Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a system that monitors and adjusts cuff pressure based on CO2 levels, and evacuates secretions. It does not mention any AI or ML algorithms for data analysis, decision making, or pattern recognition. The performance studies are bench tests and usability studies, not studies evaluating AI/ML performance metrics.

Therapeutic

Yes
The device is described as managing airways by providing continuous endotracheal cuff pressure control, monitoring carbon dioxide concentration, and evacuating secretions. These functions directly address patient health issues and improve their physiological state, fitting the definition of a therapeutic device.

Diagnostic

No

The primary functions of the AG 100s are "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." While it monitors carbon dioxide levels to detect leaks (an "objective indicator"), this monitoring is for controlling the cuff and managing the airway to prevent aspiration and ensure proper ventilation, rather than for diagnosing a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including a control unit, connection kit, endotracheal tube, and accessories like a cart and canisters.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The AG100s system is designed for airway management during intubation. Its primary functions are:
- Monitoring and controlling endotracheal cuff pressure.
- Measuring carbon dioxide levels in the subglottic space to detect leaks.
- Evacuating secretions from above the cuff.
Method of Operation: The device interacts directly with the patient's airway and uses non-invasive measurements (CO2 concentration in the subglottic space) and physical actions (cuff pressure adjustment, suction). It does not analyze samples taken from the body in a laboratory setting.

While the device measures a biological marker (CO2), it does so in a non-invasive, real-time manner within the patient's airway for the purpose of managing the airway device, not for diagnosing a disease or condition from a collected sample.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

BSK

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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

airway, trachea, lungs

Indicated Patient Age Range

Adults

Intended User / Care Setting

clinician, hospital professional team

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance bench tests were implemented to show that the modifications do not raise different questions of safety and effectiveness. The performance tests were done in order to show that the changes that were done while upgrading the AnapnoGuard 100 to the AG00s did not raise any different questions of safety and or effectiveness. The tests demonstrated that the AG100s is efficient for performing its intended use.

The following performance tests were conducted:

Performance of Suction Module - Comparative test.
Performance of Rinse Module - Comparative test
Performance of Cuff Pressure Control module - Comparative test
Performance of CO2 Reading module - Comparative test
Performance of Cuff Pressure Control Suction with standard and suction ETTs
Performance of General Suction Line module
Performance of new GSS CO2 sensor Vs. PPS CO2 sensor
Battery Test
X-ray
RFID and Diathermy
Electrical safety
EMC testing

The conclusions drawn from the nonclinical tests that demonstrate that the AG100s device is as safe, as effective, and performs as well as or better than the AnapnoGuard 100, the legally marketed predicate device and therefore is substantial equivalent to its predicate device.

No preclinical tests were conducted.
No clinical tests were conducted.

Human Factors Validation (Usability) Study: A total of 45 professional team participants, the three professional subjects that are the target population for operating the AG100s, were enrolled in the study. The results of this usability study clearly indicate that User Manual and GUI of the AG100s are clear and effective when operated by intended users- hospital professional team.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K150157

Reference Device(s)

K093126

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 868.5750 Inflatable tracheal tube cuff.

(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

1

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

2

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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Image /page/3/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue globe made of lines, with a large, stylized letter 'H' in the center. Below the globe, the words 'Hospitech Respiration' are written in a simple, sans-serif font, also in blue.

510(K) SUMMARY

AG100s

510(k) Number K180991

| Applicant's Name: | Hospitech Respiration Ltd
20 Hamagshimim St. 0
Kiryat Matalon,
Petach-Tikva, 4934829
Israel
TEL: 972-3-919-1648
FAX: 972-3-919-1647 |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Yoram Levy, Qsite
31 Haavoda St.
Binyamina, Israel 30500
Tel (972)4-638-8837; Fax (972)4-638-0510
Yoram@qsitemed.com |
| Trade Name: | AG100s |
| Summary
Preparation Date:
Classification: | April 9, 2018
Classification name: Cuff, tracheal tube, inflatable
Product Code: BSK
Regulation No: 21 CFR 868.5750
Class: II
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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Image /page/4/Picture/0 description: The image shows the logo for Hospitech Respiration. The logo features a blue letter H inside of a blue globe. The text "Hospitech Respiration" is written in blue below the globe and letter H.

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
(Submitted) | Hospitech's AnapnoGuard
100 system (K150157) | Comparison |
|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GENERAL | | | |
| Device Description | The AG 100s system is an
airway management system
designed to assist the
clinician in achieving proper
sealing of the trachea at
minimal pressure of the
endotracheal tube's cuff in
order to minimize induced
pressure on the trachea
tissue.

Achieving the optimal
pressure is the responsibility
of the clinician.

The system includes an
Endotracheal Tube, cuff
pressure monitor, carbon
dioxide (CO2) monitor and
irrigation and secretions
evacuation modules. The
system includes a cuff intra
pressure monitoring and
control module for
measuring and monitoring
the cuff pressure. The
system performs continuous
(every millisecond), online
sampling of cuff pressure
via the inflation lumen of
the endotracheal tube. It
also adjusts the cuff
pressure within the pressure
limits presented by the
clinician or alerts the
physician to decide if
needed to adjust the cuff
pressure. | The AnapnoGuard 100
AnapnoGuard system is an
airway management system
designed to assist the
clinician in achieving
optimal sealing of the trachea
at minimal pressure of the
endotracheal tube's cuff in
order to minimize induced
pressure on the trachea
tissue.

Achieving the optimal
pressure is the
responsibility of the
clinician.

The system includes an
Endotracheal Tube, cuff
pressure monitor, carbon
dioxide (CO2) monitor and
irrigation and secretions
evacuation modules. The
system includes a cuff intra
pressure monitoring and
control module for
measuring and monitoring
the cuff pressure. The system
performs continuous (every
millisecond), online
sampling of cuff pressure via
the inflation lumen of the
endotracheal tube It also
adjusts the cuff pressure
within the pressure limits
presented by the clinician or
alerts the physician to decide
if needed to adjust the cuff
pressure | Subject device has
the same device
description as the
predicate device |
| Characteristic | AG 100s system
(Submitted) | Hospitech's AnapnoGuard
100 system (K150157) | Comparison |
| Disinfection | The system does not require disinfection process after use.
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.
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
(Submitted) | Hospitech's AnapnoGuard
100 system (K150157) | Comparison |
| Airways | The AG100s may be used as follows:
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. | May be interfaced with:
1- AnapnoGuard ETT | Using the device
with other FDA
cleared devices does
not apply any
additional risk.
All functions with
other airways are
subset of identical
functions with the
AnapnoGuard tube.