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 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.

AI/ML Overview

The provided text describes the Hospitech Respiration Ltd. AG100s device, an airway management system. The document is a 510(k) premarket notification to the FDA, asserting substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria and reported device performance from a test set. Instead, it compares the characteristics of the AG100s system to its predicate device, the AnapnoGuard 100 System (K150157). The "Comparison" column in the table on pages 6-7 serves to highlight similarities and differences, and performance tests are mentioned to support substantial equivalence where differences exist.

Below is a summary of the performance-related comparison provided in the document:

Feature/Characteristic	Acceptance Criterion (Predicate Device Performance)	Reported Device Performance (AG100s)	Comparison Comment by Manufacturer
CO2 analyzer module	Measures CO2 levels, inflates/deflates cuff accordingly	Same	Performance test conducted on the subject device. CO2 analyzer module test results support substantial equivalence.
CO2 analyzer type	Nondispersive infrared sensor, 0-10k PPM	Same	Not explicitly stated as "passing" but implicitly equivalent.
Cuff pressure change based on CO2 leaks (Threshold 1 < CO2 < Threshold 2)	Increase cuff pressure by 1mmHg	Same	Not explicitly stated as "passing" but implicitly equivalent.
Cuff pressure change based on CO2 leaks (Threshold 2 < CO2)	Increase cuff pressure by formula*	Same	Not explicitly stated as "passing" but implicitly equivalent.
Rinse module	Diaphragm pump, open loop control	Peristaltic pump, closed loop control on saline volume	Performance test conducted on the subject device rinse module shows it supports substantial equivalence.
Cuff pressure control module	Regulate cuff pressure to set point	Same	Performance test conducted on the subject device in relation to cuff pressure control module show that it supports substantial equivalence.
Minimum measured pressure	10 mmHg (13 cmH2O)	10 mmHg (13 cmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Maximal cuff pressure	50 mmHg (67 cmH2O)	50 mmHg (67 cmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Control Accuracy	± 0.1 mmHg (0.13 cmH2O)	± 0.1 mmHg (0.13 cmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Recording Accuracy	± 0.1 mmHg (0.13 cmH2O)	± 0.1 mmHg (0.13 cmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Pressure drop Alarm time	0.2 Sec	0.2 Sec	Not explicitly stated as "passing" but implicitly equivalent.
Pressure rise alarm time	0.2 Sec	0.2 Sec	Not explicitly stated as "passing" but implicitly equivalent.
Steady state error	2mmHg (+2.6 cmH2O)	2mmHg (+2.6 cmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Overshoot	6 - 7 %	5 – 9 %	The range for AG100s is slightly wider (5-9% vs 6-7%), but this difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent.
Cuff Pressure Control Range	10-50mmHg (13.6 - 68 mmH2O)	10-50mmHg (13.6 - 68 mmH2O)	Not explicitly stated as "passing" but implicitly equivalent.
Vacuum regulator module	Regulate vacuum during suction	Same	Performance test conducted on the subject device suction module shows that it supports substantial equivalence.
Suction Pressure Range	-20 up to -120 mmHg (Subglottic suction)	-20 up to -120 mmHg (Subglottic suction)	Not explicitly stated as "passing" but implicitly equivalent.
Mode of operation (suction)	Manual, Intermittent	Manual, Intermittent	Not explicitly stated as "passing" but implicitly equivalent.
Closed System (suction)	Yes	Yes	Implied equivalence.
Manual control of vacuum	Yes	Yes	Not explicitly stated as "passing" but implicitly equivalent.
Evacuation of secretions from above ETT cuff	Yes	Yes	Not explicitly stated as "passing" but implicitly equivalent.
Gauge accuracy	± 1% FS	± 1.5% FS	The AG100s has a slightly less accurate gauge. This difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent.
Regulation Accuracy	± 5% FS	± 5% FS	Not explicitly stated as "passing" but implicitly equivalent.
Flow Rate	0 to 15 L/min	0 to 12 L/min	The AG100s has a slightly lower maximum flow rate. This difference is not specifically commented on as raising new questions of safety/effectiveness, implying it falls within acceptable bounds or is considered substantially equivalent.
General suction	N/A (not present in predicate)	Provide vacuum range: -20 up to -300 mmHg	This is a new function compared to the predicate, stated to be identical to general suction lines on any bedside and within common suction ranges.

