(23 days)
To locate, illuminate within, and transilluminate across nasal and sinus structures in patients aged 18 and over.
The PathAssist LED Light Fiber is a flexible instrument that emits light from the distal end. The LED Light Fiber is provided sterile and is for single use only. The device consists of a flexible illumination fiber, a protective sheath and an integrated battery powered LED light source. When the LED Light Fiber is activated the fiber will emit red light from the distal tip for over 60 minutes. It has a fiber nominal working length of 27.6cm with an outer diameter of 0.375mm (0.015").
The PathAssist LED Light Fiber is packaged alone or may be packaged with XprESS (LoProfile suction tip).
This document describes the PathAssist LED Light Fiber, a device intended to locate, illuminate within, and transilluminate across nasal and sinus structures. The document is a 510(k) summary submitted to the FDA, indicating a claim of substantial equivalence to a predicate device, rather than a clinical study establishing new performance criteria. Therefore, the information provided focuses on demonstrating equivalence to an existing device rather than presenting detailed acceptance criteria and a study proving the device meets them in a conventional sense.
Here's a breakdown based on the provided text, addressing the requested information to the extent possible:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for substantial equivalence, formal "acceptance criteria" for novel performance metrics are not explicitly stated in this document. Instead, the focus is on meeting "design specifications" and performing "as intended," which is implicitly tied to the performance of the predicate device.
| Performance Characteristic | Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Light Emission Duration | Over 60 minutes (based on predicate or new design spec) | Emits red light from the distal tip for over 60 minutes |
| Fiber Nominal Working Length | 27.6 cm (based on design specification) | 27.6 cm |
| Outer Diameter | 0.375 mm (0.015") (based on design specification) | 0.375 mm (0.015") |
| Sterility | Sterile and for single use | Provided sterile and is for single use only |
| Functional Performance | Performs as intended | Meets design specifications and performed as intended |
| Mechanical Performance | Performs as intended | Meets design specifications and performed as intended |
| Compatibility | Performs as intended | Meets design specifications and performed as intended |
| Thermal Safety | Safe | Meets design specifications and performed as intended |
| Biocompatibility | Biocompatible (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| Packaging | Adequate for sterility, shelf life (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| Shelf Life | Adequate for intended use (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
| EMC and Electrical Safety | Complies with standards (implicit from predicate) | Not submitted, but claimed equivalent to predicate |
2. Sample Size Used for the Test Set and Data Provenance
The document states: "Performance testing of the PathAssist LED Light Fiber consisted of design verification testing to support the device modifications." It does not specify a "test set" in the context of clinical or large-scale comparative studies. The testing described is primarily benchtop design verification.
- Sample Size: Not specified for individual tests.
- Data Provenance: Not applicable in the context of clinical data. It's internal company design verification data. This is retrospective in the sense that it evaluates the modified device's adherence to design specifications.
3. Number of Experts Used to Establish Ground Truth and Qualifications of Experts
This information is not applicable as the document describes design verification testing, not a clinical study involving human readers or expert ground truth panels.
4. Adjudication Method for the Test Set
This information is not applicable as there is no "test set" in the context of expert review or clinical trial adjudication. Design verification results are typically evaluated against established engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done. The document explicitly states: "animal and clinical data were not submitted."
6. Standalone Performance Study
A standalone performance study (i.e., algorithm only without human-in-the-loop performance) was not done in the clinical sense. The "performance data" refers to "design verification testing" (functional, mechanical, compatibility, thermal safety), which assesses the device's physical and operational characteristics, not its clinical efficacy in a standalone context.
7. Type of Ground Truth Used
The "ground truth" for the design verification testing would be the engineering design specifications and established quality control parameters for the device's physical and functional attributes.
8. Sample Size for the Training Set
This information is not applicable. This device is a physical medical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is 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.