TrachFlush

{0} **FDA** U.S. FOOD & DRUG ADMINISTRATION August 13, 2026 Aw Technologies Aps Jorgen Hansen QARA Manager Amalienborgvej 57 Norresundby, 9400 Denmark Re: K261499 Trade/Device Name: TrachFlush Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: July 10, 2026 Received: July 10, 2026 Dear Jorgen Hansen: 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} K261499 - Jorgen Hansen Page 2 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 Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 Management System Regulation (QMSR) (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 {2} K261499 - Jorgen Hansen Page 3 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). Sincerely, Bradley Q. Quinn -S Bradley Quinn 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # **Indications for Use** Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K261499 Device Name TrachFlush Indications for Use (Describe) The TrachFlush device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachFlush device is also intended to assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation. The TrachFlush device can be used with any mechanical ventilator. The TrachFlush device is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas: - In the intensive care ward by Respiratory Therapist 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: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov *"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 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) Summary in accordance with 21 CFR 807.92 (a) (1) Submitted by: AW Technologies Aps Amalienborgvej 57 DK-9400 Noerresundby Denmark Tel.: +45 51 26 18 27 ash@trachflush.com Contact Person: Mr. Adam Hansen Position/Title: CEO Date of Preparation: July 7, 2026 (2) Trade Name: TrachFlush Common/Classification Name: Cuff, Tracheal Tube, Inflatable Product Code(s): 21 CFR §868.5750; BSK Class: Class II (3) Predicate and Reference Device: Substantial Equivalence to: | Type | K Number | Model | Manufacturer | | --- | --- | --- | --- | | Predicate Device | K220854 | TrachCuff cuff controller | AW Technologies, Denmark | | Reference Device | K121955 | CoughAssist T70/E70 | Philips Respironics Inc, USA | Reason for Submission: Labelling change – Indications for Use update and new Trade/Product name (4) Description of Device: The TrachFlush device is an automatic cuff pressure controller specified for use in professional healthcare environments. The device provides the operator with the means to set and control the pressure for cuffed endotracheal tubes and cuffed tracheostomy tubes during mechanical ventilation, and continuous monitoring of the set cuff pressure with alarms. Page 1 of 15 {5} The TrachFlush device is mains powered via a Mains to DC power adapter, and the enclosure may be mounted on a bed rail by means of an optional mounting bracket. The TrachFlush device is provided in an enclosure with touch screen operator panel. It is designed for immediate use; no calibration or maintenance is required. A large-scale display and convenient and intuitive interaction buttons maximize safe use and visibility of all important data. The associated accessories include: - Disposable Tubing Set with Filter - Device Mount Solution – Bedside Mounting Bracket. (5) Intended use: The intended use for the TrachFlush device is the same as the predicate device: to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. Indications for Use: The TrachFlush device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachFlush device is also intended to assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation. The TrachFlush device can be used with any mechanical ventilator. The TrachFlush device is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT, in the following areas: - In the intensive care ward by Respiratory Therapist Prescription use only. (6) Technological Characteristics: The TrachFlush device utilizes exactly the same device as the predicate device to continuously measure and automatically maintain the user-set cuff pressure of an ETT or TT. Page 2 of 15 {6} Comparison of Technological Features to the Predicate Device and the Reference Devices: | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | General Information | | | | | | Manufacturer | AW Technologies ApS | AW Technologies ApS | Same | | | Model Number Device | Cuff Controller: AWT-2001 | Cuff Controller: AWT-2001 | Same | | | Model Number Disposable | Tubing Set: SACO02 | Tubing Set: SACO02 | Same | | | Product Name | TrachFlush | TrachCuff | Different | New product name | | Product Code | BSK | BSK | Same | | | Regulation Number | 21 