The Mare Dental Operative Unit and Accessories is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices.

The system delivers air, water, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.

Device Description

The Mare Dental Operative Unit provides connections for five pneumatically operated instruments. The unit can supply air, water and electricity, which may include an air water syringe, high and low speed handpiece, electric motors, ultrasonic scalers, and dental curing lights, these accessories are not part of the unit.

The unit provides automatic instrument selection by means of a five way pneumatic valve located in each instrument hanger assembly. The automatic selection takes place when a static air pressure signal is removed from the top of a diaphragm located in the handpiece control block. The Mare Dental Operative Unit consists of the following components:

l. Patient Treatment Chair: It has two controls; a foot control and a digital pad in the instruments console for all chair positions, auto return system, preset position, emergency stop system and electric cup filler. The entire Mare features an articulating, detachable headrest.
II. Cuspidor with Water Unit: The ceramic bowl, cup fillers and the bowl irrigator are detachable. The Mare features a swivel ceramic bowl.
III. Dental Light: The Unit features a lamp with two intensity settings.
IV. Instruments Console: Features an instruments auto selection system and a master digital control.
- V. Rolling Chair: Height adjustable backrest and inclination setting.

AI/ML Overview

This document describes a 510(k) premarket notification for the "Mare Dental Operative Unit" (K041458). It's important to understand that 510(k) clearances are based on demonstrating "substantial equivalence" to a predicate device, not necessarily extensive clinical studies proving new safety and efficacy as typically seen with pharmaceuticals or novel high-risk medical devices.

Therefore, the study information requested regarding acceptance criteria, sample sizes, expert adjudication, MRMC studies, and ground truth establishment is generally not applicable (N/A) for this type of device and submission. The focus of the 510(k) is on comparing technical specifications and intended use against existing legally marketed devices, along with adherence to relevant electrical and quality management standards.

However, I can extract the information that is provided regarding design specifications and compliance with standards, which serve as the "acceptance criteria" for substantial equivalence in this context.

Here's a breakdown based on the provided text, addressing your points where possible:

Acceptance Criteria and Device Performance for Denimed Electrónica Mare Dental Operative Unit (K041458)

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to predicate devices (Sirona Dental Systems C8+ Dental Operative Unit, K032543, and Spirit S1 Dental Operative Unit, K962071) in terms of intended use, technological characteristics, and material composition, as well as compliance with relevant safety standards.

Acceptance Criteria Category	Specific Criteria/Standard Adhered To	Reported Device Performance (Mare Dental Operative Unit)	Basis for Performance Claim
Intended Use Equivalence	Same as predicate devices: supply power to and serve as a base for dental devices and accessories, conveniently position dynamic instruments, deliver air, water, and electricity for dental procedures.	Meets: Intended use is identical to predicate devices.	Stated in "Intended Use" section and confirmed by FDA.
Technological Characteristics Equivalence	Similar components, design, characteristics, and mode of operation as predicate devices (e.g., chair, instrument board, cuspidor, dental light, footswitches).	Meets: Includes a patient treatment chair, cuspidor with water unit, dental light, instruments console, and rolling chair. These are generally comparable to predicate devices.	Stated in "Technological Characteristics and Substantial Equivalence" section.
Material Equivalence	Use of common dental industry materials like PVC, polyurethane tubing, stainless steel, painted steel, anodized/plated alloy compounds, ABS plastics.	Meets: Utilizes these materials, stating they are "substantially equivalent to Spirit S1 Operative Unit."	Stated in "Technological Characteristics and Substantial Equivalence" section.
Mechanical Safety	Features like safety fuses, manual and pneumatic shut-off valves for air/water lines.	Meets: "Safety fuse on the bottom of the unit, as an industry standard." "Air and water lines have both manual shut off valves and pneumatically controlled automatic shut off valves."	Stated in "Technological Characteristics and Substantial Equivalence" section.
Electrical Safety Standard	IEC 60601-1/14-12-2000	Meets: "The Mare unit successfully passed the electrical safety tested per IEC 60601-1/14-12-2000 standards, which meets the safety requirements for medical electrical systems."	Compliance Testing.
Quality Management System Standard	DNV ISO 9002:2000	Meets: "The Mare unit successfully passed, the DNV (Det Norske Veritas) ISO 9002: 2000 which meets the Quality Management System Standards."	Certification/Audit.
European Test Standards (ETS)	Adherence to applicable ETS.	In Progress: "The Mare unit is currently being tested for the ETS (European Test Standards)."	Stated status of testing. (Note: This was "in progress" at the time of the submission, but its inclusion implies an intent to meet this as a benchmark.)
Technical Specifications	Comparable operational parameters for voltage, frequency, water pressure, air pressure, air consumption, water consumption.	Meets: Comparative table shows Mare specifications are within generally comparable ranges or provide options (e.g. 110/220V) that subsume predicate specifications. - Voltage: 110 or 220 Volts (vs 110 Volts for Spirit S1) - Frequency: 50 or 60Hz (vs 50 Hz for Spirit S1) - Water Pressure: 40 psi Kg/cm2 - Air Pressure: 5 bar or 80psi (same as Spirit S1) - Air Consumption: 100 L/min (comparable to Spirit S1's "100 min") - Water Consumption: 3L/m (comparable to Spirit S1's "2 m")	Comparative table provided in section "Technological Characteristics and Substantial Equivalence."

