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 the cuff pressure as pre-set by the user.
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.
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.

AI/ML Overview

The provided text is a 510(k) summary from the FDA, which focuses on demonstrating substantial equivalence of a modified medical device (AG100s) to a previously cleared predicate device. This type of document typically does not contain detailed acceptance criteria and performance data in the format of a clinical study report with specific statistical outcomes, sample sizes, and expert qualifications.

However, I can extract the types of performance evaluations mentioned and general statements about the device's functionality.

Based on the provided document, here is an attempt to address your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics. Instead, it relies on demonstrating that the modified device (AG100s) functions equivalently to its predicate. The "performance data" section lists the types of tests conducted to support this claim.

Acceptance Criteria (Implied by equivalence claim)	Reported Device Performance (Summary)
Cuff Pressure Control: Maintain cuff pressure as pre-set by user (10-50 mmHg) when used with ETT or TT.	Comparative AG100s Cuff pressure control + suction performance when connected to ETTs & TTs: Validated the device functions as intended with both ETT and TT. The system continuously monitors and adjusts cuff pressure to prevent leaks at minimum possible pressure (within user-defined limits).
Subglottic Secretion Evacuation: Perform intermittent evacuation of subglottic secretions from above the tube's cuff (Suction Pressure Range: -20 up to -120 mmHg).	Comparative AG100s Cuff pressure control + suction performance when connected to ETTs & TTs: Validated the device functions as intended with both ETT and TT, including subglottic secretion removal.
CO2 Monitoring (with AG ETT): Automatically adjust cuff pressure based on monitoring CO2 concentration above the cuff, to prevent leaks.	Cuff Pressure Control (with AG ETT): Demonstrated the system monitors and adjusts cuff pressure based on CO2 levels to prevent leaks, reducing aspiration likelihood and maintaining low cuff pressure.
Software Functionality: Software operates as intended and is validated.	Software System V&V Test: Conducted to ensure the software's functionality and reliability.
Usability: Device is usable and user-friendly.	AG100s Usability Validation: Performed to confirm the device's usability.
Safety and Effectiveness: No new questions of safety and effectiveness are raised by the modifications.	Overall Conclusion: Verification and Validation testing demonstrated that the revised device is substantially equivalent to the previously cleared AG100s, and is as safe and effective without raising new safety or effectiveness concerns.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not specify quantitative sample sizes (e.g., number of patients, number of devices) for any of the tests mentioned (Comparative AG100s Cuff pressure control + suction performance, Software System V&V Test, Usability Validation).

Regarding data provenance: The studies were conducted by Hospitech Respiration Ltd., which is based in Israel. The nature of the studies ("Comparative," "V&V Test," "Usability Validation") suggests they are prospective validation and verification tests conducted specifically for this submission, likely involving laboratory or simulated environments, and potentially human factors evaluations. There is no mention of retrospective clinical data from patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide this information. Given the nature of the tests (performance, software V&V, usability), "ground truth" would likely be established by engineering specifications, validated test methods, and human factors validation protocols rather than expert consensus on medical images or diagnoses. For usability, experts in human factors might be involved, but their number and qualifications are not specified.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. Adjudication is typically used in clinical studies when there's uncertainty in ground truth or to resolve discrepancies among multiple readers. For the verification and validation tests described, results would likely be directly compared against predefined engineering specifications or performance metrics rather than requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. MRMC studies are typically clinical studies evaluating the performance of AI-assisted human readers compared to unassisted readers, especially in diagnostic imaging. This document describes technical verification and validation studies to demonstrate substantial equivalence of a physical medical device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device itself is an automated system for monitoring and controlling cuff pressures and evacuating secretions. Its core function is inherently "standalone" in that it performs these tasks without immediate human intervention for each action, although it is designed for use by trained medical professionals who would set initial parameters and manage the patient. The performance tests described (cuff pressure control, suction performance, CO2 monitoring functionality, software V&V) inherently evaluate the device's standalone technical performance. There isn't a separate "algorithm only" evaluation as described for, for example, an AI diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for the performance tests would be based on:

Engineering Specifications: For parameters like cuff pressure control range (10-50 mmHg), suction pressure range (-20 to -120 mmHg), and flow rate (0-12 L/min).
Validated Test Methods: Using calibrated equipment to measure and verify the device's outputs against its intended specifications.
Functional Requirements: Demonstrating that features like CO2 monitoring leading to cuff pressure adjustment, and secretion evacuation, work as designed.
User Needs/Human Factors Data: For the usability validation.

