The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Device Description

The proposed AIR-FLOW handy 3.0 PERIO is a modification of the AIR-FLOW handy PERIO Dental Handpiece previously cleared under K092289. This device modification has been submitted as a Special 510(k) Premarket Notification because the indications for use for the proposed AIR-FLOW handy 3.0 PERIO are identical to the parent AIR-FLOW handy PERIO. The fundamental technology and design of the proposed AIR-FLOW handy 3.0 PERIO are essentially identical to the AIR-FLOW handy PERIO dental handpiece.

Both the proposed AIR-FLOW handy 3.0 PERIO and the predicate AIR-FLOW handy PERIO connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and dental powder to a treatment site.

Modifications made to the AIR-FLOW handy PERIO Dental Handpiece to produce the AIR-FLOW handy 3.0 PERIO were limited to minor design changes to enhance the ergonomics of the design, including:

Location of the powder chamber is modified to improve the visibility of the mouth of the patient by the practitioner during the treatment
Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of the patient by the practitioner during the treatment.
Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
The body of the AIR-FLOW handy 3.0 PERIO is made of 2 glued molded parts instead of 1 molded part
The handpiece is shorter and slimmer to improve ergonomics.

Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the AIR-FLOW handy 3.0 PERIO device:

The provided document (K132480) is a 510(k) Premarket Notification for a dental handpiece, the AIR-FLOW handy 3.0 PERIO. This is a Special 510(k), indicating a modification to a previously cleared device (AIR-FLOW handy PERIO, K092289). The focus of this submission is on demonstrating substantial equivalence to the predicate device, primarily through non-clinical performance testing.

Acceptance Criteria and Reported Device Performance

The document states that the modifications were "limited to minor design changes to enhance the ergonomics of the design," and that "The fundamental technology and design...are essentially identical to the AIR-FLOW handy PERIO dental handpiece." This implies that the key acceptance criteria revolve around maintaining the functional performance of the predicate device while incorporating ergonomic improvements.

Since this is a Special 510(k) for minor design changes, the acceptance criteria are not explicitly numerical targets for performance metrics like accuracy or sensitivity, as would be common for diagnostic AI devices. Instead, they are more about demonstrating that the changes do not adversely affect the device's original intended function and safety, and that the ergonomic improvements are indeed effective.

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence
Maintains original intended use for non-surgical removal of subgingival plaque in pockets up to 5mm.	The "indications for use...are identical to the parent AIR-FLOW handy PERIO." The device "deliver[s] a mixture of water, air, and dental powder to a treatment site," similar to the predicate.
Delivers mixture of water, air, and dental powder effectively.	Functionally equivalent to the predicate device in its core mechanism.
Safety and Material Compatibility
Materials are safe and remain compatible with intended use.	"similar in design and materials to the AIR-FLOW handy PERIO Dental Handpiece."
Structural integrity of modified parts (e.g., glued body parts).	Not explicitly detailed, but implied by "functional verification of the hardware modifications."
Ergonomic Improvement Validation
Improved visibility of the patient's mouth due to powder chamber modification.	"Location of the powder chamber is modified to improve the visibility..." "Slimmer shape of the powder chamber to be in-line with the body...to improve the visibility..."
Improved handling due to shorter and slimmer design.	"The handpiece is shorter and slimmer to improve ergonomics."
Ease of use for filling powder chamber and removing residual powder.	"Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels."

Study Details

The primary "study" described is a non-clinical performance testing effort.

Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the devices tested. It refers to "functional verification of the hardware modifications at the component and finished device level." This likely involved testing a certain number of manufactured units, but the exact count is not provided.
- Data Provenance: The testing was "Non-clinical," meaning it was conducted in a laboratory or simulated environment, likely at the manufacturer's facility (E.M.S. ELECTRO MEDICAL SYSTEMS S.A. in Switzerland). It is retrospective in the sense that the testing was performed after the design changes were made to verify them.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document explicitly mentions "user evaluations to validate the design improvements." However, it does not specify the number of users/experts involved in this evaluation, nor their qualifications (e.g., dentists, dental hygienists, or engineering evaluators). The "ground truth" here would be subjective user feedback on ergonomics and ease of use.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- No formal adjudication method is mentioned. The "user evaluations" would likely involve collecting feedback, but there's no indication of a structured multi-expert consensus process.
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 MRMC study was done. This device is a dental handpiece, not an AI-powered diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No standalone algorithm performance study was done. This device does not incorporate AI or algorithms in its function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the functional verification, the "ground truth" was engineering specifications and performance targets (i.e., verifying that the device still sprayed correctly, held powder, etc.).
- For the user evaluations, the "ground truth" was subjective user feedback regarding ergonomic improvements (visibility, handling, ease of use).
The sample size for the training set:
- Not applicable. This device does not involve machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As above, no training set exists for this type of device.

