AG 100s

K180991 · Hospitech Respiration , Ltd. · BSK · Oct 12, 2018 · Anesthesiology

Device Facts

• Record ID: K180991
• Device Name: AG 100s
• Applicant: Hospitech Respiration , Ltd.
• Product Code: BSK · Anesthesiology
• Decision Date: Oct 12, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5750
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AG 100s 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

AG100s is an airway management system for clinical use; monitors subglottic CO2 levels via a dedicated endotracheal tube (ETT) lumen to detect cuff leaks; automatically adjusts cuff pressure to maintain seal; performs intermittent subglottic secretion evacuation and rinsing; includes a general suction port. System comprises a control unit, disposable connection kit, and ETT. Clinicians operate the device via a touch-screen interface to set pressure limits and suction levels. By maintaining optimal cuff pressure and removing secretions, the device aims to reduce aspiration risk, prevent ventilation loss, and minimize tracheal tissue pressure. The system is designed for use with AnapnoGuard ETTs or other FDA-cleared cuffed airways.

Clinical Evidence

No clinical data. Evidence consists of bench performance testing and a human factors usability study (n=45) involving hospital professional staff, which confirmed the clarity and effectiveness of the user manual and GUI.

Technological Characteristics

System includes control unit, disposable connection kit, and ETT. Features NDIR CO2 sensor (0-10k PPM), peristaltic pump (rinse), and vacuum regulator. Cuff pressure control range 10-50 mmHg; accuracy ±0.1 mmHg. Connectivity includes touch-screen interface. Complies with IEC 60601-1, IEC 60601-1-2, ISO 5361, EN ISO 10993-1, and ISO 14971.

Indications for Use

Indicated for adult patients requiring airway management via oral/nasal intubation, specifically for continuous endotracheal cuff pressure control, subglottic CO2 monitoring, and secretion evacuation.

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

• AnapnoGuard 100 (K150157)

Reference Devices

• AnapnoGuard endotracheal Tube (K093126)

Submission Summary (Full Text)

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Hospitech Respiration Ltd. % Yoram Levy Qsite General Manager Osite 31 Haavoda St. Binyamina, Israel 30500

Re: K180991

Trade/Device Name: AG 100s Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: September 13, 2018 Received: September 17, 2018

Dear Yoram 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Todd D. Courtney -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital. Respiratory. Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180991

Device Name AG100s

Indications for Use (Describe)

AG 100s 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) | |
|-------------------------------------------------|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | × |
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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# 510(K) SUMMARY

## AG100s

#### 510(k) Number K180991

| Applicant's Name: | Hospitech Respiration Ltd<br>20 Hamagshimim St. 0<br>Kiryat Matalon,<br>Petach-Tikva, 4934829<br>Israel<br>TEL: [phone]<br>FAX: [phone] |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite<br>31 Haavoda St.<br>Binyamina, Israel 30500<br>Tel [phone]; Fax [phone]<br>[e-mail] |
| Trade Name: | AG100s |
| Summary<br>Preparation Date:<br>Classification: | April 9, 2018<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:

The AG100s system is comprised of the following main components:

- The AG100s control unit
- The AnapnoGuard connection kit/harness (AG Connection Kit) connecting a cuffed airway to the AG100s control unit.
- The AnapnoGuard endotracheal tube (ETT) or another FDA cleared cuffed Airway.
- Accessories: including cart, secretions canister (Trap Bottle), ● rinsing fluid (saline) bag and antibacterial air filter.

AG100s, 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

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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.

#### Indication for Use:

AG100s 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 and reference devices is claimed:

| | K# | Company | Device Name | Clearance Date |
|-----------|---------|-----------|-------------------------------|----------------|
| Predicate | K150157 | Hospitech | AnapnoGuard 100 | Feb 16, 2016 |
| Reference | K093126 | Hospitech | AnapnoGuard endotracheal Tube | Dec 19, 2015 |

#### Comparison with Predicate Devices

The AG100s primary predicate device is the AnapnoGuard 100 Respiratory Guard System (K150157) since it has the same intended use, clinical indications and implements the same technology.

The AG100s is connected to the same AnapnoGuard ETT that is also part of the K150157 submission. The AnapnoGuard ETT is the same as the AnapnoGuard endotracheal Tube (K093126) that is referenced to this notification.

The AG100s can be interfaced with other suction ETTs, which includes maintaining cuff pressure control and intermittent subglottic suctioning, or to other FDA cleared cuffed airway to maintain preset cuff pressure control. This added ability was tested in performance tests.