Study Information Details

Given this is a 510(k) submission for a Class I dental operative unit based on substantial equivalence, the types of detailed studies typically associated with novel or high-risk devices (e.g., clinical trials with large sample sizes, expert adjudication of medical image interpretation, MRMC studies) are not applicable (N/A) here. The device is a "base for dental devices and accessories" and aims to provide user control, not to diagnose or treat conditions itself in a way that requires complex clinical efficacy data.

Therefore, for points 2 through 9, the answer is largely N/A with explanations of why.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

N/A. This submission does not involve a "test set" in the sense of clinical data or patient samples. The "testing" referred to is engineering and safety compliance testing (e.g., electrical safety according to IEC 60601-1). Data provenance is from internal company testing and certification bodies for these technical standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. No ground truth for a clinical "test set" was established by experts. Substantial equivalence relies on technical specifications, intended use comparison, and adherence to recognized standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. No clinical "test set" requiring adjudication was used.

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

N/A. MRMC studies are used for diagnostic aids, particularly those involving human interpretation of images or data, often in the context of AI assistance. This device is a dental operative unit, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This device does not have a standalone algorithm component whose performance would be assessed without human input. It is a physical dental unit operated by human practitioners.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

N/A. The "ground truth" for this submission are the established engineering standards (like IEC 60601-1 for electrical safety), quality management standards (ISO 9002:2000), and the technical specifications and intended use of the legally marketed predicate devices. The device's performance against these technical specifications and standards constitutes its "truth" for substantial equivalence.

8. The sample size for the training set

N/A. This device is not an AI/ML algorithm that requires a "training set."

9. How the ground truth for the training set was established

N/A. This device is not an AI/ML algorithm that requires a "training set."

Summary

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K041458

AUG 2 4 2004

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Denimed Electrónica Equipamientos Odontológicos

May 25, 2004

510(k) Summary

Applicant:

Denimed Electrónica Bv. De Lós Alemanes 3485 Bº Los Boulevares X5022EOG Córdoba-Argentina Tel & Fax: (0351) 475-0950 Owner/Operator Number: 9063675 Preparer:

Dental Products of USA, Inc. 1460 NW 107 Ave Suite G Miami, Florida 33172 Tel: 305-640-9894 Fax: 305-477-3206 Contact Person: George Echeverri Owner/Operator Number: 9034594

Summary Prepared Date:

May 25, 2004

Device Name:

l. Proprietary Name: Mare Dental Operative Unit II. Common/Usual Name: Dental Operative Unit III. Classification Name: Dental Operative Unit with Accessories

Predicate Devices:

1. C 8+ Dental Operative Unit with Accessories, K032543
II. Spirit S I Dental Operative Unit with Accessories, K962071

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Intended Use:

The Mare Dental Operative Unit with accessories is intended to supply power to and serve as a base for dental devices and accessories. The unit is designed to conveniently position the dentist's dynamic instruments for use during dental procedures. The unit is intended for use in the dental clinic environment and used by trained dentists and/or dental technicians and assistants. The unit delivers air, water and electricity to allow the dental practitioner an intuitive control for all common and normal patient treatment procedures performed in the dental clinic. The Mare unit system is a component of a complete dental treatment suite. Other components are the chair, suction and waste unit and task light. In a fixed location the Mare unit will be connected to an electrical supply, a wastewater trap and an air supply. The Mare Dental Operative Unit with accessories shall be subject to regular operator checks and it will be the responsibility of the dentist or dental therapist to ensure that the apparatus is fully functional before use.

