(262 days)
No
The device description and testing focus on mechanical function, material properties, and usability, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to condition inhaled air by retaining heat and moisture, and enables speech for tracheostomized patients, directly impacting a physiological function to improve patient well-being, which is characteristic of a therapeutic device.
No
Explanation: The device is described as a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended to condition inhaled air and facilitate speech for tracheostomized patients. Its function is therapeutic and supportive, not to diagnose a condition or disease.
No
The device description clearly details physical components like a Speaking Valve, HME, and a flexible membrane, and describes their mechanical function in directing airflow. There is no mention of software as a component or function of the device.
Based on the provided information, the ProTrach DualCare device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for spontaneously breathing tracheostomized patients to condition inhaled air and enable speech. This is a therapeutic and supportive function related to respiration and communication, not the diagnosis of a disease or condition.
- Device Description: The description details the mechanical function of the speaking valve and HME in managing airflow and conditioning inhaled air. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information.
- Performance Studies: The performance studies focus on physical characteristics, functionality, biocompatibility, and usability of the device in a respiratory context. There are no studies related to diagnostic accuracy, sensitivity, specificity, or other metrics typically associated with IVDs.
- Predicate and Reference Devices: The listed predicate and reference devices are also speaking valves and HMEs, which are respiratory support devices, not IVDs.
In summary, the ProTrach DualCare is a medical device used for respiratory support and communication in tracheostomized patients. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.
The entire device is for single patient use and the HME-part is for single use.
Product codes (comma separated list FDA assigned to the subject device)
JOH
Device Description
The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices".
Speaking Valve and HME 15 / 22
The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus.
The Speaking Valve has two modes: speaking mode and HME mode.
In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.
In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.
HME DigiTop and HME DigiTop O2
The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.
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 and pediatric patients greater than 10kg in weight
Intended User / Care Setting
Environment of Use: Hospitals, ICU, sub-acute care institutions and home.
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)
The following tests were performed to verify that ProTrach DualCare met applicable safety and performance requirements.
The main focus areas of testing were:
- Verification of the moisture loss, airflow resistance, leakage test and dead space.
- Verification of attachment and detachment forces in the different interfaces including the durability of the devices.
- Simulated use of all DualCare products and their Instructions for use.
- Verification of DualCare Warning label durability.
- Verification of DualCare products' function after drop test, climate testing, aging and transport.
- Biocompatibility: The proposed device was classified as a Surface device with indirect contact with mucosal membranes via air. Duration: Permanent (>30 days). The following tests were conducted in accordance with the ISO 10993 series and rendered acceptable biocompatibility results:
- cytotoxicity.
- sensitization.
- intracutaneous reactivity,
- acute systemic toxicity
- genotoxicity
- Leachables & Extractables quantitative and qualitative testing
In addition, risk management according ISO 14971 and simulated use testing (usability study) has been conducted.
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.
Fogless International AB - SPIRO Speaking Valve - (K122932)
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.
Passy-Muir Inc.- Passy Muir Speaking Valves – (K944451), Engineered Medical Systems - TrachVox – (K013728), Atos Medical - Provox FreeHands ΗΜΕ – (Κ022125)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5800 Tracheostomy tube and tube cuff.
(a)
Identification. A tracheostomy tube and tube cuff is a device intended to be placed into a surgical opening of the trachea to facilitate ventilation to the lungs. The cuff may be a separate or integral part of the tracheostomy tube and is, when inflated, intended to establish a seal between the tracheal wall and the tracheostomy tube. The cuff is used to prevent the patient's aspiration of substances, such as blood or vomit, or to provide a means for positive-pressure ventilation of the patient. This device is made of either stainless steel or plastic.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2016
Atos Medical AB Elin Algotsson Regulatory Affairs Manager Kraftgatan 8 Horby, SE-242 22 Sweden
Re: K151404
Trade/Device Name: ProTrach DualCare Regulation Number: 21 CFR 868.5800 Regulation Name: Tracheostomy Tube and Tube Cuff Regulatory Class: Class II Product Code: JOH Dated: January 13, 2016 Received: January 15, 2016
Dear Elin Algotsson:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) 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" (21 CFR 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 yours,
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151404
Device Name ProTrach DualCare
Indications for Use (Describe)
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.
The entire device is for single patient use and the HME-part is for single use.
Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
Environment of Use: Hospitals, ICU, sub-acute care institutions and home.
