(114 days)
No
The summary describes a mechanical device with features for dilation, suction, irrigation, and illumination. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities.
Yes.
The device is used to remodel bony sinus outflow tracts by balloon displacement, which is a therapeutic intervention.
No
Explanation: The device description and intended use clearly state that the device is for accessing, treating, remodeling, and recreating sinus outflow tracts via balloon dilation. It is a surgical tool designed for therapeutic intervention, not for diagnosing medical conditions. While it includes an LED light for visualization, this is to aid the therapeutic procedure, not for diagnostic imaging or assessment purposes.
No
The device description explicitly lists multiple hardware components including a shapeable catheter with inflatable balloon, LED light fiber, irrigation line, suction line, inflation syringe, and extension line. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states the device is used to access and treat the maxillary ostia/ethmoid infundibula, frontal ostia/recesses, and sphenoid sinus ostia by remodeling the bony sinus outflow tracts using balloon dilation. It also allows for suction, irrigation, and illumination within the nasal and sinus structures.
- Lack of Sample Analysis: There is no mention of the device being used to analyze any biological samples taken from the patient. Its function is entirely focused on a physical intervention within the patient's body.
The device is a surgical tool used for a therapeutic procedure, not a diagnostic test performed on a sample outside the body.
N/A
Intended Use / 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 trans-nasal approach. The bony sinus outflow tracts are remodeled by balloon displacement of adjacent bone and paranasal sinus structures.
Product codes
LRC
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary ostia/ethmoid infundibula, frontal ostia/recesses, sphenoid sinus ostia, nasal and sinus structures
Indicated Patient Age Range
patients 2 years and older (maxillary ostia/ethmoid infundibula), patients 12 years and older (frontal ostia/recesses and sphenoid sinus ostia)
Intended User / Care Setting
Not Found
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)
Verification testing performed for the subject device includes:
- l Visual Testing
- Visual Connection Indicators on Device Handle
- Marker Band Location
- I Dimensional Testing
- Catheter Shaft Working Length
- Device Weight
- Luer Connections
- Distal Tip Length and Outer Diameter
- Extension Line Length
- Balloon Working Length
- Balloon Outer Diameter
- I Functional Testing
- Bend Radius
- Pliable Shaft Fatique
- Suction Force
- Irrigation Rate
- Balloon Inflation Time
- Balloon Deflation Time
- Balloon Fatigue Test
- Balloon Burst Pressure
- LED Visibility
- LED Battery Life
- Atraumatic Tip Joint Strength
- Manifold Joint Strength
- Manifold Torque Value
- I Electrical Safety and EMC Testing
- l Biocompatibility Testing
- I Sterilization, Packaging, and Shelf-Life Testing
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Entellus Xpress Multi-Sinus Dilation System, (K152434
Reference Device(s)
Entellus PathAssist LED Light Fiber, (K152435)
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.
0
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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
1
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
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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:
-
- 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
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
Characteristic | Subject Device | Primary Predicate | Secondary
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
Dilation System | Entellus PathAssist
LED Light Fiber | N/A |
| Common Name | Balloon Sinus Dilation
System | Balloon Sinus
Dilation System | Sinus Guidewire | Similar, the EXCELENT device is a balloon
dilation system similar to the XprESS system
with an integrated LED light similar to the
PathAssist LED light fiber. |
| Device
Classification
Name | Instrument, ENT
Manual Surgical | Instrument, ENT
Manual Surgical | Instrument, ENT
Manual Surgical | Identical, all devices manual ENT surgical
instruments. |
| 510(k) Number | K230258 | K152434 | K152435 | N/A |
| Classification
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
LRC product code. |
| Intended 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 trans-nasal
approach. | 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. | To locate, illuminate
within, and
transilluminate
across nasal and
sinus structures. | Similar, the EXCELENT device shares the
same intended use as the primary predicate
and includes an LED light to illuminate the
treatment area in a manner that is similar to the
secondary predicate. |
| Product
Characteristic | Subject Device | Primary Predicate | Secondary
Predicate | Comparison of Devices |
| 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 trans-nasal
approach. The bony
sinus outflow tracts are
remodeled by balloon
displacement of
adjacent bone and
paranasal sinus
structures. | 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. | To locate, illuminate
within, and
transilluminate
across nasal and
sinus structures. | Similar, the Indications for Use of the subject
and predicate device are identical. The use of
the LED feature of the subject device is similar
to the indications for use of the secondary
predicate device.
The integrated LED light of the subject device
allows the user to confirm the positioning of the
balloon using the transillumination technique
prior to inflating the balloon. |
| Sterility | Sterile (EtO) | Sterile (EtO) | Sterile (EtO) | Identical, all products are provided sterile and
are sterilized via EtO. |
| Type of Use | Single-Patient Use,
Prescription (Rx only) | Single-Patient Use,
Prescription (Rx only) | Single-Patient Use,
Prescription (Rx
only) | Identical, all devices are single-patient use and
prescription only. |
| Balloon
Diameter and
Length | 6mm (diameter) x
20mm (length) | 6mm (diameter) x
20mm (length)
(XpreSS Ultra
Configuration) | N/A | Identical, the subject device balloon
dimensions are identical to one configuration of
the primary predicate device. |
| Distal Tip
Diameter | 1.95 mm | 1.5 mm (XprESS
Ultra Configuration) | | Similar, the distal tip diameter of the subject
device is within the range of distal tip diameters
for the predicate device. |
| Product
Characteristic | Subject Device | Primary Predicate | Secondary
Predicate | Comparison of Devices |
| | | 1.75 mm (XprESS
LoProfile
Configuration) | | |
| | | 2.0 mm (XprESS Pro
Configuration) | | |
| Maximum
Balloon Inflation
Pressure | 12 ATM | 12 ATM | N/A | Identical, the maximum balloon inflation
pressure is identical to the primary predicate
device. |
| Catheter Type | Flexible, shapeable,
with atraumatic tip,
irrigation and suction
features | Flexible, shapeable,
with atraumatic tip,
irrigation and suction
features | N/A | Similar, the catheter portion of the subject and
primary predicate devices is shapeable for use
in multiple sinuses. Both devices incorporate
irrigation and suction. Both devices are
provided with a bending tool to provide the
proper bend for each sinus. |
| Light Source | Light delivered via fiber
optic from an
integrated, battery
powered, LED light
source with > 60
minutes battery life | N/A | Light delivered via
fiber optic from an
integrated, battery
powered, LED light
source with > 60
minutes battery life | Similar, both the subject device and the
secondary predicate provide illumination from a
similar electronic component. The integration
of the LED light system in the subject device
does not raise any new questions of safety or
efficacy. |
| Inflation
Mechanism | The inflation syringe is
provided with the
system and the
incorporated pressure
gauge provides a
visual scale of
pressure in 1 ATM
increments with even
increments labeled on
the pressure gauge (2 | The inflation syringe
is provided with the
system and provides
a visual indicator
when 12 ATM balloon
pressure is achieved
(via alignment of
syringe marking and
distal syringe seal). | N/A | Similar, both inflation mechanisms provide a
visual indication of balloon pressure to allow
the user to pressurize to the maximum
pressure of 12 ATM. |
| Product
Characteristic | Subject Device | Primary Predicate | Secondary
Predicate | Comparison of Devices |
| | 4, 6, etc. and including
12 ATM). | | | |
| Biocompatibility | Biocompatible | Biocompatible | Biocompatible | Similar, the subject device has undergone
biocompatibility testing in accordance with ISO
10993-1 based on the intended nature and
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.