(239 days)
The drive unit for surgical transmission instruments is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery
The AMADEO is an electrical drive unit, including motor, attachments and accessories, for surgical transmission attachments which is indicated for: drilling, cutting, sawing, screwing (for placement) of osteosynthesis screws, implants and plates, in soft and hard tissue. The foreseen areas of application will be: ENT (ear, nose, throat) surgery and Maxillofacial surgery. The basic function is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. Depending on the treatment, a physiological saline solution is pumped to the treatment site by a displacement pump. A single-use sterile disposable irrigation tubing set is supplied within the scope of delivery and offered as an accessory. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation/deactivation of the motor and for changing parameters e.g. program, pump state and motor direction.
This document is a 510(k) Premarket Notification from the FDA for the medical device AMADEO, an electrical drive unit for surgical transmission instruments. It primarily focuses on demonstrating substantial equivalence to a predicate device, the NSK Primado2.
The document does not contain an acceptance criteria table or a study proving the device meets specific performance acceptance criteria in the manner one might expect for a new AI/software device submission. This is because the device, AMADEO, is an electro-mechanical surgical drill system, not an AI or software-only diagnostic device. The evaluation focuses on demonstrating its safety and effectiveness are substantially equivalent to a previously cleared device.
Therefore, many of the requested elements (sample size for test/training sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth) are not applicable or not explicitly detailed in the provided text as they would be for an AI diagnostic device.
However, based on the principle of the 510(k) submission, we can infer the "acceptance criteria" is that the device performs as intended and is as safe and effective as the predicate device. The "study that proves the device meets the acceptance criteria" is the entirety of the non-clinical testing performed to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, explicit "acceptance criteria" in the form of performance metrics (like sensitivity, specificity, accuracy) are not provided, as this is an electro-mechanical device, not an AI diagnostic. The "acceptance" is substantial equivalence to the predicate. The performance data and technological characteristics are compared against the predicate device.
| Characteristic | Acceptance Criteria (Equivalent to Predicate) | Reported Device Performance (AMADEO) |
|---|---|---|
| Indications for Use | Equivalent to Primado2 | Drive unit for surgical transmission instruments indicated for drilling, milling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery. (Note: Excludes neurological indications, which is noted as not impacting substantial equivalence). |
| Regulation Number | Identical to Primado2 (874.4850) | 874.4850 |
| Secondary Reg. Number | Identical to Primado2 (872.4120) | 872.4120 |
| Class | Identical to Primado2 (Class II) | II |
| Product Code | Equivalent to Primado2 | ERL, DZI (Predicate also includes GEY, HWE, HBC, DZJ, HBE, GFF, EQJ, but the core ERL, DZI are shared for the applicable uses). |
| Regulation Generic Name | Identical to Primado2 | Drill, Surgical, Ent (Electric or Pneumatic) Including Handpiece |
| Sterility | Equivalent to Primado2 (Provided non-sterile) | Provided non-sterile |
| Use | Equivalent to Primado2 (Rx only) | Rx only |
| Basic Functions | Equivalent to Primado2 | Conversion of electrical energy into mechanical rotary motion. Physiological saline solution pumped to treatment site via displacement pump. Control unit with electronics allows user to change motor speed, torque, and coolant flow rate. |
| Mains Voltage/Frequency | Identical to Primado2 (120V, 50-60 Hz) | 120 V, 50-60 Hz |
| Operating Mode | Equivalent to Primado2 | Intermittent duty S3 (load time max. 3min / rest time min. 5min). (Predicate is "intermittent duty (load/rest depending on motors used)"). |
| Foot Control | Equivalent to Primado2 | Wireless and wired options. (Predicate is wired only, but adding wireless is generally acceptable as an enhancement, not a fundamental difference in safety/effectiveness if properly validated). |
| Biocompatibility | Compliance with ISO 10993 standards | Evaluation performed according to ISO 10993-1, -10, -11, -12, -17, -18, and -23. |
| Electrical Safety/EMC | Compliance with IEC 60601 standards | In compliance with IEC 60601-1 and IEC 60601-1-2. |
| Reprocessing Validation | Per FDA Guidance Document | Validation provided per FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling." Cleaning/disinfection for control unit/foot controller, cleaning/sterilization for motor cable/handpieces. |
| Bench Testing | Meets device specifications | Functional testing performed to test application, settings, features, and touchscreen per device specifications requirements. |
| Software Verification | Compliance with IEC 62304 and FDA Guidance | Verification according to IEC 62304 and FDA Guidance Document for Software Contained in Medical Device; necessary software documentation for moderate level of concern provided. |
2. Sample Size for the Test Set and Data Provenance
Not applicable in the typical sense for an AI/software diagnostic. The "test set" here refers to the physical device and components undergoing bench testing, biocompatibility, electrical safety, and reprocessing validation. The provenance of this would be internal laboratory testing by the manufacturer. No patient data is involved in these types of tests for this device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
Not applicable for this type of electro-mechanical device submission. Ground truth, in this context, would be established by engineering standards, validated test methods, and industry-accepted protocols for safety and performance (e.g., precise measurements, material analyses).
