AnapnoGuard 100 Respiratory Guard System

K150157 · Hospitech Respiration , Ltd. · BSK · Feb 16, 2016 · Anesthesiology

Device Facts

• Record ID: K150157
• Device Name: AnapnoGuard 100 Respiratory Guard System
• Applicant: Hospitech Respiration , Ltd.
• Product Code: BSK · Anesthesiology
• Decision Date: Feb 16, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

Device Story

AnapnoGuard 100 Respiratory Guard System manages airways for intubated patients; system comprises AnapnoGuard endotracheal tube (ETT), interconnection harness, and control unit. Control unit features host computer, microcontroller, suction module, rinsing module, CO2 analyzer, and cuff pressure module. Device monitors subglottic CO2 levels to detect ETT cuff leaks; automatically adjusts cuff pressure to maintain seal and minimize tracheal tissue pressure. Suction module evacuates secretions from above ETT cuff. Used in hospitals, ICUs, and mobile intensive care units by healthcare professionals. Output displayed on monitor; assists clinicians in maintaining optimal cuff pressure and reducing aspiration risk. System provides continuous, automated management of cuff pressure and secretion removal, potentially improving ventilation and reducing complications associated with ETT cuff leaks.

Clinical Evidence

Prospective, two-arm, multi-center clinical study in ICU/post-operative patients (n=not specified). Study group (n=not specified) used full AnapnoGuard 100 system; control group (n=not specified) used system with cuff pressure control disabled. Primary endpoint: CO2 leakage (AUC). Results: Study group showed significantly lower CO2 leakage (0.09±0.04 vs 0.22±0.32, p<0.001) and higher frequency of cuff pressure within safety range (mean ratio 2.03, p<0.001). No serious device-related adverse events reported.

Technological Characteristics

System includes ETT (sizes 6.5-9.0mm), interconnection harness, and control unit. Materials compliant with ISO 10993-1. Sensing: CO2 analyzer, pressure gauges. Actuation: miniature air pump, valves for suction/rinsing/cuff pressure. Power: 110-220V with backup battery. Connectivity: I/O communication panel. Sterilization: ETO (ETT). Standards: IEC 60601-1, ISO 5361, ISO 14971, IEC 60601-1-10 (physiological closed-loop controller).

Indications for Use

Indicated for airway management in patients of all ages requiring oral or nasal intubation, including intensive care and post-operative patients undergoing mechanical ventilation.

Regulatory Classification

Identification

An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.

Predicate Devices

• PYTON Cuff Pressure Regulator (K092733)
• SIMEX subglottic Aspiration System (K141255)
• Hospitech Respiration AnapnoGuard Endotracheal Tube (ETT) (K093126)

Reference Devices

• Covidien SealGuard™ Evac (K082520)
• TELEFLEX ISIS™ (K091761)
• Mallinckrodt Ty-Care Closed Suction System (K031997)
• SUNMED CuffAlert™ (K081805)
• Ohio Push-To-Set Intermittent and Continuous Vacuum Regulators
• NS Series Vacuum/Pressure Gauges (K081778)
• MicroCap Plus/NPB-75 (K024300)
• Hamilton Cuff Pressure Regulator (IntelliCuff) (K103803)
• Boehringer Laboratories CASS Regulator Model 3720

Submission Summary (Full Text)

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

February 16, 2016

Hospitech Respiration Ltd c/o Yoram Levy Qsite General Manager Osite 31 Haavoda St. Binyamina 30500 Israel

Re: K150157

Trade/Device Name: AnapnoGuard 100 Respiratory Guard System Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK, BTR Dated: December 19, 2015 Received: December 28, 2015

Dear Mr. Levy,

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

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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 [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" (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 [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) K150157

Device Name

AnapnoGuard 100 Respiratory Guard System

#### Indications for Use (Describe)

AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H with serifs, positioned in front of a globe-like grid. The text "Hospitech Respiration" is written in blue below the symbol.

