(267 days)
The Ergonomic Products Workstation is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device is to be operated and used by dentists and other legally qualified professionals.
The Ergonomic Products Workstations provide a consolidated work area for the purpose of delivering air, water, vacuum, and electricity to handheld instruments, and is for use in a professional dental office by professional dental practitioners for administering care to dental patients. Ergonomic Products manufactures dental office delivery units in several formats, all using the same technology - Doctor Workstation, Hygiene Inwall Workstation, Universal Cart and Assistant Cart.
The Ergonomic Products Workstation is a dental operative unit.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformity to IEC 60601-1 (Medical electrical equipment - Part 1: General requirements for safety) | Device tested and found to conform. |
| Conformity to ISO 7494-1 (Dentistry - Dental units - Part 1: General requirements and test methods) | Device tested and found to conform. |
| Conformity to ISO 7494-2 (Dentistry - Dental units - Part 2: Water and air supply) | Device tested and found to conform. |
| Substantial Equivalence to Predicate Devices (A-Dec 4631 Duo Delivery System K000966, A-Dec Cascade 3072 Wallmount K935325, Spirit S1/S2 Pelton & Crane Co. K962071) based on Intended Use and basic feature set. | Device found to be substantially equivalent. |
2. Sample size used for the test set and data provenance:
No specific performance testing was conducted on clinical samples for this device. The assessment of performance was based on adherence to recognized standards and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test set requiring expert ground truthing was used. Conformity to standards and substantial equivalence claims were based on engineering and regulatory assessment.
4. Adjudication method for the test set:
Not applicable.
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:
Not applicable. This device is a dental operative unit, not an AI-assisted diagnostic or interpretative tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm.
7. The type of ground truth used:
The "ground truth" for the device's acceptability was based on established international standards for medical electrical equipment and dental units (IEC 60601-1, ISO 7494-1, ISO 7494-2) and a comparison of its intended use and technological characteristics to legally marketed predicate devices.
8. The sample size for the training set:
Not applicable. This device is not an AI/machine learning technology that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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APR 1 8 2014
Ergonomic Products, Inc. Workstation Traditional 510(k) Premarket-Notification Submission
Traditional 510(k) Summary
| A) Manufacturer: | Ergonomic Products, Inc.,767 Main Road, Suite OneWestport, MA 02790Phone Number: 1- 866-374-6487Fax: 508-636-3680 |
|---|---|
| Consultant: | Global Regulatory Compliance767 Main Road, Suite OneWestport, MA 02790401-651-6513Contact: Renee Gould |
| B) Date Prepared: | February 11, 2014 |
| C) Device Name | Unit, Operative Dental |
| Proprietary Name: | Ergonomic Products Workstation |
| Device Regulations: | 21 CFR 872.6640 |
| Class: | II |
| Product Code: | EIA |
| Review Panel: | Dental |
| D) Predicates: | K000966 A-Dec 4631 Duo Delivery System, A-Dec, Inc.K935325 A-Dec Cascade 3072 Wallmount, A-Dec, Inc.K962071 Spirit S1/S2, Pelton & Crane, Co. |
E) Device Description:
The Ergonomic Products Workstations provide a consolidated work area for the purpose of delivering air, water, vacuum, and electricity to handheld instruments, and is for use in a professional dental office by professional dental practitioners for administering care to dental patients. Ergonomic Products manufactures dental office delivery units in several formats, all using the same technology - Doctor Workstation, Hygiene Inwall Workstation, Universal Cart and Assistant Cart.
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F) Intended Use:
.
.
The Ergonomic Products Workstation is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device is to be operated and used by dentists and other legally qualified professionals.
