(207 days)
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 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.
This document is a 510(k) summary for the HFT150, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device, the AIRVO 2 Series Humidifier, rather than detailing the acceptance criteria for a specific AI algorithm or its performance in a clinical study. Therefore, most of the requested information regarding AI device performance, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not present in this document.
However, I can extract the general testing summary which outlines the types of evaluations performed on the HFT150 device to ensure its safety and performance, which are analogous to acceptance criteria in a broader sense.
Here's a breakdown of what information is available based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of specific numerical acceptance criteria for performance parameters (e.g., specific humidity levels or temperature accuracy) alongside reported device performance for the HFT150. Instead, it lists the standards to which the device was tested, implying that the acceptance criteria for these tests were meeting the requirements of those standards.
| Acceptance Criteria Category (Implied by Standard) | Reported Device Performance Summary (from document) |
|---|---|
| Safety Testing (IEC 60601-1) | "meets specified requirements" |
| EMC Testing (IEC 60601-1-2) | "meets specified requirements" |
| Biocompatibility Testing (ISO 18562, ISO 10993) | "meets specified requirements" |
| Particular Requirements (ISO 8185, 80601-2-74) | "performs as intended," "substantially equivalent to the predicate device" |
| Device Life Testing | "meets specified requirements" |
| Shelf Life Testing | "meets specified requirements" |
| Software V&V (21 CFR 820.30, FDA guidance) | "meets specified requirements" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This document refers to device verification and validation testing against engineering standards rather than clinical studies with patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. Ground truth establishment by experts is typically associated with AI/ML algorithm validation using clinical data, which is not the subject of this 510(k) summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used in clinical studies for establishing ground truth, which is not described here.
5. 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 document does not describe an AI-assisted device or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This document does not describe an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" for the device, in this context, is its adherence to the performance and safety specifications outlined in the referenced standards (e.g., "electrical safety compliance," "biocompatibility material standards," "flow rate accuracy"). These are verified through engineering and laboratory testing.
8. The sample size for the training set
Not applicable. There is no mention of an AI algorithm or a training set.
9. How the ground truth for the training set was established
Not applicable. There is no mention of an AI algorithm or a training set.
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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.
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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
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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
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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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Image /page/4/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 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, with a focus on the company's name.
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.
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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 breathingadult and pediatric patients (10 kg andup) who would benefit from receivinghigh flow warmed and humidifiedrespiratory gases. The flow may be from2- 60 L/min depending on the patientinterface. HFT150 is used in hospital andprofessional healthcare environments. | The AIRVO 2 humidifier is for thetreatment of spontaneously breathingpatients who would benefit fromreceiving high flow warmed andhumidified respiratory gases. Thisincludes patients who have had upperairways bypassed. The flow may be from2 - 60 L/min depending on the patientinterface. The AIRVO 2 is for patients inhospitals and long-term care facilities. | The indications for use aresubstantially equivalent. Thedevices are indicated todeliver humidifiedrespiratory gases tospontaneously breathingpatients. |
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 iswithin the range of thepredicate | |
| Oxygen input | < 60 L/min(internally regulated viasoftware and a flow sensor) | < 60 L/min | Identical | |
| Functionality | HFT150(Subject Device – K233707) | AIRVO 2 Series Humidifier(Primary Predicate Device – K131895) | Assessment of Differences | |
| Oxygen Range | 21 to 100% O2 via Oxygenmodule | 25 to 95% O2 | Equivalent: The HFT150 has aslightly larger range, and thisdifference does not impactsafety or performancespecifications | |
| Design | Integrated blower andhumidifier with chamber andheated breathing tube | Integrated blower andhumidifier with Integratedblower and humidifier withchamber and heated breathingtube | Similar | |
| Energy source | Electrical from mains topower blower and heating | Electrical from mains to powerblower and heating | Identical | |
