(140 days)
No
The device description and performance studies focus on the physical properties and performance of a prophylaxis powder, with no mention of AI or ML.
No
The device is a powder used for cleaning and preparation of teeth, which is a prophylactic measure rather than a therapeutic treatment for a disease or condition. Its purpose is mechanical abrasion for polishing, not treatment.
No
This device is a prophylaxis powder used for cleaning and preparation of teeth, not for diagnosing conditions.
No
The device is a prophylaxis powder, which is a physical substance used in dental procedures. The description clearly outlines its composition and how it is used with dental handpieces, indicating it is a hardware component (a consumable material) and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cleaning and preparation of teeth" using a mechanical abrasive stream. This is a physical action performed on the tooth surface, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a powder used in a dental handpiece to create a stream for cleaning. It contains a preservative, but its primary function is mechanical abrasion.
- Lack of Diagnostic Purpose: There is no mention of the device being used to detect, measure, or analyze any substance or characteristic in a sample (like blood, urine, tissue, etc.) for the purpose of diagnosing a disease or condition.
- Performance Studies: The performance studies focus on shelf life, biocompatibility, cleaning efficiency, and abrasivity – all related to the physical properties and safety of the powder for its intended cleaning purpose. There are no studies related to diagnostic accuracy or performance.
In summary, the AIR-FLOW PLUS Prophylaxis Powder is a dental device used for cleaning teeth, which is a therapeutic or prophylactic procedure, not a diagnostic one.
N/A
Intended Use / Indications for Use
The AIR-FLOW PLUS Prophylaxis Powder is indicated for use with EMS dental handpieces for cleaning and preparation of teeth.
Product codes
EJR
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
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
Shelflife testing: 24 months real time aging.
Biocompatibility testing: 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" published June 16, 2016. Device categorized as "Surface device - breached or compromised surface" per section 5.2.1(c), with limited contact of less than or equal to 24 hours. Testing included: Cytotoxicity, Sensitization, Irritation.
Comparison Testing:
Subgingival Applications (comparison to predicate powder (PERIO)): Included a cleaning test and an abrasivity test. Performance measured by capability to clean a metallic plate and abrasivity (erosion of PEEK). Results showed PLUS powder (proposed) is equivalent to PERIO in performance (abrasivity) and more efficient in cleaning.
Supragingival Applications (comparison to reference device powder (SOFT)): Cleaning efficiency test between SOFT (reference device) and PLUS (proposed) powders, and other marketed supra gingival powders (CLASSIC, COMFORT, and SOFT). Test performed using an automated test bench to clean a painted metal surface. Cleaning efficiency is a calculation of flow-rate and time to clean. Results showed PLUS (proposed) powder is more efficient than SOFT (reference device) and similar to other marketed powders.
All tests were successfully performed and all acceptance criteria were met.
Key Metrics
Not Found
Predicate Device(s)
exempt but included in K082791
Reference Device(s)
exempt but included in K110173
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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.
- 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.