(178 days)
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory. The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
The provided text appears to be an FDA 510(k) clearance letter and summary for a dental unit. It describes a medical device (BDC Dental Unit) that is essentially a dental chair with integrated controls for air, water, vacuum, and electrical power for dental devices. The device's primary function is to serve as a base and power supply for other dental instruments used by trained dental professionals.
Based on the provided document, there is NO information about an AI/ML component or study involving acceptance criteria related to AI/ML device performance. The document focuses on establishing substantial equivalence to a predicate device (A-dec 500) through non-clinical testing of mechanical, electrical, software (non-AI), and biocompatibility aspects.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/ML component.
- Sample size and data provenance for an AI/ML test set.
- Number and qualifications of experts for AI/ML ground truth.
- Adjudication method for an AI/ML test set.
- Multi Reader Multi Case (MRMC) comparative effectiveness study for AI assistance.
- Standalone (algorithm only without human-in-the-loop performance) study for an AI/ML component.
- Type of ground truth for an AI/ML component.
- Sample size for the training set (for AI/ML).
- How ground truth for the training set was established (for AI/ML).
The document explicitly states: "Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product." This further reinforces that there was no study like the one you are asking for, especially not one involving human readers or AI performance metrics.
The "Software Verification and Validation Testing" section mentions: "The software for this device was considered as a 'BASIC' level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator." This implies standard software validation, not necessarily AI/ML model validation.
In summary, the provided text does not contain the information required to answer your prompt regarding acceptance criteria and studies for an AI/ML medical device. The device described is a conventional dental unit, and its clearance is based on substantial equivalence to a predicate device through standard non-clinical performance and safety testing.
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February 7, 2025
BDC Dental Corporation Ltd. % Dave Kim FDA Regulatory Consultant Mtech Group LLC 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K242404
Trade/Device Name: BDC Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: Class I, reserved Product Code: EIA, KLC Dated: January 10, 2025 Received: January 10, 2025
Dear Dave Kim:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
MICHAEL E. ADJODHA -S
Michael Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
| Submission Number (if known) | |
|---|---|
| ------------------------------ | -- |
K242404
Device Name
BDC Dental Unit
Indications for Use (Describe)
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY K242404
I. SUBMITTER
| Date: | February 4, 2025 |
|---|---|
| Submitter's Name: | BDC Dental Corporation Ltd. |
| Submitter's HQ Address: | Part 3, No. 1 Guanchong Section, Shilian Rd., Shiqi Town, Panyu District, Guangzhou, 511450 Guangdong, P.R.China |
| Submitter's Telephone: | 020-32052929 |
| Contact Person: | Yanfei Liu, mr@o-bdc.com, RA Manager |
II. PROPOSED DEVICE
| Trade/proprietary Name: | BDC Dental Unit |
|---|---|
| Model Name: : | N1, N2, N3, N1 Plus, N2 Plus, N3 Plus, S1, S2, S3, S1 Plus, S2 Plus, S3 Plus |
| Regulation Name: | Dental Operative Unit and Accessories |
| Regulation Number: | 21 CFR 872.6640 |
| Product Code: | EIA, KLC |
| Regulatory Class: | Class I, reserved |
III. PREDICATE DEVICE
| 510(k) Number: | K213932 |
|---|---|
| Primary Manufacturer: | A-dec Inc. |
| Device Name: | A-dec 500 |
| Regulation Name: | Dental Operative Unit and Accessories |
| Regulation Number: | 21 CFR 872.6640 |
| Product Code: | EIA |
| Regulatory Class: | Class I, reserved |
IV. DEVICE DESCRIPTION
The BDC dental unit is intended to supply air, water, vacuum and electrical power to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation.
Components: The BDC dental unit consists of a patient chair, dentist element (tray table), assistant element (3-way syringe, high volume evacuator and saliva ejector), side cabinet support center, foot control, cuspidor and a dental operating light, which for patient to sit during the dental diagnosis, treatment and/or operation, these components are devices such as dental handpieces can be connected to the dental unit. Dental handpieces are not included in the BDC Dental Unit. The components of the BDC Dental unit are intended to be covered with an FDA cleared disposable barrier and reprocessed (e.g., cleaning, disinfection, and/or sterilization) per the instructions for use.
