(76 days)
No
The description focuses on induction heating and electronic control, with no mention of AI or ML capabilities.
No
The device uses induction heating to remove prostheses, which is a mechanical action rather than a direct therapeutic effect on a disease or condition.
No
The device is used for removing prostheses by using induction heating, which is a therapeutic or procedural function, not a diagnostic one. Its purpose is to perform a physical action (heating to remove a prosthesis), not to identify or determine the nature of a disease or condition.
No
The device description explicitly details hardware components such as a tip, handle, rechargeable lithium battery, and an electronic control board. It also mentions bench testing for electrical safety, EMC, biocompatibility, and battery, which are related to hardware performance and safety.
Based on the provided information, the Rodo Smilekey is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for removing prostheses inside the patient's mouth using induction heating. This is a therapeutic or procedural use, not a diagnostic one.
- Device Description: The device is used to deliver energy to a component inside the patient's mouth. It's a tool for a dental procedure.
- Anatomical Site: The device is used inside the patient's mouth. IVD devices typically analyze samples taken from the body (blood, urine, tissue, etc.) or are used to analyze the body in vitro (outside the living organism).
- Lack of Diagnostic Function: There is no mention of the device analyzing any biological samples, detecting biomarkers, or providing diagnostic information about a patient's health condition.
The Rodo Smilekey is a medical device used for a dental procedure, specifically the removal of prostheses. It does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.
Product codes
NHA
Device Description
The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
The following bench testing was conducted to demonstrate the performance of the Smilekey:
- Electrical safety testing according to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, ● C1:2009/(R)2012 And A2:2010/(R)2012
- . EMC testing according to AAMI/ANSI/IEC 60601-1-2:2014
- Biocompatibility evaluation of the patient contacting materials .
- Identical Handle material to predicate Smileloc Activator (K160786) O
- FDA guidance document titled, "Use of International Standard ISO 10993-1, O 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued on June 16, 2016
- o Cytotoxicity testing of the tip housing material according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Cleaning and disinfection testing with simulated challenge soiling and organism
- FDA guidance document titled, "Reprocessing Medical Devices in Health Care O Settings: Validation Methods and Labeling", issued on May 2, 2011
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for O reprocessing in health care facilities: A quide for medical device manufacturers
- Software verification and validation testing .
- FDA quidance document titled, "Content of Premarket Submission for Software O Contained in Medical Devices", issued on May 11, 2005
- Battery testing according to IEC 62133:2012 .
- Usability testing according to IEC 60601-1-6 Edition 3.1 2013
- . Thermal safety testing to evaluate the temperature rise on implant, abutment and restoration during the unlocking procedure using the Smilekey induction activator, to ensure that temperatures do not exceed established safety limits.
- ASTM F2182-11 testing guidelines were used which included gel media and O simulated use conditions.
- The thermal safety limits were equivalent to the predicate Smileloc Activator O (K160786).
- The results demonstrated that the temperatures were within safe limits. O
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and white and includes the words "U.S. Food & Drug Administration."
Rodo Medical, Inc. % Randy Prebula Partner Hogan Lovells US LLP 555 Thirteen Street NW Washington, District of Columbia 20004 May 23, 2018
Re: K180609
Trade/Device Name: Rodo Smilekey Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 8, 2018 Received: March 8, 2018
Dear Randy Prebula:
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. 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K180609
Device Name
Rodo Smilekey
Indications for Use (Describe)
The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.
Type of Use (Select one or both, as applicable)
X 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 Rodo Medical, Inc.'s Rodo Smilekey (K180609)
Submitter
| Company: | Rodo Medical, Inc. |
|---|---|
| Address: | 6399 San Ignacio Avenue |
| Suite 100 | |
| San Jose, CA 95119 | |
| Phone: | 408-245-7636 |
| Facsimile: | 408-338-6940 |
| Contact Person: | Michael Parsons |
| Date Prepared: | May 10, 2018 |
Subject Device
| Name of Device: | Rodo Smilekey |
|---|---|
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation: | 21 C.F.R. § 872.3630 |
| Regulatory Class: | Class II |
| Product Code: | NHA |
Predicate Device
| Company: | Rodo Medical, Inc. |
|---|---|
| Device Name: | Rodo Abutment System |
| 510(k) Number: | K160786 |
| Regulation: | 21 C.F.R. § 872.3630 |
| Product Codes: | NHA |
Device Description
The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). It is used to deliver induction energy to the Smileloc Sleeve. The Smilekey consists of a tip and handle that uses induction (alternating electromagnetic field) to deliver precise energy to the Smileloc. Only the end of the tip is inserted inside the patient's mouth while the handle is hand-held by the operator. The Smilekey is powered by a rechargeable lithium battery inside the handle. The handle also contains an electronic control board that regulates the entire operation, including LED indicators that let the operator know when energy is being applied to the Smileloc Sleeve and when the unlocking procedure has been completed.
4
Intended Use / Indications for Use
The Rodo Smilekey is intended to be used with the Rodo Abutment System for removing prostheses compatible with Smileloc Sleeve by using induction heating.
