(241 days)
The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is intended for patients suffering from periodontal disease.
The PERIO-FLOW nozzle, used with EMS PERIO-FLOW dental handpieces, is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment.
The PERIO-FLOW nozzle is a flexible, thermoplastic accessory to the PERIO-FLOW handpiece that is used with the EMS AIR-FLOW devices such as AIR-FLOW MASTER, AIR-FLOW MASTER PIEZON and AIR-FLOW handy PERIO and AIR-FLOW handy 3.0 Perio. The PERIO-FLOW nozzle includes printed markings and is molded from an alternate version of the cleared thermoplastic polyester elastomer. The marks are arranged to ensure that the user is aware of the location of the tip with respect to the pocket. There is a mark at 3 mm and 5 mm so that the user can evaluate the location of the tip during a procedure. The 5mm mark is bolder to indicate the depth limit. The line and the square located above the 5 mm line serve to ensure that the user does not insert the nozzle deeper than 5mm in the pocket. The PERIO-FLOW nozzle is provided non-sterile. The nozzle is single use only and is intended for use under clean conditions.
The principle of operation of the proposed PERIO-FLOW nozzle is identical to predicate device nozzle (DT-113) which was cleared with the predicate system AIR-FLOW handy 3.0 PERIO (K132480 cleared on 02/24/2014).
EMS dental handpieces connect to a standard turbine connection on a dental operative unit and deliver a mixture of water, air, and the prophylaxis powder to a treatment site. The air /powder mixture exits the distal end of the PERIO-FLOW handpiece through the PERIO-FLOW nozzle where it meets with a water spray in the pocket.
The PERIO-FLOW nozzle is a Class I dental accessory intended for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment, used with EMS PERIO-FLOW dental handpieces. The device was deemed substantially equivalent to its predicate, the E.M.S. Electro Medical Systems S.A., AIR-FLOW handy 3.0 PERIO (K132480).
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Meets the requirements of ISO 10993-1:2009 for "Surface device breached or compromised surface" (limited contact ≤ 24 hours), specifically for: - Cytotoxicity - Sensitization - Irritation | All biocompatibility tests (Cytotoxicity, Sensitization, Irritation) were successfully performed, and all acceptance criteria were met. |
| Comparison Testing | To function correctly with specified dental handpieces, verifying:- Connection force- Pressure resistance- Nozzle fixation | Comparison testing between the current material (predicate) and the new material (subject device) for the nozzle successfully measured connection force, pressure resistance, and nozzle fixation. All acceptance criteria were met. |
| Functional Testing | To ensure the material change does not impact performance, specifically confirming:- Placement of powder exit holes on the nozzle- Direction of powder exits- Durability of the markings | Functional testing between the current material (predicate) and the new material (subject device) for the nozzle successfully confirmed the placement of powder exit holes, the direction of powder exits, and the durability of the markings. All acceptance criteria were met. |
Study Details:
Since the device is a Class I medical device, the studies primarily focus on demonstrating substantial equivalence to a predicate device through performance testing, rather than extensive clinical efficacy studies typically seen for Class II or III devices or AI-powered diagnostics.
-
2. Sample Size for the Test Set and Data Provenance:
- The document does not explicitly state numerical sample sizes for the test sets (e.g., number of nozzles tested). It refers to "comparison testing" and "functional testing" performed on the "current material (predicate)" and "new material (this submission)" for the nozzle. This implies a sufficient number of samples were used to perform the specified engineering and material tests, but the exact count is not provided.
- Data Provenance: Not explicitly stated, however, the testing was conducted to support a submission to the U.S. FDA, indicating adherence to relevant international standards (e.g., ISO 10993-1). The tests are engineering and material-based, not clinical studies involving patient data or specific geographical origin.
-
3. Number of Experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and its testing. The "ground truth" for these tests relates to engineering specifications, material properties, and functional performance, which are evaluated against established standards and internal design specifications by engineers and material scientists, rather than clinical experts establishing a ground truth for diagnostic accuracy.
-
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. The tests described are objective, quantitative or qualitative measurements against pre-defined engineering and material specifications. There is no subjective interpretation by multiple readers requiring adjudication in the context of this submission.
-
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:
- This is not applicable. The PERIO-FLOW nozzle is a mechanical dental accessory, not an AI-powered diagnostic or therapeutic device. No MRMC study was performed.
-
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- This is not applicable. The device is a physical dental accessory, not an algorithm, and does not operate in a standalone algorithmic capacity.
-
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the tests performed is based on established engineering principles, material science standards, and the functional requirements of the device. This includes:
- Biocompatibility Standards: ISO 10993-1:2009 for biological evaluation of medical devices.
- Mechanical and Functional Specifications: Internal design specifications for connection force, pressure resistance, nozzle fixation, powder exit hole placement, direction, and marking durability.
- The "ground truth" for the tests performed is based on established engineering principles, material science standards, and the functional requirements of the device. This includes:
-
8. The sample size for the training set:
- This is not applicable. This device is not an AI/ML algorithm that requires a training set. The "new material" of the nozzle was developed and tested against established engineering and biocompatibility standards.
-
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.
§ 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.