(85 days)
For patients aged 18 and older, the Relieva Scout™ Multi-Sinus Dilation System is intended to provide a means to access the sinus space and to dilate the sinus ostia and spaces associated with the sphenoid, frontal, and maxillary sinus cavities for diagnostic and therapeutic procedures. In addition, the device is intended to illuminate within and transilluminate across nasal and sinus structures.
The Relieva Scout™ Multi-Sinus Dilation System is a sterile, single-use system that is an integrated device with a handle, rail, balloon catheter, and sinus illumination system with an illuminated ball tip. The packaged device contains the sinus balloon catheter an angle selection tool to enable angular bends for multiple sinus access (sphenoid, frontal, maxillary). The device may be used to access the sinus space and the balloon inflated with sterile water or sterile or saline to dilate the sinus ostia and infandibulum. The inflation device is provided separately. The device may be used in Operating Room and physician office settings.
Here's a breakdown of the acceptance criteria and the study information for the Relieva Scout™ Multi-Sinus Dilation System, based on the provided text:
Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical (bench) testing. Therefore, much of the information typically found in clinical studies (like specific sample sizes for test sets, number of experts for ground truth, or MRMC studies) is not present because it was not required for this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
The device is considered substantially equivalent based on non-clinical performance data. Specific numerical acceptance criteria are not detailed in this summary, but the general categories and outcomes are listed below:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Integrity | Met all acceptance criteria for dimensional attributes, cycle fatigue, balloon burst, and bond separation. |
| Biocompatibility | Demonstrated to be biocompatible in accordance with ISO 10993-1 and AAMI ANSI ISO 10993-1:2009/(R) 2013. |
| Sterilization | Sterilization process validated per AAMI/ANSI/ISO 11135-1:2007, demonstrating a sterility assurance level of 10^-6. Ethylene oxide residuals met ISO 10993-7:2008 requirements. |
| Non-Pyrogenicity | Not tested or labeled as "non-pyrogenic." |
| Packaging Shelf Life | Established per ASTM F1980-07. |
| Overall Performance | The performance data demonstrated that the device performs as intended. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. This documentation focuses on non-clinical (bench) testing, where specific "sample sizes" like those for patient data are not typically reported in this format. The testing would have involved multiple units of the device for each test (e.g., multiple balloons for burst testing).
- Data Provenance: The data is from non-clinical (bench) testing conducted by the manufacturer, Acclarent, Inc., based in Menlo Park, California, USA. It is inherently "prospective" in the sense that the tests were designed and conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable. For non-clinical bench testing, "ground truth" is established by adherence to predefined engineering specifications, standardized test methods (e.g., ISO, AAMI, ASTM standards), and regulatory requirements. There are no "experts" establishing ground truth in the clinical interpretation sense.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are relevant for clinical studies involving human interpretation or uncertain outcomes. For bench testing, results are typically objective measurements against a standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary for the Relieva Scout™ Multi-Sinus Dilation System." This type of study would be for evaluating the effectiveness of the device in a clinical setting, often involving human readers/interpreters, which was not performed for this 510(k) submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a manual surgical instrument, not an algorithm or AI-driven system. Therefore, standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical testing was established by:
- Predefined Engineering Specifications: The device's design and manufacturing specifications.
- Standardized Test Methods: Adherence to international and national standards such as ISO 10993-1, AAMI ANSI ISO 10993-1:2009/(R) 2013 for biocompatibility; AAMI/ANSI/ISO 11135-1:2007 for sterilization; ISO 10993-7:2008 for ethylene oxide residuals; and ASTM F1980-07 for packaging shelf life.
8. The Sample Size for the Training Set
Not applicable. This is a medical device, not an AI/machine learning algorithm. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of medical device.
§ 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.