ProTrach Dualcare

K151404 · Atos Medical AB · JOH · Feb 12, 2016 · Anesthesiology

Device Facts

• Record ID: K151404
• Device Name: ProTrach Dualcare
• Applicant: Atos Medical AB
• Product Code: JOH · Anesthesiology
• Decision Date: Feb 12, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5800
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended 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.

Device Story

Combined speaking valve and heat and moisture exchanger (HME) for tracheostomized patients; connects to tracheostomy tube. Device features two modes: HME mode (conditions inhaled air via moisture/heat retention) and speaking mode (one-way valve redirects exhaled air through vocal folds for speech). User rotates lid to switch modes. Used in hospitals, ICU, sub-acute care, and home settings; operated by patients or caregivers. Eliminates need for manual finger occlusion of tracheostomy tube. Benefits include restored speech capability and airway humidification. Single patient use; HME component is single-use.

Clinical Evidence

Bench testing only. Verified moisture loss, airflow resistance, leakage, dead space, attachment/detachment forces, and durability. Conducted simulated use testing and usability studies. Biocompatibility testing (cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, and leachables/extractables) performed per ISO 10993 series with acceptable results.

Technological Characteristics

Materials: Calcium chloride-treated polyurethane foam (HME), silicone and plastic (valve). Interfaces: 15mm or 22mm standard connectors. Operating principle: Mechanical one-way valve and moisture-retaining filter. Biocompatibility: ISO 10993 compliant for permanent (>30 days) mucosal contact. No electronic components or software.

Indications for Use

Indicated for spontaneously breathing tracheostomized patients (adults and pediatric >10kg) using a tracheostomy tube with a deflated cuff or no cuff. Contraindicated for unresponsive/sedated patients, those with inflated cuffs, foam-filled cuffed tubes, severe airway obstruction, thick/copious secretions, or severely reduced lung elasticity.

Regulatory Classification

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.

Predicate Devices

• SPIRO Speaking Valve (K122932)

Reference Devices

• Passy Muir Speaking Valves (K944451)
• TrachVox (K013728)
• Provox FreeHands HME (K022125)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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 AB<br>P.O Box 183<br>SE-242 22<br>Hörby Sweden | Tel - 011-46-415 198 00<br>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)<br>Passy-Muir Inc.- Passy Muir Speaking Valves – (K944451) (for reference)<br>Engineered Medical Systems - TrachVox – (K013728) (for reference)<br>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 (SPIRO<br>Speaking Valve) | ProTrach DualCare<br>HME 15 Regular | ProTrach DualCare<br>HME 15<br>XtraMoist | ProTrach DualCare<br>HME 22 |
|-------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for use:<br>For spontaneous breathing tracheotomy<br>patients. | Same | Same | Same |
| Environment of use:<br>Hospitals, ICU, sub-acute care<br>institutions and home | Same | Same | Same |
| Patient population:<br>Conscious patients, trained to use the<br>speech valve by qualified staff. | Same (Intended for spontaneously breathing tracheostomized<br>patients using a tracheostomy tube with a deflated cuff, or a<br>tracheostomy tube without cuff. Contraindicated for<br>unresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomized<br>patients using a tracheostomy tube with a deflated cuff, or a<br>tracheostomy tube without cuff. Contraindicated for<br>unresponsive or sedated patients.) | Same (Intended for spontaneously breathing tracheostomized<br>patients using a tracheostomy tube with a deflated cuff, or a<br>tracheostomy tube without cuff. Contraindicated for<br>unresponsive or sedated patients.) |
| Technology and Operating principle:<br>Eliminates the necessity of finger<br>occlusion for the patient with a<br>tracheostomy tube. | Same | Same | Same |
| Incorporated speech valve | Same | Same | Same |
| Provides heat and humidity (moisture<br>loss: 28 mgH2O/l air) | Better humidification:<br>22 mgH2O/l air | Better<br>humidification:<br>20 mgH2O/l air | Better<br>humidification:<br>21 mgH2O/l air |
| Dead space: 5.6 ml | 4.05 ml (dead space<br>does not raise concern<br>because the dead space is<br>less than predicate) | 4.05 ml (dead<br>space does not<br>raise concern<br>because the dead<br>space is less than<br>predicate) | 4.62 ml (dead<br>space does not<br>raise concern<br>because the dead<br>space is less than<br>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<br>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<br>through oxygen connector | Same | Same | Same |
| Intended to connect to tracheostomy<br>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,<br>always open for inhalation | Same | Same | Same |
| Allows exhalation to atmosphere freely | Similar for all versions of the device. The DualCare allows<br>the user to switch between speaking mode and HME mode by<br>turning the lid of the device. In speaking mode the exhaled<br>air is directed via the upper airways and vocal folds whereas<br>in HME mode the exhaled air is directed out of the<br>tracheostoma. | | |
| Contraindications:<br>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<br>Prevent Sufficient Exhalation | Same | Same | Same |
| Thick and Copious Secretions | Same | Same | Same |
| Severely Reduced Lung Elasticity That<br>May Cause Air Trapping | Same | Same | Same |
| This Device Is Not intended For Use With<br>Endotracheal Tubes | Same | Same | Same |
| Materials:<br>Materials HME: Calcium chloride<br>treated polyurethane foam | Same. The materials<br>included have been<br>assessed for<br>biocompatibility in<br>accordance with the<br>ISO 10993 series and<br>have demonstrated<br>acceptable results. | Same. The<br>materials<br>included have<br>been assessed<br>for<br>biocompatibility<br>in accordance<br>with the ISO<br>10993 series<br>and have<br>demonstrated<br>acceptable<br>results. | Same. The<br>materials<br>included have<br>been assessed<br>for<br>biocompatibility<br>in accordance<br>with the ISO<br>10993 series<br>and have<br>demonstrated<br>acceptable<br>results. |
| Materials Speaking Valve: Silicone and<br>plastic | Same. The materials<br>included have been<br>assessed for<br>biocompatibility in<br>accordance with the<br>ISO 10993 series and<br>have demonstrated<br>acceptable results. | Same. The<br>materials<br>included have<br>been assessed<br>for<br>biocompatibility<br>in accordance<br>with the ISO<br>10993 series<br>and have<br>demonstrated<br>acceptable<br>results. | Same. The<br>materials<br>included have<br>been assessed<br>for<br>biocompatibility<br>in accordance<br>with the ISO<br>10993 series<br>and have<br>demonstrated<br>acceptable<br>results. |
| | results. | results. | |
| Clinical claims in labeling and<br>supporting evidence:<br>Make the function of speech easier. | Same | Same | Same |
| The filter and Speaking valve are not<br>affected by secretions during coughing. | Same in speaking<br>mode. In HME mode<br>the filter acts as a<br>barrier preventing the<br>speaking valve from<br>being affected by<br>secretion. | Same in<br>speaking mode.<br>In HME mode<br>the filter acts as<br>a barrier<br>preventing the<br>speaking valve<br>from being<br>affected by<br>secretion. | Same in<br>speaking mode.<br>In HME mode<br>the filter acts as<br>a barrier<br>preventing the<br>speaking valve<br>from being<br>affected by<br>secretion. |

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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 ●

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.