(150 days)
The DU Series Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals. It is designed to be used by professional dental practitioners.
- The DU Series Portable Dental Unit is a combination of the speed handpieces, ultrasonic scaler, curing light, 3-way syringe, saliva ejector, clean water bottle, drain bottle, oil free air compressor, and footswitch.
- The external AC power source provides electric power to the unit. The self contained air compressor provides air source to speed handpieces. The self contained water system provides water source for the syringe, handpieces and ultrasonic scaler.
- The speed handpiece is supplied by the manufacturer of Predicate Device K991701; the ultrasonic scaler is supplied by K053555; the curing light is supplied by K080025. Other accessories are self-produced.
- The patient contacting components are in the accessories of speed handpieces and the ultrasonic scaler. All the patient-contacting materials have passed biocompatibility testing according to ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
The provided 510(k) summary (K111907) details the acceptance criteria and the study conducted for the DYNAMIC® DU Series Portable Dental Unit.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ISO 7494-2:2003 Dentistry - Dental units - Part 2: Water and air supply | Found in compliance with the standard |
| ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpieces | Found in compliance with the standard |
| EN 60601-1:2006 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005) | Passed safety testing |
| IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests | Passed safety testing |
| ISO 7405:2008 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (for patient-contacting components) | Patient-contacting materials (in speed handpieces and ultrasonic scaler) have passed biocompatibility testing. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document states that "Bench testing has been performed on a sample against the standards..." and "The DU Series Portable Dental Unit has passed bench testing...". However, the specific sample size used for the test set (i.e., the number of units tested) is not explicitly stated.
The data provenance is from bench testing conducted by the manufacturer, Shanghai Dynamic Industry Co., Ltd. in China. It is a prospective test of newly manufactured devices against established performance and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not applicable to this type of device and study. The "ground truth" for this device's performance is determined by adherence to established engineering and safety standards (e.g., water/air pressure, electrical safety, biocompatibility). There are no human experts involved in establishing a subjective "ground truth" in the way one would for diagnostic imaging. The standards themselves serve as the objective performance targets.
4. Adjudication Method for the Test Set:
This is not applicable. The testing involves objective measurements against predefined criteria in the standards. There is no need for adjudication as the results are quantitative and pass/fail based on the standards.
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:
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental operative unit, not an AI-powered diagnostic tool, so such a study would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
A standalone performance study was not done in the context of an algorithm or AI. The performance studies described are for the physical device itself (bench testing and safety testing) as a standalone unit.
7. The Type of Ground Truth Used:
The "ground truth" used for this device's evaluation is based on established international performance and safety standards (ISO and IEC standards) and biocompatibility guidelines. Compliance with these objective, measurable standards constitutes the ground truth for its safety and effectiveness.
8. The Sample Size for the Training Set:
This information is not applicable. The device is a physical medical instrument, not a machine learning or AI model. Therefore, there is no "training set" in the context of algorithm development.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable for the reasons stated in point 8.
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Shanghai Dynamic Industry Co., Ltd. No. 6 building, No. 4588 Jiasong (M) Rd., Qingpu District, Shanghai, China
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Section 5 510(k) Summary [As required by 21 CFR 807.92]
| 1. Submission Information: | |
|---|---|
| 510(k) Number: | K111907 |
| Date: | June 20th, 2011 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Submitter/Manufacturer: | Shanghai Dynamic Industry Co., Ltd. |
| No. 6 building, No. 4588 Jiasong (M) Rd., Qingpu District, Shanghai, China | |
| Contactor: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| E-mail: doris_d@126.com | |
| Tel: 86 21-31261348 | |
| Fax: 86 21-37824346 | |
| 2. Device Description: | |
| Proprietary Name: | DYNAMIC® DU Series Portable Dental Unit |
| Common Name: | Dental Operative Unit |
| Classification Name: | Dental operative unit and accessories |
| Regulation Number: | 872.6640 |
| Product Code: | EIA |
| Device Class: | I |
| Submission Type: | 510(k) |
| Review Panel: | Dental |
