(84 days)
The VenSure™ Balloon Device and VenSure™ Nav Balloon Device are used to access and treat the frontal recesses, sphenoid sinus ostia and 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 sinus structures.
The VenSure™ Nav Balloon Device is intended for use in conjunction with the Fiagon Navigation System during sinus procedures when surgical navigation or image-guided surgery may be necessary to locate and move tissue, bone or cartilaginous tissue surrounding the drainage pathways of frontal, maxillary, and sphenoid sinuses to facilitate dilation of the sinus ostia.
The Fiagon Navigation System is intended as an aid for precisely locating anatomical structures in either open or percutaneous procedures. The Fiagon Navigation system is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure in the field of ENT surgery can be identified relative to a CT or MR based model of the anatomy.
Fiagon's VenSure™ Balloon Device and VenSure™ Nav Balloon Device are sterile, singleuse devices designed to remodel the bony structures within the sinuses. The device comes in two versions a navigation ready version (VenSure™ Nav) that is compatible with the Fiagon electromagnetic navigation system, and a basic non-navigation ready version (VenSure™).
The VenSure™ and VenSure™ Nav devices, combine features of a malleable suction and a malleable probe with the tissue expansion effect of balloon dilation. The distal end of the device includes an atraumatic tip and can be shaped to fit the frontal, maxillary, and sphenoid sinuses using the Bending Tool provided with the device. Since the distal end of the device is re-shapeable, one balloon can be modified to work on multiple sinuses within the same patient.
Both versions enable a physician to track the device into the sinuses using endoscopic visualization; while the VenSure™ Nav allows for image-guided visualization when connected to the Fiagon Navigation System. The VenSure™ Nav contains an integrated sensor carrier that enables the use of image guidance through "plug and play" tracking capability when used with the Fiagon Navigation System. The sensor carrier containing localizer elements detects a signal within a low-energy magnetic field delivered from the navigation unit. The navigation software then displays the location of the sinus dilation instrument's tip within multiple patient image planes and other anatomic renderings. After confirmation of placement, the balloon of the dilation device can be inflated with saline solution, using the inflator to expand the outflow track of the targeted sinus.
A suction tube may be connected directly to the proximal luer fitting of the basic VenSure™ balloon dilation device to provide active suction. Alternately, an Extension Line connected to a syringe may be connected directly to the proximal luer fitting to provide irrigation. Suction and irrigation are not possible on the VenSure™ Nav.
The provided text describes a 510(k) premarket notification for the VenSure™ Balloon Device and VenSure™ Nav Balloon Device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through extensive clinical studies as might be seen for novel devices or PMAs.
Therefore, the information requested, particularly regarding acceptance criteria, specific study designs (like MRMC), expert consensus, and detailed ground truth establishment, is largely not present in the provided document, as it falls outside the scope of a typical 510(k) submission for this type of device.
However, I can extract the information that is available:
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "All tests met the predefined acceptance criteria." and "All tests successfully met the required acceptance criteria". However, the specific quantitative acceptance criteria values themselves are not provided in the text. Only the categories of tests performed are mentioned.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Balloon dimensional integrity | Met predefined acceptance criteria |
| Balloon pressure stability /Inflation/Deflation | Met predefined acceptance criteria |
| Inflation and Deflation Time | Met predefined acceptance criteria |
| Mechanical integrity (Torsion strength, Tensile force, Dimensions) | Met predefined acceptance criteria |
| Navigation compatibility (VenSure™ Nav only) | Met predefined acceptance criteria; demonstrated functionality and compatibility with Fiagon Navigation System |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization, Acute Systemic Toxicity) | Met required acceptance criteria |
| Sterilization Cycle Validation | Conducted in accordance with ISO 11135:2014, ISO10993-7:2018, ISO 11737-1:2018; All tests successfully completed |
| Shelf Life (Accelerated aging, Real-time aging, Package integrity, Packaging system performance) | Accelerated aging study performed, real-time aging started; All tests successfully completed |
| Electromagnetic Compatibility | Demonstrated compliance to IEC 60601-1-2, 4th edition |
2. Sample size used for the test set and the data provenance
The document specifies "Bench testing" and "Biocompatibility testing" were conducted. It does not provide specific sample sizes for these tests (e.g., number of balloons tested for dimensional integrity).
- Data Provenance: Bench testing would be conducted in a laboratory setting. Biocompatibility testing involved laboratory assays. The document does not specify a country of origin for the test data, but the submitter (Fiagon GmbH) is based in Germany. The tests are described as prospective in the sense that they were conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided. The tests described are largely objective laboratory and engineering tests (e.g., measuring balloon dimensions, pressure). For biocompatibility, the ground truth would be established by the results of standardized biological assays, not expert consensus in the clinical sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided and is generally not applicable to the types of bench and biocompatibility tests described.
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
- No, an MRMC comparative effectiveness study was not done. The devices described are physical surgical instruments (balloon dilation devices and their navigation-compatible versions), not AI/software intended for diagnostic interpretation or aiding human "readers" (e.g., radiologists). Therefore, this type of study is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. These are physical medical devices, not algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For bench testing, the ground truth would be engineering specifications, material properties, and functionality requirements (e.g., specific dimensions, pressure resistance, inflation/deflation times).
- For biocompatibility testing, the ground truth would be the defined acceptable limits and criteria for cytotoxicity, irritation, sensitization, and acute systemic toxicity as per ISO 10993-1 and related sub-standards.
- For sterilization and shelf-life, the ground truth is established by the specified standards (e.g., ISO 11135 for sterilization, ASTM F1980 for accelerated aging, ISO 11607-1 for packaging).
8. The sample size for the training set
- Not applicable. These are physical medical devices, not machine learning algorithms that require training sets. The document describes pre-market testing for device safety and performance, not AI model development.
9. How the ground truth for the training set was established
- Not applicable. As above, this concept refers to AI/ML development and is not relevant to this device submission.
§ 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.