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 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 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.

AI/ML Overview

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.
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.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
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× | 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: +41 22 99 44 771 Email: sfassiohardy@ems-ch.com

Submission Contact:

Christina Henza chenza@can-do-medical.com

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.

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(PERIO-FLOW Nozzle DT-476)	Predicate Device(PERIO-FLOW Nozzle DT-113)	Explanation ofVariation
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 GenericName	Dental Handpiece andAccessories	Dental Handpiece and Accessories	Same.
Intended use	Regulation IntendedUse	"to prepare dental cavities forrestorations, such as fillings, andfor cleaning teeth."	"to prepare dental cavities forrestorations, such as fillings, and forcleaning teeth."	Same.
	Indications	The PERIO-FLOW nozzle, usedwith EMS PERIO-FLOW dentalhandpieces, is intended forpatients suffering fromperiodontal disease.The PERIO-FLOW nozzle, usedwith EMS PERIO-FLOW dentalhandpieces, is indicated for thenon-surgical removal ofsubgingival plaque in pockets upto 5 mm after initial periodontaltreatment.	The AIR-FLOW handy 3.0 PERIO isintended for patients suffering fromperiodontal disease.The AIR-FLOW handy 3.0 PERIO isindicated for the non-surgicalremoval of subgingival plaque inpockets up to 5 mm after initialperiodontal treatment.	Same.
	Treatment Site	Subgingival	Subgingival	Same.
	Anatomical sites	Teeth and soft tissues in themouth.	Teeth and soft tissues in the mouth	Same.
	Specific Treatmentsite	Subgingival	Subgingival	Same.
	Contact duration	Limited ≤ 24 hours	Limited ≤ 24 hours	Same.
	Biocompatibility	Biocompatible	Biocompatible	Same.
	Material	Thermoplastic PolyesterElastomerInk (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 oftreatment	Projection of water/air/powdermixture	Projection of water/air/powdermixture	Same.
	CompatibleProphylaxisPowders	PERIO (Glycine)	PERIO (Glycine)	Same.
	Mode	continuous operation	continuous operation	Same.
	Service pressure tothe turbine	1 to 2.2 bar (1000-2200 hPa) witha service flow of 50-80 ml/min.)	1 to 2.2 bar (1000-2200 hPa) with aservice flow of 50-80 ml/min.)	Same.
Substantial Equivalence Table
Item for Comparison	Proposed Device(PERIO-FLOW Nozzle DT-476)	Predicate Device(PERIO-FLOW Nozzle DT-113)	Explanation ofVariation
Service pressure tothe turbineconnection: Air	Static pressure 2.7 to 3.5 bar(2700-3500 hPa)	Static pressure 2.7 to 3.5 bar (2700-3500 hPa)	Same.
Nozzle Geometry	20.3mm in length, the width ofthe device at the taper is 2.96mm thick where the taper beginsnear the shoulder and 2.03mmthick near the tip	20.3mm in length, the width of thedevice at the taper is 2.96 mm thickwhere the taper begins near theshoulder and 2.03mm thick near thetip	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.

Regulation Number and Section

§ 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.