(163 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is intended to treat the frontal, maxillary, and sphenoid sinuses in adults by dilation and displacement of anatomic structures, which constitutes a therapeutic action.
No
The device is described as a "Dilation System" intended to "access and treat" sinuses by "dilation and displacement of the anatomic structures." Its function is therapeutic, not diagnostic.
No
The device description clearly outlines multiple hardware components including a Dilation Kit (dilation device with balloon, seekers, inflation device) and a Holder. The performance studies also focus on hardware-related testing like biocompatibility, sterilization, and bench testing of physical attributes.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Sinusway Dilation System Function: The Sinusway Dilation System is a surgical tool used directly within the body (in vivo) to physically access and treat the sinuses by dilation and displacement of anatomical structures. It does not analyze or test any bodily specimens.
The description clearly indicates a surgical instrument used for a therapeutic procedure, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes
LRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
frontal, maxillary and sphenoid sinuses
Indicated Patient Age Range
adults
Intended User / Care Setting
trained surgeon
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
- Bench Testing:
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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)
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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
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.
-
- 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
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 |
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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.
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.