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 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 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.
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.

AI/ML Overview

The provided document is a 510(k) premarket notification for the Sinusway Dilation System. The information required in the request pertains to the performance criteria and studies for a device, typically AI/ML-based software. However, the Sinusway Dilation System is a physical surgical instrument (Ear, Nose, And Throat Manual Surgical Instrument). Therefore, many of the requested fields, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," and "sample size for the training set," are not applicable to this type of medical device.

The document focuses on demonstrating substantial equivalence to a predicate device through comparison of technological characteristics and bench testing, rather than clinical performance metrics typically associated with AI/ML devices.

Nevertheless, I will extract the available information related to acceptance criteria and device performance based on the provided text, while explicitly noting when requested information is not applicable.

1. A table of acceptance criteria and the reported device performance

The document states that "All tests met the predefined acceptance criteria," but it does not explicitly list the acceptance criteria or the specific numerical performance results for each test. Instead, it lists the types of bench tests performed.

Acceptance Criteria Category	Reported Device Performance
Risk Analysis	Performed per ISO 14971:2012.
Biocompatibility	Evaluation performed in compliance with ISO 10993-1, including cytotoxicity, irritation, sensitization, and acute systemic cytotoxicity testing. All tests were completed with passing results.
Sterilization, Packaging, and Shelf Life	Sterilization validation testing of the endoscope performed to demonstrate compliance with ISO 11135-1. The handle was validated for cleaning and re-use by autoclave. Shelf life and packaging testing were performed. All tests were successfully completed.
Bench Testing:	All tests (listed below) met predefined acceptance criteria. Specific numerical results or criteria are not provided, only the types of tests.
- Balloon Dilation Tool Fatigue	Met predefined acceptance criteria.
- Inflation/Deflation time test	Met predefined acceptance criteria.
- Visual and demonstration Report	Met predefined acceptance criteria.
- Dimensional Attribute	Met predefined acceptance criteria.
- Compliance (Diameter vs. Pressure) Report	Met predefined acceptance criteria.
- Balloon Rated Burst Pressure Report	Met predefined acceptance criteria. (Rated Burst Pressure: 17.4 atm. Compared to predicate: 19-22 atm for 6mm balloon, noted as "Similar, both are above the maximal inflation pressure").
- Bond Strength Report	Met predefined acceptance criteria.
- Inflation Mechanism Pressure feedback range testing Report	Met predefined acceptance criteria.
- Functionality and simulated use	Met predefined acceptance criteria.

2. Sample size used for the test set and the data provenance

For the bench testing, the document does not specify sample sizes for each test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "tests" being performed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This device is a physical surgical instrument, and its performance was evaluated through bench testing and compliance with standards, not through comparison against expert-established ground truth in a diagnostic context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for clinical studies or studies involving human interpretation of diagnostic results, which is not the case for this device's performance evaluation.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a physical device, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical device, not an algorithm. Its functionality is dependent on human use during surgery.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the device's acceptable performance was established by adherence to recognized international standards (e.g., ISO 14971:2012 for risk analysis, ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization) and internal predefined acceptance criteria for bench tests. These are engineering and safety standards, rather than clinical "ground truth" for diagnostic accuracy.

8. The sample size for the training set

Not applicable. This is a physical device. The concept of a "training set" is relevant for AI/ML models.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical device.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K181838

Device Name Sinusway Dilation System

Indications for Use (Describe)

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)
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Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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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.

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BNTMEDICAL

IV. DEVICE DESCRIPTION

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.
1. 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 MedicalSinusway DilationSystem	Entellus MedicalXprESS Multi-SinusDilation Tool	SE Justification
510(k) number	K181838	K102003 and subsequentK112506 and K121174
Product Code	LRC	LRC	Same
CFR	Class I, 21 CFR 874.4420	Class I, 21 CFR 874.4420	Same
Indications forUse	Intended to access and treatthe frontal, maxillary andsphenoid sinuses in sinusprocedures in adults, bydilation and displacementof the anatomic structuresalong the sinus drainagepathways.	Intended to access and treatthe frontal recesses.sphenoid sinus ostia,maxillary ostia/ethmoidinfundibula in adults usinga trans-nasal approach. Thebony sinus outflow tractsare remodeled by balloondisplacement of adjacentbone and paranasal sinusesstructure.	Same
Balloon Diameter	6mm	5mm, 6mm, 7mm	SameThe 3NT size isincluded within thepredicate range ofsizes
Balloon Length	10mm	8mm, 18mm	SEThe 3NT size isincluded within thepredicate range ofsizes
Distal Ball TipDiameter	1.5mm	2mm	SE
Dilation DeviceAngles	Similar to sinus seekers,pre-set by replaceable pre-bent seekers	Similar to sinus seekers,pre-set by bending ashapeable seeker	SE
Guided by DirectVisualization?	Yes	Yes	Same
Trans-NasalApproach?	Yes	Yes	Same
Inflation device	Syringe barrel and plungerbased	Syringe barrel and plungerbased	Same
Name	3NT MedicalSinusway DilationSystem	Entellus MedicalXprESS Multi-SinusDilation Tool	SE Justification
Balloon inflationsubstance	Saline	Saline	Same
PressureIndication	Visual and tactile	Visual only	SE
Rated BurstPressure	17.4 atm	19-22 atm (6mm balloon)	Similar, both areabove the maximalinflation pressure
Dilation ToolSterilization	EtO (single-use)	EtO (single-use)	Same
Biocompatibility	All surfaces which come incontact with the patient'smucosal surfaces weresuccessfully tested forbiocompatibility inaccordance with ISO10993-1.	All surfaces which come incontact with the patient'smucosal surfaces weresuccessfully tested forbiocompatibility inaccordance with ISO10993-1.	Same
Prescription Use	The device should be usedonly by trained surgeonunder a physician order.	The device should be usedonly by trained surgeonunder 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.

Regulation Number and Section

§ 874.4420 Ear, nose, and throat manual surgical instrument.

(a)
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.(b)
Classification Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 874.9.