Perio-Mate:
Perio-Mate is intended for the following application(s):
Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:
Perio Mate Nozzle Tip is intended for the following application(s):
Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Device Description

The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.

Perio-Mate is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings or hoses to the treatment area. This device is a non-sterile state and intended to be cleaned and sterilized by end-users as a reusable device. This device to be used for supragingival purpose.

During subgingival treatment, Perio Mate Nozzle Tip is connected to the handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inserted in a periodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses.

AI/ML Overview

The provided text is a 510(k) summary for a dental device, the "Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)". It outlines the device's indications for use, technological comparison to predicate devices, and non-clinical tests performed to support substantial equivalence.

However, the document does not contain information regarding acceptance criteria or a study that proves the device meets those criteria in the way typically expected for performance claims related to effectiveness measured by clinical outcomes or diagnostic accuracy (e.g., sensitivity, specificity, accuracy, effect size with human readers).

The non-clinical tests mentioned are related to:

Performance Test: Compliance with standards like ISO 20608:2018 (Dentistry - Powder jet handpieces and powders) and sterilization/reprocessing standards (ISO 17665-1, ISO 17664-1, ISO 17664-2), and FDA guidance documents related to dental handpieces and reprocessing. These tests confirm the device's functional and safety attributes, not direct clinical efficacy metrics.
Biocompatibility Test: Compliance with ISO 10993-1:2018 and FDA guidance on biological evaluation for devices with limited contact with surface medical devices and breached or compromised surfaces. This ensures the material safety of the device.

Based on the provided text, the following points can be addressed:

Table of acceptance criteria and reported device performance:
- Acceptance Criteria: The document refers to compliance with ISO standards (e.g., ISO 20608:2018 for powder jet handpieces and powders, various ISO standards for sterilization and biocompatibility) and FDA guidance documents. Specific numerical performance acceptance criteria (e.g., specific thresholds for removal efficiency of deposits, or clinical outcomes) are not detailed in this summary.
- Reported Device Performance: The summary states that "The tests demonstrate compliance with the requirements of the following standards and guidance." and "The test results demonstrate compliance with the requirements of the following standards and guidance". It doesn't provide specific quantitative performance metrics beyond stating compliance with these standards.
Sample size used for the test set and the data provenance: Not applicable. The "tests" mentioned are non-clinical, primarily for engineering performance, biocompatibility, and reprocessing validation against international standards, not clinical studies with patients or image data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood in studies involving AI or clinical diagnostic accuracy is not relevant here as the tests are non-clinical.
Adjudication method for the test set: Not applicable for the non-clinical tests described.
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: Not applicable. This device is a dental handpiece, not an AI or diagnostic imaging device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical dental tool, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the non-clinical tests, the "ground truth" is defined by the requirements and test methods outlined in the cited ISO standards and FDA guidance documents (e.g., for sterilization efficacy, material compatibility, or functional parameters of the handpiece).
The sample size for the training set: Not applicable. This is a physical device, not an AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices through non-clinical testing for performance against recognized standards (engineering, sterilization, biocompatibility) rather than clinical efficacy studies with specific acceptance criteria that would yield metrics like sensitivity, specificity, or reader improvement.

Summary

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September 20, 2024

Nakanishi Inc. Ikeda Satoru Regulatory Affairs Dept. Tix Tower Ueno 9F 4-8-1, Higashiueno Taito-ku, Tokyo 110-0015 Japan

Re: K241880

Trade/Device Name: Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I, reserved Product Code: EFB Dated: June 28, 2024 Received: June 28, 2024

Dear Ikeda Satoru:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K241880

Device Name

Air Powered Tooth Polishing System (Perio-Mate);

Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)

Indications for Use (Describe)

Perio-Mate:

Perio-Mate is intended for the following application(s):

Removal of supragingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:

Perio Mate Nozzle Tip is intended for the following application(s):

Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) #: K241880

510(k) Summary

Prepared on: 2024-09-18

Contact Details

21 CER 807.92(a)(1)

Applicant Name	NAKANISHI INC.	21 CFR 807.92(a)(1)
Applicant Address	700 Shimohinata Kanuma Tochigi 322-8666 Japan
Applicant Contact Telephone	+81-289-64-7277
Applicant Contact	Mr. Kikuchi Masaaki
Applicant Contact Email	m-kikuchi@nsk-nakanishi.co.jp
Correspondent Name	NAKANISHI INC.
Correspondent Address	TIX TOWER UENO 9F 4-8-1, Higashiueno Taito-ku Tokyo 110-0015 Japan
Correspondent Contact Telephone	+81-358-28-8590
Correspondent Contact	Mr. Ikeda Satoru
Correspondent Contact Email	nskra-contact@nsk-nakanishi.co.jp
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	Air Powered Tooth Polishing System (Perio-Mate);Air Powered Tooth Polishing System (Perio Mate Nozzle Tip)
Common Name	Dental handpiece and accessories
Classification Name	Handpiece, Air-Powered, Dental
Regulation Number	872.4200
Product Code(s)	EFB
Legally Marketed Predicate Devices	21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K151912	AIR-FLOW handy 3.0 PLUS	EFB
K171174	PERIO-FLOW nozzle	EFB

