(331 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Humidifier Heater Base, PMH7000:
Device: Humidifier Heater Base, PMH7000
This document is a 510(k) summary for a medical device. For such submissions, the primary "study" proving acceptance is typically a demonstration of substantial equivalence to an already legally marketed (predicate) device, rather than a clinical trial with specific performance metrics and acceptance criteria in the same way a novel AI algorithm might have. Therefore, many of the requested fields will reflect this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are generally that the new device (PMH7000) is as safe and effective as the predicate device (PMH5000) and that any differences do not adversely affect safety or effectiveness. The "reported device performance" is a direct comparison to the predicate.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (PMH7000 vs. PMH5000) |
|---|---|
| Intended Use: Respiratory Humidification, Adult, Hospital/Home | Identical |
| Humidification Mechanism: Heat distilled water in chamber, heater plate | Identical |
| Flow per minute: 5 liters | Identical |
| Temperature - Heater Plate: 100°C Thermostat regulated (Normal Operation) | Identical |
| Temperature Sensor: 115°C Thermostat limited | Identical |
| Population: Adult | Identical |
| Power Source: AC115V | Identical |
| Method of Connection to Patient: Patient mask through breathing circuit | Identical |
| Re-use: Multiple uses with proper care | Identical |
| Temperature Probe: Platinum Resistance RTD | Identical |
| Temperature Control: Dual Servo Control | Identical |
| Control Panel: Front Panel | Identical (with additional preset modes for IPPV/NPPV and touch panel display for alarms, which are deemed not to affect safety or effectiveness) |
| Setting Function: Manual Mode | Identical (with additional IPPV/NPPV modes, deemed not to affect safety or effectiveness) |
| Alarm Display: By LED | Identical (with additional details for alarm display on front touch panel, deemed not to affect safety or effectiveness) |
| Humidity Control: Using heater wire | Identical |
| Heater Wire Control Power Supply: Controlled by switching power supply (PMH7000) | Differs from predicate's "controlled by an internal transformer" but deemed not to affect safety or effectiveness, and reduces weight. |
Overall Acceptance: The PMH7000 is concluded to be "as safe and effective (therefore substantially equivalent)" as the predicate device, the PMH5000 (K020700).
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of a substantial equivalence submission based on documentary comparison. No specific "test set" of patient data or device performance data from a clinical study is mentioned for the direct comparison. The "test" is the comparison of specifications and design features with the predicate device.
- Data Provenance: The data provenance comes from the design specifications and technical characteristics of the Pacific Medico PMH7000 and its predicate device, the Pegasus Research PMH5000 (K020700). The context is Japan-based manufacturing (Pacific Medico Co., Ltd., Tokyo Japan). It is a descriptive comparison of technical specifications rather than a data-driven clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not explicitly stated as a formal panel for ground truth establishment. For a 510(k) submission, the "ground truth" for substantial equivalence is primarily established by the manufacturer (Pacific Medico Co., Ltd.) through their technical assessment and comparison to the predicate device. The FDA then reviews this assessment.
- Qualifications of Experts: The submission was prepared by Yukio Tomisawa (Official Contact) and Mr. Yoshio Toyama (Manager of Regulatory Affairs), who can be considered the subject matter experts from the manufacturer’s side regarding the device design and regulatory comparison. The FDA's Division of Anesthesiology, General Hospital, Infection Control and Dental Devices (Director: Chiu Lin, Ph.D. and reviewer for the letter: Samith J. Michels D.M.D.) are the regulatory experts who reviewed and accepted the claim.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the sense of a clinical test set with adjudicated outcomes. The "adjudication" in a 510(k) is the FDA's regulatory review process, where they determine if the manufacturer's claim of substantial equivalence is valid based on the submitted documentation comparing the new device to the predicate device.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging devices or AI algorithms where human readers' performance with and without AI assistance is evaluated on a set of cases. This submission is for a respiratory gas humidifier, which is a physical device, and its safety and effectiveness are established through technical specifications and comparison to a predicate, not through reader studies.
- Effect Size of Human Readers: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Study: Not applicable. The device is a physical medical device (humidifier heater base), not an algorithm or AI system. Its performance is inherent in its design and operation, not through algorithmic output without human interaction.
7. The Type of Ground Truth Used
- Ground Truth Type: Not applicable in the clinical sense of pathology or outcome data. The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Pegasus Research PMH5000, K020700). The PMH7000 aims to demonstrate that it is equally safe and effective by comparing its technical characteristics, intended use, and operational principles to this predicate. The manufacturer's declaration that "there is no difference in the technology applied in both PMH5000 and PMH7000 which may affect the safety and effectiveness of the subjective devices" serves as the basis for this ground truth in the context of substantial equivalence.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is not an AI or machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Not applicable. As there is no training set, there is no ground truth to establish for it.
