(239 days)
No
The description focuses on the mechanical and electrical functions of the device, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No
Explanation: A therapeutic device is used to treat or cure a disease or medical condition. This device is an electrical drive unit for surgical transmission instruments, indicated for procedures like drilling, milling, and sawing in surgical applications. These are surgical tools, not devices that deliver therapy.
No
Explanation: The device description states its function is the "conversion of electrical energy into a mechanical rotary motion" for surgical procedures like drilling and milling, which are interventional actions, not diagnostic ones.
No
The device description clearly states it is an "electrical drive unit, including motor, attachments and accessories" and describes hardware components like a control unit, integrated pump, touch display, and foot control. While software verification is mentioned, the device is fundamentally a hardware system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body (in vitro).
- Device Function: The description clearly states that the AMADEO is an electrical drive unit for surgical instruments used for procedures on the body (drilling, milling, sawing, screwing in soft and hard tissue). It's a surgical tool, not a diagnostic testing device.
- Intended Use: The intended use is for surgical procedures in ENT and Maxillofacial surgery, not for analyzing biological samples.
The device is a surgical instrument used during a procedure, not a device used to diagnose a condition by testing samples.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
ERL, DZI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft and hard tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical testing has been performed showing that the device performs as intended and are substantially equivalent to the predicate device Primado2 (K132264).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
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
2
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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3
510(k) Summary K213221
Image /page/3/Picture/2 description: The image shows a logo with the letters W&H inside a gray, rounded hexagon. To the right of the logo is a green arrow pointing to the right. Inside the green arrow are the words "People have Priority" in white text.
| DATE OF APPLICATION | May 25, 2022 |
|---|---|
| APPLICANT | W&H Dentalwerk Bürmoos GmbH |
| Ignaz-Glaser-Strasse 53 | |
| 5111 Bürmoos | |
| Austria | |
| 0043 - 6274/6236-0 | |
| 0043 - 6274/6236-55 | |
| CONTACT PERSON | Mag. Dr. Gerhard Weidler |
| Regulatory Affairs Manager | |
| 0043 - 6274/6236-9339 | |
| gerhard.weidler@wh.com |
1 Device Name
| Trade Name: | AMADEO (M-UK1015 incl. attachments and
accessories) |
|-----------------------------|---------------------------------------------------------------|
| Common Name: | AMADEO |
| Device Classification Name: | Ear, nose, and throat electric or
pneumatic surgical drill |
2 Classification / Product Code
The AMADEO can be classified according to following device names and product codes:
| Primary
Product
Code | Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Regulation
Number | Device
Classification |
|----------------------------|---------------------------------------------------------------------------|----------------------------------------------------------------------|------------------------------------|----------------------|----------------------|--------------------------|
| ERL | Drill, Surgical, Ent
(Electric or
Pneumatic) Including
Handpiece | Ear, nose, and
throat electric or
pneumatic surgical
drill. | Ear Nose &
Throat | Ear Nose
& Throat | 874.4250 | 2 |
4
| Secondary
Product
Code | Device | Regulation
Description | Regulation
Medical
Specialty | Review
Panel | Regulation
Number | Device
Classification |
|------------------------------|----------------------|------------------------------------------------|------------------------------------|-----------------|----------------------|--------------------------|
| DZI | Drill, Bone, Powered | Bone cutting
instrument and
accessories. | Dental | Dental | 872.4120 | 2 |
Predicate Device / Reference Device 3
| Device | Predicate
Device | Reference
Device | 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
5
6 Technological Characteristics
The technological characteristics of the AMADEO are equivalent to the technological characteristics of the predicate device.
| | W&H Dentalwerk Bürmoos
GmbH - AMADEO
(New Device) | NSK - Primado2
(Predicate Device) | Result |
|------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Device Name | AMADEO | Primado2 | ----- |
| Indications for
Use | The drive unit for surgical
transmission instruments is
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 | The Primado2 is an electrically
powered total surgical system
which is intended for cutting,
drilling, sawing and otherwise
manipulating soft tissue, hard
tissue, bone, bone cement,
prosthesis, implant and other
bone related tissue in a variety
of surgical procedures,
including but not limited to
Cranial (craniofacial and
maxillofacial), ENT,
Endoscopic/Arthroscopic,
Neuro, Orthopedic, Spinal, and
General surgical procedures. | Equivalent 1) |
| Regulation
Number | 874.4850 | 874.4850 | Identical1) |
| Secondary
Regulation
Number | 872.4120 | 872.4120 | Identical 1) |
| Class | II | II | Identical |
| Product Code | ERL, DZI | ERL, DZI, GEY, HWE, HBC,
DZJ, HBE, GFF, EQJ | Equivalent1) |
| Regulation
Generic Name
(Primary Code,
Neurology
excluded) | Drill, Surgical, Ent (Electric or
Pneumatic) Including
Handpiece | Drill, Surgical, Ent (Electric or
Pneumatic) Including
Handpiece | Identical1) |
| Sterility | Provided non-sterile | Provided non-sterile | Equivalent |
| Use | Rx only | Rx only | Equivalent |
| Basic functions | The basic function is the
conversion of electrical
energy into a mechanical
rotary motion. In addition,
depending on the treatment,
a physiological saline
solution is pumped to the
treatment site by a
displacement pump.
Via control unit with
electronics, the user can
change the most crucial
operating parameters within
predetermined limits:
Motor speed
Torque setting
Coolant flow rate via
pump speed control 0 to
100% (100%
corresponds to max.
amount of water)
Transmission ratio with
various handpieces and
contra angle handpieces) | The Primado2 consists of the
control unit, the motor, the foot
control and various handpieces
for use with specific motors.
The control unit drives the
motors during procedures and
is used to control the functions
related to that motor such as
speed and rotational direction.
The control unit also
incorporates the irrigation pump
and controls the irrigation
functions.
The software allows for the
control of the devices features
such as:
speed control
rotational direction
irrigation control
etc. | Equivalent |
| Mains voltage
Frequency | 120 V
50-60 Hz | 120 V
50/60 Hz | Identical |
| Operating Mode | intermittent duty S3 (load
time max. 3min / rest time
min. 5min) | intermittent duty (load/rest
depending on motors used) | Equivalent |
| Foot control | > wireless
wired | > wired | Equivalent |
Device Characteristics Table 6.1
6
7
- 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.