(414 days)
The dental chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Ajax Dental Unit AJ1X is a dental operative unit attached to a chair. It consists of a patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The AJ1X unit is specially designed to meet the needs of dental professionals. The concept of hygienic treatment is emphasized in the unit design. Components are designed in the way which dentist can easily maintain and clean. Concept of the unit is to optimize the work for dental practice, as well as provide a very clean and healthy treatment environment for both dentists and patients.
The provided FDA 510(k) document for the AJAX dental unit (K132245) is a premarket notification for a Class I medical device (Dental Unit with Chair). For such a device, the focus of the submission is primarily on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance studies with acceptance criteria in the way a Class II or Class III device might require for diagnostic accuracy or efficacy.
Therefore, the structure of the acceptance criteria and study information will be adapted to reflect what is typically found in a 510(k) for a dental unit. The document focuses on non-clinical testing to ensure safety and performance according to relevant standards, and comparison of technological characteristics to predicates.
Here's an interpretation of the provided information in the requested format:
Acceptance Criteria and Device Performance for AJAX dental unit (K132245)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Standard Compliance) | Reported Device Performance (Outcome) |
|---|---|---|
| Electrical Safety & EMC | Compliance with IEC 60601-1-2: General requirements for basic safety and essential performance (collateral standard: electromagnetic compatibility) | Complied with standards |
| General Electrical & Mechanical Safety | Compliance with IEC 60601-1: General Requirements for basic safety and essential performance | Fulfilled the requirements of specified standards, subjected to full test |
| Water & Air Supply | Compliance with ISO 7494-2: Requirements for water and air supply | Pass |
| General Requirements & Test Methods (Dental Units) | Compliance with ISO 7494-1: General requirements and test methods | Pass |
| Hose Connectors for Handpieces | Compliance with ISO 9168: Hose connectors for air driven dental hand pieces | Pass |
| General, Electrical, and Mechanical Requirements (Dental Patient Chairs) | Compliance with ISO 6875: General, electrical, and mechanical requirements for dental patient chairs | Pass |
| Overall Substantial Equivalence | No significant differences from predicate devices in terms of safety and effectiveness; similar technological characteristics. | Determined to be substantially equivalent to referenced predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of clinical patient data or samples for performance evaluation. The "test set" here refers to the device itself being subjected to a series of engineering and safety tests.
- Data Provenance: The tests were performed on "the device" (Ajax Dental Unit AJ1X). The specific test reports indicate dates such as 04/13/2012, 04/30/2012, 04/18/2012, etc. This is retrospective testing performed on manufactured units to demonstrate compliance with standards. The origin of the device is Guangzhou, China (manufacturer: Guangzhou Ajax Medical Equipment).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not explicitly provided in the 510(k) document. For standard compliance testing, "ground truth" is typically defined by the test protocols within the ISO and IEC standards themselves, and the assessment is performed by certified testing laboratories and their engineers/technicians, who are experts in conducting these specific tests and interpreting their results according to the standards. The nature of these tests (e.g., electrical safety, mechanical robustness) means "expert consensus" from medical practitioners is not directly involved in setting the "ground truth" for the technical compliance.
4. Adjudication Method for the Test Set
- Not applicable in the context of technical standard compliance testing. The outcome of each test (e.g., "complied," "fulfilled," "pass") is determined by whether the device's performance meets the quantitative and qualitative requirements specified by the respective IEC and ISO standards. There is no mention of a multi-reviewer adjudication process.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic devices (e.g., imaging AI) where the impact on human reader performance is being assessed. The AJAX dental unit is a Class I general dental operative unit, not a diagnostic device, and therefore this type of study is not relevant or required for its 510(k) clearance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- No, a standalone (algorithm-only) performance study was not done. This device does not feature an algorithm or AI component that would require such a study. Its function is mechanical and electrical support for dental procedures.
7. The Type of Ground Truth Used
- For the non-clinical testing, the "ground truth" is primarily defined by the established international and national engineering, electrical safety, and mechanical performance standards (e.g., IEC 60601-1, ISO 7494-1, etc.). The device's compliance or non-compliance against these predefined technical specifications constitutes the "truth" for these evaluations. There is no pathology, expert consensus (in the medical sense), or outcomes data used to establish ground truth for this type of device submission.
8. The Sample Size for the Training Set
- Not applicable. The AJAX dental unit is a physical medical device, not a machine learning algorithm. Therefore, there is no "training set" in the computational sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for a machine learning algorithm, there is no ground truth established for it.
