(232 days)
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.
The device provides heated and humidified gas to the patient.
The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.
The High Flow mode has a flow range from 1 to 60 lpm.
The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.
It is not intended for life support.
This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions.
It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.
The provided FDA 510(k) clearance letter for the HFT750U Continuous Ventilator does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the study that proves the device meets them.
The document is primarily a clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on similar indications for use, technological characteristics, and safety and performance standards. It lists types of performance testing conducted (e.g., Software Verification, Performance of Ventilation Modes), but it does not provide:
- Specific quantifiable acceptance criteria for device performance.
- Reported device performance data against those criteria.
- Details about the test set (sample size, provenance).
- Information on expert involvement in ground truth establishment or adjudication for performance studies.
- Details of any MRMC studies, standalone AI performance, or ground truth types used in specific performance evaluations.
- Training set information for any AI/ML component (which isn't explicitly mentioned as a core feature of this ventilator model, but could be implied by "Software Verification").
Given the limitations of the provided text, I will answer what can be inferred and highlight what information is missing.
Inferred Acceptance Criteria and Reported Device Performance (Table)
Based on the general nature of a continuous ventilator and the standards it claims to comply with, the acceptance criteria would revolve around meeting the specifications and a lack of hazardous function or failure. However, specific numerical acceptance criteria and direct performance metrics are not explicitly stated in the provided text.
The document implies that the device met acceptance criteria because it was cleared by the FDA and states "The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent."
Here's an attempt to structure a table based on the types of performance aspects mentioned, acknowledging that specific data and criteria are absent:
| Acceptance Criterion (Inferred from testing types) | Reported Device Performance (Inferred from clearance) |
|---|---|
| Accuracy & Stability of Ventilation Modes/Settings: (e.g., flow rate, pressure, oxygen concentration delivery) | Conforms to set parameters; deemed substantially equivalent to predicate devices for intended function. |
| Alarm Functionality: (Timeliness, accuracy, and appropriate notification for critical events) | Alarms (visual and audible) function as intended; similar to predicate devices. |
| Power Performance: (Operation with AC mains and reserve battery) | Meets performance requirements for both AC and battery power, demonstrating adequate power functionality. |
| Endurance/Reliability/Service-life: (Device longevity and consistent function over time) | Demonstrated adequate service-life and reliability through testing. |
| Environmental Performance: (Functionality within specified temperature, humidity ranges) | Operates within specified environmental conditions (e.g., 5°C to 40°C operating temperature, 0-95% storage humidity). |
| Biocompatibility: (Materials in contact with patient are safe) | Complies with ISO 10993-1 and ISO 18562-1, indicating material safety. |
| Electrical Safety & EMC: (Safety against electrical hazards and electromagnetic interference) | Complies with relevant IEC 60601 series standards for electrical safety and EMC. |
| Software Verification: (Software functions as intended, free from critical bugs) | Software functionality verified as per testing. |
| Human Factors/Usability: (Safe and effective for expected users) | Found to be usable and safe. |
| Cleaning & Disinfection Efficacy: (Ability to be effectively cleaned and disinfected) | Cleaning and disinfection protocols deemed effective. |
| Risk Management: (Identification and mitigation of risks) | Risks managed and mitigated to an acceptable level. |
| Accessory Compatibility: (Proper function with specified accessories) | Found compatible with required accessories (e.g., heated wire circuits, water chambers, patient interfaces). |
| Waveform Comparison: (Output waveforms match predicate device's expected performance) | Waveforms are comparable to the predicate, indicating similar operational characteristics. |
Missing Information from the Provided Document:
- Sample size used for the test set and the data provenance: Not mentioned. The document only lists types of tests, not the datasets or sample sizes for those tests.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is a ventilator, not an AI diagnostic tool requiring expert ground truth for image or signal interpretation. Performance is typically assessed against engineering specifications and physiological models.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned. Adjudication methods are typically used for establishing ground truth in human-in-the-loop or standalone AI studies for diagnostic/interpretive tasks, which is not the primary function of this device's "performance testing" as described.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI diagnostic or assistive device in the context of "human readers" interpreting medical images or signals. Its "performance testing" would involve engineering and software validation, not human reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document mentions "Performance of Ventilation Modes and Control Settings" and "Software Verification" which are forms of standalone testing for the device's core functionality and software. However, no specific metrics or study design for "standalone performance" (as it relates to AI algorithm performance) are provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a ventilator, "ground truth" would typically be established by:
- Engineering specifications: The device's output (flow, pressure, oxygen concentration) is measured against the design specifications.
