(130 days)
Not Found
No
The document describes a standard endoscopy system with a video processor, but there is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies.
Yes
The device is described as being used during "diagnostic and therapeutic endoscope procedures," indicating its involvement in treatment in addition to diagnosis.
Yes
The "Intended Use / Indications for Use" states that the system is intended to visualize internal cavities "during diagnostic and therapeutic endoscope procedures." This explicitly includes diagnostic purposes.
No
The device description clearly outlines multiple hardware components including a single-use flexible endoscope, a multi-use handle accessory, and a camera control unit (CCU). The performance studies also include extensive testing of these hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures." This describes a device used for direct visualization of anatomy, not for examining specimens in vitro (outside the body).
- Device Description: The description details a system for inserting a camera into the body to see internal structures. It doesn't mention any components or processes for analyzing biological samples like blood, urine, or tissue.
- Functionality: The device captures video images of internal anatomy. IVDs typically perform tests on biological samples to detect or measure substances, organisms, or genetic material.
This device is clearly an endoscope, which is a type of medical device used for internal visualization. IVDs are a distinct category of medical devices used for testing biological samples.
N/A
Intended Use / Indications for Use
The 3NT endoscopy system is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
Product codes (comma separated list FDA assigned to the subject device)
EOB
Device Description
3NT endoscopy system is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it.
3NT endoscopy system includes:
- A Single-use flexible endoscope (provided sterile) includes a distal tip CMOS imager and an integrated working channel which allows irrigation through a single channel. It is the only part that comes in contact with the patient and is disposed of at the end of the procedure.
- A Multi-use handle accessory (re-processible and auto-clavable) engages the single-use endoscope component and allows the user to mechanically control its articulation through dedicated levers.
- A Camera control unit (CCU) includes a video processor and a white LED light source. The CCU includes an attachment cable which connects to the single-use endoscope, receives video images from the endoscope, and delivers LED light to the endoscope.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ear, airways, nose and sinus cavities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The following performance data were provided in support of the substantial equivalence determination:
- Risk analysis per ISO 14971:2012
- Biocompatibility testing: An evaluation of biocompatibility was performed in compliance with ISO 10993-1. Biocompatibility evaluation included cytotoxicity, irritation and sensitization testing. All tests were completed with passing results.
- Sterilization, Packaging and Shelf Life Testing: Sterilization validation testing of the endoscope was performed to demonstrate compliance with ISO 11135-1. The handle was validated for cleaning and reuse by autoclave. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
- Bench Testing:
- Endoscope Functionality and Simulated use: Endoscope functionality was tested to demonstrate device performance according to its intended use at simulated use conditions.
- Endoscope Visual and Dimensions: Endoscope's dimensions, surface quality and weight were measured in accordance with ISO 8600 requirements and system specifications.
- CCU functionality and Dimensions verification and Transportation: CCU dimensions, surface quality and weight and CCU functionality was tested. Transportation and environmental conditions study was performed.
- Optical performance: Optical performance of 3NT Endoscopy was tested in accordance with ISO 8600 requirements and system specification.
- Endoscope Mechanical Properties: Mechanical properties of the single use endoscope were measured in accordance with system specification.
- Handle Functionality after reprocessing and Visual and Dimensions: Handle functionality and visual were tested after multiple reprocessing cycles. In addition, proper endoscope connection and disconnection to the handle and handle's levers operation were tested.
- Endoscopy system image quality performance verification: Image quality performance of 3NT Endoscopy System was verified.
- Endoscope Thermal characteristics: Endoscope's distal tip temperature was measured during system operation.
All tests met the predefined acceptance criteria.
- Cadaver Study: Cadaver studies were performed by different users. Devices performed well to users' satisfaction. Users were able to access and visualize the entire nasal anatomic landmarks observable by current endoscopes. In particular, users were able to access and visualize the maxillary sinus, frontal sinus and sphenoid sinus, with minimal or no surgical manipulation. Device credibility was very good and users were satisfied by the image quality provided by the device. Irrigation functionality was tested and performed well. The test met the predefined acceptance criteria.
- Software Validation: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".
- Electrical Safely and EMC: Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 were conducted on the 3NT endoscopy system. In addition the system complies with IEC 60601-2-18.
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.
Not Found
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
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three overlapping profiles of human faces, with flowing lines beneath them, possibly representing water or movement.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
3NT Medical Ltd. % Ms. Orly Maor Company Regulatory Consultant 25 A Sirkin Street Kfar Saba 44421, Israel
Re: K162916
Trade/Device Name: 3NT Endoscopy System Regulation Number: 21 CFR 874.4760 Regulation Name: Nasopharyngoscope (Flexible or Rigid) and Accessories Regulatory Class: Class II Product Code: EOB Dated: January 25, 2017 Received: January 25, 2017
Dear Ms. Maor:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Eric A. Mann -S
for
Malvina Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose, and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K162916
Device Name 3NT Endoscopy System
Indications for Use (Describe)
The 3NT endoscopy system is intended to visualize the internal cavities of the ear, airways, nose and sinus cavites during diagnostic and therapeutic endoscope procedures.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for 3NT Medical. The "3NT" part of the logo is in teal, while the "MEDICAL" part is in gray. The logo is simple and modern, and the colors are professional and trustworthy.
