Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical and physical principles of ultrasonic scaling and air polishing. There is no mention of AI, ML, or any computational analysis of data for diagnosis, treatment planning, or device control beyond basic automatic tuning.

Therapeutic

Yes
The device is intended for various dental applications including removing calculus deposits, periodontal therapy, root planing, and oral prophylaxis, all of which aim to treat or prevent disease and restore health.

Diagnostic

No

This device is intended for dental prophylaxis, including cleaning, scaling, and polishing, which are therapeutic and maintenance procedures, not diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description clearly details hardware components such as an ultrasonic handpiece, air polishing handpiece, liquid container, and a tuning circuit, indicating it is a physical medical device with integrated functions, not software only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The combi touch is a dental device used for cleaning teeth and surrounding tissues through ultrasonic scaling and air polishing. It performs procedures directly on the patient's teeth and in their mouth.
Lack of Specimen Analysis: The device does not analyze any specimens taken from the body. Its function is entirely external and mechanical/physical in nature, applied directly to the anatomical site (teeth and soft tissues in the mouth).

Therefore, the combi touch falls under the category of a dental device used for treatment and prophylaxis, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an airpolishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

· Removing supra and subgingival calculus deposits and stains from teeth
· Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
· Scaling and root planing
· Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
· Plugging for amalgam condensation
· Amalgam burnishing
· Preparing, cleaning and irrigating roots canals
· Cavity preparation
· Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supragingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:
· Plaque removal for placement of sealants.
· Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
· Surface preparation prior to placing composite restorations
· Effective plaque and stain removal for orthodontic patients
· Cleaning prior to bonding ortho brackets
· Cleaning implant fixtures prior to loading
· Stain removal for shade determination
· Plaque removal prior to fluoride treatment
· Plaque and stain removal prior to whitening procedures

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch 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)

ELC, KOJ

Device Description

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Teeth and soft tissues in the mouth

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)

The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above (Sodium Bicarbonate based powder, Glycine based powder):

was effective in the removal of simulated plaque from dental surfaces.
did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment;
proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device.
The results of the tests have demonstrated the safety and effectiveness of the Combi Touch device for the indication for use reported in section 5.
Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices

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.

K190124

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.

K140965

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

Regulation Number and Section

§ 872.4850 Ultrasonic scaler.

(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.

Summary

0

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The text logo has the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 15, 2023

Mectron S.p.A. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

Re: K231391

Trade/Device Name: Combi Touch Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic scaler Regulatory Class: Class II Product Code: ELC, KOJ Dated: May 12, 2023 Received: May 12, 2023

Dear Prithul Bom:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

1

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

Submission Number (if known)

K231391

Device Name

combi touch

Indications for Use (Describe)

combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an airpolishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

· Removing supra and subgingival calculus deposits and stains from teeth
· Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
· Scaling and root planing
· Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha
· Plugging for amalgam condensation
· Amalgam burnishing
· Preparing, cleaning and irrigating roots canals
· Cavity preparation
· Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supragingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:
· Plaque removal for placement of sealants.
· Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers
· Surface preparation prior to placing composite restorations
· Effective plaque and stain removal for orthodontic patients
· Cleaning prior to bonding ortho brackets
· Cleaning implant fixtures prior to loading
· Stain removal for shade determination
· Plaque removal prior to fluoride treatment
· Plaque and stain removal prior to whitening procedures

combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease. combi touch 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

Image /page/4/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo includes the word "mectron" in orange. The contact information includes the address "Via Loreto, 15/A, 16042 Carasco - GE (Italy)", the telephone number "+39 0185 35361", and the fax number "+39 0185 351374".

medical technology www.mectron.com mectron@mectron.com

electronic Submission Template And Resource (eSTAR)

Section: 510(k) Summary in accordance with 21 CRF 807.92

April 18, 2023

1. Administrative Information

Type of 510(k) submission:	Premarket Notification
Device Common Name:	Ultrasonic scaler/Air Polishing unit
Regulation description:	Ultrasonic scaler
Proprietary names of the device:	combi touch
Manufacturer:	Mectron S.p.A.
Via Loreto, 15/a
Carasco - GE 16042, Italy
FDA Registration Number:	3003933619
510(k) Owner:	Mectron S.p.A.
Via Loreto, 15/a
Carasco - GE 16042, Italy
510(k) Preparer and Contact:	Mr. Edoardo Tronchet
Regulatory Affairs Manager
Mectron S.p.A.
Telephone: +39 0185 35361
Cell: +39 3371605043

Email: edoardo.tronchet@mectron.com

2. Device identification:

Regulatory Class: ...................................Class II Classification Regulation:....21 CFR 872.4850: Ultrasonic Scaler Product Codes: ............................................................................................................................................................... .............................................................................................................................................................................. Review Panel: ........................................Dental

5

Image /page/5/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a gray line and circles underneath. The contact information includes the address Via Loreto, 15/A, 16042 Carasco - GE (Italy), as well as the telephone number +39 0185 35361 and fax number +39 0185 351374.

medical technology www.mectron.com mectron@mectron.com

3. Identification of the Predicate / Reference Devices

Predicate device:

The Substantial Equivalence of the subject device is based on the predicate device.