- Standardized test lung models: Simulation of patient physiology (e.g., lung compliance, resistance) to assess how the ventilator responds in different scenarios.
- Reference measurement devices: Highly accurate external sensors to verify the device's internal measurements and deliveries.
- Compliance with recognized standards: Adherence to standards like ISO 80601-2-12 for basic safety and essential performance of ventilators.
The document does not explicitly state the specific "ground truth" methods used, but these are the common practices for such devices.
- The sample size for the training set: Not applicable/not mentioned. The document describes a traditional medical device (ventilator) and its conformity to engineering and safety standards. There is no indication of a machine learning model that would require a "training set" in the context of an AI/ML device submission. The software verification refers to traditional software development and testing.
- How the ground truth for the training set was established: Not applicable, for the same reason as point 7.
FDA 510(k) Clearance Letter - HFT750U Continuous Ventilator
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 15, 2025
MEKICS Co., Ltd.
℅ Paul Dryden
Consultant
ProMedic Consulting LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704
Re: K242931
Trade/Device Name: Hft750u
Regulation Number: 21 CFR 868.5895
Regulation Name: Continuous Ventilator
Regulatory Class: Class II
Product Code: MNT
Dated: April 14, 2025
Received: April 15, 2025
Dear Paul Dryden:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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K242931 - Paul Dryden
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
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K242931 - Paul Dryden
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Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D.
Assistant Director
DHT1C: Division of Anesthesia,
Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia,
Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K242931
Device Name
HFT750U
Indications for Use (Describe)
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.
The device provides heated and humidified gas to the patient.
The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.
The High Flow mode has a flow range from 1 to 60 lpm.
The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.
It is not intended for life support.
Type of Use (Select one or both, as applicable)
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23)
Page 1 of 1
Page 5
K242931 510(k) Summary
Page 1 of 11
Date Prepared: 13-May-2025
Sponsor:
MEKICS Co. Ltd
21, Sangjiseok-gil, Paju-si
Gyeonggi-do South Korea
+82-70-7119-253
Sponsor Contact: Sang-Hag Lee – Regulatory Affairs Team Lead
Submission Contact: Paul Dryden
Promedic Consulting LLC
Proprietary or Trade Name: HFT750U
Common/Usual Name: Continuous Ventilator
Classification Name: Continuous Ventilator
CFR: 868.5895
Product Classification: MNT
Primary Predicate Device: Nihon Kohden NKV-330 - K213521
Classification Name: Continuous ventilator
CFR: 868.5895
Product Classification: MNT
Secondary Predicate Device: Fisher and Paykel – Airvo 3 NIV – K233643
Classification Name: Continuous ventilator
CFR: 868.5895
Product Classification: MNT
Device Description:
This HFT750U is a Continuous Ventilator, intended to provide the patient with a high flow of gas that contains a constant amount of oxygen in a non-invasive method, thereby assisting or regulating the patient's respiration use in a hospital or medical institutions.
It can be used by the upper airways bypassed patients. Equipped with various alarm and safety functions, High flow (HF), the Continuous Positive Airflow Pressure (CPAP) and Bilevel Positive Airway Pressure (bilevel) modes regulate the patient's respiration, but for correct diagnosis it should be used together with clinical information.
Principle of Operation:
HFT750U system consists of the Oxygen gas supply system, the gas control system and humidifier system.
| Item | Description |
|---|---|
| Oxygen gas supply system | It controls the amount of oxygen suppled to the patient by proportional |
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K242931 510(k) Summary
Page 2 of 11
| Item | Description |
|---|---|
| valve. It helps patients breathing or treat patients with hypoxic respiratory failure by required amount of oxygen. | |
| Humidifier system | The humidity is controlled to be sufficiently in accordance with the humidity level by user set and, humidification is maintained to not higher than the saturated humidity. The warm humidified air is supplied to the upper airway of the patient in high flow, CPAP and bilevel mode. Enhance the patient's pulmonary compliance and conductance. |
| Gas control system | It supplies the correct flow rate or pressure to the patient by blower control. The flow rate is controlled in 1 L/min and is supplied up to 60 L/min. |
Indications for Use:
The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency.
