BB 8 Sinus Dilation Kit

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May 25, 2023 Excelent Inc. % Bryan Brosseau President Brosseau Consulting LLC 2352 Kennesaw Oaks Trl NW Kennesaw, Georgia 30152 Re: K230258 Trade/Device Name: BB 8 Sinus Dilation Kit Regulation Number: 21 CFR 874.4420 Regulation Name: Ear, Nose, and Throat Manual Surgical Instrument Regulatory Class: Class I Product Code: LRC Dated: April 25, 2023 Received: April 26, 2023 Dear Bryan Brosseau: 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. 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Sincerely, Shuchen Peng -S Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K230258 Device Name BB 8 Sinus Dilation Kit Indications for Use (Describe) To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Traditional 510(k): EXCELENT INC. 68 TW Alexander Drive PO Box 13628 Research Triangle Park Durham, NC 27709 510(k) K230258 # 510(k) Summary – K230258 Date Prepared: May 23, 2023 #### Submitted By: EXCELENT INC. 68 TW Alexander Drive PO Box 13628 Research Triangle Park Durham, NC 27709 ## Contact: | Name: | Bryan Brosseau | |------------|-----------------------------| | Title: | Consultant to EXCELENT INC. | | Telephone: | (404) 610-7215 | | Email: | bryan@brosseauconsult.com | #### Device: | Trade Name: | BB 8 Sinus Dilation Kit | |------------------------|---------------------------------| | Common Name: | Sinuplasty Balloon Catheter | | FDA Product Code: | LRC | | Device Classification: | Class I | | Classification Name: | Instrument, ENT Manual Surgical | | Device Regulation: | 21 CFR 874.4420 | #### Predicate Devices: | The device is substantially equivalent to the following predicate devices: | | |----------------------------------------------------------------------------|-------------------------------------------------------| | Primary Predicate: | Entellus Xpress Multi-Sinus Dilation System, (K152434 | | Secondary Predicate: | Entellus PathAssist LED Light Fiber, (K152435) | {4}------------------------------------------------ #### Device Description: The BB 8 Sinus Dilation Kit is intended to remodel or recreate the sinus outflow tract via transnasal balloon dilation. The device combines features of a curved suction tip and a sinus ostium seeker with the tissue expansion effect of balloon dilation. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient. The device also allows the capability to suction and irrigate the surgical field to allow for removal of bodily secretions and to keep the field of view clean for improved visualization. The device includes an LED light with light fiber to locate, illuminate within, and transilluminate across nasal and sinus structures. In summary, the device includes the following components and accessories: - 1. BB 8 Sinus Dilation Kit which incorporates: - a. shapeable catheter with inflatable balloon - b. LED light fiber - c. irrigation line, and - d. suction line, - 2. Inflation syringe, - 3. Extension line used for inflation of the balloon (and to provide irrigation, if desired), and - 4. A bend template for shaping the catheter tip for treating various sinus anatomy #### Indications for Use: To access and treat the maxillary ostia/ethmoid infundibula in patients 2 years and older, and frontal ostia/recesses and sphenoid sinus ostia in patients 12 years and older using a transnasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures. #### Technological Characteristics and Performance Data (Predicate Comparison): The device has similar intended use, indications for use, mechanism of action, and performance compared to the predicate devices. The balloons of the EXCELENT and Entellus devices are both positioned over a shapeable catheter and are manually inflated with saline and a syringe until the desired inflation pressure (up to 12 ATM) is achieved. The subject and 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. The intended use, indications for use, balloon dimensions, sterilization method, maximum inflation pressure, catheter type, light feature, inflation mechanism, and biocompatibility have been demonstrated as identical or similar between the subject and predicate devices. {5}------------------------------------------------ Additionally, verification testing for the subject device is similar to the testing performed for