(324 days)
Not Found
No
The summary describes a standard dental unit with controls for air, water, electricity, and vacuum, and mentions software for controlling these functions and accessories. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices.
Yes
The device is a dental unit used by dental practitioners to perform patient treatment procedures by delivering air, water, electricity, and vacuum to dental handpieces and instruments. The system is an integral part of dental procedures, making it a therapeutic device used for treatment.
No
Explanation: The device description states its purpose is to control dental chair operations and deliver air, water, electricity, and vacuum for "patient treatment procedures." There is no mention of diagnostic functions or capabilities.
No
The device description clearly outlines multiple hardware components including a patient chair, foot control, dentist element, water unit, dental operating light, and couplings for various handpieces and accessories. The software is described as a user interface to control the operation of these physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is described as providing a user interface to control dental chair operations and attached dental devices, delivering air, water, electricity, and vacuum for patient treatment procedures. This is a functional role in a dental setting, not a diagnostic one.
- Device Description: The device description details the components of a dental unit (chair, foot control, delivery unit, etc.) and how it provides resources (air, water, electricity, vacuum) to dental instruments. It does not mention any components or functions related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological specimens (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions
- Reagents, calibrators, or controls used in laboratory testing
The device is clearly designed to facilitate dental procedures by providing power and control to dental instruments, which is a therapeutic and procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
Infinity Pro, Logic, Quality, Sprint are 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, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
Product codes
EIA, EBW
Device Description
The Olsen dental units consist of a patient chair, foot control, dentist element, water unit and a dental operating light. The Olsen dental units also include coupling for various handpieces and accessories that can be added to the Olsen Dental System such as pneumatic handpieces, handpieces with generator, optical fiber handpieces, pneumatic scalers, air/water syringes, SE (saliva ejectors) and handpieces for vacuum.
None of the Olsen dental units, parts or accessories are provided sterile.
Infinity Pro, Logic, Quality and Sprint Dental Systems serves as a base that includes components to deliver air, water, electricity, and vacuum to dental handpieces instruments.
The Infinity Pro, Logic, Quality and Sprint Dental Systems are designed to bring a patient into an ergonomic position to perform dental treatment procedures. For this purpose, the patient chair (seat and backrest) can be brought into an appropriate position, either by activating the chair positioning motors or by recalled programmed positions set by the user.
Upholsteries can be provided on PVC and a built-in massage system is available for backrest and seat. The headrest is adjusted manually according to patient height and the area in the patient's oral cavity to be treated. The headrest has mechanical adjustment that allows adjustments such as extension / retraction to adapt to the patient's stature, tilting for maxillary / mandibular treatment.
To perform the treatment, pneumatic instruments coupled to the equipment such as high speed turbines and low speed micromotors are applied by the intended user. After taking an instrument from its respective holder, it can be activated via the foot control. The air pressure for activating the instruments is pre-set at the factory, but the adjustment of the volume of water for cooling the instruments can be adjusted by the user. The optical fiber coupling, in addition to water and air, provides electricity to activate the internal lighting of this type of instrument. There is available system of continuous air jet for highspeed handpieces couplings.
Water for instruments is self-contained, and an internal water is available for patient comfort. The Olsen Dental Systems provide stainless steel trays to place dental hand instruments and materials required during treatment.
To dispose of fluids and particles deriving from the oral cavity during treatment, suction hoses with attached instruments are provided on the assistant element or Water Unit. After taking the ejection instrument from its respective holder, continuous ejection starts until instrument come back to its holder. There is also available handpiece ejector activated by command button located on chair base or foot control. Vacuum pump adaptor is also available to provide one or two handpieces connected to a vacuum line.
Also, a cuspidor bowl is available for patient rinse. The cuspidor is swivel at 90° and can be manually approached to the patient chair. Cup Filler is available for patient mouth rinse. The Spittoon Bowl can be supplied in polyester resin or porcelain. Water to Spittoon Bowl and Cup Filler is city water. Manual or automatic commands for water to spittoon bowl and cup filler are available.
An operating light providing illumination to the oral cavity can be switched ON via the touch panel, pedal, chair base commands or is operated automatically in accordance with preset adjustments in connection with the pre-programmed chair positions. It can be also switched ON/OFF via a no-touch sensor that recognizes when the hand is moved there.