CFR §868.5750 | 21 CFR §868.5750 | Same | | | FDA Clearance | K261499 | K220854 | Different | New clearance | | Classification Name | Cuff, Tracheal Tube, Inflatable | Cuff, Tracheal Tube, Inflatable | Same | | | Prescription Device | ✓ YES | ✓ YES | Same | | | Patient Population(s) | Adults at least 18 years who are intubated with ETT or TT | Adults at least 18 years who are intubated with ETT or TT | Same | | | Cuff Controller Device is Reusable | ✓ YES | ✓ YES | Same | | Page 3 of 15 {7} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Cuff Controller Tubing Set is single use disposable | ✓ YES | ✓ YES | Same | | | Accessory Tubing provided sterile | No | No | Same | | | **Intended Use (IU) including Indications for Use (IFU)** | | | | | | Indications for Use | The TrachFlush device is intended to continuously measure and automatically maintain the use-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. The TrachFlush device is also intended to assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation | The TrachCuff device is intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation. N/A | Same Different to PD Same to RD | The Indications for Use Statement for the Subject Device contains an additional statement for assisting in clearing secretions which is equivalent to the Reference Device | | **Patients, Users and Environment** | | | | | | Patients | The TrachFlush is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT | The TrachCuff is to be used during ventilation of adults at least 18 years who are intubated with ETT or TT | Same | | | User | Respiratory Therapist | Respiratory Therapist | Same | | Page 4 of 15 {8} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Environment of Use | In the intensive care ward | In the intensive care ward | Same | | | Contraindications | None | None | Same | | | **Device Description** | | | | | | Use/Application | Continuously measure and automatically maintains user-set ETT or TT cuff pressure during mechanical ventilation The TrachFlush device can also assist in clearing upper airway secretions. | Continuously measure and automatically maintains user-set ETT or TT cuff pressure during mechanical ventilation N/A | Same Different to PD Same to RD | The Use/Application for the Subject Device contains an additional feature for clearing secretions by simulating a cough which is equivalent to the Reference Device | | Device Image | | | Similar | New product name on Device | Page 5 of 15 {9} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Operating Modes/Sequences | Automatic maintenance of set Cuff Pressure Operator-initiated change of set Cuff Pressure Operator-initiated time- limited Cuff Pressure increase Operator-initiated deflate Cuff Pressure Operator-initiated quick deflate/inflate Cuff Pressure | Automatic maintenance of set Cuff Pressure Operator-initiated change of set Cuff Pressure Operator-initiated time- limited Cuff Pressure increase Operator-initiated deflate Cuff Pressure Operator-initiated quick deflate/inflate Cuff Pressure | Same | | | Default Cuff pressure setpoint: | 25 cmH_{2}O | 25 cmH_{2}O | Same | | | Cuff Pressure set range: | 5 cmH_{2}O to 50 cmH_{2}O | 5 cmH_{2}O to 50 cmH_{2}O | Same | | | Cuff Pressure setpoint and display resolution: | 1 cmH_{2}O | 1 cmH_{2}O | Same | | | Specified Cuff Pressure accuracy: | ± 1 cmH_{2}O | ± 1 cmH_{2}O | Same | | | Time-limited Cuff Pressure increase | Default: 5 cmH2O above set pressure for 5 min (adjustable up to 25 cmH2O above set pressure for 5 or 10 min) | Default: 5 cmH2O above set pressure for 5 min (adjustable up to 25 cmH2O above set pressure for 5 or 10 min) | Same | | | Deflate-cuff Cuff Pressure | 0 cmH_{2}O | 0 cmH_{2}O | Same | | | Quick Deflate/Inflate Cuff Pressure | Deflate Cuff Pressure to 0cmH2O and Inflate the Cuff Pressure to set Cuff Pressure target during an inspiratory cycle upon activation | Deflate Cuff Pressure to 0cmH2O and Inflate the Cuff Pressure to set Cuff Pressure target during an inspiratory cycle upon activation | Same | | Page 6 of 15 {10} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | **User Interface** | | | | | | Display Type | Color TFT with integrated touchscreen | Color TFT with integrated touchscreen | Same | | | Displayed Units | Default: cmH20 (or hPa, mbar) | Default: cmH20 (or hPa, mbar) | Same | | | Displayed values | Current cuff pressure, setpoint pressure | Current cuff pressure, setpoint pressure | Same | | | Displayed information (symbols) | Cuff system leakage, cuff pressure above limit, cuff deflated, time limited hold, (!) for user shutdown denied; Tubing set not connected, deflation/ inflation