TrachCuff Cuff Controller

K220854 · Aw Technologies Aps · BSK · Apr 14, 2023 · Anesthesiology

Device Facts

• Record ID: K220854
• Device Name: TrachCuff Cuff Controller
• Applicant: Aw Technologies Aps
• Product Code: BSK · Anesthesiology
• Decision Date: Apr 14, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TrachCuff Cuff Controller 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 TrachCuff Cuff Controller can be used with any mechanical ventilator. The TrachCuff Cuff Controller 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.

Device Story

TrachCuff Cuff Controller is an automatic, mains-powered device for professional healthcare environments (ICU). It inputs cuff pressure data via internal pressure sensors; uses an embedded microcontroller to control an eccentric diaphragm air pump and solenoid valves to maintain user-set pressure (5-50 cmH2O). It outputs real-time pressure readings and alarms via a color TFT touchscreen. Operated by respiratory therapists, it ensures cuff pressure stability; prevents under/over-inflation. In power loss, an internal high-capacity capacitor provides 30 seconds of operation for safe shutdown. It benefits patients by maintaining optimal cuff seal, reducing risks of aspiration or tracheal injury. It is used with any mechanical ventilator.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), software lifecycle (IEC 62304), transport testing (ISTA 3A), risk management (ISO 14971), and usability evaluation (IEC 62366). Biocompatibility of disposable tubing was verified. Durability testing confirmed performance after 600 cleaning/disinfection cycles.

Technological Characteristics

Microcontroller-driven cuff pressure controller. Components: eccentric diaphragm air pump, solenoid air valves, solid-state pressure sensors. Power: Mains AC adapter (100-240 VAC) to 5 VDC; high-capacity capacitor for 30-second power-loss backup. Interface: Color TFT touchscreen. Dimensions: 22x8x4.9 cm. Software: Major level of concern, developed per IEC 62304. Connectivity: Standalone. Sterilization: N/A (disposable tubing set).

Indications for Use

Indicated for adults ≥18 years intubated with endotracheal or tracheostomy tubes requiring continuous cuff pressure monitoring and maintenance during mechanical ventilation in intensive care settings.

Regulatory Classification

Identification

An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Predicate Devices

• IntelliCuff cuff controller (K150893)

Submission Summary (Full Text)

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April 14, 2023

AW Technologies ApS % Stephen Gorski President Imagenix, Inc. S65W35739 Piper Road Eagle, Wisconsin 53119

Re: K220854

Trade/Device Name: TrachCuff Cuff Controller Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: April 9, 2023 Received: April 11, 2023

Dear Stephen Gorski:

We have reviewed vour 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 (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 located at https://www.accessdata.fda.gov/scripts/cdrh/ofdocs/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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 [phone] or 301-796-7100).

Sincerely,

James J. Lee -S

James J. Lee, Ph.D. Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthsia 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known)

K220854

Device Name TrachCuff Cuff Controller

Indications for Use (Describe)

The TrachCuff Cuff Controller 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 TrachCuff Cuff Controller can be used with any mechanical ventilator.

The TrachCuff Cuff Controller 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.

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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### 510(k) Summary in accordance with 21 CFR 807.92

| (a) | (1) | Submitted by: | AW Technologies Aps<br>Amalienborgvej 57<br>DK-9400 Noerresundby<br>Denmark<br>Tel.: [phone]<br>[e-mail] | | |
|-----|-----|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------|
| | | Contact Person: | Mr. Adam Hansen | | |
| | | Position/Title: | CCO | | |
| | | Date of Preparation: | April 3, 2023 | | |
| | (2) | Trade Name: | TrachCuff Cuff Controller | | |
| | | Common/Classification Name: | Cuff, Tracheal Tube, Inflatable | | |
| | | Product Code(s): | 21 CFR §868.5750; BSK | | |
| | | Class: | Class II | | |
| | (3) | Predicate Device(s): | Substantial Equivalence to: | | |
| | | K Number | Model | | Manufacturer |
| | | K150893 | IntelliCuff cuff controller | | Hamilton Medical AG, Bonaduz, Switzerland |
| | | Reason for Submission: | | | New Device |

#### (4) Description of Device:

The TrachCuff Cuff Controller 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.

The TrachCuff Cuff Controller 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 TrachCuff Cuff Controller is provided in an enclosure with touch screen operator panel.

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It is designed for immediate use; no calibration or maintenance is required. A largescale 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 TrachCuff Cuff Controller is the same as the predicate device: to continuously measure and automatically maintain the user-set cuff pressure tube (ETT) or tracheostomy

## Indications for Use:

TrachCuff Cuff Controller 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 TrachCuff Cuff Controller can be used with any mechanical ventilator.

