(387 days)
Not Found
No
The summary describes a device that automatically maintains a set pressure using continuous measurement and control, which is a standard control system function and does not mention or imply the use of AI or ML.
Yes.
The 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, which is a therapeutic intervention for patients.
No
Explanation: The device continuously measures and maintains user-set cuff pressure in ETT or TT. While it monitors the pressure, its primary function is controlling and maintaining, not diagnosing medical conditions or diseases. It is a control device for a therapeutic intervention.
No
The device description explicitly states it is a physical device with an enclosure, touch screen, mains power, and associated hardware accessories (tubing set, mounting bracket). While it contains embedded software, it is not solely software.
Based on the provided information, the TrachCuff Cuff Controller is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The device is intended to measure and maintain the pressure of an endotracheal or tracheostomy tube cuff during mechanical ventilation. This is a direct interaction with the patient's airway and a physiological parameter (pressure).
- Device Description: The description focuses on controlling and monitoring pressure within the cuff, not on analyzing biological samples or providing diagnostic information based on such analysis.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device's function is purely mechanical and physiological.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TrachCuff Cuff Controller does not fit this definition. It is a medical device used to manage a physiological parameter during a medical procedure.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
BSK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults at least 18 years
Intended User / Care Setting
Respiratory Therapist, In the intensive care ward
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Tests Submitted:
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.
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.
Clinical Tests Submitted:
(none)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
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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3
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@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 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.
4
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.
5
Comparison of Technological Features to Predicate Devices:
| Product/Feature | AW Technologies
TrachCuff Cuff Controller
(Subject Device) | Hamilton Medical
IntelliCuff (Predicate
Device) | Remark |
|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | AW Technologies Aps | Hamilton Medical AG | |
| Model Number(s) | Cuff Controller:
AWT-2001
Disposable Tubing Set
with Filter: TFCO02 | Cuff Controller:
951001
Cuff Pressure Tube with
Filter: 282016 | Product range for both
devices includes both cuff
controller device and
disposable tubing set |
| 510(k) Number | (pending this submission) | K150893 | |
| Application/Intended use: | Continuously measure
and automatically
maintains user-set ETT or
TT cuff pressure during
mechanical ventilation | Continuously measure
and automatically
maintains user-set ETT or
TT cuff pressure during
mechanical ventilation | Same |
| Patient Population | Adults at least 18 years
who are intubated with
ETT or TT | Adults, pediatrics, and
neonates, who are
intubated with ETT or TT | Similar - TrachCuff
claims for adult ≥ 18
years are within the
claims of the predicate |
| Environment of Use | • In the intensive care
ward by Respiratory
Therapist | • In the intensive care
ward or in the recovery
room
• In the operation room
during intubation
narcosis
• For emergency medical
care or primary care
• During transport within
and outside of the
hospital
• During transfer by
rescue vehicles, ship,
jet, or helicopter | Similar: TrachCuff claims
for professional use
environments (ICU) is
within the claims of the
predicate IntelliCuff,
which specify
professional as well as
emergency out of hospital
transport environments. |
| Product/Feature | AW Technologies
TrachCuff Cuff Controller
(Subject Device) | Hamilton Medical
IntelliCuff (Predicate
Device) | Remark |
| Indications for use: | 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.
TrachCuff can be used
with any mechanical
ventilator.
The TrachCuff 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 | The IntelliCuff 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 device can be used
with any mechanical
ventilator, as follows:
• When used with a non-
Hamilton Medical
ventilator, IntelliCuff
adjusts the cuff pressure
to values set on the
device.
• When used with a
Hamilton Medical
ventilator, IntelliCuff
adjusts the cuff pressure
to values set either on
the device or on the
ventilator, depending on
configuration.
The device is to be used
during ventilation of adults,
pediatrics, and neonates,
who are intubated with
ETT or TT, in the following
areas:
• In the intensive care
ward or in the recovery
room
• In the operation room
during intubation
narcosis
• For emergency medical
care or primary care
• During transport within
and outside of the
hospital
• During transfer by
rescue vehicles, ship, jet,
or helicopter | Similar
The claim for TrachCuff
performing continuous
cuff control is
substantially identical to
predicate IntelliCuff.
Both devices can be used
with any mechanical
ventilator.
TrachCuff claims for adult
≥ 18 years are within the
population of IntelliCuff.
