(207 days)
No
The description mentions software control and monitoring of parameters like temperature, humidity, and flow to optimize delivery and minimize condensation. This is standard control system functionality and does not indicate the use of AI or ML. There is no mention of learning, adaptation, or complex pattern recognition.
Yes.
The device delivers warmed and humidified respiratory gases and supplemental oxygen to patients, which is a therapeutic intervention for spontaneously breathing patients.
No
The HFT150 is described as a heated humidifier with an integrated flow source designed to deliver warmed and humidified respiratory gases to patients. Its intended use is for patient treatment, not for diagnosing medical conditions.
No
The device description clearly outlines hardware components such as a motorized blower assembly, integrated oxygen module, heated humidifier, heated breathing tube, and disposable components. While software controls some functions, it is integral to the operation of the physical device.
Based on the provided information, the HFT150 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the HFT150 is for delivering warmed and humidified respiratory gases to spontaneously breathing patients. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a heated humidifier with an integrated flow source and oxygen module. This is consistent with a respiratory support device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or functions related to the analysis of biological samples (like blood, urine, tissue, etc.). There is no mention of reagents, assays, or any process for determining the state of health or disease based on in vitro examination.
In summary, the HFT150 is a medical device used for respiratory support, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.
Product codes (comma separated list FDA assigned to the subject device)
BTT
Device Description
The HFT150 is a heated humidifier with integrated flow source and a heated breathing tube to deliver warmed and humidified gas flow to a patient. The HFT150 includes an integrated oxygen module, delivering an oxygen range of 21% to 100% to the patients.
The HFT150 humidifier is comprised of two connected functional units. One is a motorized blower assembly that provides air flow and the delivery of supplemental oxygen to patients via an integrated oxygen module. The blower speed is directly related to total delivered flow and is controlled by software with a flow sensor. The blower assembly output connects directly to an integrated humidification tub.
The second functional unit of the HFT150 is a heated humidifier. The tub is integral to the HFT150. Software monitors ambient temperature, humidity, and flow to optimize the humidity delivery to the patient and minimize condensation in the patient circuit. The HFT150 is protected from contaminants and pathogens by an integral anti-bacterial filter. The nasal cannulas, heated tubes, and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors.
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 and pediatric patients (10 kg and up)
Intended User / Care Setting
nurses, respiratory therapists, or doctors / hospital and professional healthcare environments.
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)
Comprehensive testing was conducted to verify and validate that the HFT150 meets specified requirements and is substantially equivalent to the predicate device, AIRVO 2 Series Humidifier. The HFT150 was subjected to verification and validation testing according to the following standards to demonstrate that it performs as intended:
- Safety testing in accordance with IEC 60601-1:2012+AMD1:2012+AMD2:2020, Medical Electrical Equipment – part 1: General requirements for basic safety and essential performance
- EMC testing in accordance with IEC 60601-1-2:2014 ED. 4.0, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances- Requirements and tests
- Biocompatibility testing in accordance with:
- ISO 18562-1:2017, Biocompatibility Evaluation of Breathing Gas Pathways in O Healthcare Applications – Evaluation and testing within a risk management process
- ISO 18562-2:2017, Biocompatibility Evaluation of Breathing Gas Pathways in O Healthcare Applications – Tests for emissions of particulate matter
- O ISO 18562-3:2017, Biocompatibility Evaluation of Breathing Gas Pathways in Healthcare Applications - Test for emissions of volatile organic compounds (VOCs)
- O ISO 10993-1:2018, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process
- ISO 10993-5:2009, Biological Evaluation of Medical Devices Part 5: Tests for In O Vitro Cytotoxicity
- ISO 10993-10:2021, Biological Evaluation of Medical Devices Part 10: Tests for O Irritation and Skin Sensitization
- O ISO 10993-11:2017, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity
- ISO 10993-17:2002, Biological evaluation of medical devices Part 17: o Establishment of allowable limits for leachable substances
- ISO 10993-23:2021, Biological evaluation of medical devices Part 23: Tests for o irritation
- Particular Requirements testing in accordance with ISO 8185:2007, Respiratory track ● humidifiers for medical user – Particular requirements for respiratory humidification systems; and 80601-2-74:2017, Particular requirements for basic safety and essential performance of respiratory humidifying equipment
- . Device life testing
- . Shelf life testing
- Software Verification and Validation Testing in accordance with 21 CFR 820.30, the FDA guidance document, General Principles of Software Validation, and the FDA guidance document, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 14, 2024
Invent Medical Corporation David Gramse Sr. Director, Regulatory Affairs 2788 Loker Ave. W. Carlsbad, California 92010
Re: K233707
Trade/Device Name: Hft150 Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: BTT Dated: May 9, 2024 Received: May 9, 2024
Dear David Gramse:
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.
