The TRACOE® smart Cuff Manager is intended to maintain the HVLP (high volume low pressure) cuff pressure, of an endotracheal tube or tracheostomy tube, within the range of 20 to 30 cm H20 through passive control.

It is for single patient use, and indically ventilated or spontaneously breathing patients. It is used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for interor intra-facility transport.

Device Description

The TRACOE® smart Cuff Manager is an accessory device for high volume low pressure (HVLP) cuffed endotracheal/tracheostomy tubes to maintain the cuff pressure within a range of 20 cm H₂O to 30 cm H₂O. This device includes a spherical, hard shell (transparent) outer casing with an elastic inner balloon (blue), that is attached to a base housing with both a male and female luer connector. The male connector is inserted into the inflation line (pilot balloon valve of the endotracheal/tracheostomy tube HVLP cuff) and the female connector is attached to a cuff inflation device (syringe or cuff pressure monitor). When the TRACOE® smart Cuff Manager is connected to the cuff inflation line the inner balloon is inflated with a cuff inflation device until the balloon diameter is between 2/3 - 3/4 of the outer casing. The cuff inflation device is then removed from the TRACOE® smart Cuff Manager, and after a few minutes the cuff pressure is rechecked to confirm the cuff is properly inflated inner balloon of the TRACOE® smart Cuff Manager will act as a pressure reservoir, allowing the air to flow between the balloon and the endotracheal/tracheostomy cuff, through passive control, in order to maintain the pressure range.

When the endotracheal/tracheostomy tube cuff pressure increases, due to compression through patient motion, coughing etc., the surplus air flows slowly into the inner balloon of the TRACOE® smart Cuff Manager through the integrated damping function. The damping function prevents sudden changes in cuff pressure which could result in a gap between the trachea. When the cuff pressure is reduced (following the patient motion) the inner balloon will allow the stored air to freely flow (without damping) back into the endotracheal/tracheostomy tube cuff in order to reinstate the cuff pressure to the prescribed range of 20 cm H₂O to 30 cm H₂O.

The TRACOE® smart Cuff Manager is for single patient use, and provided sterile for ease of use when connecting in a sterile environment. The device is applicable for mechanically ventilated or spontaneously breathing patients under medical supervision in hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

AI/ML Overview

The provided text describes the 510(k) premarket notification for the TRACOE® smart Cuff Manager. It details the device's intended use, its technical characteristics compared to predicate devices, and a summary of non-clinical testing performed to establish substantial equivalence.

Here's the information regarding acceptance criteria and the study that proves the device meets those criteria:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly present a table of acceptance criteria and reported device performance in a numerical format. However, it states the key performance objective and describes how testing confirmed it.

The primary performance criterion for the TRACOE® smart Cuff Manager is to maintain the High Volume Low Pressure (HVLP) cuff pressure of an endotracheal tube or tracheostomy tube within the range of 20 to 30 cm H2O through passive control.

The reported device performance, demonstrated through non-clinical testing, is that the device successfully meets this criterion. The document states:

"Mechanical testing confirmed luer connections, pressure reservoir filling, damping function and maintaining the cuff pressure range (20 cm H2O to 30 cm H2O) under multiple situations (e.g., extended time periods, cuff compression)."
"Comparison testing with the predicate devices PressureEasy (K833327) and Lanz (K791045) included maintaining the cuff pressure during volume/pressure changes and over an extended period of time."
"The results of this testing demonstrated that the TRACOE® smart Cuff Manager is substantially equivalent to the legally cleared predicate devices."
"The TRACOE® smart Cuff Manager has passed all defined criteria."

2. Sample size used for the test set and the data provenance:

The document describes non-clinical performance and mechanical testing, as well as comparison testing with predicate devices. However, it does not specify the sample size for these tests (e.g., how many devices were tested, how many testing cycles). The tests are performed on the device itself (TRACOE® smart Cuff Manager) and in comparison with predicate devices.