the predicate devices and demonstrates that minor differences in the device characteristics between the subject and predicate devices do not raise any new questions of safety and efficacy. Verification testing performed for the subject device includes: - l Visual Testing - Visual Connection Indicators on Device Handle o - Marker Band Location o - I Dimensional Testing - Catheter Shaft Working Length o - Device Weight O - Luer Connections O - Distal Tip Length and Outer Diameter o - Extension Line Length O - O Balloon Working Length - Balloon Outer Diameter o - I Functional Testing - Bend Radius O - Pliable Shaft Fatique o - Suction Force o - Irrigation Rate O - Balloon Inflation Time o - Balloon Deflation Time O - Balloon Fatigue Test O - Balloon Burst Pressure O - o LED Visibility - LED Battery Life O - Atraumatic Tip Joint Strength O - Manifold Joint Strength O - Manifold Torque Value o - I Electrical Safety and EMC Testing - l Biocompatibility Testing - I Sterilization, Packaging, and Shelf-Life Testing A comparison of technological characteristics and performance data to the predicate devices is provided in Table 1, below. {6}------------------------------------------------ Traditional 510(k): EXCELENT INC. 68 TW Alexander Drive PO Box 13628 Research Triangle Park Durham, NC 27709 510(k) K230258 ## Table 1: Comparison to Predicate Devices | Product<br>Characteristic | Subject Device | Primary Predicate | Secondary<br>Predicate | Comparison of Devices | |------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Applicant | EXCELENT INC. | Entellus Medical Inc. | Entellus Medical Inc. | N/A | | Product Name | BB 8 Sinus Dilation Kit | XprESS Multi-Sinus<br>Dilation System | Entellus PathAssist<br>LED Light Fiber | N/A | | Common Name | Balloon Sinus Dilation<br>System | Balloon Sinus<br>Dilation System | Sinus Guidewire | Similar, the EXCELENT device is a balloon<br>dilation system similar to the XprESS system<br>with an integrated LED light similar to the<br>PathAssist LED light fiber. | | Device<br>Classification<br>Name | Instrument, ENT<br>Manual Surgical | Instrument, ENT<br>Manual Surgical | Instrument, ENT<br>Manual Surgical | Identical, all devices manual ENT surgical<br>instruments. | | 510(k) Number | K230258 | K152434 | K152435 | N/A | | Classification<br>Regulation | Class 1, 874.4420 | Class 1, 874.4420 | Class 1, 874.4420 | N/A | | Product Code | LRC | LRC | LRC | Identical, all products are classified under the<br>LRC product code. | | Intended Use | To access and treat<br>the maxillary<br>ostia/ethmoid<br>infundibula in patients<br>2 years and older, and<br>frontal ostia/recesses<br>and sphenoid sinus<br>ostia in patients 12<br>years and older using<br>a trans-nasal<br>approach. | To access and treat<br>the maxillary<br>ostia/ethmoid<br>infundibula in patients<br>2 years and older,<br>and frontal<br>ostia/recesses and<br>sphenoid sinus ostia<br>in patients 12 years<br>and older using a<br>trans-nasal approach. | To locate, illuminate<br>within, and<br>transilluminate<br>across nasal and<br>sinus structures. | Similar, the EXCELENT device shares the<br>same intended use as the primary predicate<br>and includes an LED light to illuminate the<br>treatment area in a manner that is similar to the<br>secondary predicate. | | Product<br>Characteristic | Subject Device | Primary Predicate | Secondary<br>Predicate | Comparison of Devices | | Indications for<br>Use | To access and treat<br>the maxillary<br>ostia/ethmoid<br>infundibula in patients<br>2 years and older, and<br>frontal ostia/recesses<br>and sphenoid sinus<br>ostia in patients 12<br>years and older using<br>a trans-nasal<br>approach. The bony<br>sinus outflow tracts are<br>remodeled by balloon<br>displacement of<br>adjacent bone and<br>paranasal sinus<br>structures. | To access and treat<br>the maxillary<br>ostia/ethmoid<br>infundibula in patients<br>2 years and older,<br>and frontal<br>ostia/recesses and<br>sphenoid sinus ostia<br>in patients 12 years<br>and older using a<br>transnasal approach.<br>The bony sinus<br>outflow tracts are<br>remodeled by balloon<br>displacement of<br>adjacent bone and<br>paranasal sinus<br>structures. | To locate, illuminate<br>within, and<br>transilluminate<br>across nasal and<br>sinus structures. | Similar, the Indications for Use of the subject<br>and predicate device are identical. The use of<br>the LED feature of the subject device is similar<br>to the indications for use of the secondary<br>predicate device.