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.

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:

BB 8 Sinus Dilation Kit which incorporates:
a. shapeable catheter with inflatable balloon
b. LED light fiber
c. irrigation line, and
d. suction line,
Inflation syringe,
Extension line used for inflation of the balloon (and to provide irrigation, if desired), and
A bend template for shaping the catheter tip for treating various sinus anatomy

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "BB 8 Sinus Dilation Kit." It does not contain information about studies to prove the device meets acceptance criteria in the way you've described.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, rather than presenting novel clinical study results.

Therefore, many of the items you requested (such as acceptance criteria, specific performance metrics from a study, sample sizes, expert qualifications, and ground truth information) are not applicable or provided in this type of submission.

Here's a breakdown of what information is available based on your request, and what is not:

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

Not Applicable in the requested format. This document presents a "Table 1: Comparison to Predicate Devices" which outlines technological characteristics and states whether they are "Identical" or "Similar" to predicate devices. It does not provide specific numerical acceptance criteria or performance results from a study designed to meet those criteria. Instead, it relies on the similarities to already cleared devices.

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

Not provided. No clinical "test set" in the context of an accuracy or performance study is mentioned. The verification testing listed is engineering and bench testing, not human clinical trials or performance assessments that would involve a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. No expert ground truth establishment for a test set is mentioned.

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

Not applicable. No adjudication method for a test set is mentioned.

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 device is a manual surgical instrument, not an AI-assisted diagnostic or therapeutic device that would involve human "readers" or AI assistance.

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

Not applicable. This is a manual surgical instrument, not an algorithm.

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

Not applicable. No ground truth for clinical performance is mentioned. The "ground truth" here is the established safety and efficacy of the predicate devices.

8. The sample size for the training set:

Not applicable. This is a physical device, not an AI model, so there is no "training set."

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

Not applicable. As above, no training set.

Summary of what the document does provide regarding device evaluation:

The document lists "Verification testing performed for the subject device" on page 5, which includes:

Visual Testing
Dimensional Testing
Functional Testing (e.g., Bend Radius, Suction Force, Irrigation Rate, Balloon Inflation/Deflation Time, Balloon Burst Pressure, LED Visibility, LED Battery Life, Joint Strengths, Torque Value)
Electrical Safety and EMC Testing
Biocompatibility Testing
Sterilization, Packaging, and Shelf-Life Testing

These are engineering and laboratory tests to ensure the device meets its design specifications and relevant standards, and that its characteristics are comparable to the predicates, not a clinical study to establish performance against specific acceptance criteria as you might see for an AI algorithm or a novel therapeutic with clinical outcomes. The "comparison of devices" table (Table 1) provides the rationale for how these tests demonstrate substantial equivalence.

Summary

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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. 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.

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

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Indications for Use

510(k) Number (if known) K230258

Device Name BB 8 Sinus Dilation Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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)

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Device Description:

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,
1. Inflation syringe,
1. Extension line used for inflation of the balloon (and to provide irrigation, if desired), and
1. 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.

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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.

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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

