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 Description

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.

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. .

AI/ML Overview

The provided document describes the TrachCuff Cuff Controller, a medical device intended to continuously measure and automatically maintain the user-set cuff pressure of an endotracheal tube (ETT) or tracheostomy tube (TT) during mechanical ventilation.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a structured comparison for each criterion. Instead, it lists the standards and types of testing performed and then states that the device "met acceptance criteria."

However, based on the Comparison of Technological Features to Predicate Devices table (page 5-6), we can infer some key performance aspects and their comparison to the predicate device. The primary performance criteria revolve around pressure control and accuracy, and usability.

Inferred Acceptance Criteria and Reported Performance:

Acceptance Criteria Category	Specific Metric/Standard	TrachCuff Cuff Controller (Subject Device) Performance	Predicate Device (IntelliCuff) Performance	Remark/Conclusion for TrachCuff
Pressure Control	Cuff pressure set range	5 cmH₂O to 50 cmH₂O	5 cmH₂O to 50 cmH₂O	Same; Met criteria.
	Cuff pressure max limit	55 cmH₂O	55 cmH₂O	Same; Met criteria.
	Pressure setpoint and display resolution	1 cmH₂O	1 cmH₂O	Same; Met criteria.
	Specified pressure accuracy	± 1 cmH₂O	± 2 cmH₂O	Similar (TrachCuff is more accurate); "Subiect device pressure accuracy has been confirmed by testing."
	Default Cuff Setpoint Pressure at power on	25 cmH₂O (fixed)	25 cmH₂O (adjustable)	Similar (TrachCuff fixed, IntelliCuff adjustable). "Default setpoint may be configured by the operator."
	Automatic maintenance of set cuff pressure	Yes	Yes	Same; Met criteria.
Safety	Electrical safety	Compliant with IEC 60601-1	Not explicitly stated, but assumed compliant as a cleared device.	"The device met acceptance criteria for compliance to the standards."
	Electromagnetic compatibility	Compliant with IEC 60601-1-2	Not explicitly stated, but assumed compliant as a cleared device.	"The device met acceptance criteria for compliance to the standards."
	Risk Management	Compliant with ISO 14971	Not explicitly stated, but assumed compliant as a cleared device.	"The device met risk management criteria for acceptability of residual risks."
	Safe Shutdown upon power interruption	30 seconds operation by high-capacity capacitor	30 seconds operation by high-capacity capacitor	"Same internal capacitor function for safe shutdown with power interruption (cuff pressure is maintained after shutdown)." "Confirmed by testing."
Usability	Usability evaluation	Compliant with IEC 62366 for professional use	Not explicitly stated, but assumed compliant as a cleared device.	"The device met evaluation criteria for usability in the user group."
	Screen lock/setting change control	3-second key press, and/or user confirmation for setting changes	Screen lock requiring long press	"Achieves a similar functionality as a screen lock."
Durability/Biocompatibility	Biocompatibility (disposable tubing set)	Met acceptance criteria (by reference to manufacturer's technical file)	Not explicitly stated.	"The disposable accessory tubing set met acceptance criteria for biocompatibility."
	Reuse life durability (cleaning/disinfection)	Up to 600 cycles (manual cleaning, low/intermediate disinfection), up to 150 cycles (bleach wipes)	Not explicitly stated.	"The device met acceptance criteria for durability and performance after testing."
Software	Software Lifecycle evaluation	Compliant with IEC 62304 (MAJOR level of concern)	Not explicitly stated, but assumed compliant as a cleared device.	"The software lifecycle process was evaluated to meet: Medical device software lifecycle process per IEC 62304."
	Software Verification & Validation	Met specified requirements and intended use(s)	Not explicitly stated.	"Device software was verified to requirements and validated to meet the specified intended use(s)."