Summary

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K132480

FEB 2 4 2014

AIR-FLOW handy 3.0 PERIO Special 510(k) Premarket Notification 510(k) Summary (per 21 CFR 807.92(c))

1. SPONSOR/MANUFACTURER

E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland

Contact Person: Suzanne Fassio-Hardy Telephone: +41 (0)22 994 47 00

Date Prepared: August 28, 2013

2. DEVICE NAME:

AIR-FLOW handy 3.0 PERIO Proprietary Name: Common/Usual Name: Dental handpiece Classification Name: Dental handpiece and accessories

3. PREDICATE DEVICE

E.M.S. ELECTRO MEDICAL SYSTEMS S.A., AIR-FLOW handy PERIO . (K082791)

4. DEVICE DESCRIPTION

Modifications made to the AIR-FLOW handy PERIO Dental Handpiece to produce the AIR-FLOW handy 3.0 PERIO were limited to minor design changes to enhance

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the ergonomics of the design, including:

· Location of the powder chamber is modified to improve the visibility of the mouth of the patient by the practitioner during the treatment
· Slimmer shape of the powder chamber to be in-line with the body of the device to improve the visibility of the mouth of the patient by the practitioner during the treatment.
· Diameter of the powder chamber cap is reduced to be in-line with new design of the powder chamber.
The powder chamber capacity has been slightly decreased to 21g from 23g to fit new ergonomic design.
· The body of the AIR-FLOW handy 3.0 PERIO is made of 2 glued molded parts instead of 1 molded part
· The handpiece is shorter and slimmer to improve ergonomics.

Accessories were included to aid in filling the powder chamber and removing residual powder from the handpiece channels.

5. INTENDED ÜSE

The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease.

The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

6. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS COMPARED TO THE PREDICATE DEVICE

The proposed AIR-FLOW handy 3.0 PERIO is similar in design and materials to the AIR-FLOW handy PERIO Dental Handpiece. Both the proposed AIR-FLOW handy 3.0 PERIO and the predicate AIR-FLOW handy PERIO connect to a standard turbine connection on a dental operative unit and consists of a hand-held device containing air and water lines, powder chamber with cap and an AIR-FLOW nozzle. The proposed and predicate handpieces deliver a mixture of water, air, and dental powder to a treatment site. Differences between the proposed and predicate handpieces were limited to design changes to improve the ergonomics of the handpiece design and ease of use.

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7. SUMMARY OF NON-CLINICAL PERFORMANCE TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Non-clinical performance testing of the modified handpiece included functional verification of the hardware modifications at the component and finished device level and user evaluations to validate the design improvements. The results confirmed that that the AIR-FLOW handy 3.0 PERIO fulfilled all prospectively defined performance specifications.

8. SUMMARY OF CLINICAL TESTING AS BASIS FOR SUBSTANTIAL EQUIVALENCE

Clinical testing was not conducted.

9. CONCLUSIONS DRAWN FROM NON-CLINICAL AND CLINICAL TESTING

The similarities in intended use, operational characteristics, and functional technological characteristics between the AIR-FLOW handy 3.0 PERIO and the AIR-FLOW handy PERIO lead to a conclusion of substantial equivalence between the proposed and predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

February 24, 2014

E.M.S. Electro Medical Systems SA C/O Cynthia J. M Nolte, Ph.D., RAC Aptiv Solution 62 Forest Street, Suite 300 Marlborough, MA 01752

Re: K132480

Trade/Device Name: AIR-FLOW handv 3.0 PERIO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental handpiece and accessories Regulatory Class: 1 Product Code: EFB Dated: December 18, 2013 Received: December 19, 2013

Dear Dr. Nolte:

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 10 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 Eederal Register.

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Page 2 - Dr. Nolte

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/ResourcesforYou/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kwame O. Ulmer -
S FDA

for

Erin I. Keith, M.S. 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 Statement

510(k) Number (if known): K132480

Device Name:

AIR-FLOW handy 3.0 PERIO

Indications for Use:

The AIR-FLOW handy 3.0 PERIO is intended for patients suffering from periodontal disease.

The AIR-FLOW handy 3.0 PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.

Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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.