The device provides heated and humidified gas to the patient.
The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included.
The High Flow mode has a flow range from 1 to 60 lpm.
The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician.
It is not intended for life support.
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K242931 510(k) Summary
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Comparison of Subject vs. Predicates
| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| K# | K213521 | K233643 | K242931 | |
| Manufacturer | Nihon Kohden – NKV-330 | F&P Airvo3 NIV | MEKICS HFT750U | |
| Product Code | MNT | MNT | MNT | |
| Classification | 21CFR858.5895 | 21CFR858.5895 | 21CFR858.5895 | |
| Indications for Use | The Nihon Kohden NKV-330 Ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. It is intended for children weighing 12.5 kg or greater to adult patients. It offers noninvasive ventilation, invasive ventilation, and respiratory monitoring. The NKV-330 is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician. | F&P Airvo 3 NIV (PT311US) When used in NIV mode: The Airvo 3 NIV provides noninvasive ventilator support for nonventilator dependent, spontaneously breathing adult patients (66 lb/30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support. When used in High Flow mode: The Airvo 3 NIV is intended to provide high flow warmed and humidified respiratory gases for administration to spontaneously breathing infant, child, adolescent and adult patients in hospitals. It adds heat and moisture to the flow of air, or blended air/medical oxygen mixture, and assures the user of the air/oxygen mixture using an integrated oxygen analyzer and visual display. The flow may be from 2 to 70 L/min depending on the patient interface. The Airvo 3 NIV provides high flow gases with simultaneous oxygen delivery to spontaneously breathing patients with or without bypassed upper airways in hospitals. The Airvo 3 NIV provides high flow gases with simultaneous oxygen | The HFT750U ventilator is intended to provide ventilation and oxygen concentration for patients who are breathing spontaneously but need partial ventilation support due to respiratory failure or chronic respiratory insufficiency. The device provides heated and humidified gas to the patient. The device is intended for pediatric patients weighing 12.5 kg or greater to adult patients in non-invasive respiratory therapy. Patients with their upper airways bypassed are included. The High Flow mode has a flow range from 1 to 60 lpm. The HFT750U is intended for use in hospitals, hospital-type facilities, and in hospital transportation by qualified and trained users under the directions of a physician. It is not intended for life support. | Similar The primary predicate patient population is the same as well as environments of use. The secondary predicate includes integrated heated humidifier and High Flow mode as well as the same environment of use. |
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K242931 510(k) Summary
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Comparison of Subject vs. Predicates
| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| delivery through nasal cannula interfaces to augment the breathing of spontaneously breathing patients suffering from respiratory distress and/or hypoxemia in the hospital setting. The Airvo 3 NIV is not intended to provide total ventilatory requirements and is not intended for use during field transport. AirSpiral NIV tube and chamber kit (900PT573): For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support. | ||||
| Fundamental scientific technology | This device uses outside air and a high pressure oxygen source or oxygen cylinder. Outside air which is taken in by the blower and oxygen which has a flow rate controlled by the proportional control valve are mixed in the mixing chamber and supplied to the patient. The microprocessor controls the blower and the proportional control valve to deliver the pressure and oxygen concentration which are set by the user. The gas delivered from the ventilator is supplied to the patient through the patient breathing circuit, flow sensor, and patient interface. | The Airvo 3 NIV design makes uses a centrifugal blower with a low inertia impeller to control the pressure based on the device setting as well as pressure and flow sensor measurements. The Airvo 3 NIV