Study Details

The document describes non-clinical testing for the TrachCuff Cuff Controller.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: The document does not specify a distinct "test set" in terms of patient data or a specific number of units for performance testing. Instead, it refers to laboratory testing and usability studies. For durability testing, "the device" was evaluated. For usability, it mentions a "representative population of USA clinical users," but no specific number.
- Data Provenance: The testing was conducted in a laboratory setting ("The TrachCuff Cuff Controller was laboratory tested"). Usability testing involved "USA clinical users," suggesting prospective data collection for that specific aspect. These are non-clinical studies.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided as the studies are primarily non-clinical engineering and usability tests against predefined standards and specifications, rather than clinical studies requiring expert ground truth for diagnostic or therapeutic accuracy. For usability, "USA clinical users" participated, implying healthcare professionals, but no specific number or detailed qualifications are given.
Adjudication method for the test set:
- This information is not applicable as the studies are non-clinical engineering and usability tests against predefined standards. There is no mention of adjudication for discrepancies in expert assessments.
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:
- No, an MRMC comparative effectiveness study was not done. This device is a medical device for controlling cuff pressure, not an AI diagnostic or assistive tool, so such a study would not be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document implies standalone non-clinical performance testing of the device's technical specifications (pressure accuracy, electrical safety, etc.) against established standards. The device itself operates automatically to maintain cuff pressure once set by a user, so its core function is "algorithm only" in terms of maintaining the set pressure. The usability evaluation, however, involves human interaction.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For technical performance, the "ground truth" is defined by established engineering and medical device standards (e.g., IEC 60601-1, IEC 60601-1-2, ISO 14971, IEC 62304, ISTA 3A, IEC 62366), device specifications (e.g., pressure range, accuracy), and manufacturer's technical files (for biocompatibility). There is no "pathology" or "outcomes data" ground truth as this is not a diagnostic device.
The sample size for the training set:
- This information is not applicable/not provided. This device is a hardware-based cuff controller with embedded software, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The software development followed IEC 62304 (software lifecycle process) rather than an AI/ML model training paradigm.
How the ground truth for the training set was established:
- This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

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 (1-800-638-2041 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 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

