(431 days)
Not Found
No
The device description and performance studies focus on standard ultrasonic scaling technology and electrical/biocompatibility testing, with no mention of AI or ML.
Yes
The device is intended to remove calculus deposits and stain, carry out periodontal pocket lavage, and clean and irrigate root canals, all of which are actions to treat or ameliorate a condition.
No
The device is an ultrasonic scaler intended for therapeutic procedures such as removing calculus and stain, performing periodontal pocket lavage, and cleaning root canals. It does not identify or characterize diseases or conditions.
No
The device description clearly outlines physical hardware components including a control unit, generator, handpiece, handpiece cord, and scaling tip. It also mentions connecting to an external water supply. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed (removing calculus and stain, periodontal pocket lavage, cleaning and irrigating root canals) are all procedures performed directly on the patient's teeth and surrounding tissues. IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a device that uses ultrasonic vibrations and water to perform mechanical actions on the teeth and root canals. This is consistent with a therapeutic or procedural device, not a diagnostic one that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this ultrasonic scaler is a medical device used for dental procedures, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ultrasonic scaler is intended to:
-
- Remove supra and sub gingival calculus deposits and stain from the teeth;
-
- Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
-
- Clean and irrigate root canals.
Product codes (comma separated list FDA assigned to the subject device)
ELC
Device Description
Ultrasonic scaler employs piezoelectric technology to produce a steady power. It is composed of a control unit housing a generator that produces piezo-electric vibrations. The working instrument for the ultrasonic scaler is the handpiece, which is connected to the control unit via a handpiece cord. A scaling tip specific to a particular procedure is attached to the end of the handpiece. The ultrasonic scaler connects to an external water supply and delivers water via connected handpiece.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, root canals
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 Tests:
Electrical safety tests according to IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
Electromagnetic Compatibility Test according to IEC 60601-1-2:2007: General requirement for basic safety and essential performance standard: compatibility - Requirements and tests;
Bench testing according to IEC 61205:1993 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics.
Biocompatibility testing according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
Moist sterilization validation according to AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, (Consolidated Text) Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities
Clinical Tests: The subject of this premarket submission, ultrasonic scaler, did not require clinical studies to support substantial equivalence.
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.
Guilin Woodpecker USD-L ultrasonic scaler, K053555
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.
Not Found
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.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 6, 2015
Nanning Baolai Medical Instruments Co., Ltd. c/o Mr. Mike Gu Osmunda Medical Device Service Group Level 7, Jin Gui Business Center 982 Cunyun Road, Baiyun District Guangzhou, Guangdong 510420 CHINA
Re: K140233
Trade/Device Name: Ultrasonic scaler P7 Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: II Product Code: ELC Dated: February 28, 2014 Received: March 3, 2015
Dear Mr. Gu:
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
Page 2 - Mr. Mike Gu
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 (QS) 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/Resourcesfor You/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/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
2
Indications for Use
510(k) Number (if known) K140233
Device Name Ultrasonic scaler P 7
Indications for Use (Describe)
The ultrasonic scaler is intended to:
-
- Remove supra and sub gingival calculus deposits and stain from the teeth;
-
- Carry out periodontal pocket lavage with simultaneous ultrasonic tip movement;
-
- Clean and irrigate root canals.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
| Submitter: | Nanning Baolai Medical Instruments Co., Ltd.,
7th Floor, General Building, Hetai Sci. &Tech. Park, No.9 Gaoxin
4th RD., Nanning ,Guangxi, 530007, China |
|---------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Contact Person: | Mike Gu
Regulatory Affairs Manager
Osmunda Medical Device Consulting Co., Ltd.
(+86)-020-62321333
(+86)-020-86330253 |
| Secondary Contact Person: | Wanqing Bi
Deputy Manager
Nanning Baolai Medical Instrument Co., Ltd.
0086-771-3815998
0086-771-3217883 |
| Device: | |
| Trade Name: | Ultrasonic scaler P7 |
| Common/Usual Name: | Ultrasonic scaler |
| Classification Names: | Ultrasonic scaler |
| Product Code: | ELC |
| RegulationNumber | 21 CFR 872.4850 |
| Date prepared | April 1th, 2015 |
| Number of submission | K140233 |
| Predicate Device(s): | Guilin Woodpecker USD-L ultrasonic scaler, K053555 |
| Device Description: | Ultrasonic scaler employs piezoelectric technology to produce a
steady power. It is composed of a control unit housing a
generator that produces piezo-electric vibrations. The working
instrument for the ultrasonic scaler is the handpiece, which is
connected to the control unit via a handpiece cord. A scaling tip
specific to a particular procedure is attached to the end of the
handpiece. The ultrasonic scaler connects to an external water
supply and delivers water via connected handpiece. |
| Intended Use: | The ultrasonic scaler is intended to:
- Remove supra and sub gingival calculus deposits and
stain from the teeth; - Carry out periodontal pocket lavage with
simultaneous ultrasonic tip movement; - Clean and irrigate root canals. |
| Technology: | The ultrasonic scaler is powered by the piezoelectric technology |
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which is also employed by the predicate device. The electric power is transduced into high-frequency vibration via an ultrasonic transducer.
The working instrument for both the proposed and predicate devices is the handpiece, which is connected to the control unit via a handpiece cord. Both the proposed and predicate ultrasonic scalers connect to an external water supply and deliver water via the handpiece.
Determination of Substantial The ultrasonic scaler and its predicate device : Equivalence:
- have the same intended use;
- both employ piezoelectric technology and produce ultrasonic vibrations at a frequency of 28kHz ± 3kHz;
- Have similar main components, i.e. control unit, handpiece cord, handpiece and detachable scaling tips.
Compared to the predicate device, most of their specifications are identical except that the handpiece of the proposed ultrasonic scaler has a metal shell made from aluminum alloy rather than the plastic material used by the predicate device. The difference does not affect the safety of the proposed device as a biocompatibility testing aiming to the handpiece metal shell was conducted and result pass.
Summary of of Non-Clinical Electrical safety tests according to IEC 60601-1: 2005+CORR. 1 Tests: (2006)+CORR. 2 (2007) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance;
Electromagnetic Compatibility Test according to IEC 60601-1-2:2007: General requirement for basic safety and essential performance standard: compatibility - Requirements and tests;
Bench testing according to IEC 61205:1993 Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics.
Biocompatibility testing according to ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity and ISO 10993-10:2006 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
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Image /page/5/Picture/0 description: The image contains a logo for BAOLAI MEDICAL. The logo features a stylized letter "b" made of several concentric lines. Below the "b" is the text "BAOLAI MEDICAL" in a bold, sans-serif font. The text and the "b" are in a blue color, and the background is white.
Moist sterilization validation according to AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013, (Consolidated Text) Comprehensive Guide To Steam Sterilization And Sterility Assurance In Health Care Facilities
Summary of Clinical Tests: The subject of this premarket submission, ultrasonic scaler, did not require clinical studies to support substantial equivalence. Conclusion: Based on the similarities in intended use, principles of operation, design rationale, test results, and performance, Nanning Baolai Medical Instrument Co., Ltd. considers the ultrasonic scaler to be substantially equivalent to the predicate device USD-L ultrasonic scaler.