PERIO-FLOW nozzle

K171174 · E.M.S Electro Medical Systems S.A · EFB · Dec 18, 2017 · Dental

Device Facts

• Record ID: K171174
• Device Name: PERIO-FLOW nozzle
• Applicant: E.M.S Electro Medical Systems S.A
• Product Code: EFB · Dental
• Decision Date: Dec 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.4200
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

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.

Device Story

Flexible thermoplastic nozzle accessory for EMS PERIO-FLOW dental handpieces; connects to dental operative unit turbine. Transforms air/powder/water mixture into directed spray for subgingival plaque removal. Features printed markings at 3mm and 5mm to guide insertion depth. Used by dental professionals in clinical settings. Output is physical removal of plaque; aids in periodontal disease management. Single-use, non-sterile device.

Clinical Evidence

Bench testing only. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993-1. Comparison testing verified connection force, pressure resistance, and nozzle fixation. Functional testing confirmed powder exit hole placement, exit direction, and durability of markings. All acceptance criteria met.

Technological Characteristics

Thermoplastic polyester elastomer nozzle with printed markings. Dimensions: 20.3mm length, 2.96mm width at taper, 2.03mm at tip. Operates via air-polishing (water/air/powder mixture). Compatible with PERIO (Glycine) powder. Service pressure 1-2.2 bar; static air pressure 2.7-3.5 bar. Single-use, non-sterile.

Indications for Use

Indicated for patients with periodontal disease requiring non-surgical removal of subgingival plaque in pockets up to 5 mm following initial periodontal treatment.

Regulatory Classification

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.

Predicate Devices

• AIR-FLOW handy 3.0 PERIO (K132480)

Reference Devices

• PERIO-FLOW nozzle (DT-113) (K132480)
• K082791

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

E.M.S. Electro Medical Systems S.A. c/o Christina Henza Regulatory Can-Do-Medical 31 CH. de la Vuarpillière CH - 1260 Nyon Switzerland

December 18, 2017

Re: K171174

Trade/Device Name: PERIO-FLOW nozzle Regulation Number: 21 CFR 872.4200 Regulation Name: Dental Handpiece And Accessories Regulatory Class: Class I Product Code: EFB Dated: November 17, 2017 Received: November 17, 2017

Dear Christina Henza:

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. 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 Federal Register.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

For Tina Kiang, Ph.D. 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

510(k) Number (if known)

K171174

Device Name PERIO-FLOW nozzle

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

× | Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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## 510 (K) SUMMARY FOR PERIO-FLOW nozzle

- SUBMITTTER/ 510(K) HOLDER l. E.M.S. Electro Medical Systems S.A. Ch. de la Vuarpillière 31 CH - 1260 Nyon Switzerland
Primary Contact:

Suzanne FASSIO-HARDY, Regulatory Affairs Manager – Dental Direct: [phone] Email: [e-mail]

Submission Contact:

Christina Henza [e-mail]

- II. Date Prepared: December 14, 2017
- III. DEVICE NAME

Proprietary Name: PERIO-FLOW nozzle Common/Usual Name: Accessories Classification Name: Dental Handpiece and Accessories (872.4200) Device Class: I Product Code: EFB

- IV. PREDICATE DEVICES
Primary Predicate: E.M.S. Electro Medical Systems S.A., AIR-FLOW handy 3.0 PERIO (K132480 cleared on 02/24/2014

- V. DEVICE DESCRIPTION
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

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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.

#### VI. INDICATIONS FOR USE

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.

### VII. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS OF PROPOSED COMPARED TO THE PREDICATE DEVICE

The proposed PERIO-FLOW nozzle is an additional accessory intended to be used with all currently available EMS PERIO-FLOW dental handpieces. The substantial equivalence claim is specific to the nozzle accessory within the predicate submission, all other system components are unaffected by this submission.

At a high level, the subject and predicate devices are based on the following same technological elements:

- . Nozzle Geometry (general shape and hole placement)
- . Projection of water/air/powder mixture
- Use with PERIO (Glycine) powder

The following technological differences exist between the subject and predicate devices:

- . The material is a different thermoplastic polyester elastomer
- . The subject device includes printed markings

The questions regarding the material change and addition of markings are whether it is biocompatible and whether the use is adequately described within the instructions. These questions apply to both the new device and the predicate. Therefore, the proposed device, PERIO-FLOW nozzle, is substantially equivalent with regards to the nozzle portion of the legally marketed predicate AIR-FLOW handy 3.0 PERIO (K132480 cleared on 02/24/2014).