Trade Name	Manufacturer	Product Code	510(k) Number
EMS AIR FLOW
PROPHYLAXIS
MASTER	EMS (Electro Medical System)	ELC, KOJ	K190124

Reference device:

For the Substantial Equivalence we have also considered the reference device:

Trade Name	Manufacturer	Product Code	510(k) Number
MULTIPIEZO	MECTRON Spa	ELC, EFB, EJR	K140965

Device description 4.

The combi touch combines, in a single appliance, a multi-purpose piezoelectric scaler and water jet, air, and powder polisher, intended for complete supra- and subgingival dental prophylaxis.

In regards to the various possible ultrasonic treatments, combi touch can be used either connected directly to the main water supply in the dental practice, or with independent irrigation through the special liquid container, which can hold different types of medical solutions.

The appliance is equipped with an automatic tuning circuit which compensates the wear of the inserts, thus always allowing operation in conditions of maximum efficiency.

The operating principle of the polisher is based on the mechanical action obtained from a jet of various crystal types accelerated by a flow of compressed air. The kinetic energy thus imprinted at the particles, dissipates almost completely due to impact against the surface of the enamel, producing a gentle but effective cleaning action. The action is completed by a jet of water which, using the vacuum created around the air-polishing handpiece, has a bellshape around the main flow, thus producing a double effect: to prevent much of the rebound and the leakage of the cloud of powder and perform continuous washing of the treated area, dissolving the powder.

6

Image /page/6/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a gray line and dots underneath. The contact information includes the address "Via Loreto, 15/A, 16042 Carasco - GE (Italy)", as well as the telephone number "+39 0185 35361" and fax number "+39 0185 351374".

dical technology mectron@mectron.com

5. Indications for use

combi touch incorporates, within a single device, the functions of an ultrasonic scaler and of an air-polishing prophylaxis unit.

Ultrasonic scaler function:

combi touch, by using the appropriate associated inserts and the ultrasonic handpiece, is intended for use in the following dental applications:

Removing supra and subgingival calculus deposits and stains from teeth .
. Periodontal therapy and debridement for all types of periodontal disease, including periodontal pocket lavage with simultaneous ultrasonic tip movement
. Scaling and root planing
Releasing crowns, bridges, inlays, and posts as well as condensing gutta percha .
. Plugging for amalgam condensation
. Amalgam burnishing
. Preparing, cleaning and irrigating roots canals
Cavity preparation
. Cleaning restorations and implant surfaces

Air-polishing prophylaxis function:

By using the appropriate air polishing handpiece, combi touch is intended for a complete supra-gingival and sub-gingival prophylaxis treatment.

The prophylaxis treatment is obtained by the projection of water, air and appropriate dental prophylaxis powders, onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth.

combi touch is intended for the following oral prophylaxis procedures:

. Plaque removal for placement of sealants
Surface preparation prior to bonding/cementation of inlays, onlays, crowns and veneers ●
Surface preparation prior to placing composite restorations .
Effective plaque and stain removal for orthodontic patients
. Cleaning prior to bonding ortho brackets
Cleaning implant fixture prior to loading
. Stain removal for shade determination
Plaque removal prior to fluoride treatment
Plaque and stain removal prior to whitening procedure

The combi touch is also intended for use as an air-polisher in patients suffering from periodontal disease.

7

Image /page/7/Picture/0 description: The image shows the logo and contact information for Mectron S.p.A. The logo features the word "mectron" in orange, with a gray line and circles underneath. The contact information includes the address, Via Loreto, 15/A, 16042 Carasco - GE (Italy), as well as the telephone number +39 0185 35361 and fax number +39 0185 351374.

medical technology www.mectron.com mectron@mectron.com

The combi touch is indicated for the non-surgical removal of subgingival plaque in pockets up to 5 mm after initial periodontal treatment

6. Comparison of the proposed device and the predicate / reference devices

A comparison of the subject device with the predicate device is shown in the following Table 1.1.

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Image /page/8/Picture/0 description: The image shows the word "mectron" in orange font. To the left of the word is a blue vertical bar. Below the word are six gray circles arranged in two rows of three.

