Sinusway Dilation System

K181838 · 3nt Medical , Ltd. · LRC · Dec 20, 2018 · Ear, Nose, Throat

Device Facts

• Record ID: K181838
• Device Name: Sinusway Dilation System
• Applicant: 3nt Medical , Ltd.
• Product Code: LRC · Ear, Nose, Throat
• Decision Date: Dec 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.4420
• Device Class: Class 1
• Attributes: Therapeutic

Indications for Use

The Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using a trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.

Device Story

Sinusway Dilation System is a manual surgical instrument for sinus procedures; used by surgeons in clinical settings. System comprises a single-use sterile Dilation Kit and a re-processible, autoclavable Holder. Dilation Kit includes an inflatable balloon device, three interchangeable pre-shaped seekers (stylets) to adjust distal end geometry, and an inflation device. Operation involves advancing the device into nasal/sinus anatomy under direct endoscopic visualization; seeker provides guidance to sinus drainage pathways; balloon is manually inflated with saline to dilate and displace anatomic structures. Inflation device provides visual and tactile pressure feedback. Device facilitates sinus drainage; benefits patient by restoring sinus patency.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including balloon fatigue, inflation/deflation timing, dimensional attributes, compliance (diameter vs. pressure), rated burst pressure, bond strength, inflation mechanism pressure feedback, and simulated use functionality. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, irritation, sensitization, acute systemic toxicity). Sterilization validated per ISO 11135-1.

Technological Characteristics

Manual surgical instrument; balloon dilation technology. Components: single-use sterile dilation device with inflatable balloon, interchangeable pre-shaped seekers, and syringe-based inflation device. Holder is re-processible/autoclavable. Biocompatibility per ISO 10993-1. Sterilization via EtO (single-use components). No software or electronic components.

Indications for Use

Indicated for adults requiring access and treatment of frontal, maxillary, and sphenoid sinuses via trans-nasal approach for dilation and displacement of sinus drainage pathway structures.

Regulatory Classification

Identification

An ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. This generic type of device includes the esophageal dilator; tracheal bistour (a long, narrow surgical knife); tracheal dilator; tracheal hook; laryngeal injection set; laryngeal knife; laryngeal saw; laryngeal trocar; laryngectomy tube; adenoid curette; adenotome; metal tongue depressor; mouth gag; oral screw; salpingeal curette; tonsillectome; tonsil guillotine; tonsil screw; tonsil snare; tonsil suction tube; tonsil suturing hook; antom reforator; ethmoid curette; frontal sinus-rasp; nasal curette; nasal rasp; nasal rongeur; nasal saw; nasal scissors; nasal snare; sinus irrigator; sinus trephine; ear curette; ear excavator; ear rasp; ear scissor, ear snare; ear spoon; ear suction tube; malleous ripper; mastoid gauge; microsurgical ear chisel; myringotomy tube inserter; ossici holding clamp; sacculotomy tack inserter; vein press; wire ear loop; microrule; mirror; mobilizer; ear, nose, and throat punch; ear, nose and throat knife; and ear, nose, and throat trocar.

Predicate Devices

• XprESS Multi-Sinus Dilation Tool (K102003, K112506, K121174)

Submission Summary (Full Text)

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December 20, 2018

3NT Medical Ltd. % Orly Maor Company Regulatory Consultant 25 Sirkin Street Kfar Saba 44421, Israel

Re: K181838

Trade/Device Name: Sinusway Dilation System Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, And Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: November 28, 2018 Received: November 28, 2018

Dear Orly 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. Although this letter refers to your product as a device. please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

## Srinivas Nandkumar -S

for Malvina B. 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) K181838

Device Name Sinusway Dilation System

Indications for Use (Describe)

The Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using a trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.

Type of Use (Select one or both, as applicable)

| <span style="font-size: 10pt;"> ☑ Prescription Use (Part 21 CFR 201 Subpart D) </span> | <span style="font-size: 10pt;"> ☐ Over-The-Counter Use (21 CFR 201 Subpart C) </span> |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|

> 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 contains the logo for 3NT MEDICAL. The logo is composed of the number 3, the letters NT, and the word MEDICAL. The number 3 and the letters NT are in blue, while the word MEDICAL is in gray.

Sinusway Dilation System K181838

### Traditional Premarket Notification Submission - 510(k) Sinusway Dilation System 510(k) Number K181838

Date Prepared: December 13, 2018

#### 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: Sinusway Dilation System Common or Usual Name: Sinusway Dilation System Classification Name: Ear, nose, and throat manual surgical instrument (21 CFR 874.4420) Regulatory Class: I (510(k) exempt) Product Code: LRC

#### III. PREDICATE DEVICE

3NT Medical Ltd. believes that the Sinusway Dilation System is substantially equivalent to the following predicate device cleared under multiple clearances:

- Entellus Medical Inc. XprESS Multi-Sinus Dilation Tool cleared under K102003, K112506 and K121174, Product code LRC.

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## BNTMEDICAL

#### IV. DEVICE DESCRIPTION

Sinusway Dilation System combines the tissue expansion effect of balloon dilation with the features of a curved sinus seeker, and by that allows the user to track the dilation device into the sinus drainage pathways. The shape of the distal end of the dilation system can be changed by inserting pre-shaped seekers into it. The system includes:

- A Dilation Kit (Single use, provided sterile) consists of the following 1. components:
- a. A Dilation Device includes an inflatable balloon at its distal end and connects to the inflation device at its proximal end.
- b. Three interchangeable pre-shaped Seekers (also referred to as stylets).
- c. An Inflation Device connects to the dilation device and inflates it while providing visual and tactile pressure indication.
- All Dilation Kit components are disposed of at the end of the procedure.
- 2. A Holder (re-processible and auto-clavable) - holds the components of the Dilation Kit in place and locks them, allowing the user to operate the dilation tool.