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| Substantial Equivalence Table | | | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Item for Comparison | Proposed Device<br>(PERIO-FLOW Nozzle DT-476) | Predicate Device<br>(PERIO-FLOW Nozzle DT-113) | Explanation of<br>Variation | |
| Regulatory Information | Name | PERIO-FLOW nozzle | EMS AIR-FLOW handy 3.0 PERIO | N/A |
| | 510(k)# | K171174 | K132480 | N/A |
| | Predicates | K132480 | K082791 | N/A |
| | Product Code | EFB | EFB | Same. |
| | Class | 1 | 1 | Same. |
| | Combination Product | No | No | Same. |
| | Regulation Number | 872.4200 | 872.4200 | Same. |
| | Regulation Generic<br>Name | Dental Handpiece and<br>Accessories | Dental Handpiece and Accessories | Same. |
| Intended use | Regulation Intended<br>Use | "to prepare dental cavities for<br>restorations, such as fillings, and<br>for cleaning teeth." | "to prepare dental cavities for<br>restorations, such as fillings, and for<br>cleaning teeth." | Same. |
| | Indications | The PERIO-FLOW nozzle, used<br>with EMS PERIO-FLOW dental<br>handpieces, is intended for<br>patients suffering from<br>periodontal disease.<br><br>The PERIO-FLOW nozzle, used<br>with EMS PERIO-FLOW dental<br>handpieces, is indicated for the<br>non-surgical removal of<br>subgingival plaque in pockets up<br>to 5 mm after initial periodontal<br>treatment. | The AIR-FLOW handy 3.0 PERIO is<br>intended for patients suffering from<br>periodontal disease.<br><br>The AIR-FLOW handy 3.0 PERIO is<br>indicated for the non-surgical<br>removal of subgingival plaque in<br>pockets up to 5 mm after initial<br>periodontal treatment. | Same. |
| | Treatment Site | Subgingival | Subgingival | Same. |
| | Anatomical sites | Teeth and soft tissues in the<br>mouth. | Teeth and soft tissues in the mouth | Same. |
| | Specific Treatment<br>site | Subgingival | Subgingival | Same. |
| | Contact duration | Limited ≤ 24 hours | Limited ≤ 24 hours | Same. |
| | Biocompatibility | Biocompatible | Biocompatible | Same. |
| | Material | Thermoplastic Polyester<br>Elastomer<br>Ink (printed markings) | Thermoplastic Polyester Elastomer | Equivalent. |
| | Sterility | Provided non-sterile | Provided non-sterile | Same. |
| | Shelf life | unrestricted | unrestricted | Same. |
| Technological Characteristics | General purpose | Cleaning and surface preparation | Cleaning and surface preparation | Same. |
| | Treatment | Air-polishing | Air-polishing | Same. |
| | Mechanism of<br>treatment | Projection of water/air/powder<br>mixture | Projection of water/air/powder<br>mixture | Same. |
| | Compatible<br>Prophylaxis<br>Powders | PERIO (Glycine) | PERIO (Glycine) | Same. |
| | Mode | continuous operation | continuous operation | Same. |
| | Service pressure to<br>the turbine | 1 to 2.2 bar (1000-2200 hPa) with<br>a service flow of 50-80 ml/min.) | 1 to 2.2 bar (1000-2200 hPa) with a<br>service flow of 50-80 ml/min.) | Same. |
| Substantial Equivalence Table | | | | |
| Item for Comparison | Proposed Device<br>(PERIO-FLOW Nozzle DT-476) | Predicate Device<br>(PERIO-FLOW Nozzle DT-113) | Explanation of<br>Variation | |
| Service pressure to<br>the turbine<br>connection: Air | Static pressure 2.7 to 3.5 bar<br>(2700-3500 hPa) | Static pressure 2.7 to 3.5 bar (2700-<br>3500 hPa) | Same. | |
| Nozzle Geometry | 20.3mm in length, the width of<br>the device at the taper is 2.96<br>mm thick where the taper begins<br>near the shoulder and 2.03mm<br>thick near the tip | 20.3mm in length, the width of the<br>device at the taper is 2.96 mm thick<br>where the taper begins near the<br>shoulder and 2.03mm thick near the<br>tip | Same. | |

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#### VIII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

### Biocompatibility testing:

The biocompatibility evaluation for the PERIO-FLOW nozzle was conducted in accordance with the FDA guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" (Attachment A) published June 16, 2016. This device is categorized in ISO 10993-1:2009 as "Surface device breached or compromised surface" per section 5.2.1(c). The device will have limited contact of less than or equal to 24 hours. Testing completed on this device includes:

- . Cytotoxicity
- . Sensitization
- . Irritation

### Comparison Testing:

To verify that the nozzles will work with the specified dental handpieces, comparison testing was completed on the current material (predicate) and the new material (this submission) for the nozzle. Comparison testing consisted of measuring connection force, pressure resistance, and nozzle fixation.

To verify that the change of material does not impact the performance on the nozzle, functional testing was completed on the current material (predicate) and the new material (this submission) for the nozzle. Functional testing consisted of confirming the placement of powder exit holes on the nozzle, the direction of powder exits, and the durability of the markings.

All tests were successfully performed and all acceptance criteria were met.

#### IX. CONCLUSIONS

Based on the information and supporting documentation provided in the premarket notification, the PERIO-FLOW nozzle is substantially equivalent to the cited predicate device. Testing demonstrates that the PERIO-FLOW nozzle fulfills prospectively defined design and performance specifications.