## 510(K) SUMMARY

# AnapnoGuard 100 Respiratory Guard System 510(k) Number K150157

| Applicant's Name: | Hospitech Respiration Ltd<br>20 Hamagshimim Street<br>Kiryat Matalon,<br>Petach-Tikva, 4934829<br>Israel<br>TEL: [phone],<br>FAX: [phone] |
|-------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda Street<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | AnapnoGuard 100 Respiratory Guard System |
| Summary<br>Preparation Date:<br>Classification: | January 15, 2015<br>Classification name: Cuff, tracheal tube, inflatable<br>Product Code: BSK<br>Regulation No: 21 CFR 868.5750<br>Class: II<br>Panel: Anesthesiology |
| Device Description: | AnapnoGuard 100 Respiratory Guard System is comprised of the<br>following three main components:<br>The AnapnoGuard endotracheal tube (ETT) with inflatable cuff (FDA cleared under K093126). The AnapnoGuard 100 Respiratory Guard System interconnection harness of tubes, connecting the ETT to the AnapnoGuard 100 control unit The AnapnoGuard 100 Respiratory Guard System control unit which consists of the following main modules: Host computer (PC) Microcontroller (MCU) |

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Image /page/4/Picture/0 description: The image shows a logo for Hospitech Respiration. The logo features a blue letter "H" in a serif font, positioned in front of a globe-like structure made of thin lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a simple, sans-serif font. The overall design is clean and corporate, suggesting a company involved in global healthcare or respiratory technology.

- Suction module (regulator and flow potency meter): including . a set of valves and pipes controlling the secretions suction/evacuation from above the ETT cuff.
- Rinsing module: Pumps saline to rinse the Suction and Vent/ ● CO2 lumens.
- CO2 analyzer module: including CO2 analyzer assembly, ● pump, valve and flow filter which sucks air from the subglottic space above the ETT cuff into the CO2 analyzer.
- . Cuff pressure module: includes two pressure gauges which monitor cuff pressure, a miniature air pump and two valves.
- Pneumatic module: valves, pipes and filters .
- Connectors panel for connecting the interconnection harness . (ETT), vacuum, trap bottle, rinsing fluid and filters.
- Operation buttons panel and navigation wheel .
- I/O communication panel .
- Display monitor .

AnapnoGuard 100 Respiratory Guard System, including its three components monitors leak between the endotracheal tube's cuff and the trachea by measuring the Carbon Dioxide levels in the subglottic area above the cuff through a dedicated lumen in the endotracheal tube. Detection of a high level of Carbon Dioxide is an objective indicator for a leak (improper sealing of the trachea by the endotracheal tube cuff). The system continuously monitors and adjusts the cuff pressure to prevent a leak at minimum possible pressure (all within pressure limits preset by the user).

Preventing a leak reduces the likelihood of aspiration of secretions from the upper airways into the lungs and increases the likelihood for no loss of ventilation and delivery of anesthetic and nebulized drugs into the lungs. Keeping the cuff pressure as low as possible reduces the mechanical pressure of the cuff on the tracheal tissue throughout the intubation period.

The system also performs evacuation of secretions from above the endotracheal tube's cuff through a dedicated lumen at the dorsal side of the endotracheal tube.

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Image /page/5/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" with serifs, positioned in front of a globe-like grid. The text "Hospitech Respiration" is written in a simple, sans-serif font below the emblem.

#### Indication for Use:

AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using noninvasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.

Predicate Devices: Substantial equivalence to the following predicate devices is claimed:

| Device Name | 510k No | Clearance Date |
|-----------------------------------------------------------------|---------|--------------------|
| PYTON Cuff Pressure<br>Regulator | K092733 | Feb 26, 2010 |
| SIMEX subglottic<br>Aspiration System (suction) | K141255 | September 22, 2014 |
| Hospitech Respiration<br>AnapnoGuard Endotracheal<br>Tube (ETT) | K093126 | March 2, 2010 |

