(19 days)
The Relieva Sinus Balloon Inflation Device is recommended for use to inflate the balloon, monitor the pressure within the balloon and deflate the balloon while performing balloon dilation procedures of the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures.
The Relieva Sinus Balloon Inflation Device is a disposable inflation device with a manometer that measures pressures ranging from vacuum to gauge capacity.
The Relieva Sinus Balloon Inflation Device is a Class I manual surgical instrument for ear, nose, and throat procedures. Its intended use is to inflate, monitor pressure, and deflate balloons during dilation of sinus ostia and paranasal sinus cavities.
Here is a summary of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Pressure Accuracy | Not explicitly stated, but implied to meet product specifications. | "conformance to product specification" |
| Pressure Decay | Not explicitly stated, but implied to meet product specifications. | "conformance to product specification" |
| Predicate Comparison | Device is substantially equivalent to marketed predicate devices with respect to intended use and technological characteristics. | Deemed substantially equivalent to predicate devices (K043527, Pre-Amendments) |
| Pressure Integrity | Not explicitly stated, but implied to meet product specifications. | "conformance to product specification" |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing focuses on conformance to product specifications for the device itself rather than clinical patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The ground truth for the device's technical specifications (pressure accuracy, decay, integrity) would be established through engineering and quality control standards, not by medical experts. The "predicate comparison" refers to regulatory comparison, not clinical expert consensus.
4. Adjudication Method for the Test Set
Not applicable. This type of device testing does not involve adjudication by experts as it is focused on technical specifications and substantial equivalence to predicate devices.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This device is a manual surgical instrument, not an AI or imaging diagnostic tool that would typically undergo MRMC studies to evaluate human reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
Not applicable. This is a manual medical device, not an algorithm, so a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used
The ground truth used for this device's testing would be:
- Engineering Specifications: For Pressure Accuracy, Pressure Decay, and Pressure Integrity, the ground truth would be defined by the device's design specifications and industry standards for pressure measurement and containment in medical devices.
- Regulatory Substantial Equivalence: For the Predicate Comparison, the ground truth is established by the U.S. FDA's criteria for substantial equivalence to legally marketed predicate devices, which involves comparing intended use, technological characteristics, and safety and effectiveness.
8. Sample Size for the Training Set
Not applicable. This device is not an AI algorithm, so there is no concept of a "training set" in the context of machine learning. The "testing" described refers to quality control and design verification.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of 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.