The TrachCuff Cuff Controller 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) Technoloqical Characteristics:

The TrachCuff Cuff Controller utilizes the same technological principles as the predicate device to continuously measure and automatically maintain the user-set cuff pressure of an ETT or TT - both devices utilize the same control methods: microcontroller-driven control of setpoint cuff pressure via air pump to cuff. Both devices utilize similar components to control the cuff pump pressure: a reciprocating air pump, solenoid air valves, and internal pressure sensors.

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# Comparison of Technological Features to Predicate Devices:

| Product/Feature | AW Technologies<br>TrachCuff Cuff Controller<br>(Subject Device) | Hamilton Medical<br>IntelliCuff (Predicate<br>Device) | Remark |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AW Technologies Aps | Hamilton Medical AG | |
| Model Number(s) | Cuff Controller:<br>AWT-2001<br>Disposable Tubing Set<br>with Filter: TFCO02 | Cuff Controller:<br>951001<br>Cuff Pressure Tube with<br>Filter: 282016 | Product range for both<br>devices includes both cuff<br>controller device and<br>disposable tubing set |
| 510(k) Number | (pending this submission) | K150893 | |
| Application/Intended use: | Continuously measure<br>and automatically<br>maintains user-set ETT or<br>TT cuff pressure during<br>mechanical ventilation | Continuously measure<br>and automatically<br>maintains user-set ETT or<br>TT cuff pressure during<br>mechanical ventilation | Same |
| Patient Population | Adults at least 18 years<br>who are intubated with<br>ETT or TT | Adults, pediatrics, and<br>neonates, who are<br>intubated with ETT or TT | Similar - TrachCuff<br>claims for adult ≥ 18<br>years are within the<br>claims of the predicate |
| Environment of Use | • In the intensive care<br>ward by Respiratory<br>Therapist | • In the intensive care<br>ward or in the recovery<br>room<br>• In the operation room<br>during intubation<br>narcosis<br>• For emergency medical<br>care or primary care<br>• During transport within<br>and outside of the<br>hospital<br>• During transfer by<br>rescue vehicles, ship,<br>jet, or helicopter | Similar: TrachCuff claims<br>for professional use<br>environments (ICU) is<br>within the claims of the<br>predicate IntelliCuff,<br>which specify<br>professional as well as<br>emergency out of hospital<br>transport environments. |
| Product/Feature | AW Technologies<br>TrachCuff Cuff Controller<br>(Subject Device) | Hamilton Medical<br>IntelliCuff (Predicate<br>Device) | Remark |
| Indications for use: | The TrachCuff device is<br>intended to continuously<br>measure and<br>automatically maintain<br>the user-set cuff pressure<br>of an endotracheal tube<br>(ETT) or tracheostomy<br>tube (TT) during<br>mechanical ventilation.<br>TrachCuff can be used<br>with any mechanical<br>ventilator.<br>The TrachCuff is to be<br>used during ventilation of<br>adults at least 18 years<br>who are intubated with<br>ETT or TT, in the<br>following areas:<br>• In the intensive care<br>ward by Respiratory<br>Therapist | The IntelliCuff device is<br>intended to continuously<br>measure and automatically<br>maintain the user- set cuff<br>pressure of an<br>endotracheal tube (ETT) or<br>tracheostomy tube (TT)<br>during mechanical<br>ventilation.<br>The device can be used<br>with any mechanical<br>ventilator, as follows:<br>• When used with a non-<br>Hamilton Medical<br>ventilator, IntelliCuff<br>adjusts the cuff pressure<br>to values set on the<br>device.<br>• When used with a<br>Hamilton Medical<br>ventilator, IntelliCuff<br>adjusts the cuff pressure<br>to values set either on<br>the device or on the<br>ventilator, depending on<br>configuration.<br>The device is to be used<br>during ventilation of adults,<br>pediatrics, and neonates,<br>who are intubated with<br>ETT or TT, in the following<br>areas:<br>• In the intensive care<br>ward or in the recovery<br>room<br>• In the operation room<br>during intubation<br>narcosis<br>• For emergency medical<br>care or primary care<br>• During transport within<br>and outside of the<br>hospital<br>• During transfer by<br>rescue vehicles, ship, jet,<br>or helicopter | Similar<br>The claim for TrachCuff<br>performing continuous<br>cuff control is<br>substantially identical to<br>predicate IntelliCuff.<br>Both devices can be used<br>with any mechanical<br>ventilator.<br>TrachCuff claims for adult<br>≥ 18 years are within the<br>population of IntelliCuff.<br>TrachCuff claims for<br>professional use<br>environments are within<br>the claims of the<br>predicate IntelliCuff,<br>which specify<br>professional as well as<br>emergency out of hospital<br>transport environments. |