	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item for
comparison	COMBI TOUCH
Subject Device	EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124	MULTIPIEZO
Reference Device - RD - K140965	Variations
1	Manufacturer	MECTRON SPA
Via Loreto 15/A
16042 Carasco - Italy	E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
31 Ch. de la Vuarpilliere
Nyon Vaud, SWITZERLAND CH-1260	MECTRON SPA
Via Loreto 15/A
16042 Carasco - Italy	N/A
2	510(k) Number	Subject of this submission	K190124	K140965	N/A
3	Regulation
panel	Dental	Dental	Dental	Identical to PD1 & RD
4	Regulation
Number	21 CFR 872.4850	21 CFR 872.4850	21 CFR 872.4850	Identical to PD1 & RD
5	Common/Usual
name and
function	Ultrasonic scaler/Air Polishing unit	Ultrasonic scaler/Air Polishing unit	Ultrasonic scaler	Identical to PD1
Identical to RD for the
ultrasonic scaler function
6	Product Code	Primary Product code: ELC
Subsequent Product Code: KOJ	Primary Product code: ELC
Subsequent Product Code: KOJ;	ELC	Identical to PD1
Identical to RD for code
ELC
7	Classification	Class II	Class II	Class II	Identical to PD1 & RD
8	Combination
Product	No	No	No	Identical to PD1 & RD
9	Device type	Table top device	Table top device	Table top device	Identical to PD1 & RD
10	Function	Ultrasonic scaling and Air-polishing	Ultrasonic scaling and Air-polishing	Ultrasonic scaling	Identical to PD1 and to
RD for the ultrasonic
scaler function
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item for
comparison	COMBI TOUCH
Subject Device	EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124	MULTIPIEZO
Reference Device - RD - K140965	Variations
11	Intended use	combi touch incorporates, within a single device, the
functions of an ultrasonic scaler and of an air-polishing
prophylaxis unit.
Ultrasonic scaler function:
combi touch, by using the appropriate associated inserts
and the ultrasonic handpiece, is intended for use in the
following dental applications:
• Removing supra and subgingival calculus deposits
and stains from teeth
• Periodontal therapy and debridement for all types
of periodontal disease, including periodontal pocket
lavage with simultaneous ultrasonic tip movement
• Scaling and root planing
• Releasing crowns, bridges, inlays, and posts as
well as condensing gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cleaning restorations and implant surfaces
Air-polishing prophylaxis function:
By using the appropriate air polishing handpiece, combi
touch is intended for a complete supra-gingival and sub-
gingival prophylaxis treatment.
The prophylaxis treatment is obtained by the projection of
water, air and appropriate dental prophylaxis powders, onto
the tooth surface. The device removes dental plaque, soft
deposits, and surface stains from pits, grooves,
interproximal spaces, or smooth surfaces of teeth.
combi touch is intended for the following oral prophylaxis
procedures:
• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of
inlays, onlays, crowns and veneers
• Surface preparation prior to placing composite
restorations
• Effective plaque and stain removal for orthodontic
patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixtures prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening
procedures
combi touch is also intended for use as an air-polisher in
patients suffering from periodontal disease.	The AIRFLOW Prophylaxis Master combines the functions of an
ultrasonic scaler and air-polishing unit within a single chassis. The
AIRFLOW Prophylaxis Master is intended for use in the following dental
and periodontal applications:
• Removing supra and subgingival calculus deposits and stains from
teeth
• Periodontal pocket lavage with simultaneous ultrasonic tip movement
• Scaling and root planning
• Releasing crowns, bridges, inlays, and posts as well as condensing
gutta percha
• Plugging for amalgam condensation
• Amalgam burnishing
• Preparing, cleaning and irrigating roots canals
• Cavity preparation
• Cementing inlays and onlays
• Retrograde preparation of roots canals
The AIRFLOW Prophylaxis Master is intended for use in the cleaning
and polishing of teeth by the projection of water, air, and dental powders
onto the tooth surface. The device removes dental plaque, soft deposits,
and surface stains from pits, grooves, interproximal spaces, or smooth
surfaces of teeth.
The AIRFLOW Prophylaxis Master can be used for the following
cleaning procedures:
• Plaque removal for placement of sealants
• Surface preparation prior to bonding/cementation of inlays, onlays,
crowns and veneers
• Surface preparation prior to placing composite restorations
• Effective plaque and stain removal for orthodontic patients