#### Reference devices:

| Device Name | 510k No | Clearance Date |
|----------------------------------------------------------------------|---------------------------------------------------------------|-------------------|
| Covidien SealGuard™ Evac | K082520 | October 2, 2008 |
| TELEFLEX ISISTM | K091761 | October 29, 2009 |
| Mallinckrodt Ty-Care<br>Closed Suction System | K031997 | November 25, 2003 |
| SUNMED CuffAlert™ | K081805 | Nov 14, 2008 |
| Ohio Push-To-Set<br>Intermittent and Continuous<br>Vacuum Regulators | class II<br>Product Code KDP<br>Regulation No. 21CFR 880.6740 | |
| NS Series Vacuum/Pressure<br>Gauges | K081778 | Sep 12, 2008 |
| MicroCap Plus/NPB-75 | K024300 | Apr 03, 2003 |
| Hamilton Cuff Pressure<br>Regulator (IntelliCuff) | K103803 | Nov 3 , 2011 |
| Boehringer Laboratories<br>CASS Regulator Model<br>3720 | class II<br>Product Code KDP<br>Regulation No. 21CFR 880.6740 | |

Hospitech AnapnoGuard™ 100 Respiration Guard System – 510k Notification

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| Characteristic | AnapnoGuard 100 Respiratory Guard System (Submitted) | PYTON Cuff Pressure Regulator (K092733) |
|------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | AnapnoGuard 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff. | To measure and regulate intra-cuff pressures of endotracheal supraglottic airways or tracheostomy tubes. The PYTON is intended for use on patients who are intubated. |
| Regulatory Class | II | II |
| Product Code, Regulation Number | BSK<br>21 CFR 868.5750 | BSK<br>21 CFR 868.5750 |
| Minimum measured pressure | 0 mmHg | 15 mmHg<br>20 Cm H2O |
| Maximal cuff pressure | 33 mmHg (47 cmH2O) | 22 mmHg<br>30 Cm H2O |
| Control Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.73 mmHg ( $\pm$ 1 cmH2O) |
| Recording Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.73 mmHg ( $\pm$ 1 cmH2O) |
| Pressure drop Alarm time<br>Pressure rise alarm time | 0.2 Sec | NA |
| Power Supply | 110 – 220 V with backup battery | 110 – 220 V with backup battery |

### Comparison with PYTON Pressure Regulator predicate device

### Comparison for the SIMEX subglottic suction predicate device

| | AnapnoGuard 100 Respiratory Guard<br>System (Submitted) | K141255<br>SIMEX subglottic<br>Aspiration System |
|-------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hospitech Respiration Ltd. | SIMEX Medizintechnik, GmbH |
| Intended use | AnapnoGuard 100 Respiratory Guard<br>System is intended for airway<br>management by oral/nasal intubation<br>while providing continuous | The SIMEX subglottic<br>Aspiration System models<br>cuff M and cuff S are<br>indicated for vacuum<br>suction, extraction. |
| | AnapnoGuard 100 Respiratory Guard<br>System (Submitted) | K141255<br>SIMEX subglottic<br>Aspiration System |
| | endotracheal cuff pressure control using<br>non-invasive measurement and<br>monitoring of carbon dioxide<br>concentration in the subglottic space<br>and evacuation of secretions from above<br>the endotracheal tube's cuff. | aspiration and removal of<br>surgical fluids, tissue<br>(including bone), bodily<br>fluids or infectious<br>materials from wounds or<br>from patient's airway or<br>respiratory system, either<br>during surgery or at<br>patient's bed side. |
| Product Code,<br>Regulation<br>Number | BSK<br>21 CFR 868.5750 | BTA<br>21 CFR 878.4780 |
| Regulatory Class | II | II |
| Suction Pressure<br>Range | -20 up to -120 mmHg | -15 to -225 mmHg<br>(-20 to -300 mbar) |
| Mode of<br>operation | Manual<br>Intermittent | Manual<br>Intermittent: |
| Closed System | Yes | Yes |
| Indications for<br>single patient<br>use | No | No |
| Allows ETT<br>replacement<br>without<br>disconnecting<br>patient from<br>ventilator | Yes | Yes |
| Manual control<br>of vacuum | Yes | Yes |
| Patient<br>Population | Adults | Adults and pediatric |
| Evacuation of<br>secretions from<br>above the<br>endotracheal<br>tube's cuff | yes | Yes |
| Biocompatibility | All materials that come in contact with<br>the patient body or liquids are | Same |
| | AnapnoGuard 100 Respiratory Guard<br>System (Submitted) | K141255<br>SIMEX subglottic<br>Aspiration System |
| | biocompatible and compliant with ISO<br>10993-1 | |
| Flow Rate | 0 to 15 L/min | 8 L/Min |

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Image /page/7/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H inside of a blue dome shape. Above the dome is a wireframe globe. Below the logo is the text "Hospitech Respiration".

