(363 days)
No
The device description details a purely mechanical system for passive pressure control using an elastic balloon and damping function, with no mention of software, algorithms, or learning capabilities.
No.
The device maintains the pressure of an endotracheal or tracheostomy tube's cuff; it does not directly treat a disease or condition, but rather manages a critical aspect of patient care related to ventilation.
No
Explanation: The device is described as an accessory to maintain cuff pressure, not to diagnose a medical condition. Its function is to regulate pressure within a specified range, which is a therapeutic or supportive function rather than a diagnostic one.
No
The device description clearly outlines physical components including a hard shell outer casing, elastic inner balloon, base housing, and luer connectors, indicating it is a hardware device.
Based on the provided information, the TRACOE® smart Cuff Manager is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is to maintain the cuff pressure of an endotracheal or tracheostomy tube. This is a mechanical function related to patient care and airway management.
- Device Description: The device is described as an accessory that uses a physical mechanism (inner balloon and outer casing) to regulate air pressure. It does not involve the examination of specimens derived from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The TRACOE® smart Cuff Manager does not fit this description.
N/A
Intended Use / Indications for Use
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 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.
Product codes
BSK
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.
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
Not Found
Intended User / Care Setting
used under medical supervision in hospitals, pre-hospital (EMS), extended care facilities or outpatient clinics and is suitable for interor intra-facility transport.
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
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:
- 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol featuring three stylized human profiles facing to the right, stacked on top of each other.
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
1
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)
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.
| 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:
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.
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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.
Intended use:
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 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 Cuff
Pressure Controller
(Radionics) | Covidien Model GV-10
Lanz Pressure Valve
(Lanz) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | 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 H2O through
passive control. | To maintain the
HVLP (high volume
low pressure) cuff
pressure, of an
endotracheal tube
within the range of
20 to 30 cm H2O
through passive
control. | To maintain the HVLP
(high volume low
pressure) cuff
pressure, of an
endotracheal tube or
tracheostomy tube,
within the range of 25
to 33 cm H2O through
passive 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 High
volume low pressure cuffed
endotracheal tube | Yes | Yes | Yes | |
| Patients requiring a High
volume low pressure cuffed
tracheostomy tube | Yes | No | Yes | |
| Patients requiring mechanical
ventilation | Yes | Yes | Yes | |
| Spontaneous breathing patients | Yes | Yes | Yes | |
| Patients under medical
supervision 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 cm
H2O | 20 cm H2O to 30 cm
H2O | 25 cm H2O to 33 cm
H2O | |
| Internal pressure reservoir
(balloon) | Elastic inner balloon
that expands and
contracts as air flows
to and from the cuff | Elastic inner balloon
that expands and
contracts as air
flows to and from
the cuff | Elastic inner balloon
that expands and
contracts as air flows
to and from the cuff | |
| Visual pressure range | Blue inner balloon
diameter | Green stripe | Beige inner balloon
diameter | |
| Damping function of air flow
from cuff to the balloon | Yes | No | Yes | |
| Free flow of air from the balloon
to the cuff | Yes | Yes | Yes | |
| Cuff pressure is maintained
when the device is
disconnected. | Yes | Yes | No | |
| Inflation via female luer
connector | Yes | Yes | Yes | |
| Inflation by syringe or cuff
pressure monitor | Yes | Yes | Yes | |
| Connection to inflation line of
cuff | 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:
6
- 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.