| Temperaturesetting | 31°C – 37°C | 31°C, 34°C, 37°C | Identical | |
| Operating principle | Delivery of humidified Air/02at constant flow to the patient | Delivery of humidified Air/02 atconstant flow to the patient | Identical | |
| Patient interface | Nasal cannula only | Nasal cannula, tracheostomydirect connection, face mask | Similar | |
| Alarms | Audible and visual forTemperature, Flow andOxygen Fraction | Audible and visual forTemperature, Flow and OxygenFraction | Identical | |
| User interface | User set point adjustment viarotary encoder knob orpressing color LCD touchscreen for temperature andflow | User set point adjustment viamenu system on color displayfor temperature and flow | Equivalent: The differencewith user adjustmentsettings does not impactsafety or performance. | |
| Display | LCD display | LED display for Temperature,Flow, Oxygen Fraction | Similar | |
| Control | Software control usingfeedback sensors withhardware back upsNonin Xpod 3012LP | Software control usingfeedback sensors withhardware backups | Identical | |
| Integrated PulseOximetry | Optional feature provided foruser convenience so users donot have to use a separate,standalone pulse oximetrydevice. | Not included | Different: Refer to theReference Devicecomparison table below. | |
| Transport mode | Limits power to flow only | Limits power to flow only | Identical | |
| Functionality | HFT150(Subject Device -K233707) | ApneaLink Air(Reference DeviceK143272) | HVT 2.0Reference DeviceK203357 | Assessment ofDifferences |
| IntegratedPulseOximetry | Nonin Xpod 3012LPOptional feature providedfor user convenience sousers do not have to use aseparate, standalone pulseoximetry device. | Nonin Xpod 3012LP | N/A | Identical technology:This additionalfeature is the sameas the referencedevice, ApneaLink Air(cleared in K143272).This additionalfeature does notimpact safety orperformance. |
| PatientContactingMaterials | Externally communicating,tissue, prolonged duration | N/A | Externally communicating,tissue, prolonged duration | Identical: bothdevices have thesame duration ofcontact. |
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Image /page/6/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 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.
_K233707 - HFT150: Traditional 510(k)
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Image /page/7/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 gray and the "vent" in blue. Below the word "invent" is the phrase "MEDICAL CORPORATION" in a smaller, sans-serif font, also in blue. The logo is simple and modern, and the use of color helps to create a sense of trust and reliability.
K233707 - HFT150: Traditional 510(k)
A technological comparison is provided below between the subject device and reference device:
SUBSTANTIAL EQUVALENCE DISCUSSION:
The subject device, HFT150, is substantially equivalent in technology, design and function to the predicate device, AIRVO 2 Series Humidifier cleared under K131895. The minor differences between predicate and subject devices are identified in the table above and are described further below.
Both the HFT150 and the predicate device support the delivery of oxygen flow up to 60 L/min. The subject device utilizes an internal mechanism for oxygen flow delivery. The predicate device utilizes an external mechanism for oxygen flow delivery.
Both the HFT150 and the predicate device support a nasal cannula patient interface. The predicate device also supports a tracheotomy and mask interface.
The HFT150 utilizes both a rotary control knob and LCD touch screen for selecting device settings. The predicate device utilizes hard keys for selecting device settings.
The HFT150 provides users the option of an integrated Nonin Xpod 3012LP for SpO2% and Pulse Rate display and alarms for low SpO2%, high SpO2%, High Pulse Rate, and Low Pulse Rate. Although both the subject device and predicate device provide supplemental oxygen, the predicate device does not provide an integrated Pulse Oximetry option. For either the subject device or predicate device, the user may choose to use an external, standalone pulse oximetry device. As such, this submission includes the reference device, ApneaLink Air (K143272), which also utilizes the same well-established Nonin Xpod 3012LP technology. Additionally, a second
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Image /page/8/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 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.
reference device, HVT 2.0 (K203357), was added to establish the duration of patient contacting materials as externally communicating, tissue, prolonged duration.
The above differences between the HFT150 subject device and the AIRVO 2 Series Humidifier do not impact substantial equivalency.
TESTING SUMMARY:
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
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Image /page/9/Picture/0 description: The image shows the logo for Invent Medical Corporation. The word "invent" is written in a sans-serif font, with the "i" in gray and the rest of the letters in blue. Below the word "invent" is the phrase "MEDICAL CORPORATION" in smaller, gray, sans-serif letters.
- 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.
CONCLUSION:
The information provided in this premarket notification established that the subject device, HFT150, and the predicate device, AIRVO 2 Series Humidifier, are substantially equivalent in comparison to indications for use, design, technology and performance.
§ 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).