The data provenance is from non-clinical testing performed by the manufacturer, TRACOE medical GmbH, in Germany. The tests are inherently prospective as they are conducted specifically to validate the device's performance against predefined criteria.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the described study is a non-clinical performance and mechanical testing, not a study evaluating expert interpretation or clinical decision-making. The "ground truth" here is the physical measurement of cuff pressure and the device's ability to maintain it within a specified range, as measured by instruments.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable for non-clinical performance and mechanical testing. Adjudication methods are typically used in clinical studies involving expert reviews or subjective assessments, which is not the nature of the described tests.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No, an MRMC comparative effectiveness study was not done. The device (TRACOE® smart Cuff Manager) is a passive mechanical device for maintaining cuff pressure, not an AI-assisted diagnostic or interpretive tool that would involve human readers. Clinical testing was explicitly stated as "not required to demonstrate substantial equivalence."

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The described testing is essentially standalone performance testing of the mechanical device. The device operates through "passive control" without active human intervention once set up, making the non-clinical tests akin to standalone performance evaluations in a controlled environment.

7. The type of ground truth used:

The ground truth used for this device is physical measurement of cuff pressure. This is a quantitative, objective measurement taken by instruments to determine if the device successfully maintains the pressure within the specified range (20-30 cm H2O).

8. The sample size for the training set:

There is no training set mentioned or implied because this is a mechanical device, not a machine learning or AI algorithm that requires training data.

9. How the ground truth for the training set was established:

As there is no training set, this question is not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 21, 2016

TRACOE medical GmbH Eva Schaeffer Head of Quality Reichelsheimer Straße 1/3 55268 Nieder-Olm Germany

Re: K152865

Trade/Device Name: TRACOE® smart Cuff Manager Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: August 21, 2015 Received: August 26, 2016

Dear Eva Schaeffer:

This letter corrects our substantially equivalent letter of September 27, 2016.

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 (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. 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 statutes and regulations administered by other Federal agencies. You must

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152865

Device Name TRACOE® smart Cuff Manager

Indications for Use (Describe)

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 as required by section 21 CFR 807.92

Date:	September 26, 2016
Submitter of 510(k):
Company name:	TRACOE medical GmbH
Establishment Registration number:	8010485
Address:	Reichelsheimer Str. 1/3
	55268 Nieder-Olm
	Germany
Phone:	(+49)61369169-0
Fax:	(+49)61369169-200
Correspondent:	Eva Schaeffer
	Head of Quality
Device Name:
Trade/Proprietary Name:	TRACOE® smart Cuff Manager
Common/Usual Name:	Cuff, tracheal tube, inflatable
Classification	Class II
Classification Name:	Inflatable tracheal tube cuff(21 CFR 868.5750, Product Code: BSK)

Legally Marketed Devices

Our device is based on the legally marketed devices cited in the table below:

Manufacturer	Device	Product Code	510(k) #
Smith Medical Inc.	PressureEasy Cuff Pressure Controller	BSK	K833327
Covidien	Model GV-10 Lanz Pressure Valve	BTR	K791045

Device Description:

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Intended use:

It is for single patient use, and indicated for mechanically ventilated or spontaneously breathing patients. It is used under medical supervision in hospital (EMS), extended care facilities or outpatient clinics and is suitable for inter- or intra-facility transport.

Summary of the Technical Characteristics

For substantial equivalence, the predicate devices K833327 PressureEasy and K791045 Lanz were selected based on their intended use and similarity in design and functionality.

