(77 days)
The Turbo 7000™ System's intended use is the cutting and removal of bone and tissue in general ENT, head & neck, and otoneurologic procedures.
Otology procedures would include:
- mastoidectomy and
- mastoidotomy.
Sinus applications would embody:
- septoplasty and
- procedures such as
- the removal of septal spurs,
- polypectomy,
- antrostomy,
- ethmoidectomy/sphenoethmoidectomy,
- frontal sinus trephination and irrigation,
- frontal sinus drill out,
- endoscopic DCR and
- trans-spehnoidal procedures.
Nasopharyngeal/Laryngeal procedures would comprise:
- adenoidectomy,
- tracheal,
- laryngeal polyectomy,
- laryngeal lesion debulking and
- tonsillectomy.
Head and neck procedures would encompass:
- soft tissue shaving,
- rhinoplasty (narrowing of the bony vault and revision of the bony pyramid),
- removal of fatty (adipose) tissue (lipo debridement) in the maxillary and mandibular regions of the face, and
- acoustic neuroma removal.
Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.
The Turbo 7000™ System is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMATM and SKEETER™ handpieces, and the Modified ESSential Shaver.
The Turbo 7000 System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate devices. The intended uses are substantially equivalent to the described predicate Modified ESSential Shaver System and the Xomed System. The Turbo 7000 System is designed to meet UL 2601-1 including German Deviations and Australian Deviations, CSA 22.2 No. 601-1-1 (EN 60601-1), IEC 601-1-2(EN 60601-1-2) and IEC 529.
Additionally, an irrigation pump is integrated into the controller unit to provide irrigant in conjunction with the procedures.
Here's a breakdown of the acceptance criteria and study information for the Turbo 7000™ System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, sensitivity, specificity). Instead, the basis for clearance is substantial equivalence to predicate devices. The document focuses on demonstrating that the Turbo 7000™ System has similar technological characteristics, power modality, mode of operation, and intended uses as the predicate devices, and that differences do not affect safety or effectiveness.
Therefore, the "acceptance criteria" here are qualitative and relate to regulatory compliance and equivalence to established devices.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Technological Equivalence: Same technological characteristics, power modality, and mode of operation as predicate devices. | "The Turbo 7000 System that is described in this notification has the same technological characteristics, power modality and mode of operation as the predicate devices." |
| Intended Use Equivalence: Substantially equivalent intended uses to predicate devices. | "The intended uses are substantially equivalent to the described predicate Modified ESSential Shaver System and the Xomed System." (Detailed intended uses listed, matching the general applications of surgical drills/shavers in ENT, head & neck, and otoneurologic procedures). |
| Safety and Effectiveness: Differences from predicate devices should not affect safety or effectiveness. | "Differences between the Turbo 7000 System and the predicate devices should not affect the safety or effectiveness." (This is a claim, not a quantified measurement of performance.) |
| Regulatory Compliance: Designed to meet relevant safety standards. | "The Turbo 7000 System is designed to meet UL 2601-1 including German Deviations and Australian Deviations, CSA 22.2 No. 601-1-1 (EN 60601-1), IEC 601-1-2(EN 60601-1-2) and IEC 529." |
| Substantial Equivalence Determination by FDA: FDA review and determination of substantial equivalence to legally marketed predicate devices. | "We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." (FDA's final decision confirms this criterion was met.) |
| Predicate Devices: Xomed XPS™ System (with STRAIGHTSHOT™, PERFORMA™, and SKEETER™ handpieces) and the Modified ESSential Shaver. | The document states the Turbo 7000™ System "is substantially equivalent to the Xomed XPSTM System used with the STRAIGHTSHOT™, PERFORMATM and SKEETER™ handpieces, and the Modified ESSential Shaver." |
| General Controls Provisions of the Act: Compliance with regulations for annual registration, device listing, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. | The FDA letter states: "You may, therefore, market the device, subject to the general controls provisions of the Act." This implies the manufacturer is expected to comply with these, as is standard for 510(k) clearance. |
2. Sample Size Used for the Test Set and the Data Provenance
The provided document does not describe a specific clinical or performance test set with a sample size. The 510(k) submission for the Turbo 7000™ System is based on demonstrating substantial equivalence to existing predicate devices through comparison of design, materials, and intended use, rather than a new clinical study. There is no mention of a "test set" and consequently no provenance information (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable as no specific "test set" or ground truth establishment by experts is described in the provided 510(k) summary. The ground truth for this type of submission is the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as no "test set" requiring adjudication is described.
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
An MRMC study was not done. The Turbo 7000™ System is an electrical surgical drill/shaver, not an AI-assisted diagnostic or imaging system. Therefore, the concept of "human readers improving with AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The Turbo 7000™ System is a hardware device (surgical drill/shaver) and does not involve algorithms or standalone performance analysis in the context of AI. It operates with a human surgeon in the loop.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this 510(k) submission, the "ground truth" is effectively the established safety and effectiveness profile of the predicate devices. The applicant is asserting that the new device is as safe and effective as these already legally marketed devices, rather than establishing a new ground truth for a novel claim.
8. The sample size for the training set
This information is not applicable as there is no "training set" mentioned or implied for this type of device submission. The device is not based on a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable as there is no "training set" for the Turbo 7000™ System.
§ 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.