(267 days)
Not Found
No
The description focuses on the device's function as a power and supply base for other dental instruments, with no mention of AI or ML capabilities.
No.
Explanation: The device is described as a "dental operative unit" used to "supply power to and serve as a base for other dental devices and accessories." It provides air, water, vacuum, and electricity to handheld instruments. While it is used in a dental care setting, it does not directly treat or diagnose a medical condition itself; rather, it is a piece of equipment that facilitates the use of other dental instruments that might be therapeutic.
No
This device is a dental operative unit that provides power, air, water, and vacuum for dental instruments. It is not described as being used for diagnosis, but rather for administering care.
No
The device description clearly states it is an AC-powered device that supplies power and serves as a base for other dental devices, indicating it is a hardware device with physical components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is a "dental operative unit" intended to "supply power to and serve as a base for other dental devices and accessories." This describes a piece of equipment used during a dental procedure, not for testing samples outside the body to diagnose a condition.
- Device Description: The description reinforces this by stating it provides "air, water, vacuum, and electricity to handheld instruments" for use in a "professional dental office by professional dental practitioners for administering care to dental patients." This is a description of a clinical tool used directly on a patient.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / 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.
Product codes
EIA
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The device is to be operated and used by dentists and other legally qualified professionals.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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 One
Westport, MA 02790
Phone Number: 1- 866-374-6487
Fax: 508-636-3680 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Consultant: | Global Regulatory Compliance
767 Main Road, Suite One
Westport, MA 02790
401-651-6513
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.
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.
1
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.
... " .. " .. .
2
.
،
G) Comparison to Predicate Device(s):
| | Ergonomic Products
Workstations | A-Dec
4631 Duo Delivery System
K000966
Cascade 3072 Wallmount
K935325 | |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Product code | EIA | EIA | |
| Intended Use/ Indication
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. | This device delivers air, water,
vacuum and electricity to
handheld instruments, for use in
a professional dental office. It is
designed to be used by
professional dental practitioners
for administering care to dental
patients. | Are dental
powered
power to
other devices
accessories
operated
other legally
professi |
| Description | Doctor/assistant tables with
instrument holder and
mechanical enclosure with
controls for air and water. | Doctor/assistant tables with
instrument holder and
mechanical enclosure with
controls for air and water. | Doctor/assistant
instrument
mechanical
controls |
7-3
3
| Product Features/
Technological Characteristics | Ergonomic Products
Carts | A-Dec Carts | Pelton &
Crane Spirit
Carts |
|----------------------------------------------------|---------------------------------|---------------------------------|------------------------------------|
| Formats | Multiple including
wallmount | Multiple including
wallmount | Multiple
including
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
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
Source | No | Optional | Optional |
| Programmable Chair
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 |
4
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.
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing another person, representing the department's mission of protecting the health of all Americans.
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.
6
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
7
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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