(122 days)
No
The description focuses on mechanical and electrical components (ultrasonic movement, peristaltic pump, LEDs) and does not mention any computational or learning capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is indicated for medical purposes such as "Periodontal pocket lavage," "Scaling and root planing," and "Removal of supra and subgingival calculus and stains from teeth," which are therapeutic interventions.
No
The device description and intended use indicate that the PIEZON 250 is used for procedures like scaling, root planing, and calculus removal, which are therapeutic and maintenance functions, not diagnostic ones. There is no mention of it being used to identify or diagnose conditions.
No
The device description clearly outlines hardware components such as a handpiece, control unit, handpiece cord, irrigating bottle, and peristaltic pump. It is a physical device with software controlling its functions, not a software-only device.
Based on the provided information, the PIEZON 250 is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The PIEZON 250 is used directly on the patient's teeth and gums for procedures like scaling and root planing.
- The intended use and device description clearly indicate a therapeutic and procedural function. It's used for physical removal of calculus and stains and for periodontal pocket lavage, not for analyzing biological samples.
- There is no mention of analyzing or testing any biological material. The device delivers ultrasonic movement and irrigant to a tip used in the mouth.
Therefore, the PIEZON 250 falls under the category of a dental device used for treatment and procedures, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- Removal of supra and subgingival calculus and stains from teeth .
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
The proposed PIEZON 250 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.
In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.
The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and the Piezon handpiece. The Piezon handpiece LED is identical to the Piezon handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon handpiece is identical to the Piezon handpiece LED, except that the Piezon handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 250 have been previously cleared (see 510(k) numbers referenced in Section 3).
The modifications made to the miniPiezon to produce the PIEZON 250 include:
- Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
- Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
- One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
- Supported handpieces (Piezon handpiece (FT-215#) and Piezon handpiece LED (FT-223#)
- Ultrasonic generator upgraded to EJ-110. In EJ-110, the Light command, Motor/Solenoid valve command and Pedal command have been added.
- Replacement of external water supply connection with an irrigating liquid bottle to supply irrigant to the handpiece via a peristaltic pump
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Subgingival and supragingival
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dentist or dental hygienist
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 performance testing demonstrates that all design inputs for the PIEZON 250 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance The similarities in intended use, operational characteristics, and requirements. functional technological characteristics between the proposed PIEZON 250 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices. No clinical testing was conducted for this submission.
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.
K050710, K992504, K896749, K022328
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
PIEZON 250 Special 510(k): Device Modification 510(k) Summary (per 21 CFR 807.92(c))
1. SUBMITTER/510(K) HOLDER
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
| Contact Person: | Suzanne Fassio-Hardy |
|---|---|
| Telephone: | +44 (0)22 994 47 00 |
Date Prepared: August 2, 2013
2. DEVICE NAME
| Proprietary Name: | PIEZON 250 |
|---|---|
| Common/Usual Name: | Ultrasonic Scaler |
| Classification Name: | Ultrasonic Scaler (21 CFR 872.4850, Product Code ELC) |
3. PREDICATE DEVICES
The proposed PIEZON 250 is a modification of the E.M.S. ELECTRO MEDICAL SYSTEMS S.A., miniPiezon (K953026).
The Piezon handpiece LED that is compatible with the proposed device was described in the 510(k) premarket notification for the Piezon Master 700 (K093000).
The instruments used with the PIEZON 250 were previously cleared for E.M.S.ELECTRO MEDICAL SYSTEMS S.A:
- · miniMaster Ultrasonic Scaler (K050710)
- · EMS Kermit (K992504)
- · miniPiezon (K953026)
- · Piezon Master 400 (K896749)
- · Piezon Master 600 (K022328)
- · Piezon Master 700 (K093000)
1
. SESCRIPTION
The proposed PIEZON 250 ultrasonic scaler is a modification of the previously cleared miniPiezon (K953026). The working instrument for the scaling function is the handpiece, which is connected to the control unit via a handpiece cord and mounted in a holder on the side of the control unit.
In the proposed PIEZON 250, irrigating liguid is pumped to the handpiece from a 350ml (or 500ml) irrigating bottle by a peristaltic pump rather than from an external water supply. The flow rate of the irrigating liquid is adjusted via a rotating knob located on the side of the control unit.
The PIEZON 250 is supplied with two handpieces - the Piezon handpiece LED (lightemitting diode) and the Piezon handpiece. The Piezon handpiece LED is identical to the Piezon handpiece LED described in K093000 for the Piezon Master 700 ultrasonic scaler (K093000) and contains 6 LEDs in the body of the handpiece and a light guide that is positioned under the nozzle. The Piezon handpiece is identical to the Piezon handpiece LED, except that the Piezon handpiece does not have LEDs or the light guide. All instruments compatible with the PIEZON 250 have been previously cleared (see 510(k) numbers referenced in Section 3).
The modifications made to the miniPiezon to produce the PIEZON 250 include:
- · Shape and contours of the control unit redesigned to accommodate the finger-tip power control, improve aesthetics, facilitate cleaning, and enhance ergonomics
- · Use of a potentiometer for power regulation via the power control knob to improve ultrasonic power control.
- · One operating mode with a Standard power range (0-100% power) for scaling procedures and a Perio range (0-37.5% power) for periodontal procedures
- · Supported handpieces (Piezon handpiece (FT-215#) and Piezon handpiece LED (FT-223#)
- · Ultrasonic generator upgraded to EJ-110. In EJ-110, the Light command, Motor/Solenoid valve command and Pedal command have been added.