Most chair and instrument related functions can be activated hands-free via foot control. The foot control is provided as progressive pedal for handpieces activation and other commands on the chair base for Quality and Sprint units, or all activation and commands combined in a remote foot pedal, available to Quality and Sprint as optional item and to Logic and Infinity Pro as standard item.
Accessories:
- Cart System
- Dental Cart Unit K10
- Monitor Holder
- Junction Box
The Cart System and Dental Cart Unit K10 are optional items that eliminates the use of a support arm connected to the Delivery Unit and provides the dentist (working table) instrument couplings, 3-Way Syringe and features on a steel base with castors, which provides mobility for the professional.
Dental Cart Unit K10 holds up to 10 handpieces including eiection and vacuum handpieces, concentrating all handpieces in one place.
Connection to the chair by a single hose for water, air, and 24V electricity supply.
The Monitor Holder is an optional item that is attached to the operating light column with a fixing ring to support one monitor. The monitor holder features swivel on the shaft, tilt adjustment and side swivel for the monitor.
The Junction Box works as a passage and connection of water, sewage, and electricity network, for connecting the equipment and the optional Cart System or Dental Cart Unit K10 or when the customer requests a connection point other than the junction box integrated in the base of the equipment.
The device description and intended use are identical for all Olsen Dental Unit models. The differences between the models and mounting configurations are cosmetic in nature such as size/shape of the operative units (working tables) and instrument holders. All critical components within the Olsen Dental Systems are the same.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental practitioner / 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)
Biocompatibility testing: The biocompatibility evaluation for the Olsen Dental Unit was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing included the following tests: Cytotoxicity, Sensitization, Irritation. Parts considered tissue contact, direct: Chair Upholstery - PVC, 3-Way Syringe including Tip (internal duct) – Stainless Steel 316L. Parts considered indirect contact: Internal fluids distribution system: Reservoir, Valves, hoses, couplings – PET Polyester, Stainless Steel 316L, Polyamide (Nylon 6.6) and Ether Based Polyurethane. All parts come into contact with the patient for a period of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC): Testing were conducted on the Olsen Dental Units, consisting of the Chair, Delivery Unit, Water Unit, Working Table with support arm, Operating Light with support arm, Foot Controls and Assistant Module. The equipment complies with the following standards for safety and EMC: IEC 60601-1, ISO 7494-1, ISO 7494-2, IEC 60601-1-2 and IEC 80601-2-60.
Software Verification and Validation Testing: Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because the functions related to the essential performance are Class moderate and derived from structures mostly LEVEL OF CONCERN MODERATE. Comparative performance testing of the functions of the integrated accessories as compared to the cleared stand-a-lone device. For the foot pedal, software verification/validation of the functions of the foot control was conducted.
Reprocessing Validation: The 3-way syringe is supplied non-sterile and is to be sterilized by autoclave prior to use. Fractional pre-vacuum cycle at 132°C for 4 min and a drying time of 25. The sterilization cycle has been validated as below: ANSI AAMI ST7, Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ISO 17665-1 and -2, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices. The cleaning method has been validated per AAMI TIR30 and the FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling. The intermediate-level disinfection method has been validation for the surfaces and internal hoses/waterlines per AAMI TIR12.
Animal Study: No Animal Studies were conducted.
Clinical Studies: No Clinical Studies were conducted.
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.
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.
Not Found
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
§ 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.