• Cleaning prior to bonding ortho brackets
• Cleaning implant fixture prior to loading
• Stain removal for shade determination
• Plaque removal prior to fluoride treatment
• Plaque and stain removal prior to whitening procedure.
The AIRFLOW Prophylaxis Master is also intended for use as an air-
polisher in patients suffering from periodontal disease. The AIRFLOW
Prophylaxis Master is indicated for the non-surgical removal of
subgingival plaque in pockets up to 5 mm after initial periodontal
treatment	The Multipiezo is a piezoelectric ultrasonic dental
scaler intended for use, with the appropriate associated
tip inserts, in the following dental applications:
Scaling: All general procedures for removal of
supragingival/subgingival and interdental calculus/
plaque deposits;
Periodontology:
Periodontal therapy and
debridement for all types of periodontal diseases,
including periodontal pocket irrigation and cleaning;
Endodontics: All treatments for root canal reaming,
irrigation, revision, filling, gutta-percha condensation
and retrograde preparation;
Restorative and Prosthetics: All general restorative
procedures including cavity preparation, removal of
prostheses, amalgam condensation, finishing of crown
preparations, inlay/onlay condensation, and
implants/restorations cleaning.	Similar to PD1 except for
"cementing inlays and
onlays" due to the combi
touch cannot perform it
and previously cleared
applications of RD
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item for
comparison	COMBI TOUCH
Subject Device	EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124	MULTIPIEZO
Reference Device - RD - K140965	Variations
		combi touch is indicated for the non-surgical removal of
subgingival plaque in pockets up to 5 mm after initial
periodontal treatment
12	Anatomical site	Teeth and soft tissues in the mouth	Teeth and soft tissues in the mouth	Teeth and soft tissues in the mouth	Identical to PD1 & RD
13	Specific
Treatment Site	Supragingival and Subgingival	Supragingival and Subgingival	Supragingival	Identical to PD1
Subgingival N/A for RD
14	Contact
duration	Limited ≤ 24 hours	Limited ≤ 24 hours	Limited ≤ 24 hours	Identical to PD1 & RD
15	Materials in
direct contact
with patient:	Stainless steel
Diamond coating
Titanium nitride coating
PEEK
EVA+LPDE
Viton
PPSU
TPX	Stainless steel
Titanium
COC
PPSU
EPDM
PEEK
Hytrel SC969	Stainless steel
Diamond coating
Titanium nitride coating
PEEK	Similar to PD1 & RD.
This difference doesn't
impact on safety or
clinical performance
16	Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Similar to PD1 & RD
17	Main
Components of
the device	• Device core unit.
• Irrigation tank complete with cap
• Pedal FS-05 with cord and plug
• Tank safety cap
• Tank cap
• Water supply hose with quick coupling
• Air supply hose with quick coupling
• Water filter
• combi touch o-ring kit
• Cleaning needle kit
• SLIM Scaler Handpiece
• Air-polishing handpiece 120°
• Air-Polishing handpiece Perio
• Water circuit disinfection kit	The Prophylaxis Master consists of:
• Unit
• Quick guide
• Piezon® training tool
• Reprocessing instructions
• Wireless Foot pedal
• US Power cable
• AIR-FLOW® PLUS Prophylaxis Powder
• AIR-FLOW® CLASSIC Prophylaxis Powder
• AIR-FLOW® PLUS Powder chamber
• AIR-FLOW® CLASSIC Powder chamber
• Piezon® handpiece cord
• AIR-FLOW® MAX handpiece cord
• Box of AIR-FLOW®
• Box of Piezon ®
• Piezon® Bottle	• Control unit.
• Irrigation liquid bottle
• Foot-pedal with cord
• Piezoelectric ultrasonic handpiece with led and
cord.
• Torque wrench to tighten the inserts on the
handpiece.
• Power supply cord.
• Range of ultrasonic insert tips to be used according
to the dental applications defined by the intended
use.
• Other accessories/attachments.	Similar There are minimal
differences in the
components related to the
Ultrasonic scaler function
and Air-polishing function
	Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices
	Item for
comparison	COMBI TOUCH
Subject Device	EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124	MULTIPIEZO
Reference Device - RD - K140965	Variations
		• Subgingival perio tips
• K9 wrench
• Ultrasonic Scaling insert S1-S
• Ultrasonic Scaling insert P3
• Black power supply cable
• Use and Maintenance Manual	• Water hose connector
• Air hose connector
• Clip + clean
• Cleaner bottle
18	Prophylaxis
Powders used
with the system	• Sodium Bicarbonate based powder
• Glycine based powder	• PERIO (Glycine)
• SOFT (Glycine)
• CLASSIC (Sodium Bicarbonate)
• PLUS (Erythritol)	N/A	The results of the tests indicated that combi touch, when used in combination with the commercially-available prophylaxis powders identified above:

