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510(k) Data Aggregation
(186 days)
SANAO 200L, SANAO 40 /SANAO 40L, SANAO 10L, SANAO PSI / SANAO PSO, SANAO 40ST
This medical device is only intended for dental treatment in the area of dentistry. Is is intended to be used for the following applications:
- SANAO 200 L / 40 ST: The removal of decayed matter, cavity and crown preparations, the removal of filings and surface finishing of tooth and restoration surfaces.
- SANAO 40 / 40 L. / 10 / 10 L.: Cavity preparations, caries excavation, endodontics, surface finishing of tooth and restoration surfaces.
- SANAO PSI / PSO: prophylaxis treatment.
All SANAO Contra-Angle and Straight dental handpieces can be powered by an air-motor or an electronic micro-motor and are intended for use by trained professionals in the field of general dentistry. They are ergonomically shaped, reusable and some models are optionally available with a glass rod lighting system. Depending on the model the devices possess a 1- or 3- port spray or no spray. For different applications and tools there is a range of devices available with different transmissions for maximum output rotations ranging from 8,000 to 200,000 rpm. The devices are color-coded according to their respective gear ratio. The shanks of the instruments are in conformance with the respective ISO standards.
The SciCan SANAO Dental Handpiece, Contra- and Right-Angle Attachment, Dental (K132356) underwent a non-clinical evaluation to demonstrate substantial equivalence to its predicate device, the STATIS Handpieces (K071891). This evaluation primarily relied on literature research and comparison of technological characteristics to existing marketed devices.
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria were based on adherence to recognized international standards for dental handpieces. The reported performance is based on the claim of compliance with these standards and comparison to the predicate devices.
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| ISO 7785-2: Dental Handpieces - Part 2 Straight and Geared Angled Handpieces | All SANAO Handpieces samples were compliant with ISO 7785-2. |
| ISO 1797: Dentistry – Shanks for rotary instruments | Shanks of SANAO instruments conform to respective ISO standards. |
| ISO 3964: Dental Handpieces Coupling dimensions | Coupling for SANAO motor conforms to ISO 3964. |
| ISO 10993-1: Biological evaluation of medical devices | Risk analysis conducted. Materials (Stainless Steel, PEEK) are biocompatible. |
| ISO 14971: Medical devices - Application of risk management to medical devices | Risk analysis was conducted, showing minor risk level. |
| ISO 17664: Sterilization of medical devices - Information to be provided by the manufacturer for the processing of resterilizable medical devices | (Implicitly met as reusable device, documentation provided - not explicitly stated but part of compliance) |
| ISO 17665-1: Sterilization of health care products - Moist heat - Part 1 | (Implicitly met as reusable device, documentation provided - not explicitly stated but part of compliance) |
| ISO 9687: Dental equipment - Graphical symbols | (Implicitly met as device is appropriately labeled/marked) |
| ISO 21531: Dentistry - Graphical symbols for dental instruments | (Implicitly met as device is appropriately labeled/marked) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not explicitly state the specific number of SANAO Handpieces tested in the bench tests. It mentions "All samples were compliant with ISO 7785-2."
- Data Provenance: The evaluation was non-clinical, based on literature research and bench testing. The data provenance would therefore be from internal SciCan testing (bench testing) and publicly available information related to existing medical devices (literature research). No specific country of origin for this data is mentioned, but SciCan GmbH is based in Germany. The study was retrospective in the sense that it relied on existing standards and market data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical evaluation based on engineering and performance standards, not a clinical study requiring expert interpretation of medical images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. As a non-clinical evaluation, there was no adjudication method involving human interpretation of results in the traditional sense of a clinical trial. Compliance with ISO standards was likely determined by engineers and quality assurance personnel.
5. Multi-Reader, Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader, multi-case comparative effectiveness study was not done. The evaluation was non-clinical and focused on device performance specifications.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is a mechanical dental handpiece, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device's evaluation was primarily compliance with established international performance standards (e.g., ISO 7785-2, ISO 1797, ISO 3964) and the demonstrated substantial equivalence to predicate devices based on their known performance and safety profiles.
8. Sample Size for the Training Set
Not applicable. There was no "training set" as this is a mechanical device, not an AI/ML algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
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