<br>The integrated LED light of the subject device<br>allows the user to confirm the positioning of the<br>balloon using the transillumination technique<br>prior to inflating the balloon. | | Sterility | Sterile (EtO) | Sterile (EtO) | Sterile (EtO) | Identical, all products are provided sterile and<br>are sterilized via EtO. | | Type of Use | Single-Patient Use,<br>Prescription (Rx only) | Single-Patient Use,<br>Prescription (Rx only) | Single-Patient Use,<br>Prescription (Rx<br>only) | Identical, all devices are single-patient use and<br>prescription only. | | Balloon<br>Diameter and<br>Length | 6mm (diameter) x<br>20mm (length) | 6mm (diameter) x<br>20mm (length)<br>(XpreSS Ultra<br>Configuration) | N/A | Identical, the subject device balloon<br>dimensions are identical to one configuration of<br>the primary predicate device. | | Distal Tip<br>Diameter | 1.95 mm | 1.5 mm (XprESS<br>Ultra Configuration) | | Similar, the distal tip diameter of the subject<br>device is within the range of distal tip diameters<br>for the predicate device. | | Product<br>Characteristic | Subject Device | Primary Predicate | Secondary<br>Predicate | Comparison of Devices | | | | 1.75 mm (XprESS<br>LoProfile<br>Configuration) | | | | | | 2.0 mm (XprESS Pro<br>Configuration) | | | | Maximum<br>Balloon Inflation<br>Pressure | 12 ATM | 12 ATM | N/A | Identical, the maximum balloon inflation<br>pressure is identical to the primary predicate<br>device. | | Catheter Type | Flexible, shapeable,<br>with atraumatic tip,<br>irrigation and suction<br>features | Flexible, shapeable,<br>with atraumatic tip,<br>irrigation and suction<br>features | N/A | Similar, the catheter portion of the subject and<br>primary predicate devices is shapeable for use<br>in multiple sinuses. Both devices incorporate<br>irrigation and suction. Both devices are<br>provided with a bending tool to provide the<br>proper bend for each sinus. | | Light Source | Light delivered via fiber<br>optic from an<br>integrated, battery<br>powered, LED light<br>source with > 60<br>minutes battery life | N/A | Light delivered via<br>fiber optic from an<br>integrated, battery<br>powered, LED light<br>source with > 60<br>minutes battery life | Similar, both the subject device and the<br>secondary predicate provide illumination from a<br>similar electronic component. The integration<br>of the LED light system in the subject device<br>does not raise any new questions of safety or<br>efficacy. | | Inflation<br>Mechanism | The inflation syringe is<br>provided with the<br>system and the<br>incorporated pressure<br>gauge provides a<br>visual scale of<br>pressure in 1 ATM<br>increments with even<br>increments labeled on<br>the pressure gauge (2 | The inflation syringe<br>is provided with the<br>system and provides<br>a visual indicator<br>when 12 ATM balloon<br>pressure is achieved<br>(via alignment of<br>syringe marking and<br>distal syringe seal). | N/A | Similar, both inflation mechanisms provide a<br>visual indication of balloon pressure to allow<br>the user to pressurize to the maximum<br>pressure of 12 ATM. | | Product<br>Characteristic | Subject Device | Primary Predicate | Secondary<br>Predicate | Comparison of Devices | | | 4, 6, etc. and including<br>12 ATM). | | | | | Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Similar, the subject device has undergone<br>biocompatibility testing in accordance with ISO<br>10993-1 based on the intended nature and<br>duration of contact. | {7}------------------------------------------------ Traditional 510(k): EXCELENT INC. 68 TW Alexander Drive Durham, NČ 27709 {8}------------------------------------------------ Traditional 510(k): EXCELENT INC. Durham, NČ 27709 {9}------------------------------------------------ Traditional 510(k): EXCELENT INC. Durham, NČ 27709 {10}------------------------------------------------ ## Conclusions: The subject device and the predicate devices underwent evaluation that confirms equivalence in the intended use of each device, biocompatibility, performance, environment of use, and the principles of operation. Therefore, the subject device is deemed substantially equivalent to the predicate devices.