- · Replacement of external water supply connection with an irrigating liquid bottle to supply irrigant to the handpiece via a peristaltic pump
5. INTENDED USE
The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
2
. . . . . . . . . . . . . . .
- Periodontal pocket lavage with simultaneous ultrasonic tip movement
- . Scaling and root planing
- Removal of supra and subgingival calculus and stains from teeth .
6. Summary of Technological Characteristics Compared to the Predicate DEVICES
The proposed PIEZON 250 is similar in design and materials to the parent miniPiezon. Both the proposed and parent devices are ultrasonic scalers consisting of a control unit housing an ultrasonic generator that produces piezo-electric vibrations to perform the scaling function. The working instrument for both the proposed and predicate devices is the handpiece, which is connected to a control unit via a handpiece cord. A scaling instrument specific to a particular scaling procedure is attached to the end of the handpiece.
Unlike the predicate miniPiezon, the proposed PIEZON 250 does not have a connection to an external water supply. Instead, the proposed PIEZON 250 contains an irrigating liquid bottle that is mounted at the back of the control unit which supplies irrigating liquid to the connected handpiece via a peristaltic pump. The overall design of the irrigant delivery system for the PIEZON 250, including the peristaltic pump and the compatible irrigation solutions, is identical to that of the predicate Piezon Master 700 with the exception that the Piezon Master 700 allows the user to choose between two irrigating liquid bottles.
Differences between the proposed PIEZON 250 and the predicate miniPiezon and Piezon Master 700 are limited to the irrigant delivery system, compatible handpieces, and the control unit modifications to improve ergonomics and ultrasonic power control described in Section 4. The similarities and differences between the proposed and parent devices are illustrated in the table at the end of this section.
7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE
Non-clinical performance testing demonstrates that all design inputs for the PIEZON 250 were satisfied by the design outputs, that the device meets electrical safety and electromagnetic compatibility requirements, and functional and performance The similarities in intended use, operational characteristics, and requirements. functional technological characteristics between the proposed PIEZON 250 and the parent miniPiezon and predicate Piezon Master 700 lead to a conclusion of substantial equivalence between the proposed and predicate devices.
3
No clinical testing was conducted for this submission.
9. SUMMARY OF OTHER INFORMATION
No other information is available.
10. Conclusions Drawn from Non-Clinical and Clinical Tests
The similarities in intended use, operational characteristics, and functional technological characteristics between the proposed PIEZON 250 and the predicate miniPiezon lead to a conclusion of substantial equivalence between the proposed and predicate devices. A side-by-side comparison of the predicate devices and the proposed device is provided in the table below.
| Item for
Comparison | PIEZON 250
(FT-216#)
Piezon handpiece
Proposed | PIEZON 250
(FT-224#)
Piezon handpiece LED
Proposed | Piezon Master 700
K093000 | EMS miniPiezon
K953026 |
|------------------------|-------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Intended for use in dental
and periodontal
applications performed
by an ultrasonic scaler. | Intended for use in
dental and periodontal
applications performed
by an ultrasonic scaler. | Intended for use in
dental and periodontal
applications performed
by an ultrasonic scaler. | Intended for use in dental
and periodontal
applications performed by
an ultrasonic scaler. |
| Treatment Site | Subgingival and
supragingival | Subgingival and
supragingival | Subgingival and
supragingival | Subgingival and
supragingival |
| Function | Ultrasonic scaling | Ultrasonic scaling | Ultrasonic scaling | Ultrasonic scaling |
| Mechanism of action | Ultrasonic energy | Ultrasonic energy | Ultrasonic energy | Ultrasonic energy |
| Components | • Control Unit
• Foot pedal
• Piezon handpiece*
• Instruments+
• Irrigating liquid bottle | • Control Unit
• Foot pedal
• Piezon handpiece
LED
• Instruments+
• Irrigating liquid
bottle | • Control Unit
• Foot pedal
• Piezon handpiece
• Instruments+
• Irrigating liquid
bottle | • Control Unit
• Foot pedal
• Universal Piezon
handpiece
• Instruments+
• Water hose with quick
connector on device |
Comparison Table for Determination of Substantial Equivalence
*Previously cleared in K093000
All instruments previously cleared (see Section 3)
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 6, 2013
E.M.S. Electro Medical Systems S.A. C/O Cynthia J.M. Nolte Director, Medical Device Regulatory Services Aptiv Solutions 62 Forest Street. Suite 300 Marlborough, MA 01752
Re: K132445
Trade/Device Name: PIEZON 250 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: October 25, 2013 Received: November 6, 2013
Dear Ms. Nolte:
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.
5
Page 2 - Ms. Nolte
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K 132445
PIEZON 250 Device Name:
Indications for Use:
..............................................................................................................................................................................
The PIEZON 250 is a device for delivering ultrasonic movement and irrigant to a stainless steel tip which is used by a dentist or dental hygienist. The indications for use are:
- Periodontal pocket lavage with simultaneous ultrasonic tip movement .
- Scaling and root planing .
- Removal of supra and subgingival calculus and stains from teeth .
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S 2013.12.04 07:46:28 -05'00'
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Special 510{k} Device Modification: PIEZON 250 August 2, 2013
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