has three modes of NIV therapy: Bi-Level S/T, Bi-Level PCV and CPAP. | This device uses outside air and a high pressure oxygen source or oxygen cylinder. Outside air which is taken in by the blower and oxygen which has a flow rate controlled by the proportional control valve are mixed in the mixing chamber and supplied to the patient. The microprocessor controls the blower and the proportional control valve to deliver the pressure and oxygen concentration which are set by the user. The warmed and humidified gas delivered from the ventilator is supplied to the patient through the patient breathing circuit, flow sensor, and patient interface. | HFT750U operates with an integrated humidifier and provides the heated and humidified gas delivered to the patient similar to the secondary predicate. The technology of a blower to generate positive pressure, plus connection to an oxygen source with similar accessories and sensor is similar to both the predicates. |
| Oxygen Input Sources | High pressure oxygen source or oxygen cylinder | High-Pressure Oxygen | High pressure oxygen source or oxygen cylinder | Similar |
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K242931 510(k) Summary
Page 5 of 11
| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| Fundamental scientific technology | This device uses outside air and a high pressure oxygen source or oxygen cylinder. Outside air which is taken in by the blower and oxygen which has a flow rate controlled by the proportional control valve are mixed in the mixing chamber and supplied to the patient. The microprocessor controls the blower and the proportional control valve to deliver the pressure and oxygen concentration which are set by the user. The gas delivered from the ventilator is supplied to the patient through the patient breathing circuit, flow sensor, and patient interface. | AirSpiral NIV tube and chamber kit (900PT573): For use with noninvasive ventilator support for non-ventilator dependent, spontaneously breathing adult patients (66 lbs./30 kg and above) with respiratory insufficiency. It is intended to be used in hospitals. It is not intended for life support. The Airvo 3 NIV design makes uses a centrifugal blower with a low inertia impeller to control the pressure based on the device setting as well as pressure and flow sensor measurements. The Airvo 3 NIV has three modes of NIV therapy: Bi-Level S/T, Bi-Level PCV and CPAP. | This device uses outside air and a high pressure oxygen source or oxygen cylinder. Outside air which is taken in by the blower and oxygen which has a flow rate controlled by the proportional control valve are mixed in the mixing chamber and supplied to the patient. The microprocessor controls the blower and the proportional control valve to deliver the pressure and oxygen concentration which are set by the user. The warmed and humidified gas delivered from the ventilator is supplied to the patient through the patient breathing circuit, flow sensor, and patient interface. | HFT750U operates with an integrated humidifier and provides the heated and humidified gas delivered to the patient similar to the secondary predicate. The technology of a blower to generate positive pressure, plus connection to an oxygen source with similar accessories and sensor is similar to both the predicates. The technology of a blower to generate positive pressure, plus connection to an oxygen source with similar accessories and sensor is similar to both the predicates. |
| Oxygen Input Sources | High pressure oxygen source or oxygen cylinder | High-Pressure Oxygen | High pressure oxygen source or oxygen cylinder | Similar |
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K242931 510(k) Summary
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| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| Humidity Source | Optional use of an external Heated Humidifier | Low-Pressure Oxygen (LPO) Integrated heated humidifier | Integrated heated humidifier | Similar to the secondary predicate both comply with ISO 80601-2-74 HFT750U operates with an integrated humidifier and displays temperature related to humidifier. |