was effective in the removal of simulated plaque from dental surfaces.
did not cause any damages to dental surfaces, as verified by the examination of tooth surfaces morphology after the treatment;
proved to be safe and effective for its intended use, producing erosion that is comparable to, or even lower than, the erosion produced by the predicate device. |
| | Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices | | | | |
| | Item for
comparison | COMBI TOUCH
Subject Device | EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124 | MULTIPIEZO
Reference Device - RD - K140965 | Variations |
| 19 | Prophylaxis
powder tanks | Two separated and removable powder tanks, both housed
in the casing of the device's console.
One tank is dedicated to be used for the supra and
subgingival treatments
One tank is dedicated to be used for the subgingival
treatments
Both powder tanks are always available to be used
according to the treatment selected from the end user on the
console's touch panel. | Two removable powder tanks
One tank is dedicated to be used for the supra and subgingival
treatments
One tank is dedicated to be used for the subgingival treatments
The tanks can be used one at time only.
The end-user must remove from the device's console the tank in use,
(containing a type of powder) and insert the tank for the other type of
powder) | N/A | Identical to PD1 |
| 20 | Technological
Characteristics

(Mechanism of
action) | Ultrasonic Scaler Function:
Piezoelectric ultrasonic technology that
generates
mechanical micro-vibration of the insert tips.
The piezoelectric transducer uses piezoceramic disks to
convert the generator's electrical signal to ultrasonic
vibration of the insert tip.
Air-polishing prophylaxis function:
It is based on the principle of projecting a pressurized air
mixed with water and a prophylaxis powder on the treatment
site (tooth surface). | Ultrasonic Scaler Function:
Piezoelectric ultrasonic technology that generates mechanical micro-
vibration of the insert tips.
The piezoelectric transducer uses piezoceramic disks to convert the
generator's electrical signal to ultrasonic vibration of the insert tip.
Air-polishing prophylaxis function:
It is based on the principle of projecting a pressurized air mixed with
water and a prophylaxis powder on the tooth surface | Ultrasonic Scaler Function:
Piezoelectric ultrasonic technology that generates
mechanical micro-vibration of the insert tips. The
piezoelectric transducer uses piezoceramic disks to
convert the generator's electrical signal to ultrasonic
vibration of the insert tip. | Similar to PD1 and to RD
as regards the ultrasonic
scaler function. |
| 21 | Ultrasonic
Transducer
Technological
characteristics | Piezoelectric Ultrasonic Technology:
The transducer uses piezoceramic disks to convert the
generator's electrical signal to ultrasonic vibration of the
scaler insert tip | Piezoelectric Ultrasonic Technology:
The transducer uses piezoceramic disks to convert the generator's
electrical signal to ultrasonic vibration of the scaler insert tip | Piezoelectric Ultrasonic Technology:
The transducer uses piezoceramic disks to convert
the generator's electrical signal to ultrasonic vibration
of the scaler insert tip | Identical to PD1 & RD |
| 22 | Led system
incorporated
inside the
ultrasonic scaler
handpiece to
provide illumina-
tion of the
operative site. | YES | YES | YES | Similar to PD1.
Identical to RD |
| 23 | Handpieces | The subject device can be used with five separate
handpieces: | The predicate device can be used has three separated handpieces.
One ultrasonic piezoelectric handpiece intended for the scaling
treatments. | The device operates with one piezoelectric ultrasonic
handpiece. | Similar to PD1 for scaling
and prophylaxis treatment
Identical to RD for the
ultrasonic scaler function |
| | Item for
comparison | COMBI TOUCH
Subject Device | EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124 | MULTIPIEZO
Reference Device - RD - K140965 | Variations |
| | | - Two ultrasonic piezoelectric handpiece intended for
the scaling treatments (SLIM scaler handpiece and LED
scaler handpiece)
One air-polishing handpiece 120° dedicated to perform
supra-gingival prophylaxis treatment.
One air-polishing handpiece 90° dedicated to perform
supra-gingival prophylaxis treatment.
