IRRIS (Infra-Red-Red Intubation System)

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, qather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 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.<br>13 Wadi El Haj<br>PO Box 1252<br>Nazareth, 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,<br>Regulation Number 21 CFR 868.5730<br>IRRIS (Infra-Red-Red Intubation System) | | 3 a | Predicate Device: | K110962 Ambu aScope 2 | | 3. | Reference Devices: | K954771- Laedal Medical Corporation- Trachlight Stylet and Tracheal<br>LightWand<br>K962361- Laedal Medical Corporation- Trachlight Stylet and Tracheal<br>LightWand | | 4. | Description: | The IRRIS is designed for use as an aid in the placement of an endotracheal<br>tube (ETT) during intubation procedures performed with video-assisted<br>devices. The IRRIS is a non-invasive electronic illumination device. The device<br>transmits light of a specific wavelength (near infra-red) to the underlying<br>tissues. The light enables to illuminate the trachea of the patient, so it can be<br>distinguished from other tissues while using video assisted devices (video-<br>laryngoscopes). | | 5. | Intended Use: | The IRRIS is intended for use as an aid in the placement of an endotracheal<br>tube (ETT) during intubation procedures performed with video-assisted<br>devices. | {4}------------------------------------------------ | 6. | Comparison of<br>Technological<br>Characteristics: | With respect to intended use, IRRIS is the same as its predicate device.<br>Although technology is somewhat different, the IRRIS is basically the same as<br>its predicate device in that they produce light. The IRRIS is a non-invasive<br>device, whereas the predicate device is invasive. Based upon the outcomes<br>their extensive testing, evaluation, and analysis, A. R Guide In Medical<br>believes that their device does not raise new concerns, and the IRRIS is<br>substantially equivalent to its predicate devices. At the end of this<br>summary, a comparison table is provided. | | |----|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--| | 7. | Performance | Non-Clinical Testing | | | | Testing: | The Biocompatibility of the device was confirmed by the following battery of<br>tests:<br>Cytotoxicity Study Using the ISO Elution Method<br>ISO Skin Irritation Study in Rabbits<br>ISO Closed Patch Sensitization Study in Guinea Pigs<br>The outcome of this testing confirmed the biocompatibility of the patient<br>contacting materials. | | | | | Software Validation of the device was performed by a professional 30 party<br>service utilizing FDA's Guidance Document for Premarket Submission of<br>Software Controlled Devices. The outcome of this testing confirmed its<br>acceptability to predetermined requirements. | | | | | As a medical electrical equipment, the device was tested in accordance with<br>IEC 60601-1 by an independent lab. The outcome of this testing confirmed its<br>compliance to the standard. | | | | | The EMC of the device was confirmed by testing to IEC 60601-1-2 by an<br>independent lab. The outcome of this testing confirmed its compliance to the<br>standard. | | | | | Clinical Testing: | | | | | An IRB approved clinical trial was conducted on 12 patients outside of the USA.<br>The results of the study verified the device aids in the placement of an ETT<br>during intubation procedures performed with video-assisted devices by<br>illuminating the trachea of the patient, so it can be distinguished from other<br>tissues. There were no adverse reactions. Prior to conducting this study, 2<br>proof of concept studies were conducted on a total 6 cadavers to evaluate the<br>clinical utility and usability of the IRRIS. The outcome of these studies<br>confirmed the acceptability of the device to proceed on humans. | | {5}------------------------------------------------ | Feature and<br>Characteristic | IRRIS (Subject Device) | Ambu aScope 2 (Predicate<br>Device) | |--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description<br>Technical<br>Description | The IRRIS is designed for use<br>as an aid in the placement of an<br>endotracheal tube (ETT) during<br>intubation procedures<br>performed with video-assisted<br>devices. The IRRIS is a non-<br>invasive electronic illumination<br>device for single patient use.<br>The device transmits light of a<br>specific wavelength (near infra-<br>red) to the underlying tissues.<br>The light enables to illuminate<br>the trachea of the patient, so it<br>can be distinguished from other<br>tissues while using video<br>assisted devices (video-<br>laryngoscopes).<br>An external disposable<br>electronic illumination device for<br>single patient use. The device is<br>comprised of disposable LED<br>lights (facing the patient skin)<br>and is operated by a battery. | Ambu aScope 2 is a flexible intubation<br>scope System consist of a single use<br>flexible intubation scope, Ambu, and a<br>monitor.<br>Ambu aScope 2 is for viewing<br>anatomical structures in the upper<br>airways, and as an aid in placement of<br>an endotracheal tube (ETT), an ETT size<br>6 or larger can be used. A camera at the<br>distal tip of the aScope provides the user<br>with an indication of the placement of the<br>aScope. The maneuverable tip allows<br>the user to guide the ETT in the desired<br>direction. Ambu aScope is for single<br>patient use and it is sterile.<br>The Ambu aScope 2 must be connected<br>to Ambu aScope Monitor. The monitor<br>displays the image and it is reusable.<br>Ambu aScope System consist of a single<br>use flexible intubation scope and a<br>monitor. The scope comprised of flexible<br>insertion cord with a maneuverable tip,<br>CMOS camera and a LED light source at<br>the distal tip of the scope. The scope has<br>a handle with a control button giving the<br>operator the ability to steer the tip of the | | | | scope up and down. The image is<br>provided on a separate monitor. | | Indications for Use | The IRRIS is intended for use<br>as an aid in the placement of an<br>endotracheal tube (ETT) during<br>intubation procedures<br>performed with video-assisted<br>devices. | The Ambu aScope 2 is intended for use<br>as an aid in the placement of an<br>Endotracheal Tube (ETT) directly or<br>through an intubating laryngeal mask<br>during non-difficult and difficult intubating<br>procedures or for a tracheostomy tube<br>during percutaneous tracheostomy<br>procedures. The Ambu aScope 2<br>achieves its purpose by providing the<br>user with a visual confirmation of where<br>the tip of the Ambu aScope 2 is in the<br>human anatomy. The flexible tip of the<br>Ambu aScope 2 allows the user to guide<br>the ETT in the desired direction. | | Intended Use | Same | Same | | Intended User<br>/ Clinical<br>Environment | Physicians or trained medical<br>personnel having adequate<br>familiarity with tracheal<br>intubation and airway<br>management in hospitals and<br>pre-hospital settings | Physicians or trained medical personnel<br>having adequate familiarity with tracheal<br>intubation and airway management in<br>hospitals settings | | Site of application<br>To Patient | Non-invasive patient's neck | Invasive via oropharynx, nasopharynx | | Ancillary<br>Equipment | 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 for<br>procedure) | The Ambu® aScope™ 2 can be<br>used/switched on for a total of 8 hours<br>from first plugged into the aScope<br>Monitor. | | Regulatory | Product Code BTR 21 CFR<br>868.5730 | Product Code BTR 21 CFR 868.5730 | {6}------------------------------------------------ ### 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.