| Parameters measured | FI-PEAK (Peak Inspiratory Flow) PIP (Peak Inspiratory Pressure) PEEP (Positive End Expiratory Pressure) RR TOT (Total Respiratory Rate) VTI (Inspiratory Tidal Volume) VT (Expiratory Tidal Volume) O2 Gas Usage Flow Rate FiO2 SpO2 PR (Pulse rate) PI (Pulse-amplitude index) | Many measured parameters. List is not available. | Flow (Peak Inspiratory Flow) PIP(Peak Inspiratory Pressure) PEEP(Positive End Expiratory Pressure) RR (Respiration rate) Vti(Inspiratory Tidal Volume) V delivery or Vt est (Expiratory Tidal Volume) O2 Gas Usage Flow Rate FiO2 SpO2 PR (Pulse rate) PI (Pulse-amplitude index) | HFT750U measures similar parameters to both the predicates. Similar Although both represent expiratory tidal volume, they are labeled separately as V delivery in Volume guarantee mode (a controlled value) and Vt est in non-VG mode (an estimated value) due to their different clinical implications. Any differences of measured parameters do not raise different risk concerns. |
| FE-PEAK (Peak Expiratory Flow) | Many measured parameters. List is | FE-PEAK (Peak Expiratory Flow) | Ventilation parameters |
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K242931 510(k) Summary
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| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| MVI (Total Inspiratory Minute Volume) MVI SPONT (Spontaneous Inspiratory Minute Volume) MV (Total Expiratory Minute Volume) MV SPONT (Spontaneous Expiratory Minute Volume) RR SPONT (Spontaneous Respiratory Rate) TI/TTOT (Inspiratory duty cycle) I:E ratio (I:E) TI (Inspiratory Time) TE (Expiratory Time) Pt. Trig (Spontaneous breathing ratio) Leak % (Leakage volume ratio) | not available. | MVI (Total Inspiratory Minute Volume) MVI SPONT (Spontaneous Inspiratory Minute Volume) MV (Total Expiratory Minute Volume) MV SPONT (Spontaneous Expiratory Minute Volume) RR SPONT (Spontaneous Respiratory Rate) TI/TTOT (Inspiratory duty cycle) I:E ratio (I:E) TI (Inspiratory Time) TE (Expiratory Time) Pt. Trig (Spontaneous breathing ratio) Leak ratio (Leakage volume ratio) | are similar to the predicate. | |
| Not provided or calculated | Not provided or calculated | S/F ratio (SpO2/FiO2 ratio) ROX (Respiratory rate-Oxygenation) | These are indexes which are generated from the similar measured parameters and displayed. They are for display to the clinician only. They do not raise different risk concerns. | |
| External Humidifier includes many measured parameters | Airway Temperature Chamber Temperature Heat plate Temperature | Airway Temperature Chamber Temperature Heat plate Temperature | Similar to the secondary predicate with integrated humidifier | |
| CO2 (I) CO2 (E) RR (Respiration Rate) (CO2). | Not available | Not available | HFT750U does not support an optional EtCO2 monitor or its measurement. | |
| Intra-hospital transport | Transit-operable | In hospital transport | Transit-operable | Similar |
| Patient Interface | Face mask or nasal mask, nasal cannula | Face mask or nasal mask, nasal cannula | Face mask or nasal mask, nasal cannula | Similar |
| Cleaning | External surface cleaning | External surface cleaning | External surface cleaning | Similar |
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K242931 510(k) Summary
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| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| Patient use | Adult and pediatric >12.5 kg patients that are breathing spontaneously but need partial ventilation support through invasive or non-invasive ventilation. | NIV – adults – 60 lbs. / 30 kg High Flow - spontaneously breathing infant, child, adolescent and adult patients | Adult and pediatric>12.5 kg patients that are breathing spontaneously but need partial ventilation support through non-invasive ventilation. | HFT750U does not provide invasive ventilation like the predicate but is similar to the secondary predicate |
| Specifications | S/T mode (Spontaneous PS/Timed PCV) - IPAP - EPAP/CPAP PRVC - Vt - EPAP Spont/PS mode (PS set to zero is CPAP) - Inspiratory Time or I:E - Pressure Release - Trigger: flow trigger or advanced trigger - Cycling off - Peak flow % | Bi-level S/T Information not available PVC / CPAP IPAP Range - 4-30cm/H2O EPAP Range - 4-25cm/H2O CPAP Range - 4-25cm/H2O Alarms Visual and audible alarm | S/T mode (Spontaneous PS/Timed PCV) - IPAP - EPAP S/T mode (Volume Guarantee) - V delivery - EPAP CPAP Mode IPAP Range - 4-40cm/H2O EPAP Range - 4-20cm/H2O CPAP Range - 4-20cm/H2O Alarms Visual and audible alarm - Pressure Release - Flow trigger - Rise Time | Similar Similar Similar |