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical image interpretation or similar diagnostic tasks, which is not relevant here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study is for evaluating human performance with and without AI assistance for diagnostic tasks. The AMADEO is a surgical drill and does not involve AI assistance for human readers/interpreters in a diagnostic context.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is relevant for AI diagnostic algorithms. The AMADEO is a physical surgical device. Its software controls the device's functions, but it's not a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for the AMADEO's performance comes from:
- Engineering Specifications and Standards: The device's design, operational parameters (e.g., motor speed, torque), electrical safety, and electromagnetic compatibility are validated against established engineering specifications and international standards (e.g., IEC 60601-1, IEC 60601-1-2).
- Biocompatibility Standards: Materials in contact with the patient are tested against ISO 10993 standards.
- Reprocessing Protocols: The ability to clean and sterilize/disinfect reusable components is validated against FDA guidance and established cleaning protocols.
- Functional Bench Testing: Verification that the device performs its intended functions (e.g., touchscreen responsiveness, motor control) according to its own design specifications.
8. Sample Size for the Training Set
Not applicable. There is no AI model being trained with a training set for this device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model.
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May 26, 2022
W&H Dentalwerk Buermoss GmbH Weidler Gerhard Regulatory Affairs Ignaz-Glaser-Strasse 53 Buermoos, Salzburg 5111 AUSTRIA
Re: K213221
Trade/Device Name: AMADEO, M-UK1015 (incl. attachments and accessories) Regulation Number: 21 CFR 874.4250 Regulation Name: Ear, Nose, And Throat Electric Or Pneumatic Surgical Drill Regulatory Class: Class II Product Code: ERL, DZI Dated: April 21, 2022 Received: April 27, 2022
Dear Weidler Gerhard:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha. M.ChE Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213221
Device Name
AMADEO (M-UK1015, incl. attachments and accessories)
Indications for Use (Describe)
The drive unit for surgical transmission instruments is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue.
Including: ENT surgery and Maxillofacial surgery
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K213221
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| DATE OF APPLICATION | May 25, 2022 |
|---|---|
| APPLICANT | W&H Dentalwerk Bürmoos GmbHIgnaz-Glaser-Strasse 535111 BürmoosAustria0043 - 6274/6236-00043 - 6274/6236-55 |
| CONTACT PERSON | Mag. Dr. Gerhard WeidlerRegulatory Affairs Manager0043 - 6274/6236-9339gerhard.weidler@wh.com |
1 Device Name
| Trade Name: | AMADEO (M-UK1015 incl. attachments andaccessories) |
|---|---|
| Common Name: | AMADEO |
| Device Classification Name: | Ear, nose, and throat electric orpneumatic surgical drill |
2 Classification / Product Code
The AMADEO can be classified according to following device names and product codes:
| PrimaryProductCode | Device | RegulationDescription | RegulationMedicalSpecialty | ReviewPanel | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| ERL | Drill, Surgical, Ent(Electric orPneumatic) IncludingHandpiece | Ear, nose, andthroat electric orpneumatic surgicaldrill. | Ear Nose &Throat | Ear Nose& Throat | 874.4250 | 2 |
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| SecondaryProductCode | Device | RegulationDescription | RegulationMedicalSpecialty | ReviewPanel | RegulationNumber | DeviceClassification |
|---|---|---|---|---|---|---|
| DZI | Drill, Bone, Powered | Bone cuttinginstrument andaccessories. | Dental | Dental | 872.4120 | 2 |
Predicate Device / Reference Device 3
| Device | PredicateDevice | ReferenceDevice | 510(k)Number | 510(k) Holder |
|---|---|---|---|---|
| AMADEO | Primado2 | -------- | K132264 | NSK |
| -------- | Implantmed | K161957 | W&H Dentalwerk |
Device Description 4
The AMADEO is an electrical drive unit, including motor, attachments and accessories, for surgical transmission attachments which is indicated for: drilling, cutting, sawing, screwing (for placement) of osteosynthesis screws, implants and plates, in soft and hard tissue.
The foreseen areas of application will be:
-
ENT (ear, nose, throat) surgery
-
Maxillofacial surgery
The basic function is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. Depending on the treatment, a physiological saline solution is pumped to the treatment site by a displacement pump. A single-use sterile disposable irrigation tubing set is supplied within the scope of delivery and offered as an accessory.
The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters.
The foot control is used for activation/deactivation of the motor and for changing parameters e.g. program, pump state and motor direction.
5 Indications for Use
The drive unit for surgical transmission instruments is indicated for: drilling, cutting, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue.
