic (to provide humidification) rather than diagnostic (to detect, diagnose, or monitor a disease or condition).
No
The device description clearly details hardware components such as a heater base, temperature probes, heater wires, and audible/visual indicators, indicating it is a physical medical device, not software-only.
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 the patient." This is a therapeutic function, directly affecting the patient's breathing environment.
- Device Description: The description details how the device warms and humidifies gases delivered to the patient through a breathing circuit. It monitors temperatures and has safety features related to gas delivery.
- Lack of IVD Characteristics: An IVD device is 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 interact with or analyze human specimens.
The device is clearly a medical device used for respiratory support and humidification, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient.
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.
Product codes
BTT
Device Description
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.
Humidifier Heater Base, PMH7000PLUS/PMH7000 was designed to comply with applicable portions of the following standards.
Medical Electrical Equipment - General Requirements IEC 60601-1 Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2 Humidifiers for Medical Use 150 8185 ISO 14971 Medical Devices
This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient.
The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm.
The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes.
The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.
The materials used have not been changed.
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)
Non-clinical testing of Humidifier Heater Base PMH7000PLUS/ PMH7000 has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy.
PMH7000PLUS/ PMH7000 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electro medical and EMC standards, and the relevant USA deviations to these in ANSI/AAMI ES60601-1. It complies with performance and safety requirements of the ISO 8185 particular standard for Humidification Systems.
The testing carried out for Humidifier Heater Base PMH7000PLUS/PMH7000 indicates that it meets design and performance functional requirements. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key performance and safety requirements from the particular standard for humidification systems.
This information indicates that Humidifier Heater Base PMH7000PLUS/PMH7000 is substantially equivalent to the predicate devices.
- Verification and validation testing have been performed which demonstrate that PMH7000PLUS/PMH7000 function as intended and is substantially equivalent to the predicate devices for the intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
MAY 01 2014
K132857
Image /page/0/Picture/1 description: The image shows the logo and contact information for Pacific Medico Co., LTD. The address is 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan. The phone number is +81-3-3818-0573, and the fax number is +81-3-3818-7392. The website address is www.pacific-medico.com.
510(k) Summary
Sumitter/510(k) Holder
PACIFIC MEDICO
Pacific Medico Co., Ltd. 2-6-4 Hongo Bunkyo-ku, Tokyo Tel: +81 3-3818-0573 Fax: +81 3-3818-7392 Registration Number: 10028261
Contact Person: Yoshio Toyama
Date of Preparation: March 20, 2014
Manufacturing Facility
Pacific Denshi Co., Ltd. 650-6, Okaisshiki, Sizuoka, 410-0012, Japan Registration #:3007584704
Device Name
Classification Reference: 21 CFR 868.5450 Product Code: BTT Device Trade Name: Humidifier Heater Base PMH7000PLUS/PMH7000 Classification Name: Respiratory Gas Humidifier Classification: Class II
Predicate Device
The predicate device is Humidifier Heater Base, PMH7000 with 510(k) number, K080149 and the concurrence date December 18, 2008.
Device Description
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is a humidifier incorporating with ventilator and provides respiratory humidification through patient breathing circuit for adult at hospital and home.
Humidifier Heater Base, PMH7000PLUS/PMH7000 was designed to comply with applicable portions of the following standards.
PACIFIC MEDICO CO., LTD. 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan Phone: +81-3-3818-0573 Fax: +81-3-3818-7392
Yoshio Toyama, General Manager Regulatory Affairs Product Development Department Yoshio.Toyama@pacific-medico.com
1
Image /page/1/Picture/0 description: The image shows the logo for Pacific Medico. The logo features a stylized letter "P" above the words "PACIFIC MEDICO". There are horizontal lines on either side of the words "PACIFIC MEDICO".
Medical Electrical Equipment - General Requirements IEC 60601-1 Electromagnetic Compatibility - Requirements and Tests IEC 60601-1-2 Humidifiers for Medical Use 150 8185 ISO 14971 Medical Devices
This heater base features a dual temperature servo control system which regulates the temperature of the gas delivered to the patient and the gas at outlet of humidifying chamber. It continuously monitors temperatures by a dual temperature probe. The heater base warms and humidifies the gas through the humidifier chamber and in addition a heater wire in the patient breathing circuit further controls same gas temperature. The operator is allowed to set the temperature of two locations: temperature of the chamber outlet gas and the gas immediately before delivered to the patient.