| O2 Therapy Mode - Flow (1 – 60 L/min) - Circuit Obstruction Alarm | HF Mode - Flow (2 – 70 L/min) - Circuit Obstruction Alarm | HF Mode - Flow (1 – 60 L/min) - Circuit Obstruction Alarm | Similar | |
| Operating temperature range | 5 ℃ to 40 ℃ | Not listed | 5 ℃ to 40 ℃ | Similar |
| Optional SpO2 | Connects to external cleared pulse oximeter | Connects to external cleared pulse oximeter | Connects to external cleared pulse oximeter | Similar |
| Performance standards | ISO 80601-2-12 Ed.1 2011-04 ISO 80601-2-55 Ed.2 2018-02 ISO 80601-2-61 Ed.2 2017-12 | ISO 80601-2-12 Ed.3 2023-11 ISO 80601-2-55 Ed.2 2018-02 ISO 80601-2-61 Ed.2 2018-02 ISO 80601-2-74 Ed.2 2021-07 ISO 80601-2-90 Ed.1 2021-08 | ISO 80601-2-12 Ed.3 2023-11 ISO 80601-2-55 Ed.2 2018-02 ISO 80601-2-61 Ed.2 2018-02 ISO 80601-2-74 Ed.2 2021-07 ISO 80601-2-90 Ed.1 2021-08 | HFT750U complies to ISO 80601-2-90 and ISO 80601-2-74 for humidification |
| Electrical Safety and EMC | ANSI AAMI ES 60601-1:2005+AC1;A2(R2021) IEC 60601-1 Ed.3.1 2012-08 IEC 60601-1-2 Ed.4.0 2014-02 | IEC 60601-1 Ed.3.2 2020-08 IEC 60601-1-2 Ed.4.1 2020-09 IEC 60601-1-6 Ed.3.1 2013-10 IEC 60601-1-8 Ed. 2012 | IEC 60601-1 Ed.3.2 2020-08 IEC 60601-1-2 Ed.4.1 2020-09 IEC 60601-1-6 Ed.3.1 2013-10 IEC 60601-1-8 ed. 2012 | Similar |
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| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| IEC 60601-1-6 Ed.3.1 2013-10 IEC 60601-1-9 Ed.2.1 2012-11 IEC 60601-2-49 Ed.2.0 2011-02 IEC 62133-2 Ed.1.0 2011-02 IEC 62366 Ed.1.1 2014-01 | IEC 62133-2 Ed.1 2021-07 IEC 62366-1 Ed.1 2015-02 | IEC 62133-2 Ed.1 2021-07 IEC 62366-1 Ed.1 2015-02 | ||
| Bench Testing | Software Verification Electrical Safety & EMC Testing Agency Testing to Applicable Standards Performance of Ventilation Modes and Control Settings Device Functionality Power performance with AC Mains power or Reserve battery power Endurance/Reliability Essential Performance and Worst Case VBS Environmental Cleaning & Disinfection Biocompatibility Waveform Comparison with Predicate Human Factors/Usability Risk Management Accessory Compatibility | Software Verification Electrical Safety & EMC Testing Performance of Ventilation Modes and Control Settings Device Functionality Power performance with AC Mains power or Reserve battery power Endurance/Reliability Cleaning & Disinfection Biocompatibility Waveform Comparison with Predicate Human Factors/Usability Risk Management Accessory Compatibility | Software Verification Electrical Safety & EMC Testing Performance of Ventilation Modes and Control Settings Device Functionality Power performance with AC Mains power or Reserve battery power Endurance/Reliability Cleaning & Disinfection Biocompatibility Waveform Comparison with Predicate Human Factors/Usability Risk Management Accessory Compatibility | Similar |
| Storage Temperature | -20 ℃ to + 65 ℃ | Not listed | -25 ℃ to + 70 ℃ | Similar |
| Storage Relative Humidity | 10 to 95 % | Not listed | 0 to 95 % | Similar |
| Nurse Call | Yes | Yes | Yes | Similar |
| Communications | N/A | N/A | N/A | Similar |
| Device weight | 7.6 kg (including the 2 batteries, but not including other accessories) | Not listed | 5.8 kg (including the 2 batteries, but not including other accessories) | Similar |
| Dimensions | 330 (W) x 340 (H) x 175 (D) mm | Not listed | 214 (W) x 219 (H) x 338 (W) mm | Similar |
| Interface | Operation Keys, Operation Knob, Touch screen. | Operation Keys, Operation Knob, Touch screen. | Operation Keys, Operation Knob, Touch screen. | |
| Power / Energy Source | 100 to 240 V~, 50 to 60 Hz, Li-ion, 14.4 Vd.c | 100 to 240 V~, 50 to 60 Hz, Battery | 100 to 240 V~, 50 to 60 Hz, Li-ion, 14.4 Vd.c | Similar |
| Biocompatibility | ISO 10993-1 Ed.5 2018-05 ISO 18562-1 Ed.1 2017-03 | ISO 10993-1 Ed.5 2018-05 ISO 18562-1 Ed.1 2017-03 | ISO 10993-1 Ed.5 2018-05 ISO 18562-1 Ed.1 2017-03 | Similar |
| Accessories | When connected to an external | Sponsor provided | User supplied | Similar accessories |
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| Primary Predicate | Secondary Predicate | Subject device | Comparison | |
|---|---|---|---|---|
| cleared humidifier then user supplied Heated wire circuits Water chambers Patient interfaces (mask) for NIV are needed but not supplied | Heated wire circuits Water chambers Patient interfaces (mask) for NIV Nasal Cannula T-piece for trach connection | Heated wire circuits Water chambers Patient interfaces (mask) for NIV Nasal Cannula T-piece for trach connection | required |