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Image /page/8/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H in a serif font, set against a backdrop of a wireframe globe. Below the symbol, the words "Hospitech Respiration" are written in a blue, sans-serif font.

## Comparison for the AnapnoGuard ETT

| Characteristics | Proposed<br>AnapnoGuard 100 Respiratory<br>Guard System | Hospitech Respiration<br>AnapnoGuard Endotracheal<br>Tube (ETT)<br>(K093126) |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | AnapnoGuard 100 Respiratory<br>Guard System is intended for<br>airway management by<br>oral/nasal intubation while<br>providing continuous<br>endotracheal cuff pressure<br>control using non-invasive<br>measurement and monitoring of<br>carbon dioxide concentration in<br>the subglottic space and<br>evacuation of secretions from<br>above the endotracheal tube's<br>cuff. | The AnapnoGuard Endotracheal<br>Tube is indicated for airway<br>management by oral or nasal<br>intubation of the trachea and for<br>evacuation or drainage of the<br>subglottic space. |
| Product Code | BSK | BTR |
| Regulation No. | 21 CFR 868.5750 | 21 CFR 868.5730 |
| Classification | Class II | Class II |
| Supplied/use | Disposable (ETT portion) | Disposable |
| Prescription<br>use/OTC use | Prescription use | Prescription use |
| Environment of<br>use | Hospitals, Intensive Care Units,<br>Mobile Intensive Care units and<br>Clinics. | Same |
| Intended users | Health care professionals | Same |
| Intended<br>population | All ages, up to the appropriate<br>ETT size | Same |
| Biocompatibility | All materials are biocompatible<br>and compliant with ISO 10993-1 | Same |
| Sterilization<br>method | ETO | ETO |
| Performance<br>Standards | ISO 5361 | Same |
| Characteristics | Proposed<br>AnapnoGuard 100 Respiratory<br>Guard System | Hospitech Respiration<br>AnapnoGuard Endotracheal<br>Tube (ETT)<br>(K093126) |
| Sizes (Input<br>Diameter) [mm] | 6.5, 7.0, 7.5, 8.0, 8.5, 9.0 mm | Same |
| Murphy's Eye | With or without | Same |
| Number of<br>lumens (except<br>main lumen) | 4 of which 2 are combined into<br>one suction lumen:<br>1: suction x 2<br>2: Vent, rinsing, air sampling<br>3: Cuff inflation/deflation | Same |
| Suction lumens | Two suction lumens combined<br>into one at the proximal end,<br>outside the tube wall | Same |
| Tracheal tube<br>maximum<br>period | 29 days | 29 days |
| Reusable or<br>disposable | Disposable | Disposable |
| Storage<br>Environment | Ambient Temperature: -20° C to<br>40°C (-4°F to 104°F)<br><br>Pressure: 430 mmHg to 795<br>mmHg | Same |
| Operating<br>environment | Ambient temperature: 0÷50°C<br>(32°F - 122°F)<br><br>Humidity: 10÷80% non-<br>condensing Altitude: -1,250 feet<br>to 15,000 feet | Same |

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Image /page/9/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H inside of a white globe. Below the globe, the words "Hospitech Respiration" are written in blue.

The AnapnoGuard 100 Respiratory Guard System primary predicate device is the PYTON Cuff Pressure Regulator (K092733) for its cuff pressure control. It has similar intended use and technology as the cuff pressure control of the AnapnoGuard 100 Respiratory Guard System section. The AnapnoGuard 100's limits of presetting the target cuff pressure range are within the PYTON Cuff Pressure Regulator predicate device limits. The AnapnoGuard 100 ETT is the same ETT that was cleared as Hospitech's AnapnoGuard Endotracheal Tube (ETT) K093126.

