(105 days)
No
The summary describes a standard ultrasonic scaling system with a digital interface and wireless foot pedal. There is no mention of AI, ML, or any features that would typically involve such technologies. The performance testing focuses on electrical safety, software validation, and basic device functionality.
Yes
The device is used for ultrasonic procedures, specifically for scaling applications and periodontal debridement, which are therapeutic interventions aimed at treating dental conditions.
No
This device is used for dental cleaning procedures (scaling and debridement), which are therapeutic, not diagnostic.
No
The device description explicitly states it is an "ultrasonic scaling unit" and includes hardware components like a digital touch screen interface, Bluetooth technology, and a wireless foot pedal. The performance studies also include testing of hardware components like the handpiece and radio frequency distance.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for ultrasonic procedures like scaling and periodontal debridement. These are procedures performed directly on the patient's teeth and gums.
- Device Description: The description details an ultrasonic scaling unit used for physical procedures within the mouth.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to be used in vitro (outside the living body) to analyze biological samples. This device is used in vivo (within the living body) for a therapeutic/procedural purpose.
N/A
Intended Use / Indications for Use
Used for ultrasonic procedures:
- All general supra and subgingival scaling applications .
- Periodontal debridement for all types of periodontal diseases .
The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaler which is intended to be used for all general supra and subgingival scaling applications as well as periodontal debridement for all types of periodontal diseases.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology. Tap-On™ Wireless Foot Pedal was cleared under premarket notification K130862 in July 2013.
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)
Performance testing focused on verification of design, ultrasonic scaling performance, and function of the Cavitron Touch® Ultrasonic Scaler. Testing performed included:
- AAMI ANSI ES 60601-1 Medical Electrical Equipment Part 1: General requirements for basic safety and essential performance (2005; reapproved 2012)
- IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility (2007)
- FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation
- Internal specification and testing for handpiece operation, including lavage control
- Internal specification and testing for autocycle operation
- Internal specification and testing for touch screen and user interface functionality
- Internal specification and testing for radio frequency distance for Tap-On™ Wireless Foot Pedal (K130862)
The results of these performance tests support the substantial equivalence of the proposed Cavitron Touch™ Ultrasonic Scaling System with the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334).
No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System.
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
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like figure with three heads, representing health, human services, and the USA. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 16, 2015
Dentsply International, Inc. Ms. Helen Lewis Director of Regulatory Affairs 221 West Philadelphia St., Suite 60W York, Pennsylvania 17401
Re: K150535
Trade/Device Name: Cavitron Touch™ Ultrasonic Scaling System Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: March 17, 2015 Received: March 19, 2015
Dear Ms. Lewis:
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.
1
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 801): medical device reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina
Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital. Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix A Indications for Use Statement
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SECTION 4. INDICATIONS FOR USE STATEMENT
K150535 510(k) Number (if known):
Device Name: Cavitron TouchTM Ultrasonic Scaling System
Indications for Use:
Used for ultrasonic procedures:
- All general supra and subgingival scaling applications .
- Periodontal debridement for all types of periodontal diseases .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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DENTSPLY International
World Headauarters Susquehanna Commerce Center 221 West Philadelphia Street PO Box 872 York, PA 17405-2558 (717) 849-4593 Fax (717) 849-4343
SECTION 5. 510(k) SUMMARY
for
Cavitron Touch™ Ultrasonic Scaling System
1. Submitter Information:
DENTSPLY International Inc. Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17401
| Contact Person: | Helen Lewis |
|---|---|
| Telephone Number: | 717-487-1332 |
| Fax Number: | 717-849-4343 |
27 February 2015 Date Prepared:
2. Device Name:
.
●
- Cavitron Touch™ Ultrasonic Scaling System Proprietary Name:
- Classification Name: Ultrasonic Scaler
- CFR Number: 872.4850 .
- Device Class: .
- Product Code: ELC .
3. Predicate Device:
| Predicate Device Name | 510(k) | Company Name |
|---|---|---|
| Cavitron® RF Ultrasonic | ||
| Scaler System with Sterimate | ||
| Handpiece | K052334 | DENTSPLY International |
| Inc. |
II
4. Description of Device:
The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaling unit that is used in all general supra and subgingival scaling applications and periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System includes a digital touch screen interface and Bluetooth technology. This device is equipped with the Tap-On™ Wireless Foot Pedal with Tap-On™ technology. Tap-On™ Wireless Foot Pedal was cleared under premarket notification K130862 in July 2013.
5
1. Indications for Use:
Used for ultrasonic procedures:
- All general supra and subgingival scaling applications ●
- . Periodontal debridement for all types of periodontal diseases
Substantial Equivalence: 6.
