(83 days)
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.
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.
The provided document is a 510(k) summary for the EMS AIR-FLOW handy PERIO, a dental handpiece. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with detailed acceptance criteria and results.
Therefore, many of the requested sections about specific study design details (sample size, expert qualifications, adjudication, MRMC, standalone performance, training set) cannot be answered from the provided text.
Here's an analysis of what can be extracted based on the document:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported performance metrics for the EMS AIR-FLOW handy PERIO. Instead, it relies on demonstrating "substantial equivalence" to predicate devices. The closest statement to performance is:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Fulfill prospectively defined performance specifications | "Testing conducted demonstrates that the EMS AIR-FLOW handy PERIO fulfills the prospectively defined performance specifications." (No specific metrics or thresholds are provided in this summary.) |
| Similar intended use, operational characteristics, and functional technological characteristics to predicate devices. | "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 handpiece component of the AIR-FLOW MASTER lead to a conclusion of substantial equivalence between the proposed and predicate devices." |
| Indicated for non-surgical removal of subgingival plaque in pockets up to 5mm after initial periodontal treatment. | As stated in "Indications for Use" section. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or the data provenance. It generally refers to "Testing conducted" without providing details on the study design for such testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. The document does not describe a study involving expert-established ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a study involving adjudication of a test set.
5. 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
Not applicable. This device is a dental handpiece, not an AI-powered diagnostic system. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a dental handpiece, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not detail a study involving the establishment of ground truth for performance evaluation in the context of diagnostic accuracy. The "testing" mentioned likely refers to physical and functional performance testing of the device itself (e.g., air flow, powder delivery, structural integrity) rather than clinical accuracy for a diagnostic task.
8. The sample size for the training set
Not applicable. The device is a dental handpiece; there is no mention of a training set as would be relevant for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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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
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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.
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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.
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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 (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
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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
§ 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.