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Image /page/10/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" in a serif font, positioned in front of a globe-like structure made of intersecting lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a blue, sans-serif font. The logo appears to be designed to convey a sense of global reach and expertise in the field of respiration technology.

The Hospitech AnapnoGuard 100 Respiratory Guard System Cuff Pressure Monitor is as safe and as effective as the PYTON Cuff Pressure Regulator (K092733) and referenced to the Hamilton Cuff Pressure Regulator (IntelliCuff) (K103803. The AnapnoGuard 100 Respiratory Guard System cuff pressure unit has similar intended use and technological characteristics and is within the cuff pressure of these devices.

The AnapnoGuard 100 Respiratory Guard System suction unit is as safe and as effective as the K141255 SIMEX subglottic Aspiration System. The K141255 SIMEX subglottic Aspiration System predicate devices, has similar intended use and technology and is as safe and as effective as the AnapnoGuard 100 Respiratory Guard System regarding the suction power and the cyclical and automatic suctioning and it can define the length and the interval of the suction as it is done by the AnapnoGuard 100 Respiratory Guard System.

The vacuum pressure of the AnapnoGuard 100 Respiratory Guard System is within the vacuum pressure parameters of its predicate device.

#### Performance Standards:

AnapnoGuard 100 Respiratory Guard System complies with the following voluntary standards:

- IEC 60601-1:2005/EN 60601-1:2006 Medical Electrical . Equipment – Part 1, General requirements for basic safety and essential performance 3rd Edition
- IEC 60601-1-2:2007 (Electromagnetic compatibility (EMC) ●
- ISO 5361:2012 (Anesthetic and Respiratory Equipment -. Tracheal Tubes and Connectors)
- . EN ISO 10993-1:2003 Biological Evaluation of Medical Devices
- ISO 14971:2007 Risk management for medical devices ●
- 60601-1-10:2014 General Requirements for Basic Safety and ● Essential Performance - Collateral Standard: Requirements for

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Image /page/11/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H with serifs, placed in front of a globe made of thin blue lines. The text "Hospitech Respiration" is written in blue below the logo.

the Development of Physiologic Closed-Loop Controllers. (General II (ES/EMC))

## Performance Bench Tests

The following bench performance testing was performed:

| Name of test | Purpose |
|---------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ETT:<br>Determination of Cuff Resting<br>Diameter | Measure the cuff resting diameter. |
| ETT:<br>Resistance to Tube Collapse | Validate that the tube doesn't cave in<br>from inward cuff pressure |
| ETT:<br>Resistance to Cuff Herniation | Validate that the cuff does not herniate<br>the tube's airway. |
| ETT:<br>Cuff Symmetry | Validate the symmetry of the cuff. |
| Suction Module:<br>Suction Safety Test | Evaluate that the suction is safe. |
| Suction Module:<br>Determination of<br>AnapnoGuard suction capacity | Validate the ability of the<br>AnapnoGuard 100 system to perform<br>suction of the secretions according to<br>the viscosity and rate of secretion<br>production of the average patient. |
| Cuff pressure:<br>Cuff Pressure Safety Test | Validate the AnapnoGuard 100 design<br>in maintaining cuff pressures precision<br>and safety boundaries |
| CO2 Analyzer:<br>CO2 Sensor Precision Test | Test the CO2 Sensor Precision. |
| Cuff Pressure:<br>Pressure Maintenance<br>Comparison (Tracoe) | Compare the ability of the AG 100 to<br>maintain constant pressure in<br>comparison to the existing Tracoe<br>Pressure Regulator |
| System:<br>Integrated Performance Test | Test the performance of the system<br>when operating in full spectrum using<br>a patient simulator. |
| Physiological closed loop | Evaluate the physiological closed loop<br>between the CO2 measurements and<br>the suction control. This was done by<br>bench testing and theoretical study in<br>conformance to applicable clauses of<br>60601-1-10 |

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Image /page/12/Picture/0 description: The image shows the Hospitech Respiration logo. The logo features a blue letter "H" with serifs, positioned in front of a globe-like grid. The words "Hospitech Respiration" are written in blue below the logo. The font appears to be sans-serif.