The Humidifier Heater Base PMH7000PLUS/PMH7000 is equipped with alarms which activate audible and visual indicators to alert the operator of adverse conditions. Alarms are provided for high and low airway temperature, high and low chamber outlet temperature probe disconnect or fault condition, heater wire fault connection, and the light identifies the area of alarm.
The Humidifier Heater Base PMH7000PLUS/PMH7000 includes several safety features such as prevention of excessive heating which can be harmful to the patient or can cause damage to the heater base itself. To ensure patient safety, the heater base will shut down under any alarm conditions if it continues for 10 minutes.
The Humidifier Heater Base are available in two models, PMH7000PLUS and PMH7000. PMH7000PLUS/PMH7000 has both inspiratory and expiratory heater wires for use in the inspiratory and expiratory limbs of breathing circuit. The use of the expiratory heater wire with PMH7000PLUS/PMH7000 is to control humidity in the expiratory limb and to reduce moisture returned to the ventilator.
The materials used have not been changed.
Description of Device Modification
The subject device has the same technological characteristics and indications for use, material composition, intended use as predicate; the hardware, and mechanical aspects of Humidifier Heater Base. PMH7000PLUS/PMH7000 have been updated to current technology equivalent to the cleared device (Humidifier Heater Base, PMH7000, K080149 dated December 18, 2008) as described below. The subject device is substantially equivalent to the predicate device.
PACIFIC MEDICO CO., LTD. 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan Phone: +81-3-3818-0573 Fax: +81-3-3818-7392
Yoshio Toyama, General Manager Regulatory Affairs Product Development Department Yoshio.Toyama@pacific-medico.com
·2/5
2
Image /page/2/Picture/0 description: The image shows the logo for Pacific Medico. The logo features a stylized letter 'P' above the words 'PACIFIC MEDICO'. There are two horizontal lines on either side of the words 'PACIFIC MEDICO'.
PACIFIC MEDICO CO., LTD.
2-15-10 Hongo, Bunkyo-ku,
Tokyo 113-0033 Japan
Phone: +81-3-3818-0573
Fax: +81-3-3818-7392
www.pacific-medico.com
Humidifier Heater Base, PMH7000PLUS/PMH7000 are modified version of Humidifier Heater Base, PMH7000.
The modification is to change the front and side panel design in order to realize the easy maneuverability and, and to change the interface for heater wire connector in order to facilitate easy and simple connectivity.
Modifications which have been made are described below.
PMH7000PLUS:
-
- changing the front and side panel design
-
- changing the interface connector for heater wire
-
- improving the maneuverability.
PMH7000:
-
- changing the front and side panel design
-
- changing the interface connector for heater wire
Because of the improvements of the maneuverability from predicate device of PMH7000, the upgraded model of PMH7000 is added under the name of PMH7000PLUS. The purpose of adding this name of PMH7000PLUS is to identify the differentiation from the predicate device.
Intended Use
The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gasses for administration to a patient.
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at hospital and home.
The intended use has not been changed.
Technological Characteristics
The Technological Characteristics of Humidifier Heater Base PMH7000PLUS/ PMH7000 are equivalent to the predicate devices Humidifier Heater Base PMH7000 (available in two models, the PMH7000D and the PMH7000S).
PMH7000PLUS/PMH7000 are equivalent to the PMH7000 in terms of: type (heated Passover humidification), configuration (chamber, heated wire breathing circuits, dual -sensor temperature probe), power usage (same heater system ratings),
PACIFIC MEDICO CO., LTD. 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan Phone: +81-3-3818-0573 Fax: +81-3-3818-7392
Yoshio Toyama, General Manager Requlatory Affairs Product Development Department Yoshio. Toyama@pacific-medico.com
3
Image /page/3/Picture/0 description: The image shows a company logo and contact information. The logo is a circular emblem with the letters "TOV" inside. The text next to the logo includes the company name "PACIFIC M", followed by the address "2-15-10 He", and the city and postal code "Tokyo 113". The contact information includes a phone number starting with "+8", a fax number starting with "+81-3", and a website address starting with "www.pacific".
performance (same temperature and humidity output), control method (electronic and PID algorithm microprocessor), and uses equivalent materials and some common components.
Non Clinical Tests
PACIFIC MEDICO
Non-clinical testing of Humidifier Heater Base PMH7000PLUS/ PMH7000 has been carried out covering mechanical, electrical and thermal safety, environmental conditions and electromagnetic compatibility, functional verification, and performance capacity and accuracy.