2. Sample size used for the test set and the data provenance

The document states that "Performance bench tests were implemented to show that the modifications do not raise different questions of safety and effectiveness." It then lists 12 performance tests (e.g., Performance of Suction Module, Performance of Cuff Pressure Control module, Performance of CO2 Reading module, Battery Test, Electrical safety, EMC testing).

Test Set Sample Size: The document does not specify the sample size for any of the non-clinical performance tests. These are described as "bench tests," implying laboratory testing rather than testing on patients or human subjects.
Data Provenance: The tests are "bench tests" conducted by Hospitech Respiration Ltd. in Israel, as indicated by the applicant's address. There is no information about the origin of data in terms of specific countries or whether it was retrospective or prospective, as these are not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided. For non-clinical bench tests, "ground truth" is typically established by engineering specifications, validated measurement equipment, and adherence to industry standards, rather than expert consensus on individual cases.

4. Adjudication method for the test set

There is no mention of an adjudication method, as the performance tests described are non-clinical bench tests against known standards and specifications, not clinical interpretations requiring expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was done. The device (AG100s) is an airway management system, not an AI-assisted diagnostic imaging device that would typically involve a multi-reader multi-case study to assess human reader improvement with AI assistance.
No AI assistance is mentioned in the description of the device's technology or function. Its operation relies on direct sensor measurements (CO2 levels, cuff pressure) and automated mechanical adjustment.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone system designed to automatically monitor and adjust cuff pressure and perform suction; however, it is a medical device that requires clinical oversight and user interaction for settings and activation. The "Performance tests" listed are essentially standalone evaluations of different modules of the device (e.g., CO2 reading, cuff pressure control, suction). These were non-clinical bench tests.

7. The type of ground truth used

For the performance tests described, the "ground truth" would be established by:

Engineering specifications and design requirements: The device's components (e.g., CO2 analyzer, cuff pressure control, rinse module, vacuum regulator) are designed to operate within specified ranges and accuracies.
Validated measurement equipment: Use of calibrated sensors and instruments to measure the device's output (e.g., actual CO2 levels, actual cuff pressure, actual flow rates) during testing.
Industry standards: Compliance with standards like IEC 60601-1, ISO 5361, EN ISO 10993-1, and ISO 14971 implies adherence to established performance benchmarks.

8. The sample size for the training set

This is not applicable. The AG100s is a hardware-based medical device with automated control mechanisms, not a machine learning or AI-based system that requires a "training set."

9. How the ground truth for the training set was established

This is not applicable, as there is no training set for this device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K180991

Device Name AG100s

Indications for Use (Describe)

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 Ltd20 Hamagshimim St. 0Kiryat Matalon,Petach-Tikva, 4934829IsraelTEL: 972-3-919-1648FAX: 972-3-919-1647
Contact Person:	Yoram Levy, Qsite31 Haavoda St.Binyamina, Israel 30500Tel (972)4-638-8837; Fax (972)4-638-0510Yoram@qsitemed.com
Trade Name:	AG100s
SummaryPreparation Date:Classification:	April 9, 2018Classification name: Cuff, tracheal tube, inflatableProduct Code: BSKRegulation No: 21 CFR 868.5750Class: IIPanel: 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.

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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).