Bench testing demonstrated that the AnapnoGuard 100 Respiratory Guard System is as safe and as efficient for performing its intended use.

#### Preclinical Performance Data

The safety and feasibility of the AnapnoGuard 100 Respiratory Guard System were not evaluated by pre-clinical study.

#### Human factors/usability studies

A total of 45 professional team participants, the target population for operating the AnapnoGuard 100 Respiratory Guard System, were enrolled in the study.

The results of this usability study clearly indicate that User Manual and the Graphic Use Interface (GUI) of the AnapnoGuard 100 Respiratory Guard System are clear. The usability study demonstrated the safety and effectiveness use of the device, when operated by intended user's hospital professional team.

#### Summary of Clinical Performance Data:

#### Background

The clinical performance of the AnapnoGuard 100 Respiratory Guard System as airway management tool in mechanically ventilated patients was evaluated in prospective, two arms controlled and multi-center study.

#### Methods

The study included intensive care and post-operative patients expected to be mechanically ventilated for at least 12 hours. Following screening and enrollment, patients were randomized to study or control group.

Study group patients were intubated with the AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System operating in its full clinical mode, where the subglottic secretions suction and cuff pressure control was enabled (ON mode).

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Control group patients were treated according to the current standard of care- patients were intubated with the AnapnoGuard ETT and connected to the control unit of the AnapnoGuard 100 Respiratory Guard System where the subglottic secretions suction was enabled but cuff pressure control was disabled (OFF mode). The cuff pressure in the control group was monitored manually according to standard of care in the ICU. In both groups, the presence of CO2 levels above the cuff was measured by the AnapnoGuard 100 control unit.

The primary end point of the study was the overall duration and level of around ETT cuff leakage (determined by CO2 Area under the Curve (AUC)). Secondary end points included number of cuff pressure measurements within the safety accepted range (24 to 40cmH2O) and number of significant CO2 leakage (readings at ≥2mmHg in the subglottic space). The non-inferiority hypothesis, compared to the standard of care use today was tested (by the primary endpoint). In addition, the performance safety of the AnapnoGuard 100 Respiratory Guard System system was evaluated by monitoring and recording device related adverse events.

#### Results

The average AUC of CO2 leakage, calculated for the study group was significantly lower compare to control group (0.09±0.04 vs. 0.22±0.32 respectively, This result was found to be statistically significant (p<0.001). The significant reduction in CO2 leakage in study group indicates the efficacy of the AnapnoGuard 100 Respiratory Guard System (while operating in full clinical mode) in optimizing cuff pressure, and the efficacy of AnapnoGuard 100 Respiratory Guard System as airway management tool.

Additional aspects of cuff pressure control during mechanical ventilation were:

- Number of cuff pressure measurements within the safety accepted range. Study result indicated that the normalized number of cuff pressure measurements within the safety range in the Study group more than twice the result of the control group (mean ratio Study / Control= 2.03, P<0.001).
- Measurements of significant leakages (CO2) were significantly lower in Study group compare to control group

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Image /page/14/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter "H" with serifs, positioned in front of a globe-like structure made of thin, curved lines. The globe is white with blue lines. Below the "H" and the globe, the words "Hospitech Respiration" are written in a simple, sans-serif font, with "Hospitech" appearing above "Respiration".

(0.056 vs. 0.642 respectively, Mean Ratio Study / Control=0.09, p<0.001).

Furthermore, no serious or device related adverse events were recorded throughout the study.

These findings further support the performance efficacy of the AnapnoGuard 100 Respiratory Guard System in optimizing cuff pressure and indicating its efficacy as airway management tool.

#### Conclusions

The AnapnoGuard 100 Respiratory Guard System was proven to meet the safety and effectiveness endpoints

#### Substantial equivalence conclusion

The performance tests and the clinical study that were conducted shows that the AnapnoGuard 100 Respiratory Guard System is as safe and effective as the listed predicate devices without raising any new questions of safety and efficacy.