(242 days)
No
The description focuses on the device's function as a light source to illuminate the trachea for visualization during intubation. There is no mention of image processing, AI, ML, or any algorithms that would interpret data or make decisions. The performance studies are related to safety, biocompatibility, and the device's ability to illuminate the trachea, not the performance of an AI/ML algorithm.
No.
The device is an aid for placement during intubation and illuminates the trachea; it does not treat or cure a disease or condition.
No
The device is an aid for endotracheal tube placement by illuminating the trachea, not for diagnosing a condition or disease.
No
The device description explicitly states it is a "non-invasive electronic illumination device" that "transmits light of a specific wavelength," indicating it is a hardware device with electronic and light-emitting components, not solely software.
Based on the provided information, the IRRIS device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- IRRIS Function: The IRRIS is a non-invasive electronic illumination device that transmits light through the patient's neck to visualize the trachea during intubation. It does not analyze any biological samples.
- Intended Use: The intended use is to aid in the placement of an endotracheal tube during a medical procedure performed directly on the patient.
Therefore, the IRRIS falls under the category of a medical device used for a procedural aid, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
BTR
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's neck (non-invasive), trachea
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians or trained medical personnel having adequate familiarity with tracheal intubation and airway management in hospitals and pre-hospital settings
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)
Non-Clinical Testing:
The Biocompatibility of the device was confirmed by the following battery of tests:
Cytotoxicity Study Using the ISO Elution Method
ISO Skin Irritation Study in Rabbits
ISO Closed Patch Sensitization Study in Guinea Pigs
The outcome of this testing confirmed the biocompatibility of the patient contacting materials.
Software Validation of the device was performed by a professional 30 party service utilizing FDA's Guidance Document for Premarket Submission of Software Controlled Devices. The outcome of this testing confirmed its acceptability to predetermined requirements.
As a medical electrical equipment, the device was tested in accordance with IEC 60601-1 by an independent lab. The outcome of this testing confirmed its compliance to the standard.
The EMC of the device was confirmed by testing to IEC 60601-1-2 by an independent lab. The outcome of this testing confirmed its compliance to the standard.
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 ETT during intubation procedures performed with video-assisted devices by illuminating the trachea of the patient, so it can be distinguished from other tissues. There were no adverse reactions. Prior to conducting this study, 2 proof of concept studies were conducted on a total 6 cadavers to evaluate the clinical utility and usability of the IRRIS. The outcome of these studies confirmed the acceptability of the device to proceed on humans.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
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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 Haj
PO Box 1252
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,
Regulation Number 21 CFR 868.5730
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
LightWand
K962361- Laedal Medical Corporation- Trachlight Stylet and Tracheal
LightWand |
| 4. | 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). |
| 5. | Intended Use: | 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. |
4
| 6. | Comparison of
Technological
Characteristics: | With respect to intended use, IRRIS is the same as its predicate device.
Although technology is somewhat different, the IRRIS is basically the same as
its predicate device in that they produce light. The IRRIS is a non-invasive
device, whereas the predicate device is invasive. Based upon the outcomes
their extensive testing, evaluation, and analysis, A. R Guide In Medical
believes that their device does not raise new concerns, and the IRRIS is
substantially equivalent to its predicate devices. At the end of this
summary, a comparison table is provided. | |
|----|----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| 7. | Performance | Non-Clinical Testing | |
| | Testing: | The Biocompatibility of the device was confirmed by the following battery of
tests:
Cytotoxicity Study Using the ISO Elution Method
ISO Skin Irritation Study in Rabbits
ISO Closed Patch Sensitization Study in Guinea Pigs
The outcome of this testing confirmed the biocompatibility of the patient
contacting materials. | |
| | | Software Validation of the device was performed by a professional 30 party
service utilizing FDA's Guidance Document for Premarket Submission of
Software Controlled Devices. The outcome of this testing confirmed its
acceptability to predetermined requirements. | |
| | | As a medical electrical equipment, the device was tested in accordance with
IEC 60601-1 by an independent lab. The outcome of this testing confirmed its
compliance to the standard. | |
| | | The EMC of the device was confirmed by testing to IEC 60601-1-2 by an
independent lab. The outcome of this testing confirmed its compliance to the
standard. | |
| | | 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 ETT
during intubation procedures performed with video-assisted devices by
illuminating the trachea of the patient, so it can be distinguished from other
tissues. There were no adverse reactions. Prior to conducting this study, 2
proof of concept studies were conducted on a total 6 cadavers to evaluate the
clinical utility and usability of the IRRIS. The outcome of these studies
confirmed the acceptability of the device to proceed on humans. | |
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| Feature and
Characteristic | IRRIS (Subject Device) | Ambu aScope 2 (Predicate
Device) |
|--------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Description
Technical
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 for single patient use.
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).
An external disposable
electronic illumination device for
single patient use. The device is
comprised of disposable LED
lights (facing the patient skin)
and is operated by a battery. | Ambu aScope 2 is a flexible intubation
scope System consist of a single use
flexible intubation scope, Ambu, and a
monitor.
Ambu aScope 2 is for viewing
anatomical structures in the upper
airways, and as an aid in placement of
an endotracheal tube (ETT), an ETT size
6 or larger can be used. A camera at the
distal tip of the aScope provides the user
with an indication of the placement of the
aScope. The maneuverable tip allows
the user to guide the ETT in the desired
direction. Ambu aScope is for single
patient use and it is sterile.
The Ambu aScope 2 must be connected
to Ambu aScope Monitor. The monitor
displays the image and it is reusable.
Ambu aScope System consist of a single
use flexible intubation scope and a
monitor. The scope comprised of flexible
insertion cord with a maneuverable tip,
CMOS camera and a LED light source at
the distal tip of the scope. The scope has
a handle with a control button giving the
operator the ability to steer the tip of the |
| | | scope up and down. The image is
provided on a separate monitor. |
| Indications for Use | 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. | The Ambu aScope 2 is intended for use
as an aid in the placement of an
Endotracheal Tube (ETT) directly or
through an intubating laryngeal mask
during non-difficult and difficult intubating
procedures or for a tracheostomy tube
during percutaneous tracheostomy
procedures. The Ambu aScope 2
achieves its purpose by providing the
user with a visual confirmation of where
the tip of the Ambu aScope 2 is in the
human anatomy. The flexible tip of the
Ambu aScope 2 allows the user to guide
the ETT in the desired direction. |
| Intended Use | Same | Same |
| Intended User
/ Clinical
Environment | Physicians or trained medical
personnel having adequate
familiarity with tracheal
intubation and airway
management in hospitals and
pre-hospital settings | Physicians or trained medical personnel
having adequate familiarity with tracheal
intubation and airway management in
hospitals settings |
| Site of application
To Patient | Non-invasive patient's neck | Invasive via oropharynx, nasopharynx |
| Ancillary
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
procedure) | The Ambu® aScope™ 2 can be
used/switched on for a total of 8 hours
from first plugged into the aScope
Monitor. |
| Regulatory | Product Code BTR 21 CFR
868.5730 | 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.