(431 days)
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.
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.
The provided text is related to the FDA 510(k) premarket notification for an Ultrasonic Scaler P7. This document is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study proving device performance against specific acceptance criteria in a clinical context with human interaction.
Therefore, many of the requested categories for a study proving acceptance criteria cannot be extracted from this document, as it focuses on demonstrating safety and efficacy through non-clinical testing and comparison to an already approved device.
Here's the information that can be extracted and a clear indication of what cannot be found in this type of document:
1. A table of acceptance criteria and the reported device performance
This document does not present acceptance criteria in a tabulated format for clinical performance or a direct measure of human improvement with AI. Instead, it lists the non-clinical tests performed to demonstrate safety and performance equivalent to the predicate device.
| Acceptance Criteria Category | Reported Device Performance (as per document) |
|---|---|
| Electrical Safety | Tested according to IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007) and passed. |
| Electromagnetic Compatibility | Tested according to IEC 60601-1-2:2007 and passed. |
| Output Characteristics (Bench Testing) | Tested according to IEC 61205:1993 (Ultrasonics-Dental descaler systems-Measurement and declaration of the output characteristics) and performance is similar to the predicate device (both operate at 28kHz ± 3kHz). |
| Biocompatibility | Tested according to ISO 10993-5:2009 (in vitro cytotoxicity) and ISO 10993-10:2006 (irritation and skin sensitization) for the metal handpiece shell. Results passed. |
| Moist Sterilization Validation | Validated according to AAMI / ANSI ST79:2010 & A1:2010 & A2:2011 & A3:2012 & A4:2013 (Consolidated Text) and passed. |
| Intended Use Equivalence | "has the same intended use" as the predicate device (removal of supra and sub gingival calculus deposits and stain, periodontal pocket lavage, clean and irrigate root canals). |
| Technology Equivalence | "both employ piezoelectric technology and produce ultrasonic vibrations at a frequency of 28kHz ± 3kHz". |
| Component Equivalence | "Have similar main components, i.e. control unit, handpiece cord, handpiece and detachable scaling tips." (Note: handpiece material changed, but biocompatibility validated). |
2. Sample size used for the test set and the data provenance
- Sample size for test set: Not applicable in this context. The testing described is non-clinical bench testing and biocompatibility. For these types of tests, "sample size" would refer to the number of units tested, which is not specified in the summary document. It's not a clinical study involving patients or a test set of data like images.
- Data provenance (country of origin, retrospective/prospective): Not applicable for the non-clinical tests described. The tests were performed to international standards (IEC, ISO, AAMI/ANSI). The manufacturing country is China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This document describes non-clinical testing and regulatory equivalence, not a clinical study with expert-established ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not a study involving expert adjudication of clinical cases.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This is not an AI/software device, and no MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the non-clinical tests, "ground truth" is established by the specifications and standards outlined (e.g., electrical safety standards, biocompatibility thresholds). The "ground truth" for showing equivalence is the performance characteristics of the predicate device.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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
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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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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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 Gaoxin4th RD., Nanning ,Guangxi, 530007, China |
|---|---|
| Primary Contact Person: | Mike GuRegulatory Affairs ManagerOsmunda Medical Device Consulting Co., Ltd.(+86)-020-62321333(+86)-020-86330253 |
| Secondary Contact Person: | Wanqing BiDeputy ManagerNanning Baolai Medical Instrument Co., Ltd.0086-771-38159980086-771-3217883 |
| 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 asteady power. It is composed of a control unit housing agenerator that produces piezo-electric vibrations. The workinginstrument for the ultrasonic scaler is the handpiece, which isconnected to the control unit via a handpiece cord. A scaling tipspecific to a particular procedure is attached to the end of thehandpiece. The ultrasonic scaler connects to an external watersupply and delivers water via connected handpiece. |
| Intended Use: | The ultrasonic scaler is intended to:1. Remove supra and sub gingival calculus deposits andstain from the teeth;2. Carry out periodontal pocket lavage withsimultaneous ultrasonic tip movement;3. 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.
§ 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.