Discussion of the Comparison and Differences
The subject device differs in the following ways from the predicate but is addressed with the provided secondary predicate device:
- Includes an integrated heated humidifier vs. the predicate attaches to an external heated humidifier, but the secondary predicate includes an integrated heated humidifier
- Has fewer ventilator modes and thus fewer measured parameters, but is a subset of the predicate but similar to the secondary predicate
- Does not include EtCO2 monitoring option which the secondary predicate does not as well
- Expiratory Tidal Volume
a. The predicate measures and present VT (expiratory tidal volume)
b. The subject device presents both V delivery and Vt est which represent the expiratory tidal volume, and due to the nature of single limb circuits, both values are indirectly measured. However, we differentiate them based on how they are derived under different ventilation modes:
c. In Volume Guarantee (VG) mode ON, the ventilator adjusts its output to achieve a set target tidal volume. The calculated value reflects the volume intentionally delivered by the ventilator as part of its control strategy. For this reason, we refer to it as "V delivery", emphasizing its alignment with the intended therapy goal.
d. In VG mode OFF, the ventilator does not regulate tidal volume. The resulting expiratory volume varies depending on patient condition and is an indirectly estimated value without active control. Therefore, it is labeled "Vt est" (estimated tidal volume).
e. Both devices present expiratory tidal volume. - Calculated indexes: S/F, ROX.
S/F Ratio = SpO₂ (%) / FiO₂(as a decimal)
S/F Ratio is well-recognized as a non-invasive surrogate for the P/F ratio (PaO₂/FiO₂) which is used in assessing oxygenation status, particularly when arterial blood gas is not available.
ROX index is calculated as:
ROX Index = (SpO₂ / FiO₂) / Respiratory Rate (breaths/min)
This index is commonly used to predict the success of high-flow nasal cannula (HFNC) therapy and has been described in peer-reviewed literature as a validated clinical tool.
These parameters are derived using clinically accepted formulas based on existing measurements—SpO₂, FiO₂, and respiratory rate—all of which are available in the subject device and the predicate device.
The subject device merely automates the calculation of these values, which clinicians could compute manually.
Furthermore:
- These calculated parameters are for informational purposes only and are not used to drive or control therapy.
- Their inclusion does not raise new questions of safety or effectiveness, as they are passive displays based on known data.
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For these reasons, the inclusion of the S/F ratio and ROX index do not impact the safety, effectiveness, or intended use of the device. These differences do not raise different concerns of risk of safety compared to the predicate.
Discussion of Differences
As presented above the outlined differences do not raise different concerns of risk or safety compared to the predicate or as applicable the secondary predicate device with integrated humidifier.
As demonstrated in the discussion of differences above, the differences do not fundamentally change the indications for use, technology, or environment of use.
Indications –
- The Indications for Use are similar to the predicates.
Patient Population –
- The patient population is similar to the predicates.
Environment of Use –
- The environment of use are similar to the predicates.
Technological Characteristics –
- The technology is similar to the predicates.
Performance Testing
Performance of the HFT750U was demonstrated by the following:
- Software Verification
- Electrical Safety & EMC Testing
- Agency Testing to Applicable Standards
- Performance of Ventilation Modes and Control Settings
- Device Functionality
- Power performance with AC Mains power or Reserve battery power
- Service-life
- Environmental
- Cleaning & Disinfection
- Biocompatibility
- Waveform Comparison with Predicate
- Human Factors/Usability
- Risk Management
- Accessory Compatibility
Substantial Equivalence Conclusion
The sponsor has demonstrated through performance testing, design and non-clinical testing that the proposed device and predicates have been found to be substantially equivalent.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).