(1)	Submitted by:	AW Technologies ApsAmalienborgvej 57DK-9400 NoerresundbyDenmarkTel.: +45 51 26 18 27ash@awtechnologies.dk
	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 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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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 TechnologiesTrachCuff Cuff Controller(Subject Device)	Hamilton MedicalIntelliCuff (PredicateDevice)	Remark
Manufacturer	AW Technologies Aps	Hamilton Medical AG
Model Number(s)	Cuff Controller:AWT-2001Disposable Tubing Setwith Filter: TFCO02	Cuff Controller:951001Cuff Pressure Tube withFilter: 282016	Product range for bothdevices includes both cuffcontroller device anddisposable tubing set
510(k) Number	(pending this submission)	K150893
Application/Intended use:	Continuously measureand automaticallymaintains user-set ETT orTT cuff pressure duringmechanical ventilation	Continuously measureand automaticallymaintains user-set ETT orTT cuff pressure duringmechanical ventilation	Same
Patient Population	Adults at least 18 yearswho are intubated withETT or TT	Adults, pediatrics, andneonates, who areintubated with ETT or TT	Similar - TrachCuffclaims for adult ≥ 18years are within theclaims of the predicate
Environment of Use	• In the intensive careward by RespiratoryTherapist	• In the intensive careward or in the recoveryroom• In the operation roomduring intubationnarcosis• For emergency medicalcare or primary care• During transport withinand outside of thehospital• During transfer byrescue vehicles, ship,jet, or helicopter	Similar: TrachCuff claimsfor professional useenvironments (ICU) iswithin the claims of thepredicate IntelliCuff,which specifyprofessional as well asemergency out of hospitaltransport environments.
Product/Feature	AW TechnologiesTrachCuff Cuff Controller(Subject Device)	Hamilton MedicalIntelliCuff (PredicateDevice)	Remark
Indications for use:	The TrachCuff device isintended to continuouslymeasure andautomatically maintainthe user-set cuff pressureof an endotracheal tube(ETT) or tracheostomytube (TT) duringmechanical ventilation.TrachCuff can be usedwith any mechanicalventilator.The TrachCuff is to beused during ventilation ofadults at least 18 yearswho are intubated withETT or TT, in thefollowing areas:• In the intensive careward by RespiratoryTherapist	The IntelliCuff device isintended to continuouslymeasure and automaticallymaintain the user- set cuffpressure of anendotracheal tube (ETT) ortracheostomy tube (TT)during mechanicalventilation.The device can be usedwith any mechanicalventilator, as follows:• When used with a non-Hamilton Medicalventilator, IntelliCuffadjusts the cuff pressureto values set on thedevice.• When used with aHamilton Medicalventilator, IntelliCuffadjusts the cuff pressureto values set either onthe device or on theventilator, depending onconfiguration.The device is to be usedduring ventilation of adults,pediatrics, and neonates,who are intubated withETT or TT, in the followingareas:• In the intensive careward or in the recoveryroom• In the operation roomduring intubationnarcosis• For emergency medicalcare or primary care• During transport withinand outside of thehospital• During transfer byrescue vehicles, ship, jet,or helicopter	SimilarThe claim for TrachCuffperforming continuouscuff control issubstantially identical topredicate IntelliCuff.Both devices can be usedwith any mechanicalventilator.TrachCuff claims for adult≥ 18 years are within thepopulation of IntelliCuff.TrachCuff claims forprofessional useenvironments are withinthe claims of thepredicate IntelliCuff,which specifyprofessional as well asemergency out of hospitaltransport environments.
Operation and Operating Principles
Control Mechanism	Embeddedmicrocontroller	Embeddedmicrocontroller	Same
Product/Feature	AW TechnologiesTrachCuff Cuff Controller(Subject Device)	Hamilton MedicalIntelliCuff (PredicateDevice)	Remark
OperatingModes/Sequences	Automatic maintenanceof set cuff pressureOperator initiated time-limited cuff pressureincreaseOperator initiated deflatecuffOperator initiateddeflate/inflate cuff	Automatic maintenanceof set cuff pressureOperator initiated time-limited cuff pressureincreaseOperator initiated deflatecuffOperator initiateddeflate/inflate cuff	Similar
Time-limited Hold Values	Default: 5 cmH₂O aboveset pressure for 5 min(adjustable up to 25cmH₂O above setpressure for 5 or 10 min)	Default: 5 cmH2O aboveset pressure for 5 min(adjustable up to 25cmH₂O above setpressure 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 anddisplay resolution:	1 cmH₂O	1 cmH2O	Same
Default Cuff SetpointPressure at power on	25 cmH₂O	25 cmH2O (adjustable)	Similar: TrachCuffprovides a fixed defaultsetpoint at power on;IntelliCuff provides anadjustable defaultsetpoint at power on.Default setpoint may beconfigured by theoperator
Specified pressureaccuracy:	± 1 cmH₂O	± 2 cmH2O	Similar
Measurement principle	Solid state pressuresensor(s)	Solid state pressuresensor(s)	Same
Pump type	Eccentric diaphragmpump for gases	Eccentric diaphragmpump for gases	Same
User Interface
Display Type	Color TFT with integratedtouchscreen	Color TFT display	Similar
Displayed Units	Default: cmH20 (hPaorder option)	Default: cmH20 (or hPa,mbar)	Same
Displayed values	Current cuff pressure,setpoint pressure	Current cuff pressure,setpoint pressure	Same
Product/Feature	AW TechnologiesTrachCuff Cuff Controller(Subject Device)	Hamilton MedicalIntelliCuff (PredicateDevice)	Remark
Displayed information(symbols)	Cuff system leakage, cuffpressure above limit, cuffdeflated, time limitedhold, (!) for usershutdown denied; Tubingset not connected,deflation/ inflation inprogress or complete	Cuff system leakage, cuffdeflated, time limitedhold, (!) for user actiondenied or technical fault,battery status includinglow battery	Similar: TrachCuffprovides additionalinformation symbols;IntelliCuff providesbattery status, TrachCuffhas no internal battery
User Input Control Keys	Power ON / OFFAlarm silenceDeflate cuffTime-limited holdDeflate/inflate cuffAdjust cuff pressureUP/DOWN	Power ON / OFFAlarm silenceDeflate cuffTime-limited holdLock control panelAdjust cuff pressure +/-	Similar: TrachCuff doesnot have screen lock butrequires 3-second keypress, and/or userconfirmation:
Visible/Audible Alarms	✓ YES	✓ YES	Same
Power
Power source: Mains	Mains AC power adapter,100 to 240 VAC / 50 to 60Hz; 24 VA rated, 1.25 VAtypical; to 5 VDC	Mains AC power adapter,100 to 240 VAC / 50 to 60Hz; 1.25 VA typ., 3.25 VAmax.; to 5 VDC	Similar for mains input
Internal Battery Type	(none)	AA (IEC-HR6) NiMHrechargeable	TrachCuff has no internalbattery
Internal Capacitor Type	High-capacity capacitor toachieve 30 seconds ofoperation with powerinterruption and safeshutdown state	High-capacity capacitor toachieve 30 seconds ofoperation with powerinterruption and safeshutdown state	Same internal capacitorfunction for safeshutdown with powerinterruption (cuffpressure is maintainedafter shutdown)
Mains power interruption	Operation of internalcapacitor provides 30seconds for alarm andorderly shutdown to safefallback function	Operation of internalcapacitor provides 30seconds for alarm andorderly shutdown to safefallback function	Same
Mechanical
Overall dimensions	Length: 22 cm (8.7 in)Width: 8 cm (3.1 in)Depth: 4.9 cm (1.9 in)	Length: 15.7 cm (6.2 in)Width: 5.5 cm (2.2 in)Depth: 3.6 cm (1.4 in)	Similar size
Weight	500g (17.7 oz)	260 g (9.2 oz)	Similar weight
Product/Feature	AW TechnologiesTrachCuff Cuff Controller(Subject Device)	Hamilton MedicalIntelliCuff (PredicateDevice)	Remark
Mounting Options	Bedside hanging bracket	Bedside hanging bracket;Rear attached railmounting clamp	Similar
Environmental Specifications
Operating Temperature	+5°C to 35°C	-15°C to 50°C / 5°F to122°F	Similar – TrachCuff isspecified for professionalhealthcare environments,IntelliCuff includes out ofhospital emergencytransport

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As summarized above, the TrachCuff Cuff Controller utilizes equivalent technological characteristics and specifications as the cleared predicate device, including the same cuff pressure setpoint ranges and limits.