PMH7000PLUS/ PMH7000 meets the requirements of the IEC 60601-1 and IEC 60601-1-2 electro medical and EMC standards, and the relevant USA deviations to these in ANSI/AAMI ES60601-1. It complies with performance and safety requirements of the ISO 8185 particular standard for Humidification Systems.
Substantial Equivalence
The modified PMH7000PLUS/PMH7000 have the following similarities to those which previously received 510(k) concurrence (PMH7000).
- · have the same intended use,
- · use the same operating principle,
- · incorporate the same basic humidifier design,
- · have the same shelf life, and
- · packaged using the same materials and process.
The comparison table is provided as a summary of the technological characteristics relative to the predicate devices. This is to demonstrate that Pacific Medico PMH7000PLUS/PMH7000 Humidifier Heater Base for respiratory therapy (heater base) is substantially equivalent to the predicate device.
Conclusion
The testing carried out for Humidifier Heater Base PMH7000PLUS/PMH7000 indicates that it meets design and performance functional requirements. The proposed device meets the requirements of international and USA medical electrical equipment standards for safety, and key performance and safety requirements from the particular standard for humidification systems.
This information indicates that Humidifier Heater Base PMH7000PLUS/PMH7000 is substantially equivalent to the predicate devices.
-
- The modification does not affect the intended use or alter the fundamental scientific technology.
PACIFIC MEDICO CO., LTD. 2-15-10 Hongo, Bunkyo-ku, Tokvo 113-0033 Japan Phone: +81-3-3818-0573 Fax: +81-3-3818-7392
- The modification does not affect the intended use or alter the fundamental scientific technology.
Yoshio Toyama, General Manager Regulatory Affairs Product Development Department Yoshio. Toyama@pacific-medico.com
4
Image /page/4/Picture/0 description: The image shows the contact information for Pacific Medico Co., LTD. The address is 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan. The phone number is +81-3-3818-0573, and the fax number is +81-3-3818-7392. The website is www.pacific-medico.com.
- Based on the results of the comparison and reproducibility studies described in this 510(k) submission, it is concluded that the Humidifier Heater Base, PMH7000PLUS/PMH7000 is equivalent to the predicate device as an aid for mitigation of dryness of airway.
-
- Under the above technological comparison, discussion on substantial equivalence, it is demonstrated that the PMH7000PLUS/PMH7000 is equivalent to the predicate device.
-
- It is determined that the Performance Testing Clinical is not required because of the above comparison.
-
- Verification and validation testing have been performed which demonstrate that PMH7000PLUS/PMH7000 function as intended and is substantially equivalent to the predicate devices for the intended use.
PACIFIC MEDICO CO., LTD. 2-15-10 Hongo, Bunkyo-ku, Tokyo 113-0033 Japan Phone: +81-3-3818-0573 Fax: +81-3-3818-7392
== PACIFIC MEDICO =
Yoshio Toyama, General Manager Regulatory Affairs Product Development Department Yoshio.Toyama@pacific-medico.com
રાદ
5
Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes resembling human figures or birds in flight.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administr 0003 New Hammehire A Silver Spring, MD 20993.
May 1. 2014
Pacific Medico Co., LTD. Mr. Yoshio Toyama. General Manager Regulatory Affairs, Product Development Department 2-6-4 Hongo. Bunkyo-ku Tokyo 113-0033 Japan
Re: K132857
Trade/Device Name: Humidifier Heater Base PMH7000PLUS/PMH7000 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory Gas Humidifier Regulatory Class: 11 Product Code: BTT Dated: March 31. 2014 Received: April 1. 2014
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 (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you. however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Tejashri Purohit-Sheth, M.D.
Clinical Deputy-Director
DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) KI32857
Device Name
Humidifier Heater Base PMH7000PLUS/PMH7000
Indications for Use (Describe)
The Humidifier Heater Base PMH7000PLUS/PMH7000 is intended to add moisture and to warm the breathing gases for administration to the patient.
The Humidifier Heater Base, PMH7000PLUS/PMH7000 is intended for use on adult at home.
Type of Use (Select one or both, as applicable) [X] 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 A SEPARATE PAGE IF NEEDED.
: : } : . : 보(월) 후 2 FOR FDA USE ONLY : 上一篇: : 第 : ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ . . . . : Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
A
2
1
Anya C. Harry -S 2014.05.05 15:58:13 -04'00'
PSC Publishing Scrvices (10)) 443-6740
EF
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