AG100s

• K Number: K221477
• Device Name: AG100s
• Manufacturer: Hospitech Respiration Ltd.
• Date Cleared: 2022-12-29 ( 220 days)
• Product Code: BSK
• Regulation Number: 868.5750

Intended Use

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation. 1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff. 3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

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. Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter. When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal 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 AG ETT). 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. The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

Predicate Devices

K180991, K150893

Reference Devices

K180991, K150893

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on automated control and monitoring based on pre-set parameters and direct measurements (CO2 levels), without mentioning learning or adaptive algorithms characteristic of AI/ML.

Therapeutic

Yes.
The device maintains cuff pressure and evacuates secretions to prevent complications like aspiration and tissue damage, which are therapeutic actions.

Diagnostic

No

The device is primarily intended to monitor and control cuff pressures and evacuate secretions, which are therapeutic and management functions, not diagnostic. While it monitors CO2 to detect leaks, this monitoring is for operational adjustment (preventing leaks) rather than diagnosing a patient's condition.

SaMD (Software as a Medical Device)

No

The device description clearly outlines multiple hardware components including a control unit, connection kit, cart, secretions canister, rinsing fluid bag, and antibacterial air filter. The device's function is dependent on the interaction and operation of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided text, the AG100s device is not an In Vitro Diagnostic (IVD).

Here's why:

• IVDs analyze samples taken from the human body. The AG100s monitors and controls cuff pressure and evacuates secretions from the subglottic space. While it interacts with the body, it does not analyze biological samples (like blood, urine, tissue, etc.) to provide diagnostic information about a patient's health status.
• The device's function is mechanical and physiological. It manages pressure, removes fluids, and monitors CO2 levels as an indicator of a physical condition (leakage), not as a diagnostic marker of a disease or condition.
• The intended use and device description focus on managing the airway and preventing complications related to intubation. This is a therapeutic and monitoring function, not a diagnostic one.

Therefore, the AG100s falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.

1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user.
2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the 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.

Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter.

When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal 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 AG ETT). 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.

The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

subglottic space, trachea, lungs

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

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)

In order to support the proposed modifications, the following tests were conducted:

• Comparative AG100s Cuff pressure control + suction performance when connected to ETTs & TTs
• Software System V&V Test
• AG100s Usability Validation

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

Not Found

Predicate Device(s)

K180991, K150893

Reference Device(s)

Not Found

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 contains 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 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.

December 29, 2022

Hospitech Respiration Ltd. % Bosmat Friedman Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269

Re: K221477

Trade/Device Name: AG100s Regulation Number: 21 CFR 868.5750 Regulation Name: Inflatable Tracheal Tube Cuff Regulatory Class: Class II Product Code: BSK Dated: May 18, 2022 Received: May 23, 2022

Dear Bosmat Friedman:

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.

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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Ethan L. Nyberg -S

for James Lee, PhD Division Director DHT1C: Division of Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K221477

Device Name AG100s

Indications for Use (Describe)

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.

1. When used with a standard ETT or TT, the device automatically maintains the cuff pressure as pre-set by the user. 2. When used with ETT or TT with suction line, the device automatically maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.

2. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the 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)

Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

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510(K) SUMMARY

[as required by section 807.92(c)] AG100s 510(k) Number K221477

5.1 SUBMITTER

Applicant's Name:

Hospitech Respiration Ltd. 15 Atir Yeda Kfar-Saba, 4464312, Israel TEL: [phone] FAX: [phone]

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: [phone] bosmat.f(@promedoss.com

Date Prepared:

September 14, 2022

5.2 DEVICE

Trade Name: AG100s

Classification Code: Classification Name: Cuff, Tracheal Tube, Inflatable Product Code: BSK Regulation No: 868.5750 Class: 2 Review Panel: Anesthesiology

5.3 PREDICATE DEVICES

Predicate Device 1 (Primary)

• AG100s, by Hospitech Respiration Ltd., Product code BSK cleared Under: ● K180991.
  Predicate Device 2 (Secondary)

• IntelliCuff, manufactured by Hamilton Medical AG., cleared under K150893; . Product Code: BSK.

5.4 DEVICE DESCRIPTION

The AG100s system is comprised of the following main components:

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• The AG100s control unit о
• The AnapnoGuard connection kit/harness (AG Connection Kit) O connecting a cuffed airway to the AG100s control unit.

Additional device components include cart, secretions canister (Trap Bottle), rinsing fluid (saline) bag and antibacterial air filter.

When the AG100s, is connected to AG ETT, it monitors leaks between endotracheal 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 AG ETT). 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.

The AG100s also performs cuff pressure monitoring and control in standard FDA cleared TTs and ETTs; depending on the tube type, the system may also perform secretions removal.

5.5 INDICATIONS FOR USE

The AG100s is intended to monitor and control the cuff pressures of endotracheal tube (ETT) or tracheostomy tube (TT) and to evacuate secretions from the subglottic space above the cuff during mechanical ventilation.

• When used with a standard ETT or TT, the device automatically maintains 1. the cuff pressure as pre-set by the user.
• When used with ETT or TT with suction line, the device automatically 2. maintains the cuff pressure as pre-set by the user and performs intermittent evacuation of subglottic secretions from above the tube's cuff.
• 3. When used with ETT with suction and venting lines (e.g., AG ETT), the device automatically maintains the cuff pressure as pre-set by the user, or automatically adjusts the cuff pressure based on monitoring of the Carbon Dioxide (CO2) concentration above the cuff. In addition, it performs evacuation, or rinsing and evacuation of subglottic secretions from above the tube's cuff.