One air-polishing handpiece PERIO dedicated to
perform sub-gingival use in periodontal treatments - use
in conjunction with the subgingival perio tips | - One air-polisher handpiece dedicated to perform supra-gingival
prophylaxis treatment.
One air-polisher handpiece dedicated to perform sub-gingival
prophylaxis treatment. | | |
| 24 | Subgingival
periodontal tip | YES | YES | N/A | Similar to PD1 |
| 25 | Max power
Consumption | 90 VA | 700 VA | 90 VA | This difference doesn't
impact on safety or
clinical performance.
Identical to RD |
| 26 | Ultrasound
Frequency | 24 kHz to36 kHz | 24 kHz to32 kHz | 24 kHz to~36 kHz | Similar to PD1 and
identical to RD |
| 27 | Flow rate
adjustment | Mechanical regulator + Touch panel | Mechanical regulator | Touch panel | Similar to PD1 and
identical to RD |
| 28 | Foot pedal | Wired | Wireless or wired | Wired | Similar to PD1 and
identical to RD |
| 29 | Electrical power
input | 100 - 240 VAC - 50/60 Hz. | 100 - 240 VAC - 50/60 Hz. | 100 - 240 VAC - 50/60 Hz. | Identical to PD1 & RD |
| 30 | Water delivery
system | One irrigating liquid bottle for ultrasonic scaling treatment
Connection to external water supply for both ultrasonic
scaling and air-polishing treatment | One irrigating liquid bottle for ultrasonic scaling treatment
Connection to external water supply for both ultrasonic scaling and
air-polishing treatment | One irrigating liquid bottle for ultrasonic scaling
treatment | Identical to PD1 and RD
for the scaling treatment |
| | Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices | | | | |
| | Item for
comparison | COMBI TOUCH
Subject Device | EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124 | MULTIPIEZO
Reference Device - RD - K140965 | Variations |
| 31 | Electrical safety | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Complies with IEC 60601-1 | Identical to PD1 & RD |
| 32 | Electromagnetic
Compatibility | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Complies with IEC 60601-1-2 | Identical to PD1 & RD |
| 33 | Device contains
software? | YES | YES | YES | Identical to PD1 & RD |
| 34 | Parts supplied
sterile | YES (Subgingival Perio Tips).
The shelf life is 5 years | NO | N/A | The Subgingival Perio Tip
material composition was
found to be incompatible
with reprocessing
by steam sterilization due
to a melting point lower
than the required
sterilization temperature
(132°C). Also for the
US market, it was decided
to make the Subgingival
Perio Tip available in
sterile condition and
for single use only. |
| 35 | Parts need to
be sterilized
prior use? | YES
SLIM scaler handpiece and LED scaler handpiece air-polishing handpiece 120° air-polishing handpiece 90° air-polishing handpiece PERIO Ultrasonic Scaling Inserts Torque wrenches Irrigation kit | YES AIR-FLOW® handpiece PERIOFLOW® handpiece Piezon ® handpiece Scaler Insert Torque wrench CLIP + CLEAN | YES SLIM scaler handpiece and LED scaler handpiece Ultrasonic Scaling Insets Torque wrenches | Similar to PD1 and RD |
| 36 | Shelf life | Unrestricted | Unrestricted | Unrestricted | Identical |
| 37 | Recommended
sterilization
method | Autoclaving (Steam Sterilization) | Autoclaving (Steam Sterilization) | Autoclaving (Steam Sterilization) | Identical to PD1 & RD |
| Table 1.1. Comparison Table for determination of Substantial Equivalence between combi touch device and Predicate / Reference Devices | | | | | |
| | Item for comparison | COMBI TOUCH
Subject Device | EMS AIRFLOW PROPHYLAXIS MASTER
Primary Predicate Device - PD1 - K190124 | MULTIPIEZO
Reference Device - RD - K140965 | Variations |
| 38 | Flush function:
washing of the liquid circuit | YES | YES | YES | Similar to PD1 and identical to RD |
| 39 | Compressed air supply | 4 to 8 Bar | 4.5 to 7 Bar | N/A | Similar-Difference with no impact on the safety and effectiveness of the subject device |
| 40 | Water supply | 1 to 6 Bar | 2 to 5 Bar | N/A | Similar-Difference with no impact on the safety and effectiveness of the subject device |
| 41 | Dimensions:
(HxWxD)
Weight (approx) | 145 x 260 x 410
4,8 Kg
Image: COMBI TOUCH | 245 x 260 x 290
5 Kg max.
Image: EMS AIRFLOW PROPHYLAXIS MASTER | 145 x 230 x 320
2,4 Kg
Image: MULTIPIEZO | Similar to PD1 and RD since all the devices have dimensions and weights consistent with the table top use |