Discussion of Differences in Indications to the Predicate Device:

The subject TrachCuff device and predicate device have the following differences in their indication statements regarding use for cuff control:

The subject device is intended to be used during ventilation of adults at least . 18 years of age who are intubated with ETT or TT. The predicate device specifies adults, pediatrics, and neonates who are intubated with ETT or TT.
. The subject device is intended to be used in the intensive care ward by Respiratory Therapists. The predicate device additionally specifies use for emergency medical care; during transport within and outside of the hospital; and during transfer by rescue vehicles, ship, jet, or helicopter.
. The subiect device may be used with any mechanical ventilator. The predicate device can be used with any ventilator, however when used with a Hamilton Medical ventilator, the predicate device adjusts the cuff pressure to values set either on the device or on the ventilator, depending on configuration.

The differences in the wording of the subject and predicate device indications for use are not critical to the intended use of the device as a cuff controller and do not affect the safety and effectiveness of the device when used as labeled for the following reasons:

. The subject device specifies an adult (≥ 18 years) patient population within the specified patient population of the predicate device.
The subject device claims for professional use environments are within the . claims of the predicate device, which specify professional as well as emergency out of hospital transport environments.
Both subject and predicate devices can be used with any mechanical . ventilator.

Therefore, in consideration of the above, the differences identified are not critical to the intended use of the device as a cuff controller and do not affect the safety and effectiveness of the device when used as labeled.

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Discussion of Technological Differences to the Predicate Device:

The subject TrachCuff device and predicate IntelliCuff device have the following technological differences:

. The specified pressure accuracy of the subject device is ± 1 cmH2O; the specified accuracy of the predicate device is ± 2 cmH2O. Both devices have a pressure setpoint and display resolution of 1 cmH2O.
The subject device does not have a screen lock but does require a 3-second . key press, and/or user confirmation to change a setting. The predicate device has a screen lock which requires a long press to lock or unlock the panel.
The subiect device does not have an internal battery and is specified for use . in professional healthcare environments. The predicate device does have an internal battery and is specified for use in professional as well as out of hospital transport environments. Both devices have an internal high-capacity capacity capacitor which provides 30 seconds of operation in the event of power loss and allows the device to achieve a safe shutdown state with cuff pressure maintained.

The technological differences in the subject and predicate device are not critical to the intended use of the device as a cuff controller and do not affect the safety and effectiveness of the device when used as labeled for the following reasons:

. The subject device specified pressure accuracy is slightly more accurate than the predicate device accuracy. Subiect device pressure accuracy has been confirmed by testing.
The subject device screen functionality includes a requirement for an . intentional long press or user confirmation for any setting to be changed, which achieves a similar functionality as a screen lock.
The lack of an internal battery does not limit the use of the subject device for . use in professional healthcare environments. In the event of mains power interruption, the subject device is able to achieve a safe shutdown state with cuff pressure maintained, which is equivalent to the predicate device safe shutdown, as confirmed by testing.

Evidence of safety and effectiveness in support of substantial equivalence were obtained from design verification and validation testing. The differences identified above were found not to affect performance or safety through design verification activities that demonstrated conformance to specifications and performance requirements, as well as applicable medical device performance standards and other non-clinical testing.

Non-Clinical Tests Submitted: (b) (1)

The TrachCuff Cuff Controller was laboratory 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.

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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
The device met risk management criteria for acceptability of residual risks.

Device and accessories usability was evaluated to the following:

Usability evaluation per IEC 62366 for professional use .
Summative usability testing of the device in a representative population of USA . clinical users, including critical use functions and user comprehension of key elements of the instructions for use.

The device met evaluation criteria for usability in the user group.

The TrachCuff 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).

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.

The TrachCuff Cuff Controller 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. the TrachCuff Cuff Controller met acceptance criteria for conformance to applicable standards, performance, biocompatibility, cleaning and disinfection, usability, and durability. Residual risks met criteria for acceptability for the intended use.

(2) Clinical Tests Submitted:

(none)

(3) Conclusions from Tests:

As described in (b)(1) and (b)(2) above, the TrachCuff Cuff Controller is equivalent to the predicate cuff controller as supported by compliance, laboratory, and biocompatibility evaluation(s).

The results of all tests demonstrate that the TrachCuff Cuff Controller meets specified requirements for device safety and substantial equivalence to the referenced predicate devices.

Regulation Number and Section

§ 868.5750 Inflatable tracheal tube cuff.

(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).