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G) Comparison to Predicate Device(s):
| Ergonomic ProductsWorkstations | A-Dec4631 Duo Delivery SystemK000966Cascade 3072 WallmountK935325 | ||
|---|---|---|---|
| Product code | EIA | EIA | |
| Intended Use/ Indicationfor Use | The Ergonomic ProductsWorkstation is a dentaloperative unit, which is an AC-powered device that is intendedto supply power to and serve asa base for other dental devicesand accessories. The device is tobe operated and used by dentistsand other legally qualifiedprofessionals. | This device delivers air, water,vacuum and electricity tohandheld instruments, for use ina professional dental office. It isdesigned to be used byprofessional dental practitionersfor administering care to dentalpatients. | Are dentalpoweredpower toother devicesaccessoriesoperatedother legallyprofessi |
| Description | Doctor/assistant tables withinstrument holder andmechanical enclosure withcontrols for air and water. | Doctor/assistant tables withinstrument holder andmechanical enclosure withcontrols for air and water. | Doctor/assistantinstrumentmechanicalcontrols |
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| Product Features/Technological Characteristics | Ergonomic ProductsCarts | A-Dec Carts | Pelton &Crane SpiritCarts |
|---|---|---|---|
| Formats | Multiple includingwallmount | Multiple includingwallmount | Multipleincludingwallmount |
| Pivoting Delivery System | Standard | Standard | Standard |
| Control Block | Standard | Standard | Standard |
| Hand Piece Oil Collector | Standard | Standard | Standard |
| Wet Dry Foot Control | Optional | Standard | Standard |
| Wet Dry Panel Control | Standard | No | No |
| Solids Collector | Standard | Standard | Standard |
| Pivoting Instrument Arm | No | Standard | Standard |
| Autoclavable HVE and Saliva Ejector | Standard | Standard | Standard |
| Self Contained Water System | Standard | Standard | Standard |
| Water Quick Disconnect | Standard | Standard | Standard |
| Flow Control For QD | No | Standard | No |
| Cable Prewiring | Standard | Standard | Optional |
| Duplex Outlet | Standard Single | Standard | Standard |
| Height Adjustable WorkSurface | Standard | Standard | Standard |
| Laminate Work Surface | No | Standard | Yes |
| Autoclavable syringe | Optional | Optional | Optional |
| Quick Disconnect for Air | Standard | Optional | Optional |
| Dual HVE | Optional | Optional | Optional |
| Quad Voltage Interoral LightSource | No | Optional | Optional |
| Programmable ChairTouchpad | No | Optional | Optional |
| Arm Mount Tray Holder | Solid Surface 2nd Tier | Optional | Standard |
| Solid Surface Worksurface | Standard | Optional | Standard |
| Computer Keyboard Tray | Standard | No | Optional |
| USB Outlet | Standard 2 Locations | No | No |
| Consumable Bin | Standard | No | No |
| Med Waste Bin | Standard | No | No |
| Bien Air handpiece integration | Optional | No | Optional |
| Piezo scaler | Optional | Optional | Optional |
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Substantial Equivalence Discussion
The Ergonomic Products Workstation has the same Intended Use, is a base for other dental devices and accessories, and has the same basic feature set as the predicate devices. Differences in format and/or options do not raise new issues of safety or effectiveness. Therefore, the Ergonomic Products Workstation is substantially equivalent to the predicate devices.
Performance
No specific performance standards promulgated for this device, and not specific performance testing was conducted.
Biocompatibility was not required as the Workstations have no patient contacting surfaces.
Conformity to Standards
- . IEC 60601-1: 2005+C1:2009 +A2: 2010 Medical electrical equipment - Part 1: General requirements for safety
- ISO 7494-1 First edition 2004-11-01 Dentistry Dental units Part 1: General . requirements and test methods
- . ISO 7494-2 First edition 2003-03-01 Dentistry - Dental units - Part 2: Water and air supply
Conclusion
The Ergonomic Products Workstation has the same Intended Use, is a base for other dental devices and accessories, and has the same basic feature set as the predicate devices. Therefore, the Ergonomic Products Workstation is substantially equivalent to the predicate devices.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 18, 2014
Ergonomic Products, Inc. C/O Ms. Renee Gould Principal Consultant Global Regulatory Compliance 240 Annette Ave Woonsocket, RI 02895
Re: K132315
Trade/Device Name: Ergonomic Products Workstation Regulation Number: 21 CFR 872.6640 Regulation Name: Unit, Operative Dental Regulatory Class: II Product Code: EIA Dated: March 4, 2014 Received: March 13, 2014
Dear Ms. Gould:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Gould
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Image /page/6/Picture/7 description: The image shows a logo with the letters FDA. The letters are stylized and have a three-dimensional appearance, with multiple outlines creating a layered effect. The logo is simple and bold, making it easily recognizable.
Digitally signed by Richard C. Chapman Date: 2014.04.18 11:13:15 -04'00'
for
Erin I. Keith, M.S. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Ergonomic Products Workstation
Indications for Use: The Ergonomic Products Workstation is a dental operative unit, which is an AC-powered device that is intended to supply power to and serve as a base for other dental devices and accessories. The device is to be operated and used by dentists and other legally qualified professionals.
Prescription Use X OR (21 CFR 801, Subpart D)
Over-the-Counter Use (21 CFR 801, Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
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§ 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.