(130 days)
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.
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.
The provided text is a Premarket Notification (510(k)) summary for the 3NT Endoscopy System. The information focuses on demonstrating substantial equivalence to predicate devices, primarily through bench testing, biocompatibility, sterilization validation, software validation, electrical safety, and a cadaver study.
However, the document does not contain the detailed information required to answer the specific questions about acceptance criteria for an AI/ML-based device and the study that proves it meets those criteria.
Here's why and what information is missing:
- This is not an AI/ML device: The document describes a "3NT Endoscopy System" which is a flexible ENT endoscope system. It consists of a single-use flexible endoscope (CMOS imager), a multi-use handle, and a Camera Control Unit (CCU) with a video processor and LED light source. There is no mention of any artificial intelligence, machine learning, or algorithmic analysis of the images for diagnostic purposes. The device is a direct visualization tool.
- No acceptance criteria for AI performance: Since it's not an AI device, there are no acceptance criteria related to AI performance metrics (e.g., sensitivity, specificity, AUC). The acceptance criteria mentioned refer to the successful completion of engineering bench tests, biocompatibility tests, sterilization, and a cadaver study for visualization.
- No "ground truth" establishment for AI: The "ground truth" described is based on the ability to visualize anatomical landmarks in a cadaver study, not on expert consensus or pathology for an AI's output.
- No "test set" and "training set" for AI: The data provenance, sample sizes for test/training sets, number of experts for ground truth, and adjudication methods are details specific to the validation of AI models, which are not applicable here.
- No MRMC study: A Multi-Reader Multi-Case (MRMC) study is relevant for evaluating the impact of AI on human reader performance, which isn't applicable to a direct visualization endoscope.
- No standalone AI performance: Standalone performance refers to the AI algorithm's performance without human intervention, which is not relevant for this device.
In summary, the provided document describes a medical device clearance for an endoscope based on traditional engineering and medical device testing, not an AI/ML product. Therefore, it does not contain the information requested in the prompt regarding AI acceptance criteria and study details.
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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
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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. .
Confidential
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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
Confidential
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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 MedicalEndoscopy system | Entellus MedicalFlexibleEndoscope andEyepiece | Vision-SciencesENT-5000 andENT-5100 VideoENT Scope withEndosheath | SEJustification |
|---|---|---|---|---|
| ComponentsIncluded | 1.Flexibleendoscope2. Handle3.CCU | 1.Flexible glassfiberopticendoscope2. Eyepiece3.Light postadaptor | 1.Flexibleendoscope2.Handle3.CCU (videoprocessor) | Entellus doesnot include avideoprocessor/camera, it is externalto the system,but their coresystem stillprovides thesamevisualizationfunctionality. |
| ImagingTechnology | Distal tip sensorand digital videoprocessor | Direct viewingfiberoptics orthrough acompatible videosystem (notincluded) | Distal tip sensorand digital videoprocessor | Similar |
| Light Source | White LED lightsource at CCU | Not included | While LED lightsource at CCU | Same as VSI.Entellus uses anexternal Xenonlight source, notpart of theirsystem |
| Field of View | 90° (air) | >55° (air) | 90° (air) | Same as VSI |
| Direction ofView | Forward | Forward | Forward | Same |
| Item | 3NT MedicalEndoscopy system | Entellus MedicalFlexibleEndoscope andEyepiece | Vision-SciencesENT-5000 andENT-5100 VideoENT Scope withEndosheath | SEJustification |
| Depth of Field | 5-50mm | 0-20mm | 3-50mm | Similar; largerdepth of fielddoes not raisenew questionsbecause depth isat least as muchas the predicatesgreater depth isnot detrimentalto performance. |
| Optimalworkingdistance | 5mm | Unknown | 10mm | Similar |
| Insertion TubeDiameter | 2.3mm | 0.5mm | 3.5mm | Similar to VSI.The 0.5mm ofEntellustypicallyrequires a sheathor cannula withtotal diametercomparable to3NT and VSI. |
| Insertion TubeWorking Length | 120mm | 128.5mm at 0.5mmdiameter section. | 280mm | Similar.The dimensionsof the 3 systemsare comparable |
| Articulation | 125° | Can bend byadhering to theshape of thecannula/sheath it ispassed through, andbend to 140° ormore | 140° without sheath125° with sheath | Similar |
| WorkingChannel | Yes, built-in | Yes, in a separablesheath or cannula.Not included | Yes, in a separablesheath (included) | Similar |
| Item | 3NT MedicalEndoscopy system | Entellus MedicalFlexibleEndoscope andEyepiece | Vision-SciencesENT-5000 andENT-5100 VideoENT Scope withEndosheath | SEJustification |
| ScopeReusability | No, Single-use | Yes, Multiple-use | Yes, Multiple-use | 3NT is a singleuse scope to bedisposed afteruse thus it is notreprocessed,which presentsless 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 andSimulated use | Endoscope functionality was tested todemonstrate device performanceaccording to its intended use atsimulated use conditions. |
| Endoscope Visual and Dimensions | Endoscope's dimensions, surfacequality and weight were measured inaccordance to ISO 8600 requirementsand system specifications. |
| CCU functionality and Dimensionsverification and Transportation | CCU dimensions, surface quality andweight and CCU functionality was |
Confidential
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3NTMEDI
| Name of test | Test description |
|---|---|
| tested.Transportation and environmentalconditions study was performed. | |
| Optical performance | Optical performance of 3NTEndoscopy was tested in accordancewith ISO 8600 requirements andsystem specification. |
| Endoscope Mechanical Properties | Mechanical properties of the singleuse endoscope were measured inaccordance with system specification |
| Handle Functionality afterreprocessing and Visual andDimensions | Handle functionality and visual weretested after multiple reprocessingcycles.In addition, proper endoscopeconnection and disconnection to thehandle and handle's levers operationwere tested. |
| Endoscopy system image qualityperformance verification | Image quality performance of 3NTEndoscopy System was verified. |
| Endoscope Thermal characteristics | Endoscope's distal tip temperaturewas 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.
§ 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.