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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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 AnapnoGuard100 system (K150157)	Comparison
GENERAL
Device Description	The AG 100s system is anairway management systemdesigned to assist theclinician in achieving propersealing of the trachea atminimal pressure of theendotracheal tube's cuff inorder to minimize inducedpressure on the tracheatissue.Achieving the optimalpressure is the responsibilityof the clinician.The system includes anEndotracheal Tube, cuffpressure monitor, carbondioxide (CO2) monitor andirrigation and secretionsevacuation modules. Thesystem includes a cuff intrapressure monitoring andcontrol module formeasuring and monitoringthe cuff pressure. Thesystem performs continuous(every millisecond), onlinesampling of cuff pressurevia the inflation lumen ofthe endotracheal tube. Italso adjusts the cuffpressure within the pressurelimits presented by theclinician or alerts thephysician to decide ifneeded to adjust the cuffpressure.	The AnapnoGuard 100AnapnoGuard system is anairway management systemdesigned to assist theclinician in achievingoptimal sealing of the tracheaat minimal pressure of theendotracheal tube's cuff inorder to minimize inducedpressure on the tracheatissue.Achieving the optimalpressure is theresponsibility of theclinician.The system includes anEndotracheal Tube, cuffpressure monitor, carbondioxide (CO2) monitor andirrigation and secretionsevacuation modules. Thesystem includes a cuff intrapressure monitoring andcontrol module formeasuring and monitoringthe cuff pressure. The systemperforms continuous (everymillisecond), onlinesampling of cuff pressure viathe inflation lumen of theendotracheal tube It alsoadjusts the cuff pressurewithin the pressure limitspresented by the clinician oralerts the physician to decideif needed to adjust the cuffpressure	Subject device hasthe same devicedescription as thepredicate device
Characteristic	AG 100s system(Submitted)	Hospitech's AnapnoGuard100 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 AnapnoGuard100 system (K150157)	Comparison
Airways	The AG100s may be used as follows:When used with theAnapnoGuard ETT the AG100s may conduct fullfunctional mode where cuffpressure is automaticallyadjusted by the system (withinthe pressure limits) based onCO2 level readings above thecuff. Intermittentsynchronized rinsing andsuction is performedperiodically.When connected to a suctionFDA cleared Endotrachealtube, the system offers onemode of operation, whichincludes maintaining cuffpressure control andintermittent subglotticsuctioning.The user may, at any time,adjust cuff pressure andperform suction by pressingthe relevant buttons on thedisplay.When connected to a standardFDA cleared cuffedEndotracheal tube, the systemoffers one mode of operationwhich includes maintainingcuff pressure control.The user may, at any time,adjust cuff pressure bypressing the relevant buttonson the display.With any Endotracheal tube,the general suction line (LowPressure or High Pressure)can be manually activated bypressing on the relevantbutton on the touch-screen.	May be interfaced with:1- AnapnoGuard ETT	Using the devicewith other FDAcleared devices doesnot apply anyadditional risk.All functions withother airways aresubset of identicalfunctions with theAnapnoGuard tube.That is:Suction withother suctiontube is identicalto "Suction"function withAnapnoGuardETT. Constant cuffpressure controlallowed withstandard cuffedairways, isidentical to the"Standby" modewith anAnapnoGuardETT
Characteristic	AG 100s system(Submitted)	Hospitech's AnapnoGuard100 system (K150157)	Comparison
Indications forsingle patientuse	No	No	Same characteristicas the predicatedevice
PatientPopulation	Adults	Adults	Same intended users
CO2 ANALYZER MODULE
CO2 analyzermodule	CO2 analyzer measures theCO2 levels in the air comingfrom the subglottic spaceabove the ETT cuff and cuffpressure inflate/deflateaccordingly.	Same	Performance testconducted on thesubject device.CO2 analyzermodule test resultssupports thesubstantialequivalence ascompared to thepredicate device
