(70 days)
The Diego RF Powered Dissector and Drill System's intended use is the cutting and removal of soft and hard tissue in general ENT, Head & Neck, and otoneurologic procedures.
Sinus applications would embody:
- applications in the most moidectorny, polypectorny, septoplasty and
- procedures such as endoscopic DCR antrostomy frontal sinus trephination and irrigation frontal sinus drill-out trans-spehnoidal procedures septal spurs removal
Nasõpharyngeal/laryngeal procedures would comprise:
adenoidectomy laryngeal polypectomy tonsillectomy
laryngeal lesion de-bulking tracheal procedures
Head & Neck procedures would encompass:
soft tissue shaving
rhinoplasty (narrowing of the bony vault & revision of the bony pyramid) removal of fatty (adipose) tissue (lipodebridement) in the maxillary and mandibular regions of the face acoustic neuroma removal
Otology procedures would include:
mastoidectomy
mastoidotomy.
The new Diego RF Powered Dissector and Drill System Console is identical to the console cleared in 510(k) # 020594 (3.08.02). However an additional panel was added to operate the current handpieces with new RF blades that can provide coagulation in addition to powered dissection. Other than coagulation during procedures, there are no new indications for use.
This document is a 510(k) summary for the Diego™ RF Powered Dissector and Drill System. It focuses on demonstrating the substantial equivalence of the new device to previously cleared predicate devices, particularly regarding the addition of RF coagulation capabilities. As such, the information typically requested for AI/ML device evaluations (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies) is not applicable to this type of device submission.
The acceptance criteria for this device and the "study" that proves it meets them are established through a comparison to predicate devices in terms of intended use, functions, and power ratings, rather than a clinical study with performance metrics in the way an AI/ML device would be evaluated. The core of the acceptance is "substantial equivalence."
Here's an breakdown based on the provided text, indicating where information is not applicable (N/A) for this type of medical device clearance:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (an electrical surgical drill/shaver with added RF coagulation), the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The performance is compared in terms of features and power, not diagnostic accuracy or clinical outcomes in a quantified sense like an AI product.
| Feature / Criteria (Derived from Predicate Comparison) | Reported Device Performance (Diego™ RF) |
|---|---|
| Intended Use | General ENT, Head & Neck, and Otoneurologic Procedures |
| Functions | Tissue Removal and RF Coagulation |
| Default Power Rating | 10 Watts |
| Maximum Power Rating | 40 Watts |
| Regulatory Class | Class II |
| Product Code | ERL |
| K020594 Equivalence (Console) | Identical to console cleared in 510(k) #020594 (3.08.02) |
| New Features | Additional panel to operate current handpieces with new RF blades for coagulation |
| New Indications for Use | No new indications for use, other than coagulation during procedures (which is a new feature, not a new clinical indication for use beyond the scope of existing procedures). |
2. Sample size used for the test set and the data provenance
- Sample Size: N/A. This is not a study involving patient data or a test set in the context of an AI/ML device. The "test" for the Diego RF System involves engineering and performance validation against internal specifications and comparison to predicate devices, not analysis of a clinical dataset.
- Data Provenance: N/A.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth in the context of diagnostic accuracy studies is not relevant here. The ground for this device would be its engineering specifications and safe operation relative to its intended use and predicate devices. Regulatory experts within the FDA review the submission.
4. Adjudication method for the test set
- N/A. This concept is typically applied to clinical studies involving human interpretation or assessment, not for the clearance of a surgical instrument.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- N/A. MRMC studies are specific to evaluating AI/ML devices that assist human readers in diagnostic tasks. This device is a surgical tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- N/A. This device is a surgical instrument operated by a human surgeon. It is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- N/A for the definition usually applied to AI/ML devices. For a surgical device, the "ground truth" would relate to its engineering performance as designed (e.g., power output, coagulation effectiveness in a lab setting, safety features) and its stated intended use, all compared against established predicate devices and recognized standards.
8. The sample size for the training set
- N/A. This device is not an AI/ML algorithm that requires training data.
9. How the ground truth for the training set was established
- N/A. This device is not an AI/ML algorithm that requires training data.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.