The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.

Device Description

The IRRIS is designed for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices. The IRRIS is a non-invasive electronic illumination device. The device transmits light of a specific wavelength (near infra-red) to the underlying tissues. The light enables to illuminate the trachea of the patient, so it can be distinguished from other tissues while using video assisted devices (video-laryngoscopes).

AI/ML Overview

The provided FDA 510(k) summary for the IRRIS (Infra-Red-Red Intubation System) offers some details about its performance evaluation but lacks specific, quantifiable acceptance criteria and a detailed breakdown of the study that proves these criteria are met. However, I can extract and infer information from the provided text to construct an answer based on what is available.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for clinical performance. Instead, it focuses on demonstrating safety, biocompatibility, and functional performance, and ultimately drawing a conclusion of "substantial equivalence." The clinical study's objective was to verify the device aids in ETT placement by illuminating the trachea, not to achieve a specific success rate or performance metric.

Acceptance Criteria (Inferred/Implicit)	Reported Device Performance (From Clinical & Pre-Clinical Studies)
Biocompatibility: Materials are safe for patient contact.	Confirmed by Cytotoxicity Study, ISO Skin Irritation Study (rabbits), and ISO Closed Patch Sensitization Study (guinea pigs). Outcome: "confirmed the biocompatibility of the patient contacting materials."
Software Validation: Software meets predetermined requirements.	Performed by a professional 3rd party service using FDA's Guidance. Outcome: "confirmed its acceptability to predetermined requirements."
Electrical Safety (IEC 60601-1): Device is electrically safe.	Tested by an independent lab. Outcome: "confirmed its compliance to the standard."
EMC (IEC 60601-1-2): Device complies with electromagnetic compatibility standards.	Tested by an independent lab. Outcome: "confirmed its compliance to the standard."
Clinical Utility/Usability: Device aids in ETT placement by illuminating the trachea and is usable pre-clinically.	Cadaver Studies (2 proof of concept studies): "confirmed the acceptability of the device to proceed on humans." Clinical Trial (12 patients): "verified the device aids in the placement of an ETT during intubation procedures performed with video-assisted devices by illuminating the trachea of the patient, so it can be distinguished from other tissues."
Safety in Clinical Use: No adverse reactions during clinical use.	Clinical Trial (12 patients): "There were no adverse reactions."

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

Sample Size for Test Set:
- Clinical Trial: 12 patients.
- Cadaver Studies (Pre-clinical): 6 cadavers (total from 2 proof of concept studies).
Data Provenance:
- Clinical Trial: Conducted "outside of the USA." This indicates international prospective data.
- Cadaver Studies: Not specified, but likely prospective.

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

The document does not explicitly state the number of experts or their qualifications for establishing ground truth in either the cadaver studies or the clinical trial. It only states that the clinical trial "verified the device aids in the placement of an ETT" and the cadaver studies "confirmed the acceptability of the device to proceed on humans," implying medical professional assessment.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set or the assessment of "aid in placement" or "illumination."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No, the document does not mention a multi-reader multi-case comparative effectiveness study. The clinical study was focused on verifying the device's function and safety, not on quantifying improvement with AI (which this device is not) or comparing human reader performance with and without its assistance in a formal MRMC setup.
Effect size of human readers improvement with AI vs without AI assistance: Not applicable, as no such study was conducted or reported. The IRRIS is an "illumination device," not an AI-powered system, and its purpose is to aid, not to replace or directly enhance diagnostic interpretation by humans in a comparative reading setting.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? This question is typically relevant for AI/algorithm-based diagnostic devices. The IRRIS is a physical illumination device, not a standalone algorithm. Its function is inherently "human-in-the-loop" as it aids a human performing intubation. Therefore, a "standalone algorithm performance" study is not applicable in the typical sense for this device. Its performance is evaluated in the context of aiding a human procedure.

7. Type of Ground Truth Used

Clinical Trial: The ground truth for proving the device "aids in the placement of an ETT... by illuminating the trachea" appears to be direct observation and assessment by the medical professionals conducting the intubation procedures. This would likely involve visual confirmation that the trachea was indeed illuminated and distinguishable, and that the ETT was successfully placed. The lack of adverse reactions also contributes to the safety aspect.
Cadaver Studies: Similar to the clinical trial, the ground truth would be direct observation by medical professionals confirming the "clinical utility and usability" and effectiveness of tracheal illumination.

