ERGONOMIC PRODUCTS WORKSTATION

K132315 · Ergonomic Products, Inc. · EIA · Apr 18, 2014 · Dental

Device Facts

• Record ID: K132315
• Device Name: ERGONOMIC PRODUCTS WORKSTATION
• Applicant: Ergonomic Products, Inc.
• Product Code: EIA · Dental
• Decision Date: Apr 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6640
• Device Class: Class 1

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.

Device Story

Ergonomic Products Workstation serves as a consolidated dental operative unit; provides air, water, vacuum, and electricity to handheld dental instruments; acts as a base for dental accessories. Used in professional dental offices by dentists and qualified practitioners. Features include doctor/assistant tables, instrument holders, mechanical controls for air/water, and various storage/utility options (e.g., consumable bins, waste bins, USB outlets). Device facilitates organized delivery of care by centralizing instrument support and utility connections. No patient-contacting surfaces; no clinical data required.

Clinical Evidence

No clinical data. Bench testing only. Device conforms to IEC 60601-1 (safety), ISO 7494-1 (dental units), and ISO 7494-2 (water/air supply). Biocompatibility testing not required as device has no patient-contacting surfaces.

Technological Characteristics

AC-powered dental operative unit. Materials: mechanical enclosure, solid surface work areas. Features: pivoting delivery system, control block, handpiece oil collector, solids collector, self-contained water system, quick disconnects. Connectivity: electrical outlets, USB outlets. Standards: IEC 60601-1, ISO 7494-1, ISO 7494-2. No software-based algorithm or patient-contacting materials.

Indications for Use

Indicated for use by dentists and legally qualified professionals as a base and power supply for dental devices and accessories in a professional dental office setting.

Regulatory Classification

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.

Predicate Devices

• A-Dec 4631 Duo Delivery System (K000966)
• A-Dec Cascade 3072 Wallmount (K935325)
• Spirit S1/S2 (K962071)

Submission Summary (Full Text)

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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.,<br>767 Main Road, Suite One<br>Westport, MA 02790<br>Phone Number: 1- 866-374-6487<br>Fax: [phone] |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consultant: | Global Regulatory Compliance<br>767 Main Road, Suite One<br>Westport, MA 02790<br>401-651-6513<br>Contact: 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.<br>K935325 A-Dec Cascade 3072 Wallmount, A-Dec, Inc.<br>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:

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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 Products<br>Workstations | A-Dec<br>4631 Duo Delivery System<br>K000966<br>Cascade 3072 Wallmount<br>K935325 | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Product code | EIA | EIA | |
| Intended Use/ Indication<br>for Use | The Ergonomic Products<br>Workstation is a dental<br>operative unit, which is an AC-<br>powered device that is intended<br>to supply power to and serve as<br>a base for other dental devices<br>and accessories. The device is to<br>be operated and used by dentists<br>and other legally qualified<br>professionals. | This device delivers air, water,<br>vacuum and electricity to<br>handheld instruments, for use in<br>a professional dental office. It is<br>designed to be used by<br>professional dental practitioners<br>for administering care to dental<br>patients. | Are dental<br>powered<br>power to<br>other devices<br>accessories<br>operated<br>other legally<br>professi |
| Description | Doctor/assistant tables with<br>instrument holder and<br>mechanical enclosure with<br>controls for air and water. | Doctor/assistant tables with<br>instrument holder and<br>mechanical enclosure with<br>controls for air and water. | Doctor/assistant<br>instrument<br>mechanical<br>controls |

7-3

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| Product Features/<br>Technological Characteristics | Ergonomic Products<br>Carts | A-Dec Carts | Pelton &<br>Crane Spirit<br>Carts |
|----------------------------------------------------|---------------------------------|---------------------------------|------------------------------------|
| Formats | Multiple including<br>wallmount | Multiple including<br>wallmount | Multiple<br>including<br>wallmount |
| 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 Work<br>Surface | 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 Light<br>Source | No | Optional | Optional |
| Programmable Chair<br>Touchpad | 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 [phone] or [phone] 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 [phone] or [phone] 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)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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