Technological Characteristics
| Proposed Device
Cavitron Touch™ Ultrasonic Scaling
System | Predicate Device
Cavitron® RF Ultrasonic Scaler System
with Sterimate Handpiece (K052334) | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use: | Indications for Use: | |
| Used for ultrasonic procedures | Used for ultrasonic procedures | |
| All general supra and subgingival
scaling applications Periodontal debridement for all
types of periodontal diseases | All general supra and subgingival
scaling applications Periodontal debridement for all
types of periodontal diseases Endodontic procedures | |
| Features:
All functions are touch screen
activated, including the power
setting, power presets, rinse, purge,
scaling, and lock/unlock. All
indicators are also visible on the
touch screen, such as battery,
service, water filter replacement,
boost, manual, and Tap-On. | Features:
All functions are controlled
through the analog power switch or
a button located on the front cover.
These functions include power
setting, rinse, purge, and scaling.
All indicators show on the
information panel, including
battery, service, boost, manual, and
Tap-On. | |
| An adjustment collar on the
handpiece offers the option of finer
water control for precise and
convenient adjustment of lavage on
the handpiece to the preferred
setting. | An adjustment collar on the
handpiece offers the option of finer
water control for precise and
convenient adjustment of lavage on
the handpiece to the preferred
setting. | |
| The power range setting can be
activated in two different ways.
The clinician can touch the screen
to move the circle up or down to
the desired setting, or select one of
the three power preset button
options that are preset to the
clinician's desired power setting. | The power range setting is
controlled by a knob. | |
| Proposed Device | Predicate Device | |
| Cavitron Touch™ Ultrasonic Scaling
System | Cavitron® RF Ultrasonic Scaler System
with Sterimate Handpiece (K052334) | |
| by lines as well as color on the
touch screen. | | |
| Depressing the Tap-On™ Wireless
Foot Pedal to the second positions
initiates Temporary Boost to
increase the stroke of the insert by
at least 25% when at min power. | Depressing the Tap-On™ Wireless
Foot Pedal to the second position
initiates Temporary Boost for a
10% increase in power. | |
| When the power boost feature is
activated, the word "boost" will
show in the "informational
bubble". | When the power boost feature is
activated, the boost indicator will
light up with a pink color
signifying that an additional 10%
of power is in use. | |
| The handpiece is autoclavable/
sterilizable as well as detachable
from the unit. | The handpiece is autoclavable/
sterilizable as well as detachable
from the unit. | |
| The unit is equipped with a round,
battery operated, ergonomically
designed, Tap-On™ Wireless Foot
Pedal. If preferred, the Tap-On™
Wireless Foot Pedal can be
attached by wire. The Tap-On™
Wireless Foot Pedal contains two
positions: one to activate the scaler
and the other to activate the boost
feature. | The unit is equipped with a round,
battery operated, ergonomically
designed, Tap-On™ Wireless Foot
Pedal. If preferred, the Tap-On™
Wireless Foot Pedal can be
attached by wire. The Tap-On™
Wireless Foot Pedal contains two
positions: one to activate the scaler
and the other to activate the boost
feature. | |
| The battery indicator is always
present on the screen. This allows
the clinician to see how much
battery life remains in the wireless
Tap-On™ Wireless Foot Pedal
before it must be recharged. | A battery symbol will light up on
the interface indicating that the
battery in the Tap-On™ Wireless
Foot Pedal needs to be replaced. | |
| The Tap-On™ Wireless Foot Pedal
allows the clinician to use a single
Tap-On™ the foot pedal to activate
or deactivate continuous scaling.
This permits the clinician to rest
their foot during the procedure. | The Tap-On™ Wireless Foot Pedal
allows the clinician to use a single
Tap-On™ the Tap-On™ Wireless
Foot Pedal to activate or deactivate
continuous scaling. This permits
the clinician to rest their foot
during the procedure. | |
| When the Tap-On™ Wireless Foot
Pedal technology is engaged, the
word "Tap-On" will appear in the
"Informational Bubble". | | |
| | Proposed Device | Predicate Device |
| | Cavitron Touch™ Ultrasonic Scaling
System | Cavitron® RF Ultrasonic Scaler System
with Sterimate Handpiece (K052334) |
| - | To deactivate the Tap-On™
technology, the clinician must push
the Tap-On™ button located on the
interface. | To deactivate the Tap-On™
technology, the clinician must
press the Purge and Turbo
simultaneously for a few seconds. |
| - | The Purge cycle allows the
clinician to purge the water lines
by pressing the Purge button
located on the touch screen. The
Purge screen appears and displays
the cycle countdown of 120
seconds or 2 minutes. After the 2
minute cycle is complete, the
screen will return to the Scale
screen. | The Purge cycle allows the
clinician to purge the water lines.
A single push button is used to
activate the 2 minute purge cycle.
