(149 days)
The system, including Image Guided Surgery compatibility, and optional Suction console, is intended for cutting, coagulation, drilling, debriding, and removal of bone, and soft and hard tissue in general ENT, Sinus / Rhinology, Nasopharyngeal / Laryngology, and Head & Neck procedures.
Specific procedures and applications would include: Sinus / Rhinology:
- FESS (Functional Endoscopic Sinus Surgery) .
- Including Endoscopic approaches to: Polypectomy, Ethmoidectomy, o
- Sphenoidectomy, Maxillary Antrostomy, Uncinectomy, Frontal Sinusotomy
- Septal Spur removal ●
- Endoscopic DCR .
- Trans-sphenoidal procedures specifically to create access through the sinuses to the . Pituitary, Skull base, and CSF leak repair
- . Turbinate Reduction / Turbinoplasty
- o Including sub mucosal resection
Nasopharyngeal / Laryngeal:
- Adenoidectomy / Tonsillectomy .
- Laryngeal procedures for Recurrent respiratory papilloma, Lesion de-bulking, . Polypectomy
Head & Neck:
- Soft tissue shaving .
The DIEGO ELITE system is the second generation of the RF Diego® system cleared under K034004. The second generation system offers many improvements over the previous system. The DIEGO ELITE includes a power console with touchscreen, footswitch, reusable handpiece, image guided surgery compatibility, an optional powered suction pump, single use disposable accessories and interchangeable burrs / blades and electrosurgical blades. This second generation device adds monopolar capability, disposable sensing technology, improved blades. improved fluid pathway, a more durable reusable handpiece, a premium tubeset with a declog feature and IGS connector, and a powered suction pump that is an optional accessory that can be used to replace the standard facility suction.
The provided 510(k) summary for the DIEGO ELITE device (K123429) lists performance testing, but it does not express these in terms of specific, quantifiable acceptance criteria or provide a detailed study that measures the device's performance against such criteria. Instead, it describes various types of tests performed to ensure the device functions as intended and meets design specifications, relying on comparative performance to predicate devices for substantial equivalence.
Here's an attempt to extract and infer the requested information based on the available text:
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary for a surgical device like an electrosurgical drill/shaver, formal acceptance criteria with specific numerical targets and measured performance values are typically not explicitly stated in the public summary. The performance is primarily demonstrated through compliance with recognized standards and comparison to predicate devices.
However, based on the "Summary of Performance Testing," we can infer the intent of the acceptance criteria as substantial equivalence to predicate devices and meeting design specifications.
| Acceptance Criterion (Inferred from testing goals) | Reported Device Performance (Summary Statements) |
|---|---|
| Electrical Safety (e.g., against IEC 60601-1, IEC 60601-2-2) | "Basic safety and performance testing was performed in accordance with IEC 60601-1 and IEC 60601-2-2." |
| Mechanical Performance (e.g., tip vibration, torque strength, endurance, force testing, reliability, durability) | "Verification and comparison bench studies were conducted to evaluate the mechanical and functional performance. Testing included: tip vibration, torque strength, endurance, dynamic seal integrity, force testing, reliability, leak testing, ship testing, baseline performance testing, age testing, joint strength, environmental conditioning, durability, aspiration, RF isolation..." |
| Functional Performance (e.g., cutting, coagulation, tissue removal, suction) | "Evidence obtained from preclinical bench tissue (ex vivo) and animal (in vivo) studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability, cutting, coagulation, and removal of tissue." |
| Biocompatibility (e.g., cytotoxicity, sensitization, irritation) | "Full biocompatibility testing (Cytotoxicity, sensitization, and irritation) to ISO10993-1 for the device category was completed... Based on the material assessment, patient contacting materials were tested in accordance with ISO 10993-1, and results are considered passing." |
| Sterility (e.g., Sterility Assurance Level of 10^-6 for EO sterilization) | "Sterilized using Ethylene Oxide, using a cycle validated in accordance with ISO 11135-1 to provide a sterility assurance level of 10^-6." (Inferred from ISO 11135-1 standard, not explicitly stated as SAL in text) |
| Shelf Life Stability (e.g., device maintains functionality and meets specifications over time) | "Accelerated shelf-life studies were conducted to support an initial one year shelf life, with real time testing in process to confirm an initial one year expiration date... The results of the accelerated age testing demonstrate that the device will be stable for the stated shelf-life." |