ProductCharacteristic	Subject Device	Primary Predicate	SecondaryPredicate	Comparison of Devices
Applicant	EXCELENT INC.	Entellus Medical Inc.	Entellus Medical Inc.	N/A
Product Name	BB 8 Sinus Dilation Kit	XprESS Multi-SinusDilation System	Entellus PathAssistLED Light Fiber	N/A
Common Name	Balloon Sinus DilationSystem	Balloon SinusDilation System	Sinus Guidewire	Similar, the EXCELENT device is a balloondilation system similar to the XprESS systemwith an integrated LED light similar to thePathAssist LED light fiber.
DeviceClassificationName	Instrument, ENTManual Surgical	Instrument, ENTManual Surgical	Instrument, ENTManual Surgical	Identical, all devices manual ENT surgicalinstruments.
510(k) Number	K230258	K152434	K152435	N/A
ClassificationRegulation	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 theLRC product code.
Intended Use	To access and treatthe maxillaryostia/ethmoidinfundibula in patients2 years and older, andfrontal ostia/recessesand sphenoid sinusostia in patients 12years and older usinga trans-nasalapproach.	To access and treatthe maxillaryostia/ethmoidinfundibula in patients2 years and older,and frontalostia/recesses andsphenoid sinus ostiain patients 12 yearsand older using atrans-nasal approach.	To locate, illuminatewithin, andtransilluminateacross nasal andsinus structures.	Similar, the EXCELENT device shares thesame intended use as the primary predicateand includes an LED light to illuminate thetreatment area in a manner that is similar to thesecondary predicate.
ProductCharacteristic	Subject Device	Primary Predicate	SecondaryPredicate	Comparison of Devices
Indications forUse	To access and treatthe maxillaryostia/ethmoidinfundibula in patients2 years and older, andfrontal ostia/recessesand sphenoid sinusostia in patients 12years and older usinga trans-nasalapproach. The bonysinus outflow tracts areremodeled by balloondisplacement ofadjacent bone andparanasal sinusstructures.	To access and treatthe maxillaryostia/ethmoidinfundibula in patients2 years and older,and frontalostia/recesses andsphenoid sinus ostiain patients 12 yearsand older using atransnasal approach.The bony sinusoutflow tracts areremodeled by balloondisplacement ofadjacent bone andparanasal sinusstructures.	To locate, illuminatewithin, andtransilluminateacross nasal andsinus structures.	Similar, the Indications for Use of the subjectand predicate device are identical. The use ofthe LED feature of the subject device is similarto the indications for use of the secondarypredicate device.The integrated LED light of the subject deviceallows the user to confirm the positioning of theballoon using the transillumination techniqueprior to inflating the balloon.
Sterility	Sterile (EtO)	Sterile (EtO)	Sterile (EtO)	Identical, all products are provided sterile andare sterilized via EtO.
Type of Use	Single-Patient Use,Prescription (Rx only)	Single-Patient Use,Prescription (Rx only)	Single-Patient Use,Prescription (Rxonly)	Identical, all devices are single-patient use andprescription only.
BalloonDiameter andLength	6mm (diameter) x20mm (length)	6mm (diameter) x20mm (length)(XpreSS UltraConfiguration)	N/A	Identical, the subject device balloondimensions are identical to one configuration ofthe primary predicate device.
Distal TipDiameter	1.95 mm	1.5 mm (XprESSUltra Configuration)		Similar, the distal tip diameter of the subjectdevice is within the range of distal tip diametersfor the predicate device.
ProductCharacteristic	Subject Device	Primary Predicate	SecondaryPredicate	Comparison of Devices
		1.75 mm (XprESSLoProfileConfiguration)
		2.0 mm (XprESS ProConfiguration)
MaximumBalloon InflationPressure	12 ATM	12 ATM	N/A	Identical, the maximum balloon inflationpressure is identical to the primary predicatedevice.
Catheter Type	Flexible, shapeable,with atraumatic tip,irrigation and suctionfeatures	Flexible, shapeable,with atraumatic tip,irrigation and suctionfeatures	N/A	Similar, the catheter portion of the subject andprimary predicate devices is shapeable for usein multiple sinuses. Both devices incorporateirrigation and suction. Both devices areprovided with a bending tool to provide theproper bend for each sinus.
Light Source	Light delivered via fiberoptic from anintegrated, batterypowered, LED lightsource with > 60minutes battery life	N/A	Light delivered viafiber optic from anintegrated, batterypowered, LED lightsource with > 60minutes battery life	Similar, both the subject device and thesecondary predicate provide illumination from asimilar electronic component. The integrationof the LED light system in the subject devicedoes not raise any new questions of safety orefficacy.
InflationMechanism	The inflation syringe isprovided with thesystem and theincorporated pressuregauge provides avisual scale ofpressure in 1 ATMincrements with evenincrements labeled onthe pressure gauge (2	The inflation syringeis provided with thesystem and providesa visual indicatorwhen 12 ATM balloonpressure is achieved(via alignment ofsyringe marking anddistal syringe seal).	N/A	Similar, both inflation mechanisms provide avisual indication of balloon pressure to allowthe user to pressurize to the maximumpressure of 12 ATM.
ProductCharacteristic	Subject Device	Primary Predicate	SecondaryPredicate	Comparison of Devices
	4, 6, etc. and including12 ATM).
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Similar, the subject device has undergonebiocompatibility testing in accordance with ISO10993-1 based on the intended nature andduration of contact.

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Traditional 510(k): EXCELENT INC. 68 TW Alexander Drive Durham, NČ 27709

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Traditional 510(k): EXCELENT INC.
Durham, NČ 27709

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Traditional 510(k): EXCELENT INC.
Durham, NČ 27709

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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.

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.