The button will stay illuminated
until the cycle is completed. |
| - | The Rinse mode allows the
clinician to rinse the area for the
patient where needed without the
tip moving. Pressing the Rinse
button on the touch screen will
bring up the Rinse screen. The tip
will not move and the system will
only rinse. Once finished with the
Rinse mode, the clinician can press
the Scale button on the touch
screen to return to the Scale screen. | The Rinse mode allows the
clinician to rinse the area for the
patient where needed without the
tip moving. To initiate the Rinse
mode, the clinician will turn the
knob to the Rinse icon until they
feel it click. Once the knob is
properly in place, the tip will not
move and the system will only
rinse. To return to scaling, turn the
knob off of the Rinse icon. |
| - | Sustained Performance System
(SPS), similar to cruise control,
will adjust the power when needed. | Sustained Performance System
(SPS), similar to cruise control,
will adjust the power when needed. |
| - | The flat surfaces of the device
make it easy to clean to minimize
the risk of cross-contamination. A
disposable barrier will be provided
to cover the screen. | This device is easy to clean. To
clean underneath the knob, simply
remove the knob from the device. |
| - | When the water filter needs to be
replaced, the Water Filter Indicator
Light will light up on the touch
screen. | |
| - | The device is internally equipped
with a water solenoid, which is
where the water comes into the
unit and continues to flow to the | The device is internally equipped
with a water solenoid, which is
where the water comes into the
unit and continues to flow to the |
| Proposed Device | Predicate Device | |
| Cavitron Touch™ Ultrasonic Scaling
System | Cavitron® RF Ultrasonic Scaler System
with Sterimate Handpiece (K052334) | |
| handpiece. | handpiece. | |
| - When the device needs to be
serviced, the Service Indicator
Light will appear on the touch
screen. The 4 pre-programmed
service indicators are: missing
handpiece, unit over temperature,
filter replacement, and battery
status. | - When the device needs to be
serviced, the Service Indicator
Light will illuminate on the
interface. | |
| - This device has Bluetooth wireless
technology capabilities. | - This device has radio frequency
(RF) wireless technology
capabilities. | |
| - The half-life of a white LED
backlight, which is used in the
LCD Screen of the device, is
approximately 20,000 hours. | | |
| - The water range setting indicator
goes from 1 – 6 with half
markings. | - The water range setting indicator
goes from 1 – 6 with half
markings. | |
| - It is recommended the plastic
water filter be replaced once a
month. | - It is recommended the plastic
water filter be replaced once a
month | |
| - The system operates over a
frequency range of 28.5 - 31.5
kHz. | - The system operates over a
frequency range of 28.5 - 31.5
kHz. | |
| - The input voltage of the scaler is
100 - 240 VAC, 50 to 60 Hz. | - The input voltage of the scaler is
100 - 240 VAC, 50 to 60 Hz. | |
| - The system provides a means for
control of power (tip stroke) and
lavage flow rates. | - The system provides a means for
control of power (tip stroke) and
lavage flow rates. | |
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The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaler which is intended to be used for all general supra and subgingival scaling applications as well as periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece cleared under premarket notification K052334. The differences in the table above do not raise any new or different types of questions of safety and effectiveness.
9
-
- Non-Clinical Performance Data.
Performance testing focused on verification of design, ultrasonic scaling performance, and function of the Cavitron Touch® Ultrasonic Scaler. Below is a summary of the testing performed:
- Non-Clinical Performance Data.
-
AAMI ANSI ES 60601-1 Medical Electrical Equipment Part 1: General requirements . for basic safety and essential performance (2005; reapproved 2012)
-
. IEC 60601-1-2 Medical Electrical Equipment PART 1-2: General Requirements for Basic Safety and Essential Performance Collateral Standard: Electromagnetic Compatibility (2007)
-
. FDA - Guidelines for the Content of Premarket Submissions for Software Contained in Medical Devices- Software Validation
-
. Internal specification and testing for handpiece operation, including lavage control
-
. Internal specification and testing for autocycle operation
-
Internal specification and testing for touch screen and user interface functionality
-
. Internal specification and testing for radio frequency distance for Tap-On™ Wireless Foot Pedal (K130862)
The results of these performance tests support the substantial equivalence of the proposed Cavitron Touch™ Ultrasonic Scaling System with the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334).
New biocompatibility testing was not required to support the substantial equivalence between the proposed Cavitron Touch™ Ultrasonic Scaling System and the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334). Biocompatibility testing was submitted with the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece and cleared under premarket notification K052334. The Cavitron® Steri-Mate™ Sterilizable Handpiece was previously cleared as Jet-Mate™ Sterilizable Handpiece under premarket notification K023697.
1. Clinical Performance Data
No data from human clinical studies has been included to support the substantial equivalence of the Cavitron Touch™ Ultrasonic Scaling System.
2. Conclusion Regarding Substantial Equivalence
The Cavitron Touch™ Ultrasonic Scaling System is an ultrasonic scaler which is intended to be used for all general supra and subgingival scaling applications as well as periodontal debridement for all types of periodontal diseases. The Cavitron Touch™ Ultrasonic Scaling System has the same intended use, incorporates the same fundamental technology, and has similar indications for use as the predicate Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece cleared under premarket notification K052334. Testing to verify the performance of the Cavitron Touch™ Ultrasonic Scaling System shows that the key features and performance of the Cavitron Touch™ Ultrasonic Scaling System are substantially equivalent to the predicate device, Cavitron® RF Ultrasonic Scaler System with Sterimate Handpiece (K052334).