Who is the manufacturer of Sinusway Dilation System?

3nt Medical , Ltd. filed the 510(k) submission for Sinusway Dilation System (K181838).

What is the FDA product code for Sinusway Dilation System?

LRC. It is classified under 21 CFR 874.4420 as a Class 1 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for Sinusway Dilation System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Sinusway Dilation System?

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

Who can help prepare an FDA 510(k) submission like Sinusway Dilation System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Intended 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)

Related Devices

K142252 — XprESS Multi-Sinus Dilation Tool · Entellus Medical, Inc. · Oct 17, 2014
K153341 — Relieva Scout Multi-Sinus Dilation System · Acclarent, Inc. · Feb 12, 2016
K111875 — RELIEVA SPIN SINUS DILATION SYSTEM · Acclarent, Inc. · Oct 11, 2011
K121174 — XPRESS MULTI-SINUS DILATION TOOL · Entellus Medical, Inc. · May 17, 2012
K112506 — XPRESS MULTI-SINUS DILATION TOOL · Entellus Medical, Inc. · Dec 21, 2011

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue. 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. {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 {2}------------------------------------------------ ### 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) | ☑ Prescription Use (Part 21 CFR 201 Subpart D) | ☐ Over-The-Counter Use (21 CFR 201 Subpart C) | |-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------| > Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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: +972.73.7154057 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: 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. {4}------------------------------------------------ ## 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. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for 3NT Medical. The "3NT" is in a dark teal color, while "MEDICAL" is in gray. The logo is simple and modern. ### 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 Sinusway Dilation System | Entellus Medical XprESS Multi-Sinus Dilation Tool | SE Justification | |------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------| | 510(k) number | K181838 | K102003 and subsequent K112506 and K121174 | | | Product Code | LRC | LRC | Same | | CFR | Class I, 21 CFR 874.4420 | Class I, 21 CFR 874.4420 | Same | | Indications for Use | Intended to access and treat the frontal, maxillary and sphenoid sinuses in sinus procedures in adults, by dilation and displacement of the anatomic structures along the sinus drainage pathways. | Intended to access and treat the frontal recesses. sphenoid sinus ostia, maxillary ostia/ethmoid infundibula in adults using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinuses structure. | Same | | Balloon Diameter | 6mm | 5mm, 6mm, 7mm | Same The 3NT size is included within the predicate range of sizes | | Balloon Length | 10mm | 8mm, 18mm | SE The 3NT size is included within the predicate range of sizes | | Distal Ball Tip Diameter | 1.5mm | 2mm | SE | | Dilation Device Angles | Similar to sinus seekers, pre-set by replaceable pre- bent seekers | Similar to sinus seekers, pre-set by bending a shapeable seeker | SE | | Guided by Direct Visualization? | Yes | Yes | Same | | Trans-Nasal Approach? | Yes | Yes | Same | | Inflation device | Syringe barrel and plunger based | Syringe barrel and plunger based | Same | | Name | 3NT Medical Sinusway Dilation System | Entellus Medical XprESS Multi-Sinus Dilation Tool | SE Justification | | Balloon inflation substance | Saline | Saline | Same | | Pressure Indication | Visual and tactile | Visual only | SE | | Rated Burst Pressure | 17.4 atm | 19-22 atm (6mm balloon) | Similar, both are above the maximal inflation pressure | | Dilation Tool Sterilization | EtO (single-use) | EtO (single-use) | Same | | Biocompatibility | All surfaces which come in contact with the patient's mucosal surfaces were successfully tested for biocompatibility in accordance with ISO 10993-1. | All surfaces which come in contact with the patient's mucosal surfaces were successfully tested for biocompatibility in accordance with ISO 10993-1. | Same | | Prescription Use | The device should be used only by trained surgeon under a physician order. | The device should be used only by trained surgeon under a physician order. | Same | {6}------------------------------------------------ # 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. {7}------------------------------------------------ # 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.