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 logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
October 19, 2022
Olsen Indústria e Comércio S.A. % Lilian Llull Regulatory Affairs Manager TechLink International 16445 Collins Ave # 522 Sunny Isles, Florida 33160
Re: K213742
Trade/Device Name: Infinity Pro, Logic, Quality, Sprint Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA, EBW Dated: September 19, 2022 Received: September 19, 2022
Dear Lilian Llull:
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, 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
510(k) Number (if known) K213742
Device Name Infinity Pro, Logic, Quality, Sprint
Indications for Use (Describe)
Infinity Pro, Logic, Quality, Sprint are 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, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
| 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) | ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☒ Prescription Use (Part 21 CFR 801 Subpart D) | ||
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K213742
l. SUBMITTER
Olsen Indústria e Comércio S.A. Avenida Ivo Lucchi, 68 - Jardim Eldorado Palhoça, SC. 88133-510, Brasil Phone: +5548 2106-6000 Fax: +5548 2106-6000
Official Contact:
Lilian Llull TechLink International Consulting 16445 Collins Ave # 522 Sunny Isles, FL 33160 TEL - (305) 206-6777 Date Prepared: Oct 14, 2022
II. DEVICE
Name of Device: Infinity Pro, Logic, Quality, Sprint Common or Usual Name: Unit, Operative Dental Classification Name: Dental Operative Unit and Accessories, per 21CFR 872.6640 Regulatory Class: Class I Product Code: EIA Additional Product Code: EBW Classification Panel: Dental
III. PREDICATE DEVICE
Olsen Infinity / Infinity Cross Flex Dental System, K180935
IV. DEVICE DESCRIPTION
The Olsen dental units consist of a patient chair, foot control, dentist element, water unit and a dental operating light. The Olsen dental units also include coupling for various handpieces and accessories that can be added to the Olsen Dental System such as pneumatic handpieces, handpieces with generator, optical fiber handpieces, pneumatic scalers, air/water syringes, SE (saliva ejectors) and handpieces for vacuum.
None of the Olsen dental units, parts or accessories are provided sterile.
Infinity Pro, Logic, Quality and Sprint Dental Systems serves as a base that includes components to deliver air, water, electricity, and vacuum to dental handpieces instruments.
4
The Infinity Pro, Logic, Quality and Sprint Dental Systems are designed to bring a patient into an ergonomic position to perform dental treatment procedures. For this purpose, the patient chair (seat and backrest) can be brought into an appropriate position, either by activating the chair positioning motors or by recalled programmed positions set by the user.
Upholsteries can be provided on PVC and a built-in massage system is available for backrest and seat. The headrest is adjusted manually according to patient height and the area in the patient's oral cavity to be treated. The headrest has mechanical adjustment that allows adjustments such as extension / retraction to adapt to the patient's stature, tilting for maxillary / mandibular treatment.
To perform the treatment, pneumatic instruments coupled to the equipment such as high speed turbines and low speed micromotors are applied by the intended user. After taking an instrument from its respective holder, it can be activated via the foot control. The air pressure for activating the instruments is pre-set at the factory, but the adjustment of the volume of water for cooling the instruments can be adjusted by the user. The optical fiber coupling, in addition to water and air, provides electricity to activate the internal lighting of this type of instrument. There is available system of continuous air jet for highspeed handpieces couplings.
Water for instruments is self-contained, and an internal water is available for patient comfort. The Olsen Dental Systems provide stainless steel trays to place dental hand instruments and materials required during treatment.
To dispose of fluids and particles deriving from the oral cavity during treatment, suction hoses with attached instruments are provided on the assistant element or Water Unit. After taking the ejection instrument from its respective holder, continuous ejection starts until instrument come back to its holder. There is also available handpiece ejector activated by command button located on chair base or foot control. Vacuum pump adaptor is also available to provide one or two handpieces connected to a vacuum line.
Also, a cuspidor bowl is available for patient rinse. The cuspidor is swivel at 90° and can be manually approached to the patient chair. Cup Filler is available for patient mouth rinse. The Spittoon Bowl can be supplied in polyester resin or porcelain. Water to Spittoon Bowl and Cup Filler is city water. Manual or automatic commands for water to spittoon bowl and cup filler are available.
An operating light providing illumination to the oral cavity can be switched ON via the touch panel, pedal, chair base commands or is operated automatically in accordance with preset adjustments in connection with the pre-programmed chair positions. It can be also switched ON/OFF via a no-touch sensor that recognizes when the hand is moved there.
Most chair and instrument related functions can be activated hands-free via foot control. The foot control is provided as progressive pedal for handpieces activation and other commands on the chair base for Quality and Sprint units, or all activation and commands combined in a remote foot pedal, available to Quality and Sprint as optional item and to Logic and Infinity Pro as standard item.