8. Sample Size for the Training Set

The document describes the IRRIS as an illumination device, not a machine learning or AI-based device that would typically have a "training set." Therefore, there is no mention of a training set or its size. The studies conducted (biocompatibility, electrical safety, software validation, cadaver, clinical) are for verification and validation, not for training a model.

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

As there is no mention of a training set for an algorithm, this question is not applicable.

Summary

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January 12, 2018

A.R Guide In Medical Ltd. % George Hattub Senior Staff Consultant MedicSense, USA 291 Hillside Avenue Somerset, Massachusetts 02726

Re: K171411

Trade/Device Name: IRRIS (Infra-Red-Red Intubation System) Regulation Number: 21 CFR 868.5730 Regulation Name: Tracheal Tube Regulatory Class: Class II Product Code: BTR Dated: December 15, 2017 Received: December 20, 2017

Dear George Hattub:

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. 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

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about medical devices and radiation-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,

Image /page/1/Figure/6 description: The image shows the name "Tara A. Ryan" in bold font, followed by the letter "S" and the word "for" in a smaller font. To the right of the name is a digital signature that reads "Digitally signed by Tara A. Ryan -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Tara A. Ryan -S, 0.9.2342.19200300.100.1.1=1300030749 Date: 2018.01.12 15:12:52-05'00'". The signature indicates that the document has been digitally signed by Tara A. Ryan on January 12, 2018.

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)

K171411

Device Name

IRRIS (Infra-Red-Red Intubation System)

Indications for Use (Describe)

The IRRIS is intended for use as an aid in the placement of an endotracheal tube (ETT) during intubation procedures performed with video-assisted devices.

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

Pursuant to CFR 807.92, the following 510(k) Summary is provided:

Submitter 1. (a) George J. Hattub MedicSense, USA Address: 291 Hillside Avenue Somerset, MA 02726 george@medicsense.com

1. (b)	Manufacturer Address:	A. R Guide In Medical Ltd.13 Wadi El HajPO Box 1252Nazareth, Israel 17111
	Mfg. Phone:	Tel.: +972-58-762-2811
	Contact Person:	Mr. Ariel Shrem, CEO
	Date:	December 28, 2017
2.	Device & Classification Name:	Tracheal Tube Accessory- classified as Class 2, BTR,Regulation Number 21 CFR 868.5730IRRIS (Infra-Red-Red Intubation System)
3 a	Predicate Device:	K110962 Ambu aScope 2
3.	Reference Devices:	K954771- Laedal Medical Corporation- Trachlight Stylet and TrachealLightWandK962361- Laedal Medical Corporation- Trachlight Stylet and TrachealLightWand
4.	Description:	The IRRIS is designed for use as an aid in the placement of an endotrachealtube (ETT) during intubation procedures performed with video-assisteddevices. The IRRIS is a non-invasive electronic illumination device. The devicetransmits light of a specific wavelength (near infra-red) to the underlyingtissues. The light enables to illuminate the trachea of the patient, so it can bedistinguished from other tissues while using video assisted devices (video-laryngoscopes).
5.	Intended Use:	The IRRIS is intended for use as an aid in the placement of an endotrachealtube (ETT) during intubation procedures performed with video-assisteddevices.

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6.	Comparison ofTechnologicalCharacteristics:	With respect to intended use, IRRIS is the same as its predicate device.Although technology is somewhat different, the IRRIS is basically the same asits predicate device in that they produce light. The IRRIS is a non-invasivedevice, whereas the predicate device is invasive. Based upon the outcomestheir extensive testing, evaluation, and analysis, A. R Guide In Medicalbelieves that their device does not raise new concerns, and the IRRIS issubstantially equivalent to its predicate devices. At the end of thissummary, a comparison table is provided.
7.	Performance	Non-Clinical Testing
	Testing:	The Biocompatibility of the device was confirmed by the following battery oftests:Cytotoxicity Study Using the ISO Elution MethodISO Skin Irritation Study in RabbitsISO Closed Patch Sensitization Study in Guinea PigsThe outcome of this testing confirmed the biocompatibility of the patientcontacting materials.
		Software Validation of the device was performed by a professional 30 partyservice utilizing FDA's Guidance Document for Premarket Submission ofSoftware Controlled Devices. The outcome of this testing confirmed itsacceptability to predetermined requirements.
		As a medical electrical equipment, the device was tested in accordance withIEC 60601-1 by an independent lab. The outcome of this testing confirmed itscompliance to the standard.
		The EMC of the device was confirmed by testing to IEC 60601-1-2 by anindependent lab. The outcome of this testing confirmed its compliance to thestandard.
		Clinical Testing:
		An IRB approved clinical trial was conducted on 12 patients outside of the USA.The results of the study verified the device aids in the placement of an ETTduring intubation procedures performed with video-assisted devices byilluminating the trachea of the patient, so it can be distinguished from othertissues. There were no adverse reactions. Prior to conducting this study, 2proof of concept studies were conducted on a total 6 cadavers to evaluate theclinical utility and usability of the IRRIS. The outcome of these studiesconfirmed the acceptability of the device to proceed on humans.