| Usability/Ergonomics (e.g., device setup, tip rotation, tip malleability) | "Preclinical... studies demonstrate that the system performs substantially equivalent to the predicate devices in relevant aspects associated with usability... Cadaver - evaluated in vivo: Ergonomics, Usability aspects such as device setup, tip rotation, and tip malleability, Overall design confidence. Animal - evaluated in vivo using porcine models: Ergonomics, Usability aspects such as device setup, tip rotation, and tip malleability, Overall design confidence." |
| Thermal Properties (e.g., thermal margin, thermal impact) | "Bench tissue - evaluated ex vivo using bovine tissue: Thermal margin, Thermal impact, Visual comparison of coagulation." |
| Overall Substantial Equivalence (to predicate devices as outline during market approval) | "Testing demonstrated that the device performs as well as or better than the predicate devices." and "The performance of the DIEGO ELITE was compared against the known performance characteristics of the predicate devices. Testing demonstrated that the performance requirements were met, and that the DIEGO ELITE exhibited comparable performance characteristics to the predicates." |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Sizes: The document does not specify exact sample sizes for any of the non-clinical or preclinical tests (e.g., number of bench tissue samples, number of cadavers, number of animals). It only refers to "Representative samples" for stability testing.
- Data Provenance:
- Bench Tissue: Ex vivo using bovine tissue.
- Cadaver: In vivo (though cadaver tissue is technically ex vivo in a surgical context, it implies human anatomy simulation). The country of origin is not specified.
- Animal: In vivo using porcine models. The country of origin is not specified.
- Non-Clinical (electrical, mechanical, functional): Performed in a lab setting; provenance not specified.
- Retrospective or Prospective: These appear to be prospective tests specifically conducted for the 510(k) submission to demonstrate device performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not specify the number of experts or their qualifications for establishing ground truth for the test sets.
- It mentions "surgeon input" was used to confirm appropriate tissue medium for simulated use and bench testing. This suggests expert involvement, but details are absent.
- For preclinical studies, outcomes like "Overall design confidence" were evaluated, implying expert assessment, but again, no specifics on the experts.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for evaluating the test set results. The tests are primarily functional and comparative, with "ground truth" established by the design specifications, recognized standards, and direct observation of performance against predicate devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No, an MRMC comparative effectiveness study was not done. The device being a surgical tool (drill/shaver/electrosurgical unit) means its performance is assessed directly on tissue/cadavers/animals, not through human reader interpretation of images or data.
- Therefore, there is no effect size reported for how human readers improve with or without AI assistance, as AI assistance in this context is not applicable in the way it is for diagnostic imaging devices.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- This question is framed for AI/software devices. In the context of this electrosurgical and drill system, the "standalone" performance refers to the device's intrinsic functional capabilities.
- Yes, standalone performance (without a human-in-the-loop in an interpretive sense) was extensively tested. All the non-clinical/preclinical tests described (electrical, mechanical, functional, biocompatibility, stability, cutting, coagulation, tissue removal, suction, thermal impact) represent the device's standalone performance characteristics. The human operator is integral to using the device, but the device's performance itself is evaluated directly.
7. The Type of Ground Truth Used
The ground truth for this device's performance testing appears to be based on:
- Compliance with Recognized Standards: Meeting the requirements outlined in standards such as IEC 60601-1, IEC 60601-2-2, ISO 10993-1, ISO 14971, etc.
- Design Specifications: The device's ability to "function as intended and met design specifications."
- Comparative Performance to Predicate Devices: "performs substantially equivalent to the predicate devices" and "exhibited comparable performance characteristics to the predicates."
- Direct Observation/Measurement: For aspects like cutting efficiency, coagulation effect, tissue removal, suction efficacy, thermal margins, and mechanical properties.
- Surgeon Input: Used to confirm appropriateness of tissue models and likely for evaluation of usability aspects.
8. The Sample Size for the Training Set
- Not applicable. This device is a surgical instrument, not an AI or machine learning model that requires a "training set." The concept of a training set is relevant for data-driven algorithms.
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, the establishment of ground truth for a training set is not relevant. The device's design and functionality are based on engineering principles, material science, and established medical knowledge, not on learning from a data set.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.