Device Description:

l. Patient Treatment Chair: It has two controls; a foot control and a digital pad in the instruments console for all chair positions, auto return system, preset position, emergency stop system and electric cup filler. The entire Mare features an articulating, detachable headrest.
II. Cuspidor with Water Unit: The ceramic bowl, cup fillers and the bowl irrigator are detachable. The Mare features a swivel ceramic bowl.
III. Dental Light: The Unit features a lamp with two intensity settings.
IV. Instruments Console: Features an instruments auto selection system and a master digital control.
- V. Rolling Chair: Height adjustable backrest and inclination setting.

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Technological Characteristics and Substantial Equivalence:

The Mare Dental Operative Unit with Accessories is substantially equivalent to Sirona Dental Systems C8+ Dental Operative Unit, K032543 and the Spirit S1 Dental Operative Unit, K962071. The Mare unit has the same intended use as the predicates in that they are all used to supply power to, and serve as a base for dental devices and accessories. The components that make up this delivery system in many instances are generic to the dental industry and are made of the same materials utilized by other manufacturers that provide an equivalent product. These materials include; poly vinyl compounds (PVC), polyurethane tubing, stainless steel, painted steel, anodized and plated alloy compounds and ABS plastics which is substantially equivalent to Spirit S1 Operative Unit. The Mare unit system is designed as a dental chair mounted unit and mounts on a two inch steel post. The mechanical safety similarities between the Mare unit and Spirit SI unit are very similar they both have a sufety fuse on the bottom of the unit, as an industry standard. The polyurethane air and water supply lines are connected in a floor mounted metal utility box. The air and water lines have both manual shut off valves and pneumatically controlled automatic shut off valves. The on/off switch located on the control section of the Mare unit, controls the pneumatic valves. The water lines are specially designed for disinfecting, using common bleach/water rinsing without suffering deterioration.

Mare Technical Information	Spirit S1 Technical Information
Voltage:	110 ó/or 220 Volts	Voltage:	110 Volts
Frequency:	50ó/or 60Hz	Frequency:	50 Hz
Water Pressure:	40 psi Kg/cm2	Water Pressure:	cm2
Air Pressure:	5 baró/or 80psi	Air Pressure:	80 psi
Air Consumption:	100 L/min	Air Consumption:	100 min
Water Consumption:	3L/m	Water Consumption:	2 m

Energy/Water and Air, Used and/or Delivered:

The technological characteristics of the proposed and predicate devices are the same in that they include similar components, and are similar in design, characteristics and mode of operation. Both the proposed and predicate devices include a chair, dentist's instrument board, cuspidor, assistant's board, dental light and footswitches for control of the various components. The Mare unit also includes additional features that do not change the fundamental technology of the device or raise new questions of safety or effectiveness. The Mare unit successfully passed the electrical safety tested per IEC 60601-1/14-12-2000 standards, which meets the sufety requirements for medical electrical systems. The Mare unit successfully passed, the DNV (Det Norske Veritas) ISO 9002: 2000 which meets the Quality Management System Standards. The Mare unit is currently being tested for the ETS (European Test Standards).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized lines or stripes, possibly representing a stylized human figure or a symbol of health and well-being.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 4 2004

Denimed Electrónica S.H. C/O Mr. George Echeverri Export Sales Director Dental Products of USA, Incorporated 1460 NW 107 Avenue Suite G Miami, Florida 33172

Re: K041458

Trade/Device Name: Mare Dental Operative Unit Regulation Number: 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: May 25, 2004 Received: August 5, 2004

Dear Mr. Echeverri:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to such 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 Lederal Register.

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Page 2 - Mr. Echeverri

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. or the rist or any with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms feter notification. The FDA finding of substantial equivalence of your device to a premainer letter one in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the maj votant of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

C. Liu, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (If know): X(\||<}<

Device Name: Mare Dental Operative Unit

Statement of Indications for Use:

Intended Use for the Mare Dental Operative Unit:

The system delivers air, water, and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental office.

Prescription Use______________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, office of Device Evaluation (ODE)

Susan Bunn

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041153

Regulation Number and Section

§ 872.6640 Dental operative unit and accessories.

(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.