| Operation and Operating Principles | | | |
| Control Mechanism | Embedded<br>microcontroller | Embedded<br>microcontroller | Same |
| Product/Feature | AW Technologies<br>TrachCuff Cuff Controller<br>(Subject Device) | Hamilton Medical<br>IntelliCuff (Predicate<br>Device) | Remark |
| Operating<br>Modes/Sequences | Automatic maintenance<br>of set cuff pressure<br>Operator initiated time-<br>limited cuff pressure<br>increase<br>Operator initiated deflate<br>cuff<br>Operator initiated<br>deflate/inflate cuff | Automatic maintenance<br>of set cuff pressure<br>Operator initiated time-<br>limited cuff pressure<br>increase<br>Operator initiated deflate<br>cuff<br>Operator initiated<br>deflate/inflate cuff | Similar |
| Time-limited Hold Values | Default: 5 cmH₂O above<br>set pressure for 5 min<br>(adjustable up to 25<br>cmH₂O above set<br>pressure for 5 or 10 min) | Default: 5 cmH2O above<br>set pressure for 5 min<br>(adjustable up to 25<br>cmH₂O above set<br>pressure for 5 or 10 min) | Same |
| Cuff pressure set range: | 5 cmH2O to 50 cmH2O | 5 cmH2O to 50 cmH2O | Same |
| Cuff pressure max limit: | 55 cmH₂O | 55 cmH₂O | Same |
| Pressure setpoint and<br>display resolution: | 1 cmH₂O | 1 cmH2O | Same |
| Default Cuff Setpoint<br>Pressure at power on | 25 cmH₂O | 25 cmH2O (adjustable) | Similar: TrachCuff<br>provides a fixed default<br>setpoint at power on;<br>IntelliCuff provides an<br>adjustable default<br>setpoint at power on.<br>Default setpoint may be<br>configured by the<br>operator |
| Specified pressure<br>accuracy: | ± 1 cmH₂O | ± 2 cmH2O | Similar |
| Measurement principle | Solid state pressure<br>sensor(s) | Solid state pressure<br>sensor(s) | Same |
| Pump type | Eccentric diaphragm<br>pump for gases | Eccentric diaphragm<br>pump for gases | Same |
| User Interface | | | |
| Display Type | Color TFT with integrated<br>touchscreen | Color TFT display | Similar |
| Displayed Units | Default: cmH20 (hPa<br>order option) | Default: cmH20 (or hPa,<br>mbar) | Same |
| Displayed values | Current cuff pressure,<br>setpoint pressure | Current cuff pressure,<br>setpoint pressure | Same |
| Product/Feature | AW Technologies<br>TrachCuff Cuff Controller<br>(Subject Device) | Hamilton Medical<br>IntelliCuff (Predicate<br>Device) | Remark |
| Displayed information<br>(symbols) | Cuff system leakage, cuff<br>pressure above limit, cuff<br>deflated, time limited<br>hold, (!) for user<br>shutdown denied; Tubing<br>set not connected,<br>deflation/ inflation in<br>progress or complete | Cuff system leakage, cuff<br>deflated, time limited<br>hold, (!) for user action<br>denied or technical fault,<br>battery status including<br>low battery | Similar: TrachCuff<br>provides additional<br>information symbols;<br>IntelliCuff provides<br>battery status, TrachCuff<br>has no internal battery |
| User Input Control Keys | Power ON / OFF<br>Alarm silence<br>Deflate cuff<br>Time-limited hold<br>Deflate/inflate cuff<br>Adjust cuff pressure<br>UP/DOWN | Power ON / OFF<br>Alarm silence<br>Deflate cuff<br>Time-limited hold<br>Lock control panel<br>Adjust cuff pressure +/- | Similar: TrachCuff does<br>not have screen lock but<br>requires 3-second key<br>press, and/or user<br>confirmation: |
| Visible/Audible Alarms | ✓ YES | ✓ YES | Same |
| Power | | | |
| Power source: Mains | Mains AC power adapter,<br>100 to 240 VAC / 50 to 60<br>Hz; 24 VA rated, 1.25 VA<br>typical; to 5 VDC | Mains AC power adapter,<br>100 to 240 VAC / 50 to 60<br>Hz; 1.25 VA typ., 3.25 VA<br>max.; to 5 VDC…