5.6 SUBSTANTIAL EQUIVALENCE

The AG100s is substantially equivalent to the predicate device based on the following:

Intended Use

The intended use of the proposed device remains unchanged. The indication for use has been modified to include the ability to connect to TT as well as to provide

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clarifications regarding device functionality when connected to various airway tubes.

Technology

The proposed device modifications introduce the ability to connect the system to TT through minor GUI modifications. All changes have been validated demonstrating that the device functions as intended. Testing demonstrates that the modified AG100s functions in an equivalent manner as the previously cleared AG100s.

Discussion

The modified AG100s has the same intended use as the previously cleared AG100s, and a slightly modified indications for use statement (for clarification purposes). The main technological difference between the devices is the ability to connect the AG100s to a TT as well as ETT.

Verification and Validation testing demonstrated that the revised device is substantially equivalent to the previously cleared AG100s. Consequently, the AG100s is as safe and effective as its predicates without raising any new safety and/or effectiveness concerns.

| Characteristics | Subject Device
AG100s System | Primary Predicate
AG100s (K180991) | Comments |
|-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Hospitech Respiration, Ltd. | Hospitech Respiration, Ltd. | Same |
| 510(k) Number | TBD | K180991 | -- |
| Product Code(s) | BSK | BSK | Same |
| Regulation | 868.5750 | 868.5750 | Same |
| Class | 2 | 2 | Same |
| Indications for Use | The AG100s is intended to monitor and control the
cuff pressures of endotracheal tube (ETT) or
tracheostomy tube (TT) and to evacuate secretions
from the subglottic space above the cuff during
mechanical ventilation.
a. When used with a standard ETT or TT, the
device automatically maintains the cuff
pressure as pre-set by the user.
b. When used with ETT or TT with suction line,
the device automatically maintains the cuff
pressure as pre-set by the user and performs
intermittent evacuation of subglottic
secretions from above the tube's cuff.
c. When used with ETT with suction and
venting lines (e.g., AG ETT), the device
automatically maintains the cuff pressure as
pre-set by the user, or automatically adjusts
the cuff pressure based on monitoring of the
Carbon Dioxide (CO2) concentration above
the cuff. In addition, it performs evacuation,
or rinsing and evacuation of subglottic
secretions from above the tube's cuff. | AG100s 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. | Same overall intended use.
Indications for use slightly
modified to include the ability to
connect to TT as well as provide
clarity regarding device
functionality with various tubes.
Changes have been validated via
performance testing. No new
question of safety and
effectiveness. |
| Indications for single
patient use | No | No | Same |
| Allows tube replacement
without disconnecting
patient from ventilator | Yes, both TT and ETT | Yes, ETT only | Similar, in predicate device TT
was not used. |
| Patient Population | Adults | Adults | Same |
| Biocompatibility | No new patient contacting materials | All materials that come in
contact with the patient body | Same |

Substantial Equivalency Table

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| Characteristics | Subject Device
AG100s System | Primary Predicate
AG100s (K180991) | Comments |
|------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | or liquids are biocompatible
and compliant with ISO
10993-1 | |
| Latex Free | Yes | Yes | Same |
| Power Supply | 100-240 V with backup battery | 100-240 V with backup
battery | Same |
| CO2 analyzer module | CO2analyzer measures the CO2levels in the air
coming from the subglottic space above the ETT
cuff and cuff pressure inflate/deflate accordingly. | CO2analyzer measures the
CO2levels in the air coming
from the subglottic space
above the ETT cuff and cuff
pressure inflate/deflate
accordingly. | Same |
| Rinse module | Includes peristaltic pump and sensors with closed
loop control on the saline volume. | Includes peristaltic pump and
sensors with closed loop
control on the saline volume. | Same |
| Cuff pressure control
module | Regulate the cuff pressure according to a pre-
determined set point. | Regulate the cuff pressure
according to a pre-determined
set point. | Same |
| Cuff Pressure Control
Range | 10-50mmHg
(13.6-68 mmH2O) | 10-50mmHg
(13.6 - 68 mmH2O) | Same |
| Vacuum regulator module
(suction module) | Regulates the vacuum level during suction
procedure. | Regulates the vacuum level
during suction procedure. | Same |
| Suction Pressure Range | Subglottic suction: -20 up to -120 mmHg | Subglottic suction: -20 up to -
120 mmHg | Same |
| Mode of operation | Manual Intermittent | Manual Intermittent | Same |
| Closed System | Yes | Yes | Same |
| Manual control of vacuum | Yes | Yes | Same |
| Evacuation of secretions
from above the
endotracheal tube's cuff | Yes | Yes | Same |
| Flow Rate | 0 to 12 L/min | 0 to 12 L/min | Same |
| General suction | Not available | Yes | Different; the general suction
option was removed as it was
not regularly used by end user.
No impact on device safety or
effectiveness. |

5.7 PERFORMANCE DATA

In order to support the proposed modifications, the following tests were conducted:

• Comparative AG100s Cuff pressure control + suction performance when । connected to ETTs & TTs
• Software System V&V Test l
• -AG100s Usability Validation

5.8 CONCLUSION

Hospitech Respiration has demonstrated that the AG100s is substantially equivalent to the predicate device. Differences between the AG100s and the predicate device do not raise new questions of safety or effectiveness.