| Indications for use: | The DU Series Portable Dental Unit is intended to supply power and serve as a |
| base for dental devices and accessories. This device delivers air, water, vacuum, | |
| and electricity to handheld instruments, for use in dental clinics and hospitals. | |
| It is designed to be used by professional dental practitioners. | |
| Device Description: | 1) The DU Series Portable Dental Unit is a combination of the speed |
| handpieces, ultrasonic scaler, curing light, 3-way syringe, saliva ejector, clean | |
| water bottle, drain bottle, oil free air compressor, and footswitch. | |
| 2) The external AC power source provides electric power to the unit. The self | |
| contained air compressor provides air source to speed handpieces. The self | |
| contained water system provides water source for the syringe, handpieces and | |
| ultrasonic scaler. | |
| 3) The speed handpiece is supplied by the manufacturer of Predicate Device | |
| K991701; the ultrasonic scaler is supplied by K053555; the curing light is | |
| supplied by K080025. Other accessories are self-produced. | |
| 4) The patient contacting components are in the accessories of speed handpieces | |
| and the ultrasonic scaler. All the patient-contacting materials have passed | |
| biocompatibility testing according to ISO 7405:2008 Dentistry - Evaluation of | |
| biocompatibility of medical devices used in dentistry. | |
| Bench testing has been performed on a sample against the standards of ISO | |
| Performance data: |
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Shanghai Dynamic Industry Co., Ltd. No. 6 building, No. 4588 Jiasong (M) Rd., Qingpu District, Shanghai, China
7494-2:2003 and ISO 9168:2009, and found it in compliance with the standards.
3. Substantial Equivalence:
Detailed comparison data is included in "Section 9 - Substantial Equivalence Discussion" of this 510(k) submission.
| Predicate 510(k) Number: | K022217 |
|---|---|
| Marketing clearance date: | Oct 24, 2002 |
| Product name: | AEU-425 Transport II Portable Electronic Dental Operative System |
| Manufacturer: | ASEPTICO, INC. |
| Equivalence conclusion: | In all important respects, the DYNAMIC® DU Series Portable Dental Unit aresubstantially equivalent to the AEU-425 Transport II Portable Dental System(K022217). This conclusion is based upon comparison on design, technicalcharacteristics, operation mode, intended use, and safety standards compliedwith. Any differences in the technological characteristics do not raise any newsafety and effectiveness issues. |
4. Safety and Effectiveness of the device:
The DU Series Portable Dental Unit has passed bench testing according to
ISO 7494-2:2003 Dentistry - Dental units - Part 2: Water and air supply
ISO 9168:2009 Dentistry - Hose connectors for air driven dental handpieces
and safety testing according to
EN 60601-1:2006 Medical Electrical Equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005)
IEC 60601-1-2:2007 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
The handpieces and ultrasonic scaler, which are supplied by 510(k) approved manufacturers, have passed the biocompatibility testing according to ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
The conclusion drawn from the bench testing and safety testing is that the device is as safe and effective as the predicate device. Furthermore, the device complies with the recognized standards and performs its intended tasks as well as or better than the legally marketed predicate device.
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Image /page/2/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo features a stylized symbol with three curved lines, resembling a stylized human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Shanghai Dynamic Industry Company, Limited C/O Ms. Doris Dong Manager Shanghai CV Technology Company, Limited RM 1706, No. 128 Songle Road Songjiang Area Shanghai CHINA 201600
DEC = 2 2011
Re: K111907
Trade/Device Name: DYNAMIC® DU Series Portable Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: November 17, 2011 Received: November 23, 2011
Dear Ms. Dong:
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. Dong
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 vours.
Anthony D. Watson
Anthony D. Watson, B.S., M.S., M.B.A. 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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Section 4 Indications for Use Statement
K 111907 510(k) Number (if known):
Device Name:
DYNAMIC® DU Series Portable Dental Unit
Indications for Use: The DU Series Portable Dental Unit is intended to supply power and serve as a base for dental devices and accessories. This device delivers air, water, vacuum, and electricity to handheld instruments, for use in dental clinics and hospitals.
It is designed to be used by professional dental practitioners.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use __ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Susan Ruane
Division Sign-Off Division of Surgical, Orthopedic, And Restorative Devices
510(k) Number K111907
Susan Ruane
Page 1 of 1
(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Division of Anesthesion of Anesthesion of Anesther Infection Control, Dental Devices
510(k) Number:
§ 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.