1
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" (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 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-reportingcombination-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.
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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Ethan L. Nyberg -S
Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and
2
Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233707
Device Name
HFT150
Indications for Use (Describe)
HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.
| 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) |
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HFT150 510(k) Summary
This 510(k) summary of safety and effectiveness is submitted in accordance with the requirements of 21 CFR 807.92.
| SUBMITTER: | Invent Medical Corporation |
|---|---|
| 2788 Loker Ave. W. | |
| Carlsbad, CA 92010 | |
| Contact Person: | David Gramse |
| Sr. Director Regulatory Affairs | |
| P: (442) 888-7673 | |
| E: dave@invent-medical.com | |
| Preparation Date: | May 08, 2024 |
| Name of Device: | HFT150 |
| Common or Usual Name: | Humidifier, Respiratory Gas, (Direct Patient Interface) |
| Regulation Name: | Respiratory gas humidifier |
| Regulation Number: | 21 CFR 868.5450 |
| Product Code: | BTT |
| Device Class: | Class 2 |
| Primary Predicate: | |
| Trade Name: | AIRVO 2 Series Humidifier |
| 510(k) Number: | K131895 |
| Reference Device: | |
| Trade Name: | ApneaLink Air |
| 510(k) Number: | K143272 |
| Reference Device: | |
| Trade Name: | HVT 2.0 |
| 510(k) Number: | K203357 |
DEVICE DESCRIPTION:
The HFT150 is a heated humidifier with integrated flow source and a heated breathing tube to deliver warmed and humidified gas flow to a patient. The HFT150 includes an integrated oxygen module, delivering an oxygen range of 21% to 100% to the patients.
The HFT150 humidifier is comprised of two connected functional units. One is a motorized blower assembly that provides air flow and the delivery of supplemental oxygen to patients via an integrated oxygen module. The blower speed is directly related to total delivered flow and is controlled by software with a flow sensor. The blower assembly output connects directly to an integrated humidification tub.
5
Image /page/5/Picture/0 description: The image shows the logo for Invent Medical Corporation. The word "invent" is written in a sans-serif font, with the "in" in light gray and the "vent" in blue. Below the word "invent" is the phrase "MEDICAL CORPORATION" in smaller, gray, sans-serif letters. The logo is simple and modern, and the use of color helps to make it stand out.
The second functional unit of the HFT150 is a heated humidifier. The tub is integral to the HFT150. Software monitors ambient temperature, humidity, and flow to optimize the humidity delivery to the patient and minimize condensation in the patient circuit. The HFT150 is protected from contaminants and pathogens by an integral anti-bacterial filter. The nasal cannulas, heated tubes, and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors and water tubs are disposable and are for single use only. The HFT150 may be operated by nurses, respiratory therapists, or doctors.
Indications for Use
HFT150 is for spontaneously breathing adult and pediatric patients (10 kg and up) who would benefit from receiving high flow warmed and humidified respiratory gases. The flow may be from 2 - 60 L/min depending on the patient interface. HFT150 is used in hospital and professional healthcare environments.
| HFT150 Indications for Use
(Subject Device – K233707) | AIRVO 2 Series Humidifier
(Primary Predicate Device – K131895) | Assessment of Differences |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| HFT150 is for spontaneously breathing
adult and pediatric patients (10 kg and
up) who would benefit from receiving
high flow warmed and humidified
respiratory gases. The flow may be from
2- 60 L/min depending on the patient
interface. HFT150 is used in hospital and
professional healthcare environments. | The AIRVO 2 humidifier is for the
treatment of spontaneously breathing
patients who would benefit from
receiving high flow warmed and
humidified respiratory gases. This
includes patients who have had upper
airways bypassed. The flow may be from
2 - 60 L/min depending on the patient
interface. The AIRVO 2 is for patients in
hospitals and long-term care facilities. | The indications for use are
substantially equivalent. The
devices are indicated to
deliver humidified
respiratory gases to
spontaneously breathing
patients. |
SUBJECT AND PREDICATE DEVICE INDICATIONS FOR USE COMPARISON:
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE:
A technological comparison table is provided below that compares the subject device and predicate device:
| Functionality | HFT150
(Subject Device – K233707) | AIRVO 2 Series Humidifier
(Primary Predicate Device –
K131895) | Assessment of Differences | |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Flow range | 2 – 60 L/min | 2 – 60 L/min | Equivalent: The HFT150 is
within the range of the
predicate | |
| Oxygen input |