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
Non Confidential Summary
12 February 2016 Page 1 of 4
Section 5 – 510(k) Summary
| Atos Medical AB
P.O Box 183
SE-242 22
Hörby Sweden | Tel - 011-46-415 198 00
Fax - 011-46-415 198 98 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Elin Algotsson - Regulatory Affairs Manager |
| Proprietary or Trade Name: | ProTrach DualCare |
| Common/Usual Name: | Speaking Valve |
| Classification | Class II - 21 CFR 868.5800 |
| Classification Name/Code: | JOH - Tracheotomy Tube and Tube Cuff |
| Device: | ProTrach DualCare |
| Predicate Devices: | Fogless International AB - SPIRO Speaking Valve - (K122932)
Passy-Muir Inc.- Passy Muir Speaking Valves – (K944451) (for reference)
Engineered Medical Systems - TrachVox – (K013728) (for reference)
Atos Medical - Provox FreeHands HΜΕ – (Κ022125) (for reference) |
Device Description:
The Speaking Valve, the HME DigiTop and the HME DigiTop O2 (sold separately) are all used to enable speaking. They will therefore be referenced to as "speaking devices".
Speaking Valve and HME 15 / 22
The reusable Speaking Valve is used with a single use 15 mm or 22 mm Heat and Moisture Exchanger (HME). The HME is placed so that it prevents direct contact between the Speaking Valve and the airways. This prevents the Speaking Valve from being clogged or soiled by mucus.
The Speaking Valve has two modes: speaking mode and HME mode.
In speaking mode, a flexible membrane is positioned in the airflow openings and acts as a one way valve. It opens during inhalation so the patient can inhale through the device. During exhalation, the membrane remains closed and the air is re-directed through the upper airways and the vocal folds. Thereby the patient is able to speak. In speaking mode the inhaled air does not get conditioned since the exhaled air goes out through the upper airways.
In HME mode the membrane is moved out of the airflow so that the patient both inhales and exhales through the device. The inhaled air is conditioned by the heat and moisture that is retained from the exhaled air in the impregnated HME mode, speaking is not possible. The device is switched between the modes by rotating the lid of the Speaking Valve until it clicks into the desired position.
HME DigiTop and HME DigiTop O2
The HME DigiTop and the HME DigiTop O2 enable use of the HME without the Speaking Valve, and can manually be occluded to enable speaking.
4
Non Confidential Summary
12 February 2016 Page 2 of 4
Indications for Use:
ProTrach DualCare is a combined Speaking Valve and Heat and Moisture Exchanger (HME) intended for spontaneously breathing tracheostomized patients using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
In HME-mode the device conditions inhaled air by retaining heat and moisture from the exhaled air.
By turning the lid of the Speaking Valve into speaking mode air is re-directed to enable speech.
The entire device is for single patient use and the HME-part is for single use.
Patient Population: For spontaneously breathing tracheostomized patients (adults and pediatric patients greater than 10kg in weight) using a tracheostomy tube with a deflated cuff, or a tracheostomy tube without cuff.
Environment of Use:
Environments of use include; Hospitals, ICU, sub-acute care institutions and home.
Substantial Equivalence Comparison to Predicates
There are no significant differences between the ProTrach DualCare compared to the predicate device in terms of indications, materials, design and operating principles as summarized below.
| Attributes of predicate (SPIRO
Speaking Valve) | ProTrach DualCare
HME 15 Regular | ProTrach DualCare
HME 15
XtraMoist | ProTrach DualCare
HME 22 |
|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use:
For spontaneous breathing tracheotomy
patients. | Same | Same | Same |
| Environment of use:
Hospitals, ICU, sub-acute care
institutions and home | Same | Same | Same |
| Patient population:
Conscious patients, trained to use the
speech valve by qualified staff. | Same (Intended for spontaneously breathing tracheostomized
patients using a tracheostomy tube with a deflated cuff, or a
tracheostomy tube without cuff. Contraindicated for
unresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomized
patients using a tracheostomy tube with a deflated cuff, or a
tracheostomy tube without cuff. Contraindicated for
unresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomized
patients using a tracheostomy tube with a deflated cuff, or a
tracheostomy tube without cuff. Contraindicated for
unresponsive or sedated patients.) |
| Technology and Operating principle:
Eliminates the necessity of finger
occlusion for the patient with a
tracheostomy tube. | Same | Same | Same |
| Incorporated speech valve | Same | Same | Same |
| Provides heat and humidity (moisture
loss: 28 mgH2O/l air) | Better humidification:
22 mgH2O/l air | Better
humidification:
20 mgH2O/l air | Better
humidification:
21 mgH2O/l air |
| Dead space: 5.6 ml | 4.05 ml (dead space
does not raise concern
because the dead space is
less than predicate) | 4.05 ml (dead
space does not
raise concern
because the dead
space is less than
predicate) | 4.62 ml (dead
space does not
raise concern
because the dead
space is less than
predicate) |
| Dimensions (mm): | | | |