Performance Data
The following bench testing was conducted to demonstrate the performance of the Smilekey:
- Electrical safety testing according to AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, ● C1:2009/(R)2012 And A2:2010/(R)2012
- . EMC testing according to AAMI/ANSI/IEC 60601-1-2:2014
- Biocompatibility evaluation of the patient contacting materials .
- Identical Handle material to predicate Smileloc Activator (K160786) O
- FDA guidance document titled, "Use of International Standard ISO 10993-1, O 'Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process", issued on June 16, 2016
- o Cytotoxicity testing of the tip housing material according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- . Cleaning and disinfection testing with simulated challenge soiling and organism
- FDA guidance document titled, "Reprocessing Medical Devices in Health Care O Settings: Validation Methods and Labeling", issued on May 2, 2011
- AAMI TIR12:2010 Designing, testing, and labeling reusable medical devices for O reprocessing in health care facilities: A quide for medical device manufacturers
- Software verification and validation testing .
- FDA quidance document titled, "Content of Premarket Submission for Software O Contained in Medical Devices", issued on May 11, 2005
- Battery testing according to IEC 62133:2012 .
- Usability testing according to IEC 60601-1-6 Edition 3.1 2013
- . Thermal safety testing to evaluate the temperature rise on implant, abutment and restoration during the unlocking procedure using the Smilekey induction activator, to ensure that temperatures do not exceed established safety limits.
- ASTM F2182-11 testing guidelines were used which included gel media and O simulated use conditions.
- The thermal safety limits were equivalent to the predicate Smileloc Activator O (K160786).
- The results demonstrated that the temperatures were within safe limits. O
Substantial Equivalence
The proposed Rodo Smilekey and the predicate Smileloc Activator (part of the Rodo Abutment System K160786) have a similar intended use and similar indications of removing the Smileloc Sleeve from the Rodo Abutment. Both devices are intended to activate the Smileloc Sleeve to release a compatible prosthesis with the Rodo Abutment. Although the subject device uses induction heating instead of resistance heating, this difference in technological characteristics does not raise different questions of safety or effectiveness. Both devices deliver energy to increase the temperature of the Smileloc Sleeve. The induction energy is within safe levels for
5
the oral application. In addition, the performance of the Rodo Abutment System and the thermal safety was verified and validated using the same scientific methodology as the predicate device. In addition, bench testing of the subject device has demonstrated substantial equivalent performance to the predicate device.
Conclusions
The Smilekey is an additional remover device intended for use with the predicate Rodo Abutment System (K160786). Similar to the predicate Smileloc Activator, the Smilekey uses heat to activate and to remove the Smileloc Sleeve. Although the Smilekey has a different heating method when compared to the Smileloc Activator, this difference in technological characteristics does not raise different questions of safety or effectiveness. Performance bench testing of the Smilekey demonstrated equivalent performance as the predicate device. Thus, the Smilekey can be found substantially equivalent to the predicate device.
| | Subject Device
Rodo Smilekey | Predicate Device
Smileloc Activator of Rodo
Abutment System (K160786) | Comparison |
|----------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Rodo Smilekey is intended to
be used with the Rodo Abutment
System for removing prostheses
compatible with Smileloc Sleeve
by using induction heating. | Rodo Abutment System is
intended to be used in
conjunction with compatible
implant systems in the maxillary
or mandibular arch to provide
support for crowns, bridges or
overdentures. | The Indications for Use of
the subject device is derived
from the labeling of the
Smileloc Activator
component of the
overarching Rodo Abutment
System. |
| Heating Method | Induction heating | Resistance heating | Difference in heating
method does not raise
different questions of safety
or effectiveness |
| Type of battery
charge | Lithium Ion | Lithium Ion | Same |
| Is battery
rechargeable? | Yes | No | Battery rechargeability does
not raise additional
questions of safety or
effectiveness |
| Time needed for
tip on crown to
activate | 5 seconds for acrylic restorations,
9 seconds for non-acrylic
restorations (e.g., lithium
disilicate, zirconia) | 15 seconds | Difference in activation time
does not raise different
questions of safety or
effectiveness. Maximum
implant and abutment
temperatures reached
during activation remain
below safety limits. |
| Maximum
implant/abutment
temperature
reached during
activation | Maximum implant and abutment
temperatures during activation
remain below safety limits
established by AAMI/ANSI
ES60601-1:2005/® 2012 and
A1:2012, c1:2009/® 2012 and
a2:2010/® 2012 and Eriksson, AR
et al. | Maximum implant and abutment
temperatures during activation
remain below safety limits
established by AAMI/ANSI
ES60601-1:2005/® 2012 and
A1:2012, c1:2009/® 2012 and
a2:2010/® 2012 and Eriksson, AR
et al. | Same |
Table 1: Comparison of Subject and Predicate Devices
6
| | Subject Device
Rodo Smilekey | Predicate Device
Smileloc Activator of Rodo
Abutment System (K160786) | Comparison |
|-------------------------------------------------------------------|-----------------------------------|-----------------------------------------------------------------------------|------------|
| Type of
indicators to
inform the end
user | LED | LED | Same |
| Regulation of
energy delivery | Internal timer | Internal timer | Same |
| Type of barrier
employed for
infection control
of device | FDA-cleared dental barrier sleeve | FDA-cleared dental barrier sleeve | Same |