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13

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16

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Mectron S.p.A. Via Loreto, 15/A 16042 Carasco – GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374

medical technology

www.mectron.com mectron@mectron.com

Substantial Equivalence Discussion

The proposed device and the predicate device AIRFLOW Prophylaxis Master (K190124 cleared on 20/10/2019) have the intended use substantially identical

The proposed device and the predicate device share also many identical features, including identical/equivalent principle of operation and technological characteristics

The differences identified in the above table 1.1 clearly have no impact on safety or effectiveness of the device. Any differences identified in above table does not introduce any new questions regarding safety and effectiveness.

These considerations are also confirmed by the performance test carried out in comparison with the predicate device PD1.

The data presented in this submission demonstrates the identities existing between the combi touch device and the predicate devices, and thus support a finding of substantial equivalence between the subject device and the referenced predicated devices, which are already in commercial distribution in the United States.

7. Summary of Non-Clinical Testing - List of Standards

Testing was performed to verify compliance of the combi touch with the list standards listed here below:

| Standard | Title | FDA
Recognition
Number |
|------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| CEI UNI EN ISO 14971:2019 | Medical devices - Application of risk management to medical devices | 5-125 |
| ISO/TR 24971:2020 | Medical devices — Guidance on the application of ISO14971 | - |
| IEC 60601-1:2015, AMD1:2012 | Medical electrical equipment — Part 1 — General Requirements for Safety | 19-46 |
| IEC 60601-1-2:2014; IEC 60601-1-
2:2014/AMD1:2020 | Medical Electrical equipment - PART 1-2: General Requirements for basic
safety and essential performance - Collateral Standard: Electromagnetic
Disturbances — Requirements and tests | 19-36 |
| IEC 60601-1-6:2010 AMD1:2013 | General requirements for basic safety and essential performance -
Collateral standard: Usability | 5-89 |
| IEC 62366: 2007/AMD1:2014 | Medical devices - Application of usability engineering to medical devices | - |
| IEC 62304:2006 +
IEC 62304:2006/AMD1:2015 | Medical device software - Software life-cycle processes | 13-79 |
| ASTM D4169-16 | Standard Practice for Performance Testing of Shipping Containers and
Systems | 14-499 |
| ISO 7153-1:2016 | Surgical Instruments - Materials - Part 1: Metals | 8-344 |
| ASTM F899-20 | Standard Specification for Wrought Stainless Steel for Surgical Instruments | 8-527 |
| ASTM F136-13 | Standard Specification for Wrought Titanium-6Aluminum- 2013 4 Vanadium
ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS
R56401) | 8-377 |
| EN 10088-3:2014 | Stainless steels - Part 3: Technical delivery conditions for semi-finished
products, bars, rods, wire, sections and bright products of corrosion
resisting steels for general purposes | - |
| EN ISO 11737-1:2018/AMD 1:2021 | Determination of a population of microorganisms on products | 14-577 |
| EN ISO 11737-2:2020 | Tests of sterility performed in the definition, validation and maintenance of a
sterilization process | 14-540 |
| Standard | Title | FDA
Recognition
Number |
| EN 62353:2015 | Medical electrical equipment - Recurrent test and test after repair of
medical electrical equipment | - |
| IEC 62471:2006
EN 62471:2008 | Photo biological safety of lamps and lamp systems | 12-249 |
| IEC 80601-2-60:2019 | Medical electrical equipment - Part 2-60: Particular requirements for the
basic safety and essential performance of dental equipment | 4-262 |
| ISO 10993-1:2018 | Biological evaluation of medical devices - Evaluation and testing within a
risk management process | 2-258 |
| UNI EN ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for in vitro
cytotoxicity | 2-245 |
| UNI EN ISO 10993-7:2008 | Biological evaluation of medical devices - Part 7: Ethylene oxide
sterilization residuals [Including: Technical Corrigendum 1 (2009),
AMENDMENT 1: Applicability of allowable limits for neonates and infants
(2019)] | 2-275 |
| ISO 10993-10:2021 | Biological evaluation of medical devices - Part 10: Tests skin sensitization | 2-296 |
| ISO 10933-11:2017 | Biological evaluation of medical devices - Part 11: Tests for systemic
toxicity | 2-255 |
| ISO 10993-12:2021 | Biological evaluation of medical devices Sample preparation and reference
materials | 2-289 |
| ISO 11607-1:2019 | Packaging for terminally sterilized medical devices - Part 1: Requirements
for materials, sterile barrier systems and packaging systems | 14-530 |
| ISO 11607-2:2019 | Packaging for terminally sterilized medical devices - Part 2: Validation
requirements for forming, sealing and assembly processes | 14-530 |
| UNI EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements
and test methods | - |
| EN ISO 15223-1:2021 | Medical devices - Symbols to be used with information to be supplied by
the manufacturer - Part 1: General requirements | 5-134 |
| UNI 556-1:2002/AC:2006 | Sterilization of Medical devices - Requirements for medical devices to be
designated "STERILE" – Part 1 – Requirements for terminally sterilized
medical devices. | - |
