(114 days)
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.
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
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.
§ 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.