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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 SafetyRequirements for Medical Electrical System |
|---|---|
| IEC 60601-1-2 | Medical electrical Equipment-Part 1: General Requirements forSafety-2. Collateral Standard: Electromagnetic Compatibility -Requirements and Tests |
| IEC 60601-1-4 | Medical Electric Equipment Part 1: General Requirements forSafety 4. Collateral Standard:Programmable Electrical Medical Systems |
| ISO 8185 | Humidifiers for Medical Use-General Requirements forHumidification Systems |
| ISO 10993-1 | Biological evaluation of medical devices Part 1: Evaluation andTesting |
| ISO 14971 | Medical Devices-Application of Risk Management to MedicalDevices |
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:Heat distilled water in thehumidification chamber placed onthe heater base.(2) Heater Plate:Using heater plate to heat distilledwater.(3) Humidified Gas:Humidified gas generated in thechamber led to patient's breathingcircuit through inspiratory tube.(4) Inhaling humidified gas:Patient inhale ventilator suppliedgas together with humidified gas.(5) Flow per minute:5 liters | (1) Humidification:Heat distilled water in thehumidification chamber placed onthe heater base.(2) Heater Plate:Using heater plate to heat distilledwater.(3) Humidified Gas:Humidified gas generated in thechamber led to patient'sbreathing circuit throughinspiratory tube.(4) Inhaling humidified gas:Patient inhale ventilator suppliedgas together with humidified gas.(4) Flow per minute5 liters |
| Mechanism(Setting) Range | (1) Temperature - Heater Plate100°C Thermostat regulated(Normal Operation) | (1) Temperature - Heater Plate100°C Thermostat regulated(Normal Operation) |
| SensorTechnology | 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 toThe Patient | breathing circuit | breathing circuit |
| Re-use | (1) Heater Base main unit:Multiple uses with proper care andmaintenance in accordance withmanual and with all other applicableregulations.(2) Heater Wire - InspiratoryMultiple uses with proper care andmaintenance in accordance withmanual and with all other applicableregulations.(3) Heater Wire - ExpiratoryMultiple uses with proper care andmaintenance in accordance withmanual and with all other applicableregulations.(4) Temperature ProbeMultiple uses with proper care andmaintenance in accordance withmanual and with all other applicableregulations. | (1) Heater Base main unit:Multiple uses with proper care andmaintenance in accordance withmanual and with all otherapplicable regulations.(2) Heater Wire - InspiratoryMultiple uses with proper care andmaintenance in accordance withmanual and with all otherapplicable regulations.(3) Heater Wire - ExpiratoryMultiple uses with proper care andmaintenance in accordance withmanual and with all otherapplicable regulations.(4) Temperature ProbeMultiple uses with proper care andmaintenance in accordance withmanual and with all otherapplicable 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 | TemperatureProbe | TemperatureControl | Control Panel | Setting Function | Alarm | Humidity Control | Population | Power Source | Method ofConnection to | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ComparisonParameter | Pegasus ResearchPMH5000K020700 | Pacific MedicoPMH7000 | Discussion ofDifferences andSimilarities | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode:Temperature can be setmanually. | All alarms : displayed by LED | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
| Intended Use | The Humidifier Heater BasePMH5000 is intended to addmoisture and to warm thebreathing gases foradministration to a patient.The humidifier is intended foruse with flows of 5 liters perMinute or more through thehumidifier. | The Humidifier Heater Base PMH7000 isintended to add moisture and to warm thebreathing gases for administration to a patient.The Humidifier Heater Base, PMH7000 isintended for use on adult at hospital and home. | No difference | Platinum Resistance RTD | Dual Servo Control | Front Panel | Manual Mode: same as in PMH5000IPPV Mode: Patient side & Chamber sidetemperature can be pre-set.Patient side: 40°CChamber side: 37°CNPPV Mode: Patient side & Chamber sidetemperature can be pre-set.Patient side: 34°CChamber side: 37°CBoth IPPV and NPPV mode are controlled onfront touch panel. | All alarms: displayed by LED at the illustratedportion on the front touch panel.* Refer below note for alarm details | Using heater wire | Adult | AC 115V | Using patient breathing circuit |
| TemperatureSetting | Patient Side : 30 to 40 °CChamber Side: 23 to 34°C | Patient Side : 30 to 40 °CChamber Side: 23 to 34°C | No difference | No difference | No Difference | No difference | Differences donot affect safetyor effectiveness | Differences donot affect safetyor effectiveness | No difference | No difference | No difference | No difference |
F
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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 antransformer | 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:
-
- 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.
-
- 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.
-
- 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 (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
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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
§ 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).