Accessories:
-
-Cart System
-
Dental Cart Unit K10 -Monitor Holder
-
-Junction Box
-
Palhoça, SC, Brasi
5
The Cart System and Dental Cart Unit K10 are optional items that eliminates the use of a support arm connected to the Delivery Unit and provides the dentist (working table) instrument couplings, 3-Way Syringe and features on a steel base with castors, which provides mobility for the professional.
Dental Cart Unit K10 holds up to 10 handpieces including eiection and vacuum handpieces, concentrating all handpieces in one place.
Connection to the chair by a single hose for water, air, and 24V electricity supply.
The Monitor Holder is an optional item that is attached to the operating light column with a fixing ring to support one monitor. The monitor holder features swivel on the shaft, tilt adjustment and side swivel for the monitor.
The Junction Box works as a passage and connection of water, sewage, and electricity network, for connecting the equipment and the optional Cart System or Dental Cart Unit K10 or when the customer requests a connection point other than the junction box integrated in the base of the equipment.
The device description and intended use are identical for all Olsen Dental Unit models. The differences between the models and mounting configurations are cosmetic in nature such as size/shape of the operative units (working tables) and instrument holders. All critical components within the Olsen Dental Systems are the same.
V. INDICATIONS FOR USE
Infinity Pro, Logic, Quality, Sprint are 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, electricity, and vacuum to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed by the dentist / dental assistant.
The Indications for Use statement for the Olsen Infinity Cross Flex Dental System device is not identical to the predicate device due the "electricity" term; however, the difference does not alter the intended therapeutic use of the device, nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have intended use for dental procedures performing, by patient accommodation and provision of lighting, and conditions for operating dental instruments.
6
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
e 4 of 9
| | | Infinity Pro, Logic, Quality,
Sprint
(Subject Device) | Infinity and Infinity Cross Flex
(Predicate Device) |
|--------------------------------------|-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------|
| Construction | | CHAIR / DELIVERY UNIT /
WORKING TABLE /
ASSISTANT MODULE /
OPERATING LIGHT /
FOOT PEDAL / STOOL | CHAIR / DELIVERY UNIT /
WORKING TABLE /
ASSISTANT MODULE /
OPERATING LIGHT /
FOOT PEDAL / STOOL |
| Chair | Headrest | Single and Double-Articulating
Headrest | Double-articulating headrest |
| | Safety switch
function | Emergency Stop Switch
and/or a Stop System | Emergency Stop Switch
and a Stop System, |
| | Stop function | The safety switch and/or any
movement switch stops the chair
operation | The safety switch stops the
chair operation. |
| | Programmable
chair position | Programmable chair position:
Total 3 positions | Programmable chair position:
Total 3 positions |
| | Operation | The chair performs seat and
backrest movements individually
and independently through
spindle drive motors. | The chair performs seat and
backrest movements individually
and independently through
spindle drive motors. |
| | Chair Operating System | Electric System | Electric System |
| | Chair Controls | Available on chair base, remote
pedal, or touch panel. | Available on remote pedal and
touch panel. |
| | Construction and
Material | Metal Frame built with SAE
1020.
Upholstery coated with PVC,
built with injected foam. | Metal Frame built with SAE 1020.
