The proposed AIR-FLOW PLUS Prophylaxis Powder is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) as a preservative. This prophylaxis powder is intended to be used with all currently available EMS dental handpieces for AIR-FLOW and PERIO-FLOW treatments. The addition of CPC is to preserve the powder from bacterial contamination by humidity and microorganisms when the container is opened. Clinical studies have not been conducted to demonstrate that the presence of CPC in this device results in improved clinical outcomes.

The principle of operation of the proposed AIR-FLOW PLUS Prophylaxis Powder is identical to predicate and reference device powder is mixed with air and water in the dental handpiece nozzle to create a mechanically abrasive stream used in polishing procedures.

AI/ML Overview

The device in question is the AIR-FLOW PLUS Prophylaxis Powder. It is an erythritol powder containing 0.05% Cetyl Pyridinium Chloride (CPC) used with EMS dental handpieces for cleaning and preparation of teeth. The provided document is a 510(k) summary for this device, determining its substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list specific numerical acceptance criteria in a table. Instead, it describes functional testing and biocompatibility assessments, concluding that "All tests were successfully performed and all acceptance criteria were met". Based on the descriptions, the implicit acceptance criteria are:

Acceptance Criteria Category	Reported Device Performance	Study Type
Shelflife	Met 24 months real-time aging requirements.	Real-time aging study
Biocompatibility	- Cytotoxicity: Passed requirements.	- Sensitization: Passed requirements.
Subgingival Performance (Cleaning)	More efficient at cleaning painted metal plates compared to the PERIO (predicate) powder.	Comparison testing: Cleaning test
Subgingival Performance (Abrasivity)	Equivalent abrasivity to the PERIO (predicate) powder (based on erosion of PEEK).	Comparison testing: Abrasivity test
Supragingival Performance (Cleaning Efficiency)	More efficient than the SOFT (reference device) powder and similar to other marketed supragingival powders (CLASSIC, COMFORT, SOFT) in cleaning painted metal surfaces.	Comparison testing: Cleaning efficiency test using an automated test bench

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes (e.g., number of test specimens, number of repetitions) for any of the performance tests.

Shelflife testing: Not specified.
Biocompatibility testing: Not specified (e.g., number of cell culture replicates, number of animal subjects if applicable).
Comparison testing (Subgingival and Supragingival): Not specified (e.g., number of metal plates, number of PEEK samples, number of cleaning cycles).

The data provenance is from E.M.S. Electro Medical Systems S.A. (Switzerland), the manufacturer. The studies appear to be prospective in nature, as they were conducted specifically to support the 510(k) submission for the new device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This device is not an AI/ML device that generates diagnoses or predictions. Therefore, the concept of "ground truth" established by experts in the context of clinical interpretation (e.g., radiologists interpreting images) does not directly apply. The "ground truth" in this context refers to the defined objective outcomes of the physical and chemical tests.

Shelflife: Determined by laboratory testing following established protocols (e.g., stability assays over time).
Biocompatibility: Determined by standardized laboratory tests conforming to ISO 10993-1, interpreted by qualified toxicologists or biocompatibility experts. The number of such experts is not specified.
Comparison Testing: The "ground truth" for cleaning efficiency and abrasivity is based on objective laboratory measurements (e.g., visual assessment of paint removal, weight loss of PEEK, calculated cleaning efficiency). The "experts" in this case would be the laboratory personnel conducting and analyzing the tests, ensuring adherence to protocols and accurate data collection. Their specific qualifications and numbers are not mentioned.

4. Adjudication Method for the Test Set

Given that the studies are primarily about physical and chemical performance, and not diagnostic or interpretive tasks, a formal "adjudication method" like 2+1 or 3+1 by multiple clinical experts is not applicable. The results are based on objective measurements and established laboratory protocols. Any potential "adjudication" would involve internal quality control processes to ensure test validity and reliability.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML devices that assist human readers in diagnostic tasks, where the impact on human performance is measured. This device is a dental prophylaxis powder, and its performance is evaluated based on physical and chemical properties, not diagnostic accuracy or human interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone AI/ML algorithm performance study was not done. This device is a physical product (prophylaxis powder), not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance evaluation of the AIR-FLOW PLUS Prophylaxis Powder is based on objective laboratory measurements and established physical/chemical standards:

Shelflife: Measured degradation or stability of the product over time.
Biocompatibility: Results of standardized toxicology and irritation assays.
Cleaning efficiency: Quantifiable removal of a paint layer from a metal plate using an automated test bench.
Abrasivity: Measurable erosion of a standard material (PEEK).

This is not expert consensus, pathology, or outcomes data in the traditional clinical sense, but rather factual, measurable outcomes from controlled experiments.

8. The Sample Size for the Training Set

This question is not applicable. The AIR-FLOW PLUS Prophylaxis Powder is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The product's formulation and manufacturing processes are likely developed through research and development, but this is distinct from training an algorithm.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no training set for an AI/ML algorithm.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 11, 2017

E.M.S. Electro Medical Systems S.A. Suzanne Fassio-Hardy Regulatory Affairs Manager -- Dental Chemin de la Vuarpilliere 31 CH-1260 Nyon SWITZERLAND

Re: K171189

Trade/Device Name: AIR-FLOW PLUS Prophylaxis powder Regulation Number: 21 CFR 872.6030 Regulation Name: Oral Cavity Abrasive Polishing Agent Regulatory Class: Class I Product Code: EJR Dated: June 20, 2017 Received: June 20, 2017

Dear Suzanne Fassio-Hardy:

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education (DICE) 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 (DICE) 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.