CO2 analyzer	Nondispersive infrared sensorwith measurement range of 0-10k PPM	Same
Cuff pressurechange based onCO2 leaks	If Threshold 1 $<$ CO2 $<$ Threshold 2, Increase cuffpressure by 1mmHgIf Threshold 2 $<$ CO2,Increase cuff pressure byformula** (Max pressure limit -current pressure limit)/2mmHg	Same
RINSE MODULE
Rinse module	Include peristaltic pump andsensors with closed loopcontrol on the saline volume.	Include diaphragm pumpwith open loop control on thesaline volume.	Performance testconducted on thesubject device rinsemodule shows that itsupports thesubstantialequivalence ascompared to thepredicate devicerinse module
CUFF PRESSURE CONTROL MODULE
Characteristic	AG 100s system(Submitted)	Hospitech's AnapnoGuard100 system (K150157)	Comparison
Cuff pressurecontrol module	Regulate the cuff pressureaccording to determined setpoint.	Same	Performance testconducted on thesubject device inrelation to cuffpressure controlmodule show that itsupports thesubstantialequivalence ascompared to thepredicate device cuffpressure controlmodule
Minimummeasuredpressure	10 mmHg (13 cmH2O)	10 mmHg (13 cmH2O)
Maximal cuffpressure	50 mmHg (67 cmH2O)	50 mmHg (67 cmH2O)
Control Accuracy	$\pm$ 0.1 mmHg (0.13 cmH2O)	$\pm$ 0.1 mmHg (0.13 cmH2O)
RecordingAccuracy	$\pm$ 0.1 mmHg (0.13 cmH2O)	$\pm$ 0.1 mmHg (0.13 cmH2O)
Pressure dropAlarm time	0.2 Sec	0.2 Sec
Pressure risealarm time	0.2 Sec	0.2 Sec
Steady state error	2mmHg (+2.6 cmH2O)	2mmHg (+2.6 cmH2O)
Overshoot	5 – 9 %	6 - 7 %
Cuff PressureControl Range	10-50mmHg(13.6 - 68 mmH2O)	10-50mmHg(13.6 - 68 mmH2O)
		VACUUM REGULATOR MODULE
Vacuumregulatormodule (suctionmodule)	Regulate the vacuum levelduring suction procedure.	Same	Performance testconducted on thesubject devicesuction moduleshows that itsupports thesubstantialequivalence ascompared to thepredicate devicesuction module
Suction PressureRange	Subglottic suction: -20 up to -120 mmHg	Subglottic suction: -20 up to-120 mmHg
Mode ofoperation	ManualIntermittent	ManualIntermittent
Closed System	Yes	Yes	predicate devicesuction module
Manual controlof vacuum	Yes	Yes
Evacuation ofsecretions fromabove theendotrachealtube's cuff	Yes	Yes
Gauge accuracy	$\pm$ 1.5% FS	$\pm$ 1% FS
RegulationAccuracy	$\pm$ 5% FS	$\pm$ 5% FS
Characteristic	AG 100s system(Submitted)	Hospitech's AnapnoGuard100 system (K150157)	Comparison
Flow Rate	0 to 12 L/min	0 to 15 L/min
General suction	Provide vacuum range: -20 upto -300 mmHg	N/A	General suctionfunction is identicalto the generalsuction line on anybedside, allowingthe clinician to use itfor general suctionpurposes. Standardsuction regulatorsallow suction up tominus 500 and moremmHg. Themaximum suctionlevel allowed by theAG100s is 300mmHgThe preset suctionlevel by the user isindicated/displayedon the suctionbutton.

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Performance Standards

AG100s complies with the following voluntary standards:

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

Non-Clinical Performance Tests

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

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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:

	Name of test
1.	Performance of Suction Module - Comparative test.
2.	Performance of Rinse Module - Comparative test
3.	Performance of Cuff Pressure Control module - Comparative test
4.	Performance of CO2 Reading module - Comparative test
5.	Performance of Cuff Pressure Control Suction with standard and suction
	ETTs
6.	Performance of General Suction Line module
7.	Performance of new GSS CO2 sensor Vs. PPS CO2 sensor
8.	Battery Test
9.	X-ray
10.	RFID and Diathermy
11.	Electrical safety
12.	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.

Pre-clinical Performance Data

No preclinical tests were conducted.

Summary of Clinical Performance Data

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.

Substantial equivalence conclusion

The performance tests that were conducted show that the AG100s is substantially equivalent to the listed predicate device without raising any different questions of safety and 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).