Upholstery coated with PVC, built
with injected foam. |
| | Optional Item | Anti-Stress System | Not available |
| | UNIT/CHAIR form type | Over-arm Contour type | Over-arm Contour type |
| Delivery
Unit
Working
Table | Working Table Arm | Mechanical or pneumatic brake
Free Horizontal Moments | Pneumatic brake
Free Horizontal Moments |
| | Handpiece holder | 3 or 4 steady holders (up to 5 or
6 optional) | 4 steady holders (up to 6 optional) |
| | | Retractable Rods Available
(optional) | Retractable Rods available (Cross
Flex) |
| | Handle | Adjustable handle | Adjustable handle |
| | Touchpad | Capacitive Panel | Capacitive Panel |
| | Handpiece water
and air cooling | Only water is adjustable | Only water is adjustable |
| | Flex arm tension | Not available | Not available |
| | Working Table Relative
position to the chair | Both Sides (Ambidextrous) | Left Side (Standard) |
| | Stainless Steel Tray | Available | Available |
| | Optional Items | Coupling for Optical Fiber
Handpieces, X-Ray Viewer, Air
Jet, Thermo Comfort, Chronolub. | Not available |
| Water Unit | Cuspidor (Spittoon) | Spittoon bowl / Rinsing pipe | Spittoon bowl / Rinsing pipe |
| | Water System | City Water / Distilled Water | City Water / Distilled Water |
| | Valves Composition
(fluid contact area) | Stainless Steel 316L | Stainless Steel 316L |
| | Cuspidor | Attach/detachable POLYESTER or
PORCELAIN, disassemble for
cleaning | Attach/detachable POLYESTER,
disassemble for cleaning |
| Support | Solids collector | Equipped | Equipped |
| Center | Distilled water
reservoir | Equipped | Equipped |
| | Cup water system | Available | Not available |
| Vacuum system | | Central Vacuum system or Air
Vacuum System | Central Vacuum system or Air
Vacuum system |
| 3-Way Syringe | | Adjusting the Water / Air / Spray
function is used in the syringe
button | Adjusting the Water / Air / Spray
function is used in the syringe
button |
| Accessories
Tools | Accessories holder | SE, Vortex Ejector, 3-WAY
syringe and
Vacuum Pump Adaptor attached | SE, 3-WAY syringe and
Vacuum Pump Adaptor attached |
| | Holder structure | Rotation and individual
holder | Rotation and individual
holder |
| | Light head
structure | 3-axis and 2-axis head
adjustment method | 3-axis head adjustment
method |
| Operating
Light | Description | ABS made, with multifaceted
mirror, with gradual and cyclical
intensity control | ABS made, with multifaceted
mirror, with gradual intensity
control |
| | Technical Features | LED: 3,7V x 3VA / LED 12-24V x
12VA
Luminosity: 8.000 to 30.000 Lux
Color Temperature: 4500K | LED: 24V x 5W.
Luminosity: 4.000 to 24.000 Lux
Color Temperature: 4500K |
| | ON/OFF control | Auto and manual ON/OFF | Auto and manual ON/OFF |
| Accessories | Accessories attached
to the device | Dental Chair / 3-way syringe | Dental Chair / 3-way syringe |
| | Other | Cart System, Dental Cart Unit
K10, Monitor Holder, Junction
Box | Dental Cart Unit K10 |
| | Operation Method | Control panel / Assistant control
panel / Foot controller / Chair
Base Commands | Control panel / Assistant control
panel / Foot controller |
| Electric
Information | Power Supply /
Frequency | AC 118V/127V/220V/230V
50/60Hz | AC 118V/127V/220V/230V
50/60Hz |
| | Power Shock Protection | Class I | Class I |
| | | Electric Protection | B Type |
| | Dimesions (mm) | Infinity Pro: 2232 x 2176 x 3216
Logic: 2273 x 2043 x 3355
Quality: 2308 x 1975 x 2623
Sprint: 2268 x 1971 x 2650 | Infinity: 2258 x 2176 x 3215
Infinity Cross Flex: 2258 x 2176 x
3374 |
Subject Device and Predicate Device Comparison Table:
7
WWW.OLSEN ODBER INOISen Page 5 of 9
8
Page 6 of 9
The following items are considered as common technological principles for both subject and predicate device:
-
Dental Chair with backrest and seat with movements through electric motors, to accommodate patient in an ergonomic way to perform dental procedures.
-
Adjustable headrest for positioning and access to the patient's oral cavity.
-
Base that includes components to deliver air and water to in appropriate conditions for the correct performance of dental handpieces.
-
Provide Ejection and Vacuum options to dispose fluids and particles deriving from oral cavity during treatment, where ejection works with venturi system using compressed air that feeds the equipment and vacuum is generated by an external vacuum pump.
-
Provide cuspidor bowl for patient rinse supplied with city water.
-
Operating Light with multifaceted mirror reflector generates LED illumination and it has a range of motion that allows positioning for the necessary lighting to carry out the dental procedure.
-
Foot control for handpieces activation and chair movements commands in order to provide a handsfree equipment operation.
At a high level, the subject and predicate devices are based on the following same technological elements:
- -Dental Chair, with adjustable headrest to receive and position the patient.