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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" superimposed on a globe with visible latitude and longitude lines. Below the logo, the words "Hospitech Respiration" are written in a simple font, with "Hospitech" appearing above "Respiration."

The AG100s works, unlike the predicate device, with a disposable single use kit with no direct or indirect contact with any of the system components.

The AG100s is also equipped, unlike the AnapnoGuard 100 Respiratory Guard System, with a general suction port to provide general suction needs with two preset (by the user) suction levels.

#### Complying with AnapnoGuard ETT or another FDA cleared ETTs:

When used with the AnapnoGuard ETT the AG100s may conduct full functional mode where cuff pressure is automatically adjusted by the system (within the pressure limits) based on CO2 level readings above the cuff. Intermittent synchronized rinsing and suction is performed periodically.

When connected to a suction FDA cleared Endotracheal tube, the system offers one mode of operation, which includes maintaining cuff pressure control and intermittent subglottic suctioning.

The user may, at any time, adjust cuff pressure and perform suction by pressing the relevant buttons on the display.

When connected to a standard FDA cleared cuffed Endotracheal tube, the system offers one mode of operation which includes maintaining cuff pressure control.

The user may, at any time, adjust cuff pressure by pressing the relevant buttons on the display.

With any Endotracheal tube, the general suction line (Low Pressure or High Pressure) can be manually activated by pressing on the relevant button on the touch-screen.

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### Technological Comparison between the subject device and its predicate device.