Traditional Premarket Notification Submission - 510(k) 3NT endoscopy system 510(k) Number K162916
Date Prepared: January 25, 2017
I. SUBMITTER
3NT Medical Ltd. 22 Hamelacha Street. PO Box 11384, Rosh Ha'ayin 4809169, Israel Tel: +972.73.7154056 Fax: +972.73.7154058
Contact Person
Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: +972-9-7453607 Fax: +972-153-9-7453607 oram.ma@gmail.com
II. DEVICE
Name of Device: 3NT endoscopy system Common or Usual Name: 3NT endoscopy system Classification Name: Nasopharyngoscope (flexible or rigid) and accessories (21 CFR 874.4760) Regulatory Class: II Product Code: EOB
III. PREDICATE DEVICE
3NT Medical Ltd. believes that the 3NT endoscopy system is substantially equivalent to the following predicate devices:
- Entellus Medical Inc. Flexible Endoscope and Eyepiece cleared under ● K082569.
- Vision-Sciences, Inc. Flexible Videoscope cleared under K072073. .
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IV. DEVICE DESCRIPTION
3NT endoscopy system is a single-use flexible ENT (ear, nose & throat) endoscope (provided sterile) which allows the user to steer through the anatomy and visualize it.
3NT endoscopy system includes:
- A Single-use flexible endoscope (provided sterile) includes a distal tip CMOS 1. imager and an integrated working channel which allows irrigation through a single channel. It is the only part that comes in contact with the patient and is disposed of at the end of the procedure.
- A Multi-use handle accessory (re-processible and auto-clavable) engages the 2. single-use endoscope component and allows the user to mechanically control its articulation through dedicated levers.
- A Camera control unit (CCU) includes a video processor and a white LED 3. light source. The CCU includes an attachment cable which connects to the single-use endoscope, receives video images from the endoscope, and delivers LED light to the endoscope.
V. INDICATIONS FOR USE
The 3NT endoscopy system is intended to visualize the internal cavities of the ear, airways, nose and sinus cavities during diagnostic and therapeutic endoscope procedures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The 3NT endoscopy system has the same intended use as the predicate devices. Its indications for use are identical to that of the Entellus predicate and similar to that of the VSI predicate device. 3NT endoscopy system, same as the predicate devices, is a flexible endoscope which utilizes a visualization technology. All of 3NT flexible endoscope, VSI predicate device and Entellus predicate device provide a working channel which can be used for irrigation. Both 3NT flexible endoscope and the VSI predicate device can be articulated. In Entellus predicate device, the insertion tube can be inserted into an angulated cannula or catheter and assume its angulation and then advance and extend beyond the distal end of the cannula in the direction of the assumed angulation. By that, it is similar to the articulation of 3NT flexible endoscope. The dimensions of the 3 systems are comparable and all devices are advanced and articulated within the anatomy to observe it, under direct visualization. Similar tests and tests methods performed in accordance with the same standards
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3NTMEDICAL
were used in both 3NT endoscope and the VSI predicate device to validate the design. The testing results showed that the minor differences in device characteristics and principles of operation between the subject device and predicate devices do not raise any new questions of safety or effectiveness.
| Item | 3NT Medical
Endoscopy system | Entellus Medical
Flexible
Endoscope and
Eyepiece | Vision-Sciences
ENT-5000 and
ENT-5100 Video
ENT Scope with
Endosheath | SE
Justification |
|----------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components
Included | 1.Flexible
endoscope
2. Handle
3.CCU | 1.Flexible glass
fiberoptic
endoscope
2. Eyepiece
3.Light post
adaptor | 1.Flexible
endoscope
2.Handle
3.CCU (video
processor) | Entellus does
not include a
video
processor/camer
a, it is external
to the system,
but their core
system still
provides the
same
visualization
functionality. |
| Imaging
Technology | Distal tip sensor
and digital video
processor | Direct viewing
fiberoptics or
through a
compatible video
system (not
included) | Distal tip sensor
and digital video
processor | Similar |
| Light Source | White LED light
source at CCU | Not included | While LED light
source at CCU | Same as VSI.
Entellus uses an
external Xenon
light source, not
part of their
system |
| Field of View | 90° (air) | >55° (air) | 90° (air) | Same as VSI |
| Direction of
View | Forward | Forward | Forward | Same |
| Item | 3NT Medical
Endoscopy system | Entellus Medical
Flexible
Endoscope and
Eyepiece | Vision-Sciences
ENT-5000 and
ENT-5100 Video
ENT Scope with
Endosheath | SE
Justification |
| Depth of Field | 5-50mm | 0-20mm | 3-50mm | Similar; larger
depth of field
does not raise
new questions
because depth is
at least as much
as the predicates
greater depth is
not detrimental
to performance. |
| Optimal
working
distance | 5mm | Unknown | 10mm | Similar |
| Insertion Tube
Diameter | 2.3mm | 0.5mm | 3.5mm | Similar to VSI.