There is no mention of pathology, expert consensus on clinical cases, or outcomes data in humans presented in this summary to establish ground truth.

8. The Sample Size for the Training Set

This document is for a modified physical medical device, not an AI/ML algorithm that requires a "training set" in the computational sense. Therefore, the concept of a training set sample size is not applicable here. The device's operation is governed by pre-programmed logic, not by a machine learning model trained on data.

9. How the Ground Truth for the Training Set Was Established

As stated above, the concept of a "training set" is not applicable to this device.

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

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.
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: 972-3-919-1648 FAX: 972-3-919-1647

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 980-308-1636 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

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.
1. 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 DeviceAG100s System	Primary PredicateAG100s (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 thecuff pressures of endotracheal tube (ETT) ortracheostomy tube (TT) and to evacuate secretionsfrom the subglottic space above the cuff duringmechanical ventilation.a. When used with a standard ETT or TT, thedevice automatically maintains the cuffpressure as pre-set by the user.b. When used with ETT or TT with suction line,the device automatically maintains the cuffpressure as pre-set by the user and performsintermittent evacuation of subglotticsecretions from above the tube's cuff.c. When used with ETT with suction andventing lines (e.g., AG ETT), the deviceautomatically maintains the cuff pressure aspre-set by the user, or automatically adjuststhe cuff pressure based on monitoring of theCarbon Dioxide (CO2) concentration abovethe cuff. In addition, it performs evacuation,or rinsing and evacuation of subglotticsecretions from above the tube's cuff.	AG100s is intended forairway management byoral/nasal intubation whileproviding continuousendotracheal cuff pressurecontrol using non-invasivemeasurement and monitoringof carbon dioxideconcentration in the subglotticspace and evacuation ofsecretions from above theendotracheal tube's cuff.	Same overall intended use.Indications for use slightlymodified to include the ability toconnect to TT as well as provideclarity regarding devicefunctionality with various tubes.Changes have been validated viaperformance testing. No newquestion of safety andeffectiveness.
Indications for singlepatient use	No	No	Same
Allows tube replacementwithout disconnectingpatient from ventilator	Yes, both TT and ETT	Yes, ETT only	Similar, in predicate device TTwas not used.
Patient Population	Adults	Adults	Same
Biocompatibility	No new patient contacting materials	All materials that come incontact with the patient body	Same

Substantial Equivalency Table

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Characteristics	Subject DeviceAG100s System	Primary PredicateAG100s (K180991)	Comments
		or liquids are biocompatibleand compliant with ISO10993-1
Latex Free	Yes	Yes	Same
Power Supply	100-240 V with backup battery	100-240 V with backupbattery	Same
CO2 analyzer module	CO2analyzer measures the CO2levels in the aircoming from the subglottic space above the ETTcuff and cuff pressure inflate/deflate accordingly.	CO2analyzer measures theCO2levels in the air comingfrom the subglottic spaceabove the ETT cuff and cuffpressure inflate/deflateaccordingly.	Same
Rinse module	Includes peristaltic pump and sensors with closedloop control on the saline volume.	Includes peristaltic pump andsensors with closed loopcontrol on the saline volume.	Same
Cuff pressure controlmodule	Regulate the cuff pressure according to a pre-determined set point.	Regulate the cuff pressureaccording to a pre-determinedset point.	Same
Cuff Pressure ControlRange	10-50mmHg(13.6-68 mmH2O)	10-50mmHg(13.6 - 68 mmH2O)	Same
Vacuum regulator module(suction module)	Regulates the vacuum level during suctionprocedure.	Regulates the vacuum levelduring 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 secretionsfrom above theendotracheal 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 suctionoption was removed as it wasnot regularly used by end user.No impact on device safety oreffectiveness.

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.

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).