#### V. INDICATIONS FOR USE

Sinusway Dilation System is intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults using the trans-nasal approach, by dilation and displacement of the anatomic structures along the sinus drainage pathways.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The Sinusway Dilation System has the same intended use and indications for use as the Entellus predicate device. Sinusway Dilation System, same as the predicate device, use balloon dilation technology to access and treat the target anatomy. Both balloons are positioned over a rigid pre-shaped seeker and are manually inflated with saline until the desired result is achieved. The Sinusway Dilation System and Entellus predicate device principles of operation are identical. Both devices are advanced into the nasal and sinus anatomy under direct endoscopic visualization and treat the anatomy by dilating and displacing anatomic structures along the sinus drainage pathways. Both devices are used through a trans-nasal approach.

Similar tests and tests methods performed in accordance with the same standards were used in both Sinusway Dilation System and the 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 device do not raise any new questions of safety or effectiveness.

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### Sinusway Dilation System K181838

The Sinusway Dilation System has the same technological characteristics as the predicate devices as demonstrated in the table below:

| Name | 3NT Medical<br>Sinusway Dilation<br>System | Entellus Medical<br>XprESS Multi-Sinus<br>Dilation Tool | SE Justification |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------|
| 510(k) number | K181838 | K102003 and subsequent<br>K112506 and K121174 | |
| Product Code | LRC | LRC | Same |
| CFR | Class I, 21 CFR 874.4420 | Class I, 21 CFR 874.4420 | Same |
| Indications for<br>Use | Intended to access and treat<br>the frontal, maxillary and<br>sphenoid sinuses in sinus<br>procedures in adults, by<br>dilation and displacement<br>of the anatomic structures<br>along the sinus drainage<br>pathways. | Intended to access and treat<br>the frontal recesses.<br>sphenoid sinus ostia,<br>maxillary ostia/ethmoid<br>infundibula in adults using<br>a trans-nasal approach. The<br>bony sinus outflow tracts<br>are remodeled by balloon<br>displacement of adjacent<br>bone and paranasal sinuses<br>structure. | Same |
| Balloon Diameter | 6mm | 5mm, 6mm, 7mm | Same<br>The 3NT size is<br>included within the<br>predicate range of<br>sizes |
| Balloon Length | 10mm | 8mm, 18mm | SE<br>The 3NT size is<br>included within the<br>predicate range of<br>sizes |
| Distal Ball Tip<br>Diameter | 1.5mm | 2mm | SE |
| Dilation Device<br>Angles | Similar to sinus seekers,<br>pre-set by replaceable pre-<br>bent seekers | Similar to sinus seekers,<br>pre-set by bending a<br>shapeable seeker | SE |
| Guided by Direct<br>Visualization? | Yes | Yes | Same |
| Trans-Nasal<br>Approach? | Yes | Yes | Same |
| Inflation device | Syringe barrel and plunger<br>based | Syringe barrel and plunger<br>based | Same |
| Name | 3NT Medical<br>Sinusway Dilation<br>System | Entellus Medical<br>XprESS Multi-Sinus<br>Dilation Tool | SE Justification |
| Balloon inflation<br>substance | Saline | Saline | Same |
| Pressure<br>Indication | Visual and tactile | Visual only | SE |
| Rated Burst<br>Pressure | 17.4 atm | 19-22 atm (6mm balloon) | Similar, both are<br>above the maximal<br>inflation pressure |
| Dilation Tool<br>Sterilization | EtO (single-use) | EtO (single-use) | Same |
| Biocompatibility | All surfaces which come in<br>contact with the patient's<br>mucosal surfaces were<br>successfully tested for<br>biocompatibility in<br>accordance with ISO<br>10993-1. | All surfaces which come in<br>contact with the patient's<br>mucosal surfaces were<br>successfully tested for<br>biocompatibility in<br>accordance with ISO<br>10993-1. | Same |
| Prescription Use | The device should be used<br>only by trained surgeon<br>under a physician order. | The device should be used<br>only by trained surgeon<br>under a physician order. | Same |

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# 3NTMEDICAL

#### Sinusway Dilation System K181838

Based on the above analysis, 3NT Medical Ltd. believes that the Sinusway Dilation 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 10993-1. Biocompatibility evaluation included cytotoxicity, irritation, sensitization and acute systemic cytotoxicity 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 re-use by autoclave. In addition, shelf life and packaging testing were performed to support the labeled shelf life. All tests were successfully completed.

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# ЗПТМЕДІСАЦ

Sinusway Dilation System K181838

#### Bench Testing -

Bench testing included the following:

- Balloon Dilation Tool Fatigue ●
- Inflation/Deflation time test protocol ●
- Visual and demonstration Report
- Dimensional Attribute ●
- Compliance (Diameter vs. Pressure) Report ●
- Balloon Rated Burst Pressure Report
- Bond Strength Report
- Inflation Mechanism Pressure feedback range testing Report ●
- Functionality and simulated use ●

All tests met the predefined acceptance criteria.

#### VIII. CONCLUSIONS

The Sinusway Dilation System has the same intended use as the predicate device. 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 device do not raise any new questions of safety or effectiveness. Performance data has been provided, establishing that the Sinusway Dilation System performs as intended and in a manner that is substantially equivalent to the predicate. Therefore, the device may be found substantially equivalent.