(126 days)
The Relieva UltirraNav TM Sinus Balloon Catheter is an instrument intended to dilate the sinus ostia and spaces within the maxillary, frontal, and sphenoid paranasal sinus cavities for diagnostic and therapeutic procedures.
For children aged 17 and under, the balloon catheter system is intended to dilate sinus ostia and spaces associated with the maxillary sinus for diagnostic and therapeutic procedures.
The Relieva UltirraNav™ Sinus Balloon Catheter may be utilized in conjunction with the Navigation Guidewire and CARTO® ENT System to to confirm placement in the accessed anatomy relative to pre-acquired CT images.
The Relieva Ultirra® Nav Sinus Balloon Catheter is a flexible catheter that is intended to dilate sinus ostia. The shaft allows for inflation of the sinus balloon and permits the passage of an electromagnetic navigable sinus guidewire or sinus illumination system to facilitate access to the target sinus ostia. A hypotube is incorporated on the proximal end to provide rigidity during insertion through a sinus guide catheter.
Here's an analysis of the acceptance criteria and study information for the Acclarent Relieva Ultirra® Nav Sinus Balloon Catheter, based on the provided text:
Important Note: The provided document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a detailed clinical study demonstrating device effectiveness from scratch. Therefore, many of the typical acceptance criteria and study details for a novel AI/software device may not be explicitly present or directly applicable. This document primarily describes non-clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Dimensional Specifications | (Implicit: Device dimensions meet pre-defined requirements) | The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including dimensional specifications. |
| Balloon Performance | - Balloon burst pressure |
- Deflation time
- Balloon cycle fatigue | The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including... balloon burst pressure, joint separation force, deflation time, and balloon cycle fatigue. |
| Joint Integrity | - Joint separation force | The Relieva Ultirra® Nav Sinus Balloon Catheter met all performance acceptance criteria including... joint separation force... |
| Shelf Life | - Per ASTM F1980-07 - Per ASTM F88/F88M-09
- Per ISTA 2A
- Per ASTM F2096-04 | Shelf life was established per ASTM F1980-07 ASTM F88/F88M-09, ISTA 2A, and ASTM F2096-04 requirements. |
| Biocompatibility | (Implicit: Meets biocompatibility standards for patient contact) | Testing also showed that the Relieva Ultirra® Nav Sinus Balloon Catheter is biocompatible. |
| Sterilization | - Sterility Assurance Level (SAL) of 10^-6 per AAMI/ANSI/ISO 11135:2014 (overkill/half-cycle approach) - Ethylene oxide residuals meet ISO 10993-7:2008 | The sterilization process has been validated per AAMI/ANSI/ISO 11135:2014 and demonstrated a sterility assurance level of 10-6. The method used for sterilization validation was the overkill (half-cycle approach) in a fixed chamber. Ethylene oxide residuals were tested and met ISO 10993-7:2008 requirements. |
| Packaging Shelf Life | - Per ASTM F1980-07 | Packaging shelf life has been established per ASTM F1980-07. |
| Simulated Use Performance| - Effectiveness in accessing paranasal sinuses when used with Acclarent NavWire Sinus Navigation Guidewire and CARTO ENT System (performed by ENT surgeons) | Simulated use testing was performed with ENT surgeons performing balloon dilation of the paranasal sinuses utilizing the UltirraNav Sinus Balloon Catheter, Acclarent NavWire Sinus Navigation Guidewire and the CARTO ENT System. The testing demonstrated that the UltirraNav Sinus Balloon used with the Acclarent NavWire and the CARTO ENT System could effectively access the paranasal sinuses. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a numerical count of devices or cases for each test. The document refers to "testing" that was performed and "simulated use testing."
- Data Provenance: The tests described (dimensional, burst pressure, fatigue, biocompatibility, sterilization, simulated use) are non-clinical studies conducted by the manufacturer, Acclarent, Inc. There is no mention of country of origin of data or whether it's retrospective or prospective, as these are non-clinical lab/bench tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- For non-clinical performance tests (e.g., balloon burst, sterilization), "ground truth" is typically established by engineering specifications, material science, and validated test methods rather than expert consensus on interpretation.
- For the simulated use testing, "ENT surgeons" were used. The specific number and qualifications (e.g., years of experience) of these surgeons are not provided in this summary. Their role was to perform surgical tasks, effectively acting as "experts" validating the device's functional performance in a simulated environment.
4. Adjudication Method for the Test Set
- For the non-clinical tests, adjudication methods like 2+1 or 3+1 typically apply to subjective expert reviews of images or cases. These are not applicable here as the criteria are objective measurements against specifications.
- For the simulated use testing, the document states it "demonstrated that the UltirraNav Sinus Balloon used with the Acclarent NavWire and the CARTO ENT System could effectively access the paranasal sinuses." It does not specify an adjudication method among multiple surgeons, implying it was a functional demonstration and evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device (a balloon catheter), not an AI or imaging-based diagnostic/screening tool that would typically involve MRMC studies. The device is a manual surgical instrument intended for dilation.
- Therefore, there is no information on the effect size of human readers improving with AI vs. without AI assistance, as AI assistance is not the primary function or innovation being evaluated here. The "Nav" in the device name refers to its compatibility with an existing navigation system (CARTO® ENT System), which is an aid for surgeons, not an AI interpreting clinical data in the way an AI diagnostic tool would.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- No, a standalone study was not done. This is a hardware medical device (catheter) that is manually operated by a surgeon. It is not an algorithm that can perform standalone without human intervention. Its "navigation" feature is a human-in-the-loop system where the device provides information to the surgeon for guidance.
7. Type of Ground Truth Used
- For the non-clinical tests: Objective specifications and validated test methods/standards (e.g., ISO, ASTM standards, internal engineering specifications for burst pressure, dimensions, etc.).
- For the simulated use testing: Performance by ENT surgeons in a simulated environment, demonstrating "effective access" to paranasal sinuses. This is a form of functional performance validation.
8. Sample Size for the Training Set
- Not applicable. This summary describes the validation of a physical medical device (balloon catheter), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As this is not an AI algorithm, there is no training set or ground truth establishment relevant to machine learning.
§ 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.