- -Borden or Midwest coupling provides compressed air for propulsion and cooling water for rotary dental instruments.
- 3-Way Syringe to emits air and water jet or spray (mixture of both). -
- -Venturi Saliva Ejector for patient oral cavity ejection.
- -Vacuum Pump Adaptor for patient oral cavity ejection.
- Concept Plus and LED Premium operating lights with 3 adjustment axes, multifaceted mirror for indirect LED Illumination and jointed arm support.
- -Remote foot control for hands-free operation of handpieces and chair movements.
The following technological differences exist between the subject and predicate devices:
- -Midwest coupling with 3,1V electrical feeding for optical fiber handpieces.
- Continuous air jet through the highspeed coupling itself, dispensing the use of a syringe for this function.
- -Thermo Comfort System which is a water heater to provide warm water in the 3-way syringe with the output between 35°C and 45°C.
- -Chair Base Commands: Sprint and Quality Dental Units present as serial item the command switches located on the chair base. The positioning of the commands on the base does not
9
interfere with the performance of the dental procedure or with the safety of using the equipment. Remote foot pedal as an optional item.
- -Stop System instead of Emergency Stop Switch: the equipment is not supplied with the Emergency Stop Switch but instead includes a Stop System located close to the operator (user). As for the electrical issue, the ON/OFF switch is located in the same place where Emergency Stop Switch should be, to cut off the device's main power supply if necessary.
- -Stop function: All chair movement command buttons can stop the chair operation and not only one safety switch, does not matter if it is located on the remote foot pedal, equipment chair base or equipment panel commands.
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the Olsen Dental Unit was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. Testing included the following tests:
- -Cytotoxicity
- Sensitization ।
- । Irritation
Parts considered tissue contact, direct: Chair Upholstery - PVC 3-Way Syringe including Tip (internal duct) – Stainless Steel 316L
Parts considered indirect contact:
Internal fluids distribution system: Reservoir, Valves, hoses, couplings – PET Polyester, Stainless Steel 316L, Polyamide (Nylon 6.6) and Ether Based Polyurethane
All parts come into contact with the patient for a period of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Olsen Dental Units, consisting of the Chair, Delivery Unit, Water Unit, Working Table with support arm, Operating Light with support arm, Foot Controls and Assistant Module. The equipment complies with the following standards for safety and EMC: IEC 60601-1, ISO 7494-1, ISO 7494-2, IEC 60601-1-2 and IEC 80601-2-60.
10
Software Verification and Validation Testing
Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern because the functions related to the essential performance are Class moderate and derived from structures mostly LEVEL OF CONCERN MODERATE. Comparative performance testing of the functions of the integrated accessories as compared to the cleared stand-a-lone device. For the foot pedal, software verification/validation of the functions of the foot control was conducted.
Reprocessing Validation
The 3-way syringe is supplied non-sterile and is to be sterilized by autoclave prior to use. Fractional pre-vacuum cycle at 132°C for 4 min and a drying time of 25.
The sterilization cycle has been validated as below:
- ANSI AAMI ST7, Comprehensive guide to steam sterilization and sterility assurance in health care facilities
- -ISO 17665-1 and -2, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices
The cleaning method has been validated per AAMI TIR30 and the FDA Guidance Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling.
The intermediate-level disinfection method has been validation for the surfaces and internal hoses/waterlines per AAMI TIR12.
11
Page 9 of 9
Animal Study
No Animal Studies were conducted.
Clinical Studies
No Clinical Studies were conducted.
VIII. CONCLUSIONS
Subject device has the same method of development, design and assembly, same composition, technical specifications, technological and operational principles, same intended use, and has the same performance and safety tests. The non-clinical data support the safety of the device and the hardware and software verification, and validation demonstrate that the Olsen Dental System, Infinity Pro, Logic, Quality, Sprint should perform as intended in the specified use conditions and performs comparably to the predicate device that is currently marketed for the same intended use.
The different technological characteristics do not raise new concerns of substantial equivalence. The performance data and testing of the Olsen Dental System, Infinity Pro, Logic, Quality, Sprint are the same. Hence, the device is deemed to be substantially equivalent.