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for Lori Wiggins, MPT, CLT Acting 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) K171189

Device Name

AIR-FLOW PLUS Prophylaxis Powder

Indications for Use (Describe)

The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

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) Summary for AIR-FLOW PLUS Prophylaxis Powder (K171189)

Date: May 10, 2017

l. SUBMITTTER/ 510(K) HOLDER

E.M.S. Electro Medical Systems S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Primary Contact:

Suzanne FASSIO-HARDY, Regulatory Affairs Manager – Dental Direct: +41 22 99 44 771 Email: sfassiohardy@ems-ch.com

Submission Contact:

Christina Henza chenza@can-do-medical.com

II. DEVICE NAME
Proprietary Name: AIR-FLOW PLUS Prophylaxis Powder Common/Usual Name: Prophylaxis Powder

Classification Name: Oral cavity abrasive polishing agent (872.6030) Device Class: I Product Code: EJR

III. PREDICATE DEVICES

The AIR-FLOW PLUS Prophylaxis Powder is a substantially equivalent new version of the legally marketed 510(k) exempt powders E.M.S PERIO Powder (predicate, exempt but included in K082791 cleared on 02/18/2009) and E.M.S. Soft Powder(reference device exempt but included in K110173 cleared on 04/07/2011). The proposed device is submitted via premarket notification [510(k) pathway] because the addition of CPC will exceed the limitations of the exemptions listed in Sec. 872.9 (b); since CPC has preservative properties, it is considered to be a different fundamental technology.

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Neither the predicate device nor reference device have not been subject to a designrelated recall.

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE

The proposed AIR-FLOW PLUS Prophylaxis Powder is intended to be used with all currently available EMS AIR-FLOW and PERIO-FLOW dental handpieces.

At a high level, the subject and predicate devices are based on the following same technological elements:

Used in EMS AIR-FLOW devices
Powder is mixed with water and air

The following technological differences exist between the subject and predicate devices:

The proposed powder material is erythritol with CPC, the predicate powders are Glycine
. Reduced grain size of powder

The safety and effectiveness questions regarding the material differences are biocompatiblity and performance within the dental handpiece devices. These questions apply to both the new device and the predicate and so the new device does not raise different questions of safety and efficacy. Therefore, the proposed device, AIR-FLOW PLUS Prophylaxis Powder, meets substantial equivalence requirements with regards to the legally marketed 510(k) exempt powders PERIO Prophylaxis Powder.

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VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Shelflife testing:

24 months real time aging

Biocompatibility testing:

The biocompatibility evaluation for the AIR-FLOW PLUS Prophylaxis Powder was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "Surface device -breached or compromised surface" per section 5.2.1(c). The device will have limited contact of less than or equal to 24 hours. Testing completed on this device includes:

Cytotoxicity
Sensitization
Irritation

Comparison Testing:

To verify that the change of material (ingredients and size) does not impact the performance of the powder, functional testing was completed on the proposed device and the predicate devices. Since the requirements for a subgingival powder differ from the requirements of a supra gingival powder, comparison testing is separated into two reports as described below.

Subgingival Applications [comparison to predicate powder (PERIO)]

Comparison testing between the PERIO (predicate) and PLUS (proposed) powders included a cleaning test and an abrasivity test.

The performance of the powder is measured by the capability to clean a metallic plate and by the abrasivity of the powder itself. The cleaning test compares the ability of the powders' to remove paint from a metal plate and the abrasivity test compares the powders' erosion of a known material (PEEK). The results of these two comparison tests show that the two powders are equivalent with respect to performance (abrasivity test) however the PLUS powder (proposed) is more efficient with respect to cleaning.

Supragingival Applications [comparison to reference device powder (SOFT) ]

Comparison testing consists of cleaning efficiency test between the SOFT (reference device) and PLUS (proposed) powders, as well as several other marketed supra gingival powders (CLASSIC, COMFORT, and SOFT). The test is performed using an automated test bench to clean a painted metal surface. Cleaning efficiency is a calculation of flow-rate and time to clean. The results of this comparison test show that the PLUS (proposed) powder is more efficient than the SOFT (reference device), however the cleaning efficiency is similar to other marketed powders.

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All tests were successfully performed and all acceptance criteria were met, thus confirming that AIR-FLOW PLUS Prophylaxis Powder satisfactorily meet requirements. No new questions of safety and effectiveness were identified during review of Risk Management documentation or during execution of comparison testing.

CONCLUSIONS VIII.

Based on the information and supporting documentation provided in the premarket notification, the AIR-FLOW PLUS Prophylaxis Powder is substantially equivalent to the cited predicate and reference devices. Testing demonstrates that the AIR-FLOW PLUS Prophylaxis Powder fulfills prospectively defined design and performance specifications.

Regulation Number and Section

§ 872.6030 Oral cavity abrasive polishing agent.

(a)
Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.