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Feature andCharacteristic	IRRIS (Subject Device)	Ambu aScope 2 (PredicateDevice)
DescriptionTechnicalDescription	The IRRIS is designed for useas an aid in the placement of anendotracheal tube (ETT) duringintubation proceduresperformed with video-assisteddevices. The IRRIS is a non-invasive electronic illuminationdevice for single patient use.The device transmits light of aspecific wavelength (near infra-red) to the underlying tissues.The light enables to illuminatethe trachea of the patient, so itcan be distinguished from othertissues while using videoassisted devices (video-laryngoscopes).An external disposableelectronic illumination device forsingle patient use. The device iscomprised of disposable LEDlights (facing the patient skin)and is operated by a battery.	Ambu aScope 2 is a flexible intubationscope System consist of a single useflexible intubation scope, Ambu, and amonitor.Ambu aScope 2 is for viewinganatomical structures in the upperairways, and as an aid in placement ofan endotracheal tube (ETT), an ETT size6 or larger can be used. A camera at thedistal tip of the aScope provides the userwith an indication of the placement of theaScope. The maneuverable tip allowsthe user to guide the ETT in the desireddirection. Ambu aScope is for singlepatient use and it is sterile.The Ambu aScope 2 must be connectedto Ambu aScope Monitor. The monitordisplays the image and it is reusable.Ambu aScope System consist of a singleuse flexible intubation scope and amonitor. The scope comprised of flexibleinsertion cord with a maneuverable tip,CMOS camera and a LED light source atthe distal tip of the scope. The scope hasa handle with a control button giving theoperator the ability to steer the tip of the
		scope up and down. The image isprovided on a separate monitor.
Indications for Use	The IRRIS is intended for useas an aid in the placement of anendotracheal tube (ETT) duringintubation proceduresperformed with video-assisteddevices.	The Ambu aScope 2 is intended for useas an aid in the placement of anEndotracheal Tube (ETT) directly orthrough an intubating laryngeal maskduring non-difficult and difficult intubatingprocedures or for a tracheostomy tubeduring percutaneous tracheostomyprocedures. The Ambu aScope 2achieves its purpose by providing theuser with a visual confirmation of wherethe tip of the Ambu aScope 2 is in thehuman anatomy. The flexible tip of theAmbu aScope 2 allows the user to guidethe ETT in the desired direction.
Intended Use	Same	Same
Intended User/ ClinicalEnvironment	Physicians or trained medicalpersonnel having adequatefamiliarity with trachealintubation and airwaymanagement in hospitals andpre-hospital settings	Physicians or trained medical personnelhaving adequate familiarity with trachealintubation and airway management inhospitals settings
Site of applicationTo Patient	Non-invasive patient's neck	Invasive via oropharynx, nasopharynx
AncillaryEquipment	Requires video-laryngoscopes	Require a separate monitor
Power Source	Battery	The monitor requires a battery
Technology	LED	LED and CMOS camera
Wave Length	~850 nm	Visible
Temperature	25 degrees C at surface	Unknown
Duration of use	10 minutes (sufficient forprocedure)	The Ambu® aScope™ 2 can beused/switched on for a total of 8 hoursfrom first plugged into the aScopeMonitor.
Regulatory	Product Code BTR 21 CFR868.5730	Product Code BTR 21 CFR 868.5730

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Summary

Based on the results of the non-clinical performance testing, which included Biocompatibility Confirmation, Electrical Safety & EMC Tests, and Software Validation, as well as the outcomes from the pre-clinical cadaver studies and the performance in the clinical study, we believe that the IRRIS raises no new safety concerns or efficacy issues. Therefore, A.R. Guide In Medical believes that the IRRIS is substantially equivalent to it predicate device for its intended use.

Regulation Number and Section

§ 868.5730 Tracheal tube.

(a)
Identification. A tracheal tube is a device inserted into a patient's trachea via the nose or mouth and used to maintain an open airway.(b)
Classification. Class II (performance standards).