| Characteristic | AG 100s system<br>(Submitted) | Hospitech's AnapnoGuard<br>100 system (K150157) | Comparison |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GENERAL | | | |
| Device Description | The <b>AG 100s system</b> is an<br>airway management system<br>designed to assist the<br>clinician in achieving proper<br>sealing of the trachea at<br>minimal pressure of the<br>endotracheal tube's cuff in<br>order to minimize induced<br>pressure on the trachea<br>tissue.<br><br>Achieving the optimal<br>pressure is the responsibility<br>of the clinician.<br><br>The system includes an<br>Endotracheal Tube, cuff<br>pressure monitor, carbon<br>dioxide (CO2) monitor and<br>irrigation and secretions<br>evacuation modules. The<br>system includes a cuff intra<br>pressure monitoring and<br>control module for<br>measuring and monitoring<br>the cuff pressure. The<br>system performs continuous<br>(every millisecond), online<br>sampling of cuff pressure<br>via the inflation lumen of<br>the endotracheal tube. It<br>also adjusts the cuff<br>pressure within the pressure<br>limits presented by the<br>clinician or alerts the<br>physician to decide if<br>needed to adjust the cuff<br>pressure. | The AnapnoGuard 100<br>AnapnoGuard system is an<br>airway management system<br>designed to assist the<br>clinician in achieving<br>optimal sealing of the trachea<br>at minimal pressure of the<br>endotracheal tube's cuff in<br>order to minimize induced<br>pressure on the trachea<br>tissue.<br><br>Achieving the optimal<br>pressure is the<br>responsibility of the<br>clinician.<br><br>The system includes an<br>Endotracheal Tube, cuff<br>pressure monitor, carbon<br>dioxide (CO2) monitor and<br>irrigation and secretions<br>evacuation modules. The<br>system includes a cuff intra<br>pressure monitoring and<br>control module for<br>measuring and monitoring<br>the cuff pressure. The system<br>performs continuous (every<br>millisecond), online<br>sampling of cuff pressure via<br>the inflation lumen of the<br>endotracheal tube It also<br>adjusts the cuff pressure<br>within the pressure limits<br>presented by the clinician or<br>alerts the physician to decide<br>if needed to adjust the cuff<br>pressure | Subject device has<br>the same device<br>description as the<br>predicate device |
| Characteristic | AG 100s system<br>(Submitted) | Hospitech's AnapnoGuard<br>100 system (K150157) | Comparison |
| Disinfection | The system does not require disinfection process after use.<br>The device is designed such that secretions pass only through the disposable, single use connection kit, all valves are external "pinch valves" which open and close the pipes by applying external pressure on the silicon pipes.<br>No direct or indirect contact between the secretions and any of part of the control unit. | The system requires disinfection between consecutive clinical uses since the evacuated secretions pass through the internal pipes and valves of the control unit | The AG100s, as described in the left column, routes the secretion through a single use disposable kit, not allowing any contact between the secretion and any of the control unit parts. By this design it removes the need of disinfection process of the control unit (except of external cleaning) and dramatically reduced the risk of cross contamination. |
| Characteristic | AG 100s system<br>(Submitted) | Hospitech's AnapnoGuard<br>100 system (K150157) | Comparison |
| Airways | The <i>AG100s</i> may be used as follows:<br>When used with the<br>AnapnoGuard ETT the <i>AG100s</i> may conduct full<br>functional mode where cuff<br>pressure is automatically<br>adjusted by the system (within<br>the pressure limits) based on<br>CO2 level readings above the<br>cuff. Intermittent<br>synchronized rinsing and<br>suction is performed<br>periodically.<br><br>When connected to a suction<br>FDA cleared Endotracheal<br>tube, the system offers one<br>mode of operation, which<br>includes maintaining cuff<br>pressure control and<br>intermittent subglottic<br>suctioning.<br>The user may, at any time,<br>adjust cuff pressure and<br>perform suction by pressing<br>the relevant buttons on the<br>display.<br><br>When connected to a standard<br>FDA cleared cuffed<br>Endotracheal tube, the system<br>offers one mode of operation<br>which includes maintaining<br>cuff pressure control.<br>The user may, at any time,<br>adjust cuff pressure by<br>pressing the relevant buttons<br>on the display.<br><br>With any Endotracheal tube,<br>the general suction line (Low<br>Pressure or High Pressure)<br>can be manually activated by<br>pressing on the relevant<br>button on the touch-screen. | May be interfaced with:<br>1- AnapnoGuard ETT | Using the device<br>with other FDA<br>cleared devices does<br>not apply any<br>additional risk.<br>All functions with<br>other airways are<br>subset of identical<br>functions with the<br>AnapnoGuard tube.<br><br>That is:<br>Suction with<br>other suction<br>tube is identical<br>to "Suction"<br>function with<br>AnapnoGuard<br>ETT. Constant cuff<br>pressure control<br>allowed with<br>standard cuffed<br>airways, is<br>identical to the<br>"Standby" mode<br>with an<br>AnapnoGuard<br>ETT |
| Characteristic | <i>AG 100s system</i><br>(Submitted) | <i>Hospitech's AnapnoGuard</i><br>100 system (K150157) | Comparison |
| Indications for<br>single patient<br>use | No | No | Same characteristic<br>as the predicate<br>device |
| Patient<br>Population | Adults | Adults | Same intended users |
| CO2 ANALYZER MODULE | | | |
| CO2 analyzer<br>module | CO2 analyzer measures the<br>CO2 levels in the air coming<br>from the subglottic space<br>above the ETT cuff and cuff<br>pressure inflate/deflate<br>accordingly. | Same | Performance test<br>conducted on the<br>subject device.<br>CO2 analyzer<br>module test results<br>supports the<br>substantial<br>equivalence as<br>compared to the<br>predicate device |
| CO2 analyzer | Nondispersive infrared sensor<br>with measurement range of 0-<br>10k PPM | Same | |
| Cuff pressure<br>change based on<br>CO2 leaks | If Threshold 1 $<$ CO2 $<$ Threshold 2, Increase cuff<br>pressure by 1mmHg<br><br>If Threshold 2 $<$ CO2,<br>Increase cuff pressure by<br>formula*<br><br>* (Max pressure limit -<br>current pressure limit)/2<br>mmHg | Same | |
| RINSE MODULE | | | |
| Rinse module | Include peristaltic pump and<br>sensors with closed loop<br>control on the saline volume. | Include diaphragm pump<br>with open loop control on the<br>saline volume. | Performance test<br>conducted on the<br>subject device rinse<br>module shows that it<br>supports the<br>substantial<br>equivalence as<br>compared to the<br>predicate device<br>rinse module |
| CUFF PRESSURE CONTROL MODULE | | | |
| Characteristic | AG 100s system<br>(Submitted) | Hospitech's AnapnoGuard<br>100 system (K150157) | Comparison |
| Cuff pressure<br>control module | Regulate the cuff pressure<br>according to determined set<br>point. | Same | Performance test<br>conducted on the<br>subject device in<br>relation to cuff<br>pressure control<br>module show that it<br>supports the<br>substantial<br>equivalence as<br>compared to the<br>predicate device cuff<br>pressure control<br>module |
| Minimum<br>measured<br>pressure | 10 mmHg (13 cmH2O) | 10 mmHg (13 cmH2O) | |
| Maximal cuff<br>pressure | 50 mmHg (67 cmH2O) | 50 mmHg (67 cmH2O) | |
| Control Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.1 mmHg (0.13 cmH2O) | |
| Recording<br>Accuracy | $\pm$ 0.1 mmHg (0.13 cmH2O) | $\pm$ 0.1 mmHg (0.13 cmH2O) | |
| Pressure drop<br>Alarm time | 0.2 Sec…