	TRACOE®smart Cuff Manager	Smith Medical Inc.PressureEasy CuffPressure Controller(Radionics)	Covidien Model GV-10Lanz Pressure Valve(Lanz)
Intended Use	To maintain the HVLP(high volume lowpressure) cuffpressure, of anendotracheal tube ortracheostomy tube,within the range of 20to 30 cm H2O throughpassive control.	To maintain theHVLP (high volumelow pressure) cuffpressure, of anendotracheal tubewithin the range of20 to 30 cm H2Othrough passivecontrol.	To maintain the HVLP(high volume lowpressure) cuffpressure, of anendotracheal tube ortracheostomy tube,within the range of 25to 33 cm H2O throughpassive control.
Device Classification	2	2	2
510k Number	K152865	K833327	K791045
Classification Product Code	BSK	BSK	BTR
Regulation Number	868.5750	868.5750	868.5730
Patient Population
Patients requiring a Highvolume low pressure cuffedendotracheal tube	Yes	Yes	Yes
Patients requiring a Highvolume low pressure cuffedtracheostomy tube	Yes	No	Yes
Patients requiring mechanicalventilation	Yes	Yes	Yes
Spontaneous breathing patients	Yes	Yes	Yes
Patients under medicalsupervision in hospitals, pre-hospitals, emergency rooms(ER), extended care facilities,outpatient clinics	Yes	Yes	Yes
Technical Characteristics
Type of control	Passive	Passive	Passive
Cuff pressure range	20 cm H2O to 30 cmH2O	20 cm H2O to 30 cmH2O	25 cm H2O to 33 cmH2O
Internal pressure reservoir(balloon)	Elastic inner balloonthat expands andcontracts as air flowsto and from the cuff	Elastic inner balloonthat expands andcontracts as airflows to and fromthe cuff	Elastic inner balloonthat expands andcontracts as air flowsto and from the cuff
Visual pressure range	Blue inner balloondiameter	Green stripe	Beige inner balloondiameter
Damping function of air flowfrom cuff to the balloon	Yes	No	Yes
Free flow of air from the balloonto the cuff	Yes	Yes	Yes
Cuff pressure is maintainedwhen the device isdisconnected.	Yes	Yes	No
Inflation via female luerconnector	Yes	Yes	Yes
Inflation by syringe or cuffpressure monitor	Yes	Yes	Yes
Connection to inflation line ofcuff	Yes	Yes	Yes
Single patient use	Yes	Yes	Yes
Patient contact:	Skin surface	Skin surface	Skin surface
Provided sterile	Yes	No	Yes

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The TRACOE® smart Cuff Manager intended use represents a combination of the predicate devices intended use, therefore any differences in the intended use are not considered critical and do not affect the safety and effectiveness of the device. The similarities in design and technology are the basis and reason for substantial equivalence of the TRACOE® smart Cuff Manager to the legally marketed predicate devices.

Summary of Non- clinical testing

Performance and mechanical testing was performed with clear acceptance criteria that addressed design, performance, and functionality of the device. In addition, predicate device comparison testing was performed which demonstrated substantial equivalence between the TRACOE® smart Cuff Manager to the legally marketed predicate devices. This testing included:

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Sterilization and Packaging Validation in accordance with ISO 1135-1 and ISO 10993-7.
. Intra and inter-facility transportation testing includes shock and vibration testing, external pressure and temperature testing while maintaining the cuff pressure range (20 cm H₂O to 30 cm H2O).
. Mechanical testing confirmed luer connections, pressure reservoir filling, damping function and maintaining the cuff pressure range (20 cm H₂O to 30 cm H₂O) under multiple situations (e.g. extended time periods, cuff compression).
. Comparison testing with the predicate devices PressureEasy (K833327) and Lanz (K791045) included maintaining the cuff pressure during volume/pressure changes and over an extended period of time.

The results of this testing demonstrated that the TRACOE® smart Cuff Manager is substantially equivalent to the legally cleared predicate devices.

Summary of Clinical testing

Clinical testing was not required to demonstrate substantial equivalence.

Conclusion

The TRACOE® smart Cuff Manager has passed all defined criteria. The device has performed as well or better than the predicate devices and is therefore considered substantially equivalent to the cleared 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).