(71 days)
The ACCLARENT® SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used in sinus procedures.
The ACCLARENT SE Inflation Device is an instrument intended to inflate, deflate and monitor pressure in balloon catheters used during sinus procedures. When used in a Balloon Sinuplasty dilation procedure, the inflation device enables the user to inflate the sinus balloon catheter, monitor the pressure within the balloon, and deflate the balloon. The device has a pressure gauge that indicates the atmospheric pressure at which the attached balloon is inflated, a high pressure syringe barrel that indicates the amount of fluid in the chamber, a mechanism to lock/unlock the piston, an ergonomic piston handle, and high pressure tubing used to attach the inflation device to the balloon catheters. The ACCLARENT SE Inflation Device should only be used with Acclarent Sinus Balloon Catheters with balloon sizes less than or equal to 7mmx24mm. Consult the individual Acclarent sinus balloon catheter carton labels for balloon size information.
The Acclarent SE Inflation Device is an instrument designed to inflate, deflate, and monitor pressure in balloon catheters used in sinus procedures.
Here is an analysis of its acceptance criteria and the supporting study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document broadly states that "Bench testing met all acceptance criteria for attributes such as dimensional attributes, cycle fatigue, and reliability following three years of simulated accelerated aging." Specific numerical acceptance criteria are not detailed in the provided text. However, the performance is reported as meeting these criteria.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Attributes | Met acceptance criteria |
| Cycle Fatigue | Met acceptance criteria |
| Reliability (after 3 years simulated accelerated aging) | Met acceptance criteria |
| Intracutaneous Reactivity | Pass |
| Sensitization | Pass |
| In Vitro Cytotoxicity | Pass |
| Systemic Toxicity | Pass |
| Sterility Assurance Level | Demonstrated 10⁻⁶ |
| Ethylene Oxide Residuals | Met ISO 10993-7:2008 requirements |
| Packaging Shelf Life | Established at three years |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify the sample sizes for the "bench testing" that evaluated dimensional attributes, cycle fatigue, and reliability. It also does not specify the provenance of any data (e.g., country of origin, retrospective or prospective). Given that this is a premarket notification for a Class I device and clinical data was deemed "not necessary," it is highly likely that the testing was conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not describe the use of experts to establish a "ground truth" for the test set. Given that the performance data mainly involves bench testing (physical and chemical properties), expert consensus, as typically understood in clinical or image-based studies, would not be applicable here.
4. Adjudication Method for the Test Set
Not applicable. The reported studies are focused on bench testing and biocompatibility, not expert review or adjudication of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data was not necessary to establish the safety and efficacy of the ACCLARENT SE Inflation Device."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This question is not applicable as the device is a manual surgical instrument (an inflation device), not an AI algorithm. Its performance is inherent to its physical and material properties.
7. The Type of Ground Truth Used
For the bench testing, the "ground truth" would be established by engineering specifications, material standards, and validated testing protocols. For biocompatibility, the ground truth is established by the accepted standards (e.g., ISO 10993 series) which define acceptable biological responses. For sterility, the ground truth is a sterility assurance level of 10⁻⁶ validated per AAMI/ANSI/ISO 11135-1: 2007.
8. The Sample Size for the Training Set
Not applicable. The device is a physical instrument, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reason as point 8.
§ 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.