3NT endoscopy system

K162916 · 3nt Medical , Ltd. · EOB · Feb 24, 2017 · Ear, Nose, Throat

Device Facts

• Record ID: K162916
• Device Name: 3NT endoscopy system
• Applicant: 3nt Medical , Ltd.
• Product Code: EOB · Ear, Nose, Throat
• Decision Date: Feb 24, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4760
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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.

Device Story

3NT Endoscopy System is a single-use flexible ENT endoscope; provides visualization of ear, nose, throat, and sinus cavities. System components: sterile single-use flexible endoscope with distal CMOS imager and integrated irrigation channel; multi-use autoclavable handle for mechanical articulation; Camera Control Unit (CCU) with video processor and white LED light source. Physician operates device by manually controlling articulation levers on handle to navigate anatomy. CCU receives video from endoscope and provides illumination. Output is real-time video displayed for clinician to perform diagnostic or therapeutic procedures. Single-use design eliminates reprocessing risks for the endoscope component. Benefits include direct visualization of nasal/sinus landmarks and irrigation capability to assist in procedures.

Clinical Evidence

Bench testing included biocompatibility (ISO 10993-1), sterilization validation (ISO 11135-1), electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and optical/mechanical performance verification. A cadaver study was conducted to evaluate clinical utility; users successfully accessed and visualized nasal, maxillary, frontal, and sphenoid sinus landmarks with satisfactory image quality and irrigation performance. All tests met predefined acceptance criteria.

Technological Characteristics

Flexible endoscope with distal CMOS imager; multi-use autoclavable handle; CCU with white LED light source. Insertion tube diameter 2.3mm, working length 120mm, 125° articulation. Connectivity: CCU to endoscope via attachment cable. Standards: ISO 8600 (optical/dimensions), ISO 10993-1 (biocompatibility), ISO 11135-1 (sterilization), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-18 (endoscopic equipment).

Indications for Use

Indicated for visualization of internal ear, airway, nose, and sinus cavities during diagnostic and therapeutic endoscopic procedures in patients requiring such examinations.

Regulatory Classification

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.

Predicate Devices

• Entellus Medical Inc. Flexible Endoscope and Eyepiece (K082569)
• Vision-Sciences, Inc. Flexible Videoscope (K072073)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone]

### Contact Person

Orly Maor 25A Sirkin Street Kfar Saba 44421, Israel Tel: [phone] Fax: [phone] [e-mail]

### 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 Medical<br>Endoscopy system | Entellus Medical<br>Flexible<br>Endoscope and<br>Eyepiece | Vision-Sciences<br>ENT-5000 and<br>ENT-5100 Video<br>ENT Scope with<br>Endosheath | SE<br>Justification |
|----------------------------------|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components<br>Included | 1.Flexible<br>endoscope<br>2. Handle<br>3.CCU | 1.Flexible glass<br>fiberoptic<br>endoscope<br>2. Eyepiece<br>3.Light post<br>adaptor | 1.Flexible<br>endoscope<br>2.Handle<br>3.CCU (video<br>processor) | Entellus does<br>not include a<br>video<br>processor/camer<br>a, it is external<br>to the system,<br>but their core<br>system still<br>provides the<br>same<br>visualization<br>functionality. |
| Imaging<br>Technology | Distal tip sensor<br>and digital video<br>processor | Direct viewing<br>fiberoptics or<br>through a<br>compatible video<br>system (not<br>included) | Distal tip sensor<br>and digital video<br>processor | Similar |
| Light Source | White LED light<br>source at CCU | Not included | While LED light<br>source at CCU | Same as VSI.<br>Entellus uses an<br>external Xenon<br>light source, not<br>part of their<br>system |
| Field of View | 90° (air) | >55° (air) | 90° (air) | Same as VSI |
| Direction of<br>View | Forward | Forward | Forward | Same |
| Item | 3NT Medical<br>Endoscopy system | Entellus Medical<br>Flexible<br>Endoscope and<br>Eyepiece | Vision-Sciences<br>ENT-5000 and<br>ENT-5100 Video<br>ENT Scope with<br>Endosheath | SE<br>Justification |
| Depth of Field | 5-50mm | 0-20mm | 3-50mm | Similar; larger<br>depth of field<br>does not raise<br>new questions<br>because depth is<br>at least as much<br>as the predicates<br>greater depth is<br>not detrimental<br>to performance. |
| Optimal<br>working<br>distance | 5mm | Unknown | 10mm | Similar |
| Insertion Tube<br>Diameter | 2.3mm | 0.5mm | 3.5mm | Similar to VSI.<br>The 0.5mm of<br>Entellus<br>typically<br>requires a sheath<br>or cannula with<br>total diameter<br>comparable to<br>3NT and VSI. |
| Insertion Tube<br>Working Length | 120mm | 128.5mm at 0.5mm<br>diameter section. | 280mm | Similar.<br>The dimensions<br>of the 3 systems<br>are comparable |
| Articulation | 125° | Can bend by<br>adhering to the<br>shape of the<br>cannula/sheath it is<br>passed through, and<br>bend to 140° or<br>more | 140° without sheath<br>125° with sheath | Similar |
| Working<br>Channel | Yes, built-in | Yes, in a separable<br>sheath or cannula.<br>Not included | Yes, in a separable<br>sheath (included) | Similar |
| Item | 3NT Medical<br>Endoscopy system | Entellus Medical<br>Flexible<br>Endoscope and<br>Eyepiece | Vision-Sciences<br>ENT-5000 and<br>ENT-5100 Video<br>ENT Scope with<br>Endosheath | SE<br>Justification |
| Scope<br>Reusability | No, Single-use | Yes, Multiple-use | Yes, Multiple-use | 3NT is a single<br>use scope to be<br>disposed after<br>use thus it is not<br>reprocessed,<br>which presents<br>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<br>Simulated use | Endoscope functionality was tested to<br>demonstrate device performance<br>according to its intended use at<br>simulated use conditions. |
| Endoscope Visual and Dimensions | Endoscope's dimensions, surface<br>quality and weight were measured in<br>accordance to ISO 8600 requirements<br>and system specifications. |
| CCU functionality and Dimensions<br>verification and Transportation | CCU dimensions, surface quality and<br>weight and CCU functionality was |

Confidential

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# 3NTMEDI

| Name of test | Test description |
|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | tested.<br>Transportation and environmental<br>conditions study was performed. |
| Optical performance | Optical performance of 3NT<br>Endoscopy was tested in accordance<br>with ISO 8600 requirements and<br>system specification. |
| Endoscope Mechanical Properties | Mechanical properties of the single<br>use endoscope were measured in<br>accordance with system specification |
| Handle Functionality after<br>reprocessing and Visual and<br>Dimensions | Handle functionality and visual were<br>tested after multiple reprocessing<br>cycles.<br>In addition, proper endoscope<br>connection and disconnection to the<br>handle and handle's levers operation<br>were tested. |
| Endoscopy system image quality<br>performance verification | Image quality performance of 3NT<br>Endoscopy System was verified. |
| Endoscope Thermal characteristics | Endoscope's distal tip temperature<br>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.