| AAMI ST77:2013/®:2018 | Containment devices for reusable medical device sterilization. | 14-396 |
| AAMI ST79:2017 | Comprehensive guide to steam sterilization and sterility assurance in health
care facilities. | 14-562 |
| AAMI ST8:2013 | Hospital Steam Sterilizers | 14-406 |
| ISO 15883-1:2007 | Washer-disinfectors - Part 1: General requirements, terms and definitions
and tests | - |
| ISO/TS 15883-5:2005 | Washer-disinfectors - Part 5: Test soils and methods for demonstrating
cleaning efficacy 2005. | - |
| ISO 15883-5:2021 | Washer-disinfectors - Part 5: Performance requirements and test method
criteria for demonstrating cleaning efficacy | - |
| AAMI TIR12:2010 | Designing, testing, and labeling reusable medical devices for reprocessing
in health care facilities: A guide for medical device manufacturers | - |
| AAMI TIR28:2016 | Product adoption and process equivalence for ethylene oxide sterilization | - |
| AAMI TIR30:2011 (R2016) | A compendium of processes, materials, test methods, and acceptance
criteria for cleaning reusable medical devices | - |
| ISO 17664-1:2021 | Processing of health care products - Information to be provided by the
medical device manufacturer for the processing of medical devices - Part
1: Critical and semi-critical medical devices | 14-578 |
| EN ISO 15883-4:2018 | Washer-disinfectors - Part 4: Requirements and tests for washer
disinfectors employing chemical disinfection for thermolabile endoscopes | - |
| ASTM E1837- 96 (Reapproved
2014) | Standard Test Method to Determine Efficacy of Disinfection Processes for
Reusable Medical Devices (Simulated Use Test) | - |
| AFNOR NF T 72-281, 2014 | Methods of airborne disinfection of surfaces Determination of bactericidal,
yeasticidal, mycobactericidal, tuberculicidal, sporicidal and virucidal activity,
including bacteriophages. | - |
| EN 1276:2019 | Chemical disinfectants and antiseptics - Quantitative suspension test for
the evaluation of bactericidal activity of chemical disinfectants and | - |
| Standard | Title | FDA
Recognition
Number |
| | antiseptics used in food, industrial, domestic and institutional areas – Test
method and requirements (phase 2, step 1). | |
| EN ISO 11135:2014/A1:2019 | Sterilization of health-care products – Ethylene oxide – Requirements for
the development, validation and routine control of a sterilization process for
medical devices | 14-529 |
| ISO 11138-1:2017 | Sterilization of health care products – Biological indicators – Part 1:
General requirements | 14-502 |
| ISO 11138-2:2017 | Sterilization of health care products – Biological indicators – Part 2:
Biological indicators for ethylene oxide sterilization processes | - |
| ISO 11138-3:2017 | Sterilization of health care products – Biological indicators – Part 3:
Biological indicators for moist heat sterilization processes | - |
| ISO 11138-7:2017 | Sterilization of health care products – Biological indicators – Part 7:
Guidance for the selection, use and interpretation of results | - |
| EN ISO 11737-1:2015 | Sterilization of health care products – Microbiological methods – Part 1:
Determination of a population of microorganism on products | - |
| EN ISO 11737-2:2020 | Sterilization of health care products – Microbiological methods – Part 2:
Test of sterility performed in the definition, validation and maintenance of a
sterilization process | - |
| UNI EN 868-2:2009 | Packaging for terminally sterilized medical devices – Part 2: Sterilization
wrap - Requirements and test methods | - |
| ISO 17665-1:2006 | Sterilization of health care products – Moist heat – Requirements for
development, validation and routine control of a sterilization process for
medical devices. | 14-333 |
| AAMI/ISO TIR 17665-2:2009 | Sterilization of health care products – Moist heat – Part 2: Guidance on
the application of ISO 17665-1. | 14-277 |
| EN ISO 5349-1:2001 | Mechanical vibration – Measurement and evaluation of human exposure to
hand-transmitted vibration – Part 1: General requirements | - |
| ISTA 2A :2011 | Packaged-Products 150 lb (68 kg) or less | - |
| UNI EN ISO 5349-2:2015 | Mechanical vibration – Measurement and evaluation of human exposure
to hand-transmitted vibration – Part 2: Practical guidance for measurement
at the workplace | - |
| EN ISO 20417:2021 | Medical devices - Information to be supplied by the manufacturer | 5-135 |

17

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Mectron S.p.A.
Via Loreto, 15/A
16042 Carasto, 15/A
16042 Carasto – GE (Italy)
Tel. +39 0185 35361
Fax +39 0185 351374

medical technology

www.mectron.com
mectron@mectron.com

18

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Mectron S.p.A. Via Loreto, 15/A 16042 Carasco - GE (Italy) Tel. +39 0185 35361 Fax +39 0185 351374

medical technology

www.mectron.com mectron@mectron.com

The results of the tests have demonstrated the safety and effectiveness of the Combi Touch device for the indication for use reported in section 5.

Summary of Clinical Testing 8.

Animal or clinical testing were not required to prove combi touch's substantial equivalence when compared to the predicate/reference devices

CONCLUSION 9.

Based on the comparative analysis and testing contained within this submission, it is concluded that the combi touch device has intended use, safety and effectiveness profile, and technological characteristics, substantially equivalent to the identified predicate / reference devices which are already in commercial distribution in the United States.