TrachCuff claims for
professional use
environments are within
the claims of the
predicate IntelliCuff,
which specify
professional as well as
emergency out of hospital
transport environments. |
| Operation and Operating Principles | | | |
| Control Mechanism | Embedded
microcontroller | Embedded
microcontroller | Same |
| Product/Feature | AW Technologies
TrachCuff Cuff Controller
(Subject Device) | Hamilton Medical
IntelliCuff (Predicate
Device) | Remark |
| Operating
Modes/Sequences | Automatic maintenance
of set cuff pressure
Operator initiated time-
limited cuff pressure
increase
Operator initiated deflate
cuff
Operator initiated
deflate/inflate cuff | Automatic maintenance
of set cuff pressure
Operator initiated time-
limited cuff pressure
increase
Operator initiated deflate
cuff
Operator initiated
deflate/inflate cuff | Similar |
| Time-limited Hold Values | 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 |
| 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
display resolution: | 1 cmH₂O | 1 cmH2O | Same |
| Default Cuff Setpoint
Pressure at power on | 25 cmH₂O | 25 cmH2O (adjustable) | Similar: TrachCuff
provides a fixed default
setpoint at power on;
IntelliCuff provides an
adjustable default
setpoint at power on.
Default setpoint may be
configured by the
operator |
| Specified pressure
accuracy: | ± 1 cmH₂O | ± 2 cmH2O | Similar |
| Measurement principle | Solid state pressure
sensor(s) | Solid state pressure
sensor(s) | Same |
| Pump type | Eccentric diaphragm
pump for gases | Eccentric diaphragm
pump for gases | Same |
| User Interface | | | |
| Display Type | Color TFT with integrated
touchscreen | Color TFT display | Similar |
| Displayed Units | Default: cmH20 (hPa
order option) | Default: cmH20 (or hPa,
mbar) | Same |
| Displayed values | Current cuff pressure,
setpoint pressure | Current cuff pressure,
setpoint pressure | Same |
| Product/Feature | AW Technologies
TrachCuff Cuff Controller
(Subject Device) | Hamilton Medical
IntelliCuff (Predicate
Device) | Remark |
| 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
deflated, time limited
hold, (!) for user action
denied or technical fault,
battery status including
low battery | Similar: TrachCuff
provides additional
information symbols;
IntelliCuff provides
battery status, TrachCuff
has no internal battery |
| User Input Control Keys | Power ON / OFF
Alarm silence
Deflate cuff
Time-limited hold
Deflate/inflate cuff
Adjust cuff pressure
UP/DOWN | Power ON / OFF
Alarm silence
Deflate cuff
Time-limited hold
Lock control panel
Adjust cuff pressure +/- | Similar: TrachCuff does
not have screen lock but
requires 3-second key
press, and/or user
confirmation: |
| Visible/Audible Alarms | ✓ YES | ✓ YES | Same |
| Power | | | |
| Power source: Mains | Mains AC power adapter,
100 to 240 VAC / 50 to 60
Hz; 24 VA rated, 1.25 VA
typical; to 5 VDC | Mains AC power adapter,
100 to 240 VAC / 50 to 60
Hz; 1.25 VA typ., 3.25 VA
max.; to 5 VDC | Similar for mains input |
| Internal Battery Type | (none) | AA (IEC-HR6) NiMH
rechargeable | TrachCuff has no internal
battery |
| Internal Capacitor Type | High-capacity capacitor to
achieve 30 seconds of
operation with power
interruption and safe
shutdown state | High-capacity capacitor to
achieve 30 seconds of
operation with power
interruption and safe
shutdown state | Same internal capacitor
function for safe
shutdown with power
interruption (cuff
pressure is maintained
after shutdown) |
| Mains power interruption | Operation of internal
capacitor provides 30
seconds for alarm and
orderly shutdown to safe
fallback function | Operation of internal
capacitor provides 30
seconds for alarm and
orderly shutdown to safe
fallback 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 Technologies
TrachCuff Cuff Controller
(Subject Device) | Hamilton Medical
IntelliCuff (Predicate
Device) | Remark |
| Mounting Options | Bedside hanging bracket | Bedside hanging bracket;
Rear attached rail
mounting clamp | Similar |
| Environmental Specifications | | | |
| Operating Temperature | +5°C to 35°C | -15°C to 50°C / 5°F to
122°F | Similar – TrachCuff is
specified for professional
healthcare environments,
IntelliCuff includes out of
hospital emergency
transport |
6
7
8
9
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.
10
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.
11
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.