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Brief of differences between all models
| Model | DentistElement(Traditional) | DentistElement(TraditionalCart Type) | DentistElement(Continental) | DentistElement(ContinentalCart Type) | Left/rightArmSwivel | Discfootcontrol | Leverfootcontrol |
|---|---|---|---|---|---|---|---|
| N1 | √ | √ | |||||
| N2 | √ | √ | |||||
| N3 | √ | √ | |||||
| N1 Plus | √ | √ | |||||
| N2 Plus | √ | √ | |||||
| N3 Plus | √ | √ | |||||
| S1 | √ | √ | |||||
| S2 | √ | √ | √ | ||||
| S3 | √ | √ | √ | ||||
| S1 Plus | √ | √ | √ | ||||
| S2 Plus | √ | √ | √ | ||||
| S3 Plus | √ | √ | √ |
V. INDICATIONS FOR USE
The BDC Dental Unit is intended to supply power to and serve as a base for dental devices and accessories. This device includes a dental chair and is intended for use in the dental clinic environment and is designed for use by trained dental professionals, dentists and/or dental assistants.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Table 2
| Items | Subject device | Predicate device | Comparison |
|---|---|---|---|
| Manufacturer | BDC Dental Corporation Ltd. | A-dec Inc. | |
| 510(k) Number | K242404 | K213932 | |
| Product name | Dental Unit | A-dec 500 Delivery System | |
| Model | N1, N2, N3, N1 Plus, N2 Plus, N3Plus, S1, S2, S3, S1 Plus, S2 Plus, S3Plus | A-dec 500 | |
| Design | The BDC dental unit is mainlycomposed of a patient chair, dentistelement(tray table, 3-way syringe),assistant element (3-way syringe,high volume evacuator and salivaejector), side cabinet support center,foot control, cuspidor and a dentaloperating light. | A-dec 500 dental system iscomposed of dental chair, deliverysystem, assistant arm, dental light,cuspidor. | Similar |
| Indications for Use | The BDC Dental Unit is intended tosupply power to and serve as a basefor dental devices and accessories.This device includes a dental chairand is intended for use in the dentalclinic environment and is designedfor use by trained dentalprofessionals, dentists and/or dentalassistants. | The A-dec Delivery System isintended to provide a mountinglocation in addition to providingair, water, vacuum, and electricalpower to dental devices for useduring diagnostic and therapeutictreatment by licensed health careprofessionals. Delivery systemsmay be mounted to dental chairs,dental carts,dental cabinets, and walls. | Similar |
| Dentist Element | - Control of water and air supply,Table Height, Patient ChairPositioning, Light On/Off, HandpieceFunction, Timer, Mode Selection | -Turn on/Turn off the air, water,and power, Position the DeliverySystem, Position the HandpieceHolders, Operate TouchpadLockout, User Setting andAuxiliary Device Control,Position the Chair, Operate theDental Light, Operate theCuspidor, Operate Handpiece | Same |
| Assist Table(AssistantElement) | - Components: 3-way Syringe, SalivaEjector, High Volume Evacuator(Large Saliva Ejector)- Control of Light On/Off, Cup/Spittoon (Cuspidor) Water Dispenser,Changing the Settings, Positionmemories | -Components: Syringe, SalivaEjector, High Volume Evacuator-Position the HandpieceHolders, Adjust theWorksurface andInstrumentation Height, Operatethe Dental Light,Operate the Cuspidor | Same |
| Main Components | The BDC dental unit is mainlycomposed of a patient chair, dentistelement(tray table, 3-way syringe),assistant element (3-way syringe,high volume evacuator and salivaejector), side cabinet support center,foot control, cuspidor and a dentaloperating light. | Dental system is composed ofdental Chair , delivery system,assistant arm, dental light ,cuspidor. | Same |
| Control of waterand air | Uses pneumatically controlled valesto water control the flow of air andwater on /off and intensity controlledby foot control. | Use air coolant and watercoolant to adjust Air and water,speed controlled by foot control. | Same |
| Software-controlledcomponents | Software functions are reflected inthe dentist element and assistantelement panel .Software can controldental patient chair up, down, tiltforward, tilt backward and settreatment position, dental operatinglight on/off, cuspidor flush and cup-filler. | Software functions are reflectedin the delivery system andassistant arm panel .Software can control dental chairbase up, down, and set treatmentposition, dental light on/off/intensity, bowl flush andcupfill, handpieces, electrichandpiece. | Similar |
| Table(Dentist Element) | - Control of water supply, scalervibration power, table height,patientposition, System Power, Film viewer,Patient Chair Positioning, LightOn/Off, Handpiece function, Timer,Mode Selection, LED Display | - Control of water and air supply,Table Height, Patient ChairPositioning, Light On/Off,Handpiece Function, Timer,Mode Selection | Similar |
| Assist Table(AssistantElement) | - Accessories: Saliva Ejector(Small,Large), 3-way Syringe - Control ofLight On/Off, Cup/Spittoon WaterDispenser, Changing the Settings,Position memories | - Components: 3-way Syringe,Saliva Ejector, High VolumeEvacuator (Large SalivaEjector)- Control of Light On/Off, Cup/Spittoon (Cuspidor) WaterDispenser, Changing theSettings, Position memories | Same |
| Main Components | Chair, Unit, Table, Seat, Stool, MonitorArm, Operation table | Chair, Unit (side cabinet supportcenter), Table (Assistant Element),Seat (Upholstery Seat), Stool,Operation table (Dentist Element) | Same |
| Power& UtilitySupply | AC110- 120 / 220-240V,50/60Hz, compressed air and water | AC100- 120/220-240V, 50/60Hz,compressed air and water | Same |
| Syringe | 3-way syringe | 3- way syringe | Same |
| Control of waterand air | Uses pneumatically controlled vales towater control the flow of air and wateron/off and intensity controlled by footpedal | Uses pneumatically controlled valesto water control the flow of air andwater on /off and intensitycontrolled by foot pedal. | Same |
| Air Pressure | 0.55-0.8MPa / 5.5-8.0bar | 550kPa(min)/800kPa(max) | Similar |
| Water Pressure | 0.20-0.40MPa / 2.0-