Including: ENT surgery and Maxillofacial surgery
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6 Technological Characteristics
The technological characteristics of the AMADEO are equivalent to the technological characteristics of the predicate device.
| W&H Dentalwerk BürmoosGmbH - AMADEO(New Device) | NSK - Primado2(Predicate Device) | Result | |
|---|---|---|---|
| Device Name | AMADEO | Primado2 | ----- |
| Indications forUse | The drive unit for surgicaltransmission instruments isindicated for: drilling, milling,cutting, sawing; screwing (forpositioning) ofosteosynthesis screws,implants and plate systemsin soft and hard tissue.Including: ENT surgery andMaxillofacial surgery | The Primado2 is an electricallypowered total surgical systemwhich is intended for cutting,drilling, sawing and otherwisemanipulating soft tissue, hardtissue, bone, bone cement,prosthesis, implant and otherbone related tissue in a varietyof surgical procedures,including but not limited toCranial (craniofacial andmaxillofacial), ENT,Endoscopic/Arthroscopic,Neuro, Orthopedic, Spinal, andGeneral surgical procedures. | Equivalent 1) |
| RegulationNumber | 874.4850 | 874.4850 | Identical1) |
| SecondaryRegulationNumber | 872.4120 | 872.4120 | Identical 1) |
| Class | II | II | Identical |
| Product Code | ERL, DZI | ERL, DZI, GEY, HWE, HBC,DZJ, HBE, GFF, EQJ | Equivalent1) |
| RegulationGeneric Name(Primary Code,Neurologyexcluded) | Drill, Surgical, Ent (Electric orPneumatic) IncludingHandpiece | Drill, Surgical, Ent (Electric orPneumatic) IncludingHandpiece | Identical1) |
| Sterility | Provided non-sterile | Provided non-sterile | Equivalent |
| Use | Rx only | Rx only | Equivalent |
| Basic functions | The basic function is theconversion of electricalenergy into a mechanicalrotary motion. In addition,depending on the treatment,a physiological salinesolution is pumped to thetreatment site by adisplacement pump.Via control unit withelectronics, the user canchange the most crucialoperating parameters withinpredetermined limits:> Motor speed> Torque setting> Coolant flow rate viapump speed control 0 to100% (100%corresponds to max.amount of water)> Transmission ratio withvarious handpieces andcontra angle handpieces) | The Primado2 consists of thecontrol unit, the motor, the footcontrol and various handpiecesfor use with specific motors.The control unit drives themotors during procedures andis used to control the functionsrelated to that motor such asspeed and rotational direction.The control unit alsoincorporates the irrigation pumpand controls the irrigationfunctions.The software allows for thecontrol of the devices featuressuch as:> speed control> rotational direction> irrigation controletc. | Equivalent |
| Mains voltageFrequency | 120 V50-60 Hz | 120 V50/60 Hz | Identical |
| Operating Mode | intermittent duty S3 (loadtime max. 3min / rest timemin. 5min) | intermittent duty (load/restdepending on motors used) | Equivalent |
| Foot control | > wireless> wired | > wired | Equivalent |
Device Characteristics Table 6.1
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- The indications of use of the AMADEO do not include neurological indications. Considering FDA's Guideline "Bundling Multiple Devices or Multiple Indications in a Single Submission, issued June 22, 2007" bundling of different review panels within different review division/group, OHT1 for ENT, Dental and OHT5 for Neurology, is not appropriate. The removal of neurological indications does not influence the device's substantial equivalence. Burs or other corresponding accessories are not part of the submission.
6.2 Summary of Technological Characteristics
The proposed device is similar in terms of design, operating principles and intended use and has similar technological characteristics as the predicate device. The new device shares technological characteristics with the predicate device but also has some differences. The differences in the technological characteristics can be evaluated as minor and reflect market strategy and/or perceived user preferences. The differences do not impact substantial equivalence of the device.
The materials used on this device are also used in the legally marketed predicate device.
7 Performance Data
Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device Primado2 (K132264).
7.1 Biocompatibility
An evaluation of biocompatibility according to ISO 10993-1, ISO 10993-10, ISO 10993-10, ISO 10993-
11, ISO 10993-12, ISO 10993-17, ISO 10993-18 and ISO 10993-23 was performed.
7.2 Electromagnetic Compatibility and Electrical Safety
Electrical safety and EMC testing were conducted. The AMADEO is in compliance with IEC 60601- 1 as well as IEC 60601-1-2.
7.3 Reprocessing Validation
Reprocessing validation was provided per the FDA Guidance Document for "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". Cleaning and intermediate level disinfection validation was provided for the control unit and foot controller. Cleaning and sterilization was provided for the motor cable and handpieces.
7.4 Bench Testing
Functional testing of the AMADEO to test the application, settings, features, and touchscreen per the device specifications requirements.
8 Software
Software verification according to IEC 62304 and the FDA Guidance Document for Software Contained in Medical Device was conducted and the necessary software documentation according to the defined moderate level of concern was provided.
9 Substantial Equivalence Summary / Conclusion
Based on available 510(k) information provided herein, our AMADEO is considered to be substantially equivalent to the predicate device Primado2 in terms of indication for use, materials and technology, design and performance specifications.
§ 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.