(83 days)
Not Found
No
The summary describes a mechanical dental handpiece and powder for subgingival plaque removal, with no mention of AI, ML, image processing, or data-driven algorithms.
Yes
The device is intended for the "non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment" for patients with periodontal disease, which is a therapeutic intervention.
No
The device is described as an instrument for the non-surgical removal of subgingival plaque, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "handpiece" and is a modification of a previously cleared "Dental Handpiece," indicating it is a physical hardware device.
Based on the provided information, the EMS AIR-FLOW handy PERIO is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body ("in vitro").
- Device Function: The EMS AIR-FLOW handy PERIO is a dental handpiece used for the physical removal of subgingival plaque within the patient's mouth. It's a therapeutic device used directly on the patient, not for analyzing specimens in a lab.
- Intended Use: The intended use clearly states "non-surgical removal of subgingival plaque in pockets up to 5 mm". This is a direct treatment procedure.
Therefore, the EMS AIR-FLOW handy PERIO falls under the category of a dental device used for treatment, not an IVD.
N/A
Intended Use / Indications for Use
The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease.
The EMS AIR-FLOW handy 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 EMS AIR-FLOW handy PERIO is a modification of the AIR-FLOW handy 2 Dental Handpiece that was cleared for marketing as K022119. The proposed EMS AIR-FLOW handy PERIO handpiece is supplied with a flexible thermoplastic nozzle and a prophylaxis powder (cleared for use with the AIR-FLOW MASTER, subject of K.082791) that are specially designed to permit use of the device for the non-surgical removal of subgingival plaque.
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)
Testing conducted demonstrates that the EMS AIR-FLOW handy PERIO fulfills the prospectively defined performance specifications.
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.
Not Found
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
OCT 20 2009
510(k) Summary
for the
E.M.S. ELECTRO MEDICAL SYSTEMS SA EMS AIR-FLOW handy PERIO
1. SPONSOR
E.M.S. ELECTRO MEDICAL SYSTEMS SA Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Contact Person: Suzanne Fassio-Hardy 022 994 47 00 · Telephone:
Date Prepared: October 20, 2009
2. DEVICE NAME
| Proprietary Name: | EMS AIR-FLOW handy PERIO |
|---|---|
| Common/Usual Name: | Dental handpiece |
| Classification Name: | Dental handpiece and accessories |
3. PREDICATE DEVICES
- Electro Medical Systems S.A., AIR-FLOW MASTER (K082791) .
- Electro Medical Systems S.A., AIR-FLOW handy 2 (K022119) .
4. INTENDED USE
The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease.
The EMS AIR-FLOW handy PERIO is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
ם
1
5. DEVICE DESCRIPTION
The EMS AIR-FLOW handy PERIO is a modification of the AIR-FLOW handy 2 Dental Handpiece that was cleared for marketing as K022119. The proposed EMS AIR-FLOW handy PERIO handpiece is supplied with a flexible thermoplastic nozzle and a prophylaxis powder (cleared for use with the AIR-FLOW MASTER, subject of K.082791) that are specially designed to permit use of the device for the non-surgical removal of subgingival plaque.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The proposed EMS AIR-FLOW handy PERIO is similar in design and materials to the AIR-FLOW handy 2 Dental Handpiece and the PERIO-FLOW handpiece component of the AIR-FLOW MASTER. Both the proposed EMS AIR-FLOW handy PERIO and the predicate AIR-FLOW handy 2 connect to a standard turbine connection on a dental operative unit. The PERIO-FLOW handpiece functions as a component of the standalone AIR-FLOW MASTER air polishing unit.
Both the proposed and predicate handpieces deliver a mixture of water, air, and dental powder to a treatment site. The proposed EMS AIR-FLOW handy PERIO handpiece is supplied with a nozzle and prophylaxis powder that allows the device to be used for the nonsurgical removal of subgingival plaque. The predicate AIR-FLOW MASTER is indicated for both supragingival and subgingival use. The predicate AIR-FLOW handy 2 Dental Handpiece is restricted to supragingival applications.
Testing conducted demonstrates that the EMS AIR-FLOW handy PERIO fulfills the prospectively defined performance specifications. The similarities in intended use, operational characteristics, and functional technological characteristics between the AIR-FLOW handy PERIO, the AIR-FLOW handy 2, and the PERIO-FLOW handoiece component of the AIR-FLOW MASTER lead to a conclusion of substantial equivalence between the proposed and predicate devices.
2
Image /page/2/Picture/0 description: The image shows a circular seal with an eagle-like bird in the center. The bird is facing right and has its wings spread. The seal is labeled "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the edge. The text is arranged in a circular fashion to match the shape of the seal.
DEPARTMENT OF REALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
CT & 0 2009
EMS Electro Medical Systems S.A. C/O Cynthia J.M. Nolte, Ph.D., RAC Senior Regulatory Consultant Medical Device Consultants, Incorporated 49 Plain Street North Attleboro, Massachusetts 02760
Re: K092289
Trade/Device Name: EMS AIR-FLOW Handy PERIO Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece and Accessories Regulatory Class: I Product Code: EFB Dated: July 24, 2009 Received: July 29, 2009
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 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.
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.
3
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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Scctions 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 go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Reporta Problem/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/ResourcesforYou/Industry/default.htm.
Sincerely Nours,
Susan Runne
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
EMS AIR-FLOW handy PERIO Device Name:
Indications for Use:
The EMS AIR-FLOW handy PERIO is intended for patients suffering from periodontal disease.
The EMS AIR-FLOW handy 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
RSBetz DDS for Dr. K. Mulay
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K092289