in progress or complete | Cuff system leakage, cuff pressure above limit, cuff deflated, time limited hold, (!) for user shutdown denied; Tubing set not connected, deflation/ inflation in progress or complete | Same | | | User Input Control Keys | Power ON / OFF Alarm silence Adjust cuff pressure UP/DOWN Time-limited hold Deflate cuff Quick Deflate/inflate cuff | Power ON / OFF Alarm silence Adjust cuff pressure UP/DOWN Time-limited hold Deflate cuff Quick Deflate/inflate cuff | Same | | | Visible Alarms | Display and LED Alarm bar | Display and LED Alarm bar | Same | | | Auditory Alarm Volume | 50 dB(A) ± 6 dB(A), 1 m distance | 50 dB(A) ± 6 dB(A), 1 m distance | Same | | | High Priority Alarms | Cuff system leakage | Cuff system leakage | Same | | Page 7 of 15 {11} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Medium Priority Alarms | Pressure above set limit; Cuff Deflated; User Shutdown Denied | Pressure above set limit; Cuff Deflated; User Shutdown Denied | Same | | | Additional Alarms/Alerts | Power Failure; Technical fault(s) | Power Failure; Technical fault(s) | Same | | | Alarm Silence Input | Alarm silence key | Alarm silence key | Same | | | Alarm Silence Indicator | Alarm silence icon, 2 minutes | Alarm silence icon, 2 minutes | Same | | | **Control components** | | | | | | Pump type | Eccentric diaphragm pump for gases, design supports medical device applications | Eccentric diaphragm pump for gases, design supports medical device applications | Same | | | Pressure sensor type | Integrated solid state pressure sensor | Integrated solid state pressure sensor | Same | | | **Power Specifications** | | | | | | Power source: Mains | Mains AC power adapter, 100 to 240 VAC / 50 to 60 Hz; 24 VA rated, 1.25 VA typical | Mains AC power adapter, 100 to 240 VAC / 50 to 60 Hz; 24 VA rated, 1.25 VA typical | Same | | | DC Power input | 5V DC | 5V DC | Same | | | Internal Battery Type | None | None | Same | | Page 8 of 15 {12} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Mains power interruption | Internal capacitor backup | Internal capacitor backup | Same | | | **Mechanical Characteristics** | | | | | | Housing Construction | Clamshell construction | Clamshell construction | Same | | | Housing Material | ABS | ABS | Same | | | Overall dimensions | Length: 22 cm Width: 8 cm Depth: 4.9 cm | Length: 22 cm Width: 8 cm Depth: 4.9 cm | Same | | | Weight | 500g (17.6 oz) | 500g (17.6 oz) | Same | | | Mounting Options | Bedside bracket | Bedside bracket | Same | | | **Environmental Specifications** | | | | | | Operating Temperature | +5°C to 35°C | +5°C to 35°C | Same | | | Operating Humidity | 30% to 75%, noncondensing | 30% to 75%, noncondensing | Same | | | Storage Temperature | -15°C to 70°C/ 5°C to 158°F | -15°C to 70°C/ 5°C to 158°F | Same | | | Storage Humidity | 5% to 95%, noncondensing | 5% to 95%, noncondensing | Same | | | Environmental Pressure Range | 70.0 kPa to 106.0 kPa (-300 m/-1,000 ft. to +3048 m/ 10,000 ft.) | 70.0 kPa to 106.0 kPa (-300 m/-1,000 ft. to +3048 m/ 10,000 ft.) | Same | | Page 9 of 15 {13} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | **Cleaning and Disinfection Methods** | | | | | | Cleaning and Disinfection Methods | Surface wipe of device reusable components per manufacturer specified wet contact times | Surface wipe of device reusable components per manufacturer specified wet contact times | Same | | | Cleaning/Low-Level Disinfection Agent(s) | 70% Isopropyl alcohol wipes - WEBCOL/Curity Alcohol Prep Pads or equivalent | 70% Isopropyl alcohol wipes - WEBCOL/Curity Alcohol Prep Pads or equivalent | Same | | | Cleaning/Intermediate Level Disinfection Agent(s) | Super Sani-Cloth® Germicidal Disposable Wipe (PDI, Inc., Woodcliff Lake, NJ, USA); Quarternary ammonium chlorides 0.55%; Isopropyl Alcohol 55.0%; 2- min. contact time; EPA Registration No. 9480-4 | Super Sani-Cloth® Germicidal Disposable Wipe (PDI, Inc., Woodcliff Lake, NJ, USA); Quarternary ammonium chlorides 0.55%; Isopropyl Alcohol 55.0%; 2- min. contact time; EPA Registration No. 9480-4 | Same | | | Intermediate Level Disinfection Agent(s) | Sani-Cloth® Bleach Germicidal Disposable Wipe (PDI, Inc., Woodcliff Lake, NJ, USA); Sodium Hypochlorite 0.63%; 4- min. contact time; EPA Registration No 9480-8 | Sani-Cloth® Bleach Germicidal Disposable Wipe (PDI, Inc., Woodcliff Lake, NJ, USA); Sodium Hypochlorite 0.63%; 4- min. contact time; EPA Registration No 9480-8 | Same | | | **Disposable Tubing Set** | | | | | | Tubing Material | DEHP free PVC | DEHP free PVC | Same | | | Filter Housing Material | DEHP free PVC | DEHP free PVC | Same | | | Filter Material | PTFE | PTFE | Same | | | Tubing Filter Material(s) | 0.2 μm bacterial filter | 0.2 μm bacterial filter | Same | | Page 10 of 15 {14} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Tubing Overall Length | 200 cm / 79 in | 200 cm / 79 in | Same | | | Disposable Tubing and Filter Packaging | Tyvek (PET/PP) peel pouch | Tyvek (PET/PP) peel pouch | Same | | | **Safety Compliance** | | | | | | Electrical Protection Class | Class II, Type BF applied part per IEC 60601-1 | Class II, Type BF applied part per IEC 60601-1 | Same | | | Magnetic resonance rated | MR Unsafe (device label) | MR Unsafe (device label) | Same | | | Ingress Protection Rating | IP33 | IP33 | Same | | | Standards Compliance – Device | IEC 60601-1:2005, AMD1:2012 IEC 60601-1-2:2014 IEC 62366-1:2020 IEC 60601-1- 8:2006/AMD1:2012 IEC 62304:2006/AMD1:2015 | IEC 60601-1:2005, AMD1:2012 IEC 60601-1-2:2014 IEC 62366-1:2020 IEC 60601-1- 8:2006/AMD1:2012 IEC 62304:2006/AMD1:2015 ISO 14971 Risk Management | Same | | | Non-Clinical Testing | Electrical safety testing per IEC 60601-1 Electromechanical compatibility testing per IEC 60601-1-2 Software Lifecycle evaluation to IEC 62304 Transport testing per ISTA 3A Usability evaluation per IEC 62366 | Electrical safety testing per IEC 60601-1 Electromechanical compatibility testing per IEC 60601-1-2 Software Lifecycle evaluation to IEC 62304 Transport testing per ISTA 3A Usability evaluation per IEC 62366 | Same | | Page 11 of 15 {15} | Product/Feature | TrachFlush (Subject Device) | TrachCuff (Predicate Device) | Same, Similar or Different | Comments | | --- | --- | --- | --- | --- | | Clinical Testing | Yes | N/A | Different to PD | Clinical testing results are included in this submission which demonstrates that the update of Indications for Use statement for the Subject Device does not raise any issues of safety and effectiveness | In the summary SE table above, we have demonstrated that the PD and SD are Substantial Equivalent in all Design Input Specifications for: - Indications for Use for the "continuously measure and automatically maintain the use-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation" - Patients, Users and Use Environment - All Operational modes - Technological performance including the - User Interface, - Control Components, - Power Specifications, - Mechanical Characteristics, - Environmental Specifications - Cleaning requirements, - Disposable Tubing Set and - Safety compliance In the summary SE table above, we have also demonstrated that the SD is different to the PD, but equivalent to the Reference Device, with the addition of the Indications for Use statement of - "assist in clearing upper airway secretions by simulating an artificial cough during mechanical ventilation" The differences between the SD and PD in Indications for Use statement was additionally evaluated through clinical testing. The Equivalence evaluation between the SD and the Reference Device of the artificial cough maneuver technique was evaluated through an artificial cough maneuver technological comparison description. ### (b) (1) Non-Clinical testing: Page 12 of 15 {16} As demonstrated in the previous submission **K220854**, the TrachFlush device was developed and tested to current applicable standards for medical device electrical safety and electromagnetic compatibility. The following standards were utilized in compliance testing: - Electrical safety testing per IEC 60601-1 - Electromagnetic compatibility testing per IEC 60601-1-2 - Software Lifecycle evaluation to IEC 62304 - Transport testing per ISTA 3A The device met acceptance criteria for compliance to the standards. As demonstrated in the previous submission **K220854**, Risk management, risk and hazard analysis of the device and accessories was performed to the following standard: - Application of risk management to medical devices per ISO 14971 - Usability evaluation per IEC 62366 for professional use The device met risk management criteria for acceptability of residual risks. As demonstrated in the previous submission **K220854**, the TrachFlush device embedded software was developed in accordance with FDA guidelines for MAJOR level of concern devices. The software lifecycle process was evaluated to meet: - Medical device software lifecycle process per IEC 62304 (also assessed by independent compliance laboratory). - Device software was verified to requirements and validated to meet the specified intended use(s). As demonstrated in the previous submission **K220854**, the disposable accessory tubing set with filter was evaluated for biocompatibility by reference to the manufacturer's technical file. The disposable accessory tubing