The 0.5mm of
Entellus
typically
requires a sheath
or cannula with
total diameter
comparable to
3NT and VSI. |
| Insertion Tube
Working Length | 120mm | 128.5mm at 0.5mm
diameter section. | 280mm | Similar.
The dimensions
of the 3 systems
are comparable |
| Articulation | 125° | Can bend by
adhering to the
shape of the
cannula/sheath it is
passed through, and
bend to 140° or
more | 140° without sheath
125° with sheath | Similar |
| Working
Channel | Yes, built-in | Yes, in a separable
sheath or cannula.
Not included | Yes, in a separable
sheath (included) | Similar |
| Item | 3NT Medical
Endoscopy system | Entellus Medical
Flexible
Endoscope and
Eyepiece | Vision-Sciences
ENT-5000 and
ENT-5100 Video
ENT Scope with
Endosheath | SE
Justification |
| Scope
Reusability | No, Single-use | Yes, Multiple-use | Yes, Multiple-use | 3NT is a single
use scope to be
disposed after
use thus it is not
reprocessed,
which presents
less risk. |
The 3NT endoscopy system has the same technological characteristics as the predicate devices as demonstrated in the table below:
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Image /page/6/Picture/0 description: The image shows the logo for 3NTMEDICAL. The "3NT" portion of the logo is in a dark teal color, while the "MEDICAL" portion is in a light gray color. The "N" in "3NT" is stylized with a line connecting the two vertical lines.
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Based on the above analysis. 3NT Medical Ltd. believes that the 3NT flexible endoscope system is substantially equivalent to the legally marketed predicate devices
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Risk analysis per ISO 14971:2012 -
- -Biocompatibility testing
An evaluation of biocompatibility was performed in compliance with ISO Biocompatibility evaluation included cytotoxicity, irritation and 10993-1. sensitization testing. All tests were completed with passing results.
Sterilization, Packaging and Shelf Life Testing -
Sterilization validation testing of the endoscope was performed to demonstrate compliance with ISO 11135-1. The handle was validated for cleaning and reuse by autoclave. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.
Bench Testing
Bench testing included the following:
| Name of test | Test description |
|---|---|
| Endoscope Functionality and | |
| Simulated use | Endoscope functionality was tested to |
| demonstrate device performance | |
| according to its intended use at | |
| simulated use conditions. | |
| Endoscope Visual and Dimensions | Endoscope's dimensions, surface |
| quality and weight were measured in | |
| accordance to ISO 8600 requirements | |
| and system specifications. | |
| CCU functionality and Dimensions | |
| verification and Transportation | CCU dimensions, surface quality and |
| weight and CCU functionality was |
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3NTMEDI
| Name of test | Test description |
|---|---|
| tested. | |
| Transportation and environmental | |
| conditions study was performed. | |
| Optical performance | Optical performance of 3NT |
| Endoscopy was tested in accordance | |
| with ISO 8600 requirements and | |
| system specification. | |
| Endoscope Mechanical Properties | Mechanical properties of the single |
| use endoscope were measured in | |
| accordance with system specification | |
| Handle Functionality after | |
| reprocessing and Visual and | |
| Dimensions | Handle functionality and visual were |
| tested after multiple reprocessing | |
| cycles. | |
| In addition, proper endoscope | |
| connection and disconnection to the | |
| handle and handle's levers operation | |
| were tested. | |
| Endoscopy system image quality | |
| performance verification | Image quality performance of 3NT |
| Endoscopy System was verified. | |
| Endoscope Thermal characteristics | Endoscope's distal tip temperature |
| was measured during system operation |
All tests met the predefined acceptance criteria.
Cadaver Study
Cadaver studies were performed by different users. Devices performed well to users' satisfaction. Users were able to access and visualize the entire nasal anatomic landmarks observable by current endoscopes. In particular, users were able to access and visualize the maxillary sinus, frontal sinus and sphenoid sinus, with minimal or no surgical manipulation. Device credibility was very good and users were satisfied by the image quality provided by the device. Irrigation functionality was tested and performed well.
The test met the predefined acceptance criteria
Software Validation
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.".
Electrical Safely and EMC -
Electrical Safety per IEC 60601-1 and Electromagnetic compatibility (EMC) per IEC 60601-1-2 were conducted on the 3NT endoscopy system. In addition the system complies with IEC 60601-2-18.
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3NTMEDICAL
VIII. CONCLUSIONS
The 3NT endoscopy system has the same intended use as the predicate devices. The principal features of the device that were described, as well as the testing provided, show that the minor differences in device characteristics between the subject device and predicate devices do not raise any new questions of safety or effectiveness.
Performance data and software validation has been provided, establishing that the 3NT endoscopy system performs as intended and in a manner that is substantially equivalent to the predicates.
Therefore, the device may be found substantially equivalent.