(262 days)
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.
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.
The provided text is a Premarket Notification (510(k)) for a medical device called "ProTrach DualCare." This document is a regulatory submission to the FDA demonstrating that the new device is substantially equivalent to legally marketed predicate devices. It focuses on comparing the new device to existing ones and presenting non-clinical studies to support safety and performance.
The document does not contain information about studies involving human subjects, clinical efficacy, or the statistical metrics often associated with AI/ML device performance (like sensitivity, specificity, AUC) from a test set with corresponding ground truth established by experts. Therefore, many of the requested items cannot be directly extracted from this document.
However, I can extract information related to the device's technical specifications and the non-clinical testing performed to establish its performance and substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document provides a comparison table between the ProTrach DualCare and its predicate device (SPIRO Speaking Valve) for several performance attributes. While explicit "acceptance criteria" (numerical thresholds) are not always stated, the comparison implies that "same" or "better" performance is the acceptance criterion for substantial equivalence.
| Acceptance Criteria (Implied) | ProTrach DualCare Performance (Reported) |
|---|---|
| Moisture Loss: Better than 28 mgH2O/l air | HME 15 Regular: 22 mgH2O/l air (Better) |
| HME 15 XtraMoist: 20 mgH2O/l air (Better) | |
| HME 22: 21 mgH2O/l air (Better) | |
| Dead Space: Less than 5.6 ml | HME 15 Regular: 4.05 ml (Less) |
| HME 15 XtraMoist: 4.05 ml (Less) | |
| HME 22: 4.62 ml (Less) | |
| Attachment and Detachment forces: Acceptable | Verified |
| Durability of devices: Acceptable | Verified |
| Simulated use: Acceptable | Verified |
| Warning label durability: Acceptable | Verified |
| Function after drop test: Acceptable | Verified |
| Function after climate testing: Acceptable | Verified |
| Function after aging: Acceptable | Verified |
| Function after transport: Acceptable | Verified |
| Biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, Leachables & Extractables): Acceptable | Acceptable results (in accordance with ISO 10993 series) |
| Risk management (ISO 14971): Compliant | Conducted |
| Usability (simulated use testing): Acceptable | Conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The studies mentioned are primarily non-clinical engineering and biocompatibility tests. There is no mention of "test sets" in the context of clinical data or human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe studies involving expert-established ground truth for a clinical test set. The ground truth for the non-clinical tests (e.g., moisture loss, dead space) would be established by the measurement instruments and methodology prescribed by relevant engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reviewed "test set" and thus no need for an adjudication method.
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
An MRMC comparative effectiveness study was not done. This submission is for a physical medical device (speaking valve/HME) and does not involve AI or human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests: The "ground truth" for reported performance metrics like moisture loss, airflow resistance, leakage, and dead space would be derived from standardized physical measurements using laboratory equipment, following recognized testing standards (e.g., those related to HMEs and tracheostomy accessories). For biocompatibility, the ground truth is established by the results of biological tests according to ISO 10993 series.
8. The sample size for the training set
This information is not applicable/not provided. This device does not use a "training set" in the context of AI/ML.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
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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
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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
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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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Non Confidential Summary
12 February 2016 Page 1 of 4
Section 5 – 510(k) Summary
| Atos Medical ABP.O Box 183SE-242 22Hörby Sweden | Tel - 011-46-415 198 00Fax - 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.
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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 (SPIROSpeaking Valve) | ProTrach DualCareHME 15 Regular | ProTrach DualCareHME 15XtraMoist | ProTrach DualCareHME 22 |
|---|---|---|---|
| Indication for use:For spontaneous breathing tracheotomypatients. | Same | Same | Same |
| Environment of use:Hospitals, ICU, sub-acute careinstitutions and home | Same | Same | Same |
| Patient population:Conscious patients, trained to use thespeech valve by qualified staff. | Same (Intended for spontaneously breathing tracheostomizedpatients using a tracheostomy tube with a deflated cuff, or atracheostomy tube without cuff. Contraindicated forunresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomizedpatients using a tracheostomy tube with a deflated cuff, or atracheostomy tube without cuff. Contraindicated forunresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomizedpatients using a tracheostomy tube with a deflated cuff, or atracheostomy tube without cuff. Contraindicated forunresponsive or sedated patients.) |
| Technology and Operating principle:Eliminates the necessity of fingerocclusion for the patient with atracheostomy tube. | Same | Same | Same |
| Incorporated speech valve | Same | Same | Same |
| Provides heat and humidity (moistureloss: 28 mgH2O/l air) | Better humidification:22 mgH2O/l air | Betterhumidification:20 mgH2O/l air | Betterhumidification:21 mgH2O/l air |
| Dead space: 5.6 ml | 4.05 ml (dead spacedoes not raise concernbecause the dead space isless than predicate) | 4.05 ml (deadspace does notraise concernbecause the deadspace is less thanpredicate) | 4.62 ml (deadspace does notraise concernbecause the deadspace is less thanpredicate) |
| 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 SummaryPage 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 oxygenthrough oxygen connector | Same | Same | Same |
| Intended to connect to tracheostomytube 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 allowsthe user to switch between speaking mode and HME mode byturning the lid of the device. In speaking mode the exhaledair is directed via the upper airways and vocal folds whereasin HME mode the exhaled air is directed out of thetracheostoma. | ||
| 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 MayPrevent Sufficient Exhalation | Same | Same | Same |
| Thick and Copious Secretions | Same | Same | Same |
| Severely Reduced Lung Elasticity ThatMay Cause Air Trapping | Same | Same | Same |
| This Device Is Not intended For Use WithEndotracheal Tubes | Same | Same | Same |
| Materials:Materials HME: Calcium chloridetreated polyurethane foam | Same. The materialsincluded have beenassessed forbiocompatibility inaccordance with theISO 10993 series andhave demonstratedacceptable results. | Same. Thematerialsincluded havebeen assessedforbiocompatibilityin accordancewith the ISO10993 seriesand havedemonstratedacceptableresults. | Same. Thematerialsincluded havebeen assessedforbiocompatibilityin accordancewith the ISO10993 seriesand havedemonstratedacceptableresults. |
| Materials Speaking Valve: Silicone andplastic | Same. The materialsincluded have beenassessed forbiocompatibility inaccordance with theISO 10993 series andhave demonstratedacceptable results. | Same. Thematerialsincluded havebeen assessedforbiocompatibilityin accordancewith the ISO10993 seriesand havedemonstratedacceptableresults. | Same. Thematerialsincluded havebeen assessedforbiocompatibilityin accordancewith the ISO10993 seriesand havedemonstratedacceptableresults. |
| results. | results. | ||
| Clinical claims in labeling andsupporting evidence:Make the function of speech easier. | Same | Same | Same |
| The filter and Speaking valve are notaffected by secretions during coughing. | Same in speakingmode. In HME modethe filter acts as abarrier preventing thespeaking valve frombeing affected bysecretion. | Same inspeaking mode.In HME modethe filter acts asa barrierpreventing thespeaking valvefrom beingaffected bysecretion. | Same inspeaking mode.In HME modethe filter acts asa barrierpreventing thespeaking valvefrom beingaffected bysecretion. |
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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.
§ 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.