set met acceptance criteria for biocompatibility. As demonstrated in the previous submission **K220854**, the TrachFlush device was evaluated for reuse life durability for per the reprocessing methods specified in device labeling: - Manual cleaning, low-level and intermediate-level disinfection: up to 600 cycles - Intermediate level disinfection (bleach wipes): up to 150 cycles The device met acceptance criteria for durability and performance after testing. In summary, as demonstrated in the previous submission **K220854**, the TrachFlush device met acceptance criteria for conformance to applicable standards, performance, biocompatibility, cleaning and disinfection, and durability. Residual risks met criteria for acceptability for the intended use. ## **(2) Clinical Testing:** Page 13 of 15 {17} Investigator driven scientific peer reviewed studies have investigated the use of the TrachFlush device to remove airway secretions, simulating an artificial cough maneuver: - Nielsen AH, Karbing DS, Sølling CG, Winding RR, Rees SE, Dey N. Efficacy of an automated secretion removal technology at different inspiratory pressures. Respiratory Care 2023 Nov;68(11):1502-1509 - Sinnige JS, Karbing DS, Valk CMA, Schultz MJ, Rees SE, Paulus F. A prospective, longitudinal study evaluating the efficacy of an automated secretion removal technology. Respiratory Care 2024;69(8):931–936. - Vivona L, Madotto F, Carlesso E, Florio G, Rees SE, Karbing DS, Sodi F, Zainaghi I, Rossi V, Panigada M, Zanella A. Evaluation of a new device for clearing secretions from lower airways. Respiratory Care 2025, Ahead of print In the study of Nielsen et al. 20 intensive care patients were studied at low (21.8 ± 3.8 cmH2O) and high (25.6 ± 3.6 cmH2O) inspiratory pressure settings. Thirty-eight (86 %) of artificial cough maneuvers were considered successful, with removal of the primary symptom indicating need for tracheal suctioning and no subsequent endotracheal suctioning performed, eliminating the need for suctioning in 18 of 20 patients. No significant differences were seen in measured values of Critical-care Pain Observation Tool scores on application of the artificial cough maneuver. In the study of Sinnige et al. 28 intensive care patients were studied at low (20.0 ± 1.5 cmH2O) inspiratory pressures during the duration of mechanical ventilation. Forty-seven (56%) of artificial cough maneuvers were considered successful, such that there were no longer secretions in the airways that needed to be removed, and that no tracheal suctioning was performed such that application of the maneuver reduced the need for ETS by more than 70 % in 13 of 24 subjects. The artificial cough maneuver was well tolerated and had side effects similar to those seen in artificial airway suctioning. In the study of Vivona et al. 28 intensive care patients were studied at higher inspiratory pressures (35 cmH2O). Flow around the cuff due to the artificial cough maneuver was shown to mobilize tracheal secretions to the mouth in 78% of cases with adverse events consistent with artificial airway suctioning. In summary, these peer reviewed studies have shown clinical efficacy and safety by using the TrachFlush device to remove airway secretions, simulating an artificial cough maneuver. ### (3) Reference Devices technological comparison description: An equivalence evaluation of the artificial cough maneuver technique between the RD and SD was evaluated through an artificial cough maneuver technological comparison description. AWT has identified an existing reference device cleared by the FDA (K121955) for secretion removal using the artificial cough maneuver technique. Page 14 of 15 {18} This identified reference device is based on the maximal inspiratory-expiratory pressure delivery, aka. the MI-E functionality and/or method. Is summary, our analysis and comparison description found that the TrachFlush artificial cough maneuver technique is equivalent to the Reference Device artificial cough maneuver technique ### (3) Conclusions: As described in (b)(1) above, the TrachFlush device is equivalent to the Predicate Device as supported by non-clinical testing. As described in (b)(2) above, the TrachFlush device is safe and effective when removing airway secretions, simulating an artificial cough maneuver. As described in (b)(3) above, the TrachFlush artificial cough maneuver technique is equivalent to the Reference Device artificial cough maneuver technique. All of the above demonstrates that the TrachFlush device meets specified requirements for device safety and efficacy and is therefore substantial equivalent to the Predicate Device. Page 15 of 15