(200 days)
No
The device description focuses on mechanical and ergonomic modifications to a dental handpiece, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended for the non-surgical removal of subgingival plaque in patients with periodontal disease, which is a therapeutic intervention aimed at treating a medical condition.
No
Explanation: The device is described as being indicated for the "non-surgical removal of subgingival plaque" and delivers a mixture used for treatment. There is no mention of it being used to diagnose conditions or gather diagnostic information.
No
The device description clearly indicates it is a physical dental handpiece that connects to a dental operative unit and delivers a mixture of water, air, and powder. It describes hardware modifications and functional verification of hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The AIR-FLOW handy 3.0 PERIO is a dental handpiece that physically removes subgingival plaque using a mixture of water, air, and powder. It is a therapeutic device used directly on the patient's mouth.
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the patient. It is a tool for a physical procedure.
Therefore, the AIR-FLOW handy 3.0 PERIO falls under the category of a medical device used for treatment, not an in vitro diagnostic device used for diagnosis based on sample analysis.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EFB
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Clinical testing was not conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K132480
FEB 2 4 2014
11
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
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
1
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.
2
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.
3
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.
4
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
5
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)