Perio-Mate

This device is used to remove stains and deposits by spraying the polishing powder and water mixed by compressed air when connected with chair units through couplings and hoses to the treatment area. This device consists of a handpiece and a powder case. Couplings connected with powder case of this device have different structures, This device is developed, considering the connection with each manufacture's type. Some of them have the direct connection with hose that is with accordance with ISO 9186. This device is delivered in a non-sterile state and sterilized by end-users as a reusable device. This device to be used for sub and supraginal purpose. During subgingival treatment, Perio Mate Nozzle Tip is of

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the handpiece.

Perio Mate Nozzle Tip

This device is connected to the Perio-Mate handpiece. The compressed air makes the tooth polishing agent in the Perio-Mate mixed and transfers it to the tip. The product is inseriodontal pocket, sprays the tooth polishing agent/water to the treatment area in the subgingival area, and enables to remove the deposits from teeth surface or prostheses. The product is EOG sterile single-use device.

Intended Use/Indications for Use

21 CFR 807.92(a)(5)

Perio-Mate:

Perio-Mate is intended for the following application(s):

Removal of supragival/subgingival soft deposits and soft deposits on prostheses (including implant abutments).

Perio Mate Nozzle Tip:

Perio Mate Nozzle Tip is intended for the following application(s):

Removal of subgingival soft deposits and soft deposits on prostheses (including implant abutments).

The Perio Mate Nozzle Tip and Perio-Mate is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Indications for Use Comparison

Both the Indications for Use for the subject device and the Indications for Use for the predicate device are intended for dental applications, including the removal of supragingival soft deposits on prostheses (including implant abutments).

The subject, predicate and reference device are indical for the non-surgical removal of subgingival plague in pockets up to 5 mm. The only difference between the Indictments for Use is the Device Name and product description.

Technological Comparison

21 CFR 807.92(a)(6)

21 CFR 807.92(a)(5)

The Air Powered Tooth Polishing System includes the Perio-Mate, which consists of a handpiece and the Perio Mate Nozzle Tip, which is connected to the end of the Perio-Mate handpiece.

The subject device shares these technical characteristics with the predicate device. These differences are only minor, such as the Perio Mate Nozzle Tip being an EOG sterilized disposable device, and dimensions. The Perio Mate Nozzle Tip being EOG sterilized, disposable, features that are not present in the predicate device but are present in the references reflect user preferences and market strategies and do not affect the substantial equivalence of the subject device.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CER 807.92(b)

Non-Clinical Tests

For Air Powered Tooth Polishing System, the following non-clinical tests were performed to support substantial equivalence of the subject device.

Performance Test:

The Air Powered Tooth Polishing System subjected to verification and validation testing for product performance and reprocessing to support substantial equivalence. The rests demonstrate compliance with the requirements of the following standards and guidance.

· ISO 20608:2018 "Dentistry - Powder jet handpieces and powders"

• ISO 17665-1:2006 "Sterilization of health care products - Moist heat - Part 1: Requirements for the development validation and routine control of a sterilization process for medical devices"

· ISO 17664-1:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices"

· ISO 17664-2:2021 "Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices."

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· FDA guidance document "Dental Handpieces - Premarket Notification [510(k)] Submissions"

· FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" Biocompatibility Test:

Based on its Indications for Use, the Air Powered Tooth Polishing System, is classified as a device that has limited contact (less than 24 hours) with surface medical devices and breached or compromised surfaces.

To support substantial equivalence, biocompatibility testing was conducted. The test results demonstrate compliance with the requirements of the following standards and guidance:

· ISO 10993-1:2018 "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process"
· FDA guidance document "Biological evaluation of medical devices Part 1: Evaluation and testing within a risk process"

The Non-Clinical Tests result support the substantial equivalence of the subject Air Polishing System to the predicate device.

Regulation Number and Section

§ 872.4200 Dental handpiece and accessories.

(a)
Identification. A dental handpiece and accessories is an AC-powered, water-powered, air-powered, or belt-driven, hand-held device that may include a foot controller for regulation of speed and direction of rotation or a contra-angle attachment for difficult to reach areas intended to prepare dental cavities for restorations, such as fillings, and for cleaning teeth.(b)
Classification. Class I.