(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.
§ 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).