{0}------------------------------------------------
Image /page/0/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the image in a circular fashion.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 5, 2014
John Neacsu Business Owner Pro Dental Services, LLC 1121 Player Way Herndon, VA 20170
Re: K132245
Trade/Device Name: AJAX dental unit Regulation Number: 21 CFR 872. 6640 Regulation Name: Dental Unit with Chair Regulatory Class: I Product Code: EIA Dated: May 1, 2014 Received: August 6, 2014
Dear Mr. Neacsu:
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.
{1}------------------------------------------------
Page 2 - Mr. Neacsu
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); 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mary S. Runner -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Device Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known): K132245
Device Name: Dental Unit With Chair Model AJ1X
Indications For Use:
The dental chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair.
Prescription Use __ X __ AND/OR Over-The-Counter Use
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
{3}------------------------------------------------
510(k) Summary
(per CFR 807.92(c))
| Submission Date: | Dec 09, 2013 | |
|---|---|---|
| Submission Correspondent: | Pro Dental Services Llc.1121 Player WayHerndon, VA 20170USAPhone:Fax:Email:Contact: | (703) 206-8570(703) 436-2735johnn@prodentalservices.comJohn NeacsuBusiness Owner |
| Sponsor and Manufacturer: | Guangzhou Ajax Medical EquipmentNo. 80 Zhujiang RoadShilou TownPanyu DistrictGuangzhou, ChinaPhone:Email:Contact: | 086-20-8484-7938ajax@ajaxdent.comKent Zhao |
| Device trade name: | Ajax Dental Unit - AJ1X | |
| Common name: | Dental Unit with Chair | |
| Device classification name: | EIA, Dental operative unit and accessories, 21 CFR 872.6640 | |
| Legally marketed device towhich device issubstantially equivalent: | 1. A-DEC 200 Dental System, K102234, Manufactured byA-DEC, Inc.2. Dental Unit with Chair, K080438, Manufactured by North WestMedical Instrument (Group) Co., Ltd. | |
| Description of device: | Ajax Dental Unit AJ1X is a dental operative unit attached to a chair. Itconsists of a patient chair, dentist element, assistant element, waterunit, arm system, cuspidor unit, and dental light. The AJ1X unit isspecially designed to meet the needs of dental professionals. Theconcept of hygienic treatment is emphasized in the unit design.Components are designed in the way which dentist can easily maintainand clean. Concept of the unit is to optimize the work for dentalpractice, as well as provide a very clean and healthy treatmentenvironment for both dentists and patients. | |
| Intended use of device: | The dental chair is used so that the patient at the dentist office may sit on it while the dentist is performing diagnosis, treatment, and/or operation. The dental unit consists of patient chair, dentist element, assistant element, water unit, arm system, cuspidor unit, and dental light. The Dental Unit with Chair is intended to supply power to and serve as a base for dental devices and accessories. It is intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. This product is attached with a dental chair. |
{4}------------------------------------------------
-
Technological characteristics: The technological characteristics between the predicate and proposed device are similar. Both are chair mounted dental units which supply power and serve as a base for dental devices and accessories.
-
Non clinical testing: - IEC 60601-1-2 Test for Medical Electrical Equipment was performed on 04/13/2012 for General requirements for basic safety and essential performance (collateral standard: electromagnetic compatibility) with the following outcome: complied with standards.
-
IEC 60601-1 Test for Medical Electrical Equipment was performed on 04/30/2012 for General Requirements for basic safety and essential performance with the following outcome: fulfilled the requirements of specified standards, was subjected to full test.
-
ISO7494-2 Test was performed on 04/18/2012 for requirements for water and air supply with the following outcome: pass.
-
ISO7494-1 Test was performed for General requirements and test methods with the following outcome: pass.
-
ISO9168 Test was performed on 04/25/2012 for Hose connectors for air driven dental hand pieces with the following outcome: pass.
-
ISO6875 Test was performed on 04/20/2012 for General, electrical, and mechanical requirements with the following outcome: pass.
Conclusions: There are no significant differences between the Ajax Dental Unit AJ1X and the predicate devices, therefore, the proposed device does not raise any questions regarding safety and effectiveness.
The Ajax Dental Unit AJ1X, as designed, is as safe and effective as the predicate device. Comparisons have been made to a legally marketed predicate device, and the device is determined to be substantially equivalent to the referenced predicate device currently on the market.
§ 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.