| Outer diameter: 26.9 | 27.6 | 27.6 | 27.6 |
| Inner diameter: 25.5 | 20.8-22.9 | 20.8-22.9 | 21.1-22.9 |
| Non Confidential Summary
Page 3 of 4 | | | |
| Height (contributing to dead space) 11.8 | 11.9 | 11.9 | 13.35 |
| Height (total): 26.9 | 26.1 | 26.1 | 15.2 |
| Can provide supplemental oxygen
through oxygen connector | Same | Same | Same |
| Intended to connect to tracheostomy
tube of spontaneously breathing patient | Same | Same | Same |
| Intended for single patient use | Same | Same | Same |
| HME exchanged at least every 24 h. | Same | Same | Same |
| Prescription use | Same | Same | Same |
| Standard 15/22 mm connectors | Same (15 mm connector) | Same (15 mm connector) | Same (22 mm connector) |
| Speech valve one-way closed position,
always open for inhalation | Same | Same | Same |
| Allows exhalation to atmosphere freely | Similar for all versions of the device. The DualCare allows
the user to switch between speaking mode and HME mode by
turning the lid of the device. In speaking mode the exhaled
air is directed via the upper airways and vocal folds whereas
in HME mode the exhaled air is directed out of the
tracheostoma. | | |
| Contraindications:
Unconscious and/or Comatose Patients | Same | Same | Same |
| Inflated Tracheostomy Tube Cuff | Same | Same | Same |
| Foam Filled Cuffed Tracheostomy Tube | Same | Same | Same |
| Severe Airway Obstruction Which May
Prevent Sufficient Exhalation | Same | Same | Same |
| Thick and Copious Secretions | Same | Same | Same |
| Severely Reduced Lung Elasticity That
May Cause Air Trapping | Same | Same | Same |
| This Device Is Not intended For Use With
Endotracheal Tubes | Same | Same | Same |
| Materials:
Materials HME: Calcium chloride
treated polyurethane foam | Same. The materials
included have been
assessed for
biocompatibility in
accordance with the
ISO 10993 series and
have demonstrated
acceptable results. | Same. The
materials
included have
been assessed
for
biocompatibility
in accordance
with the ISO
10993 series
and have
demonstrated
acceptable
results. | Same. The
materials
included have
been assessed
for
biocompatibility
in accordance
with the ISO
10993 series
and have
demonstrated
acceptable
results. |
| Materials Speaking Valve: Silicone and
plastic | Same. The materials
included have been
assessed for
biocompatibility in
accordance with the
ISO 10993 series and
have demonstrated
acceptable results. | Same. The
materials
included have
been assessed
for
biocompatibility
in accordance
with the ISO
10993 series
and have
demonstrated
acceptable
results. | Same. The
materials
included have
been assessed
for
biocompatibility
in accordance
with the ISO
10993 series
and have
demonstrated
acceptable
results. |
| | results. | results. | |
| Clinical claims in labeling and
supporting evidence:
Make the function of speech easier. | Same | Same | Same |
| The filter and Speaking valve are not
affected by secretions during coughing. | Same in speaking
mode. In HME mode
the filter acts as a
barrier preventing the
speaking valve from
being affected by
secretion. | Same in
speaking mode.
In HME mode
the filter acts as
a barrier
preventing the
speaking valve
from being
affected by
secretion. | Same in
speaking mode.
In HME mode
the filter acts as
a barrier
preventing the
speaking valve
from being
affected by
secretion. |
5
6
12 February 2016
Page 4 of 4
Non Confidential Summary
The differences noted in the table above are addressed by the testing summarized below:
Summary of Non-Clinical Testing:
The following tests were performed to verify that ProTrach DualCare met applicable safety and performance requirements.
The main focus areas of testing were:
- . Verification of the moisture loss, airflow resistance, leakage test and dead space.
- . Verification of attachment and detachment forces in the different interfaces including the durability of the devices.
- Simulated use of all DualCare products and their Instructions for use.
- Verification of DualCare Warning label durability.
- . Verification of DualCare products' function after drop test, climate testing, aging and transport.
- . Biocompatibility: The proposed device was classified as a Surface device with indirect contact with mucosal membranes via air. Duration: Permanent (>30 days). The following tests were conducted in accordance with the ISO 10993 series and rendered acceptable biocompatibility results:
- cytotoxicity. ●
- sensitization. .
- intracutaneous reactivity,
- acute systemic toxicity ●
- genotoxicity
- Leachables & Extractables quantitative and qualitative testing ●
- . Biocompatibility: The proposed device was classified as a Surface device with indirect contact with mucosal membranes via air. Duration: Permanent (>30 days). The following tests were conducted in accordance with the ISO 10993 series and rendered acceptable biocompatibility results:
In addition, risk management according ISO 14971 and simulated use testing (usability study) has been conducted.
Substantial Equivalence Conclusion:
Based on the comparison information and non-clinical performance testing Atos Medical AB concludes that the ProTrach DualCare is as safe, as effective, and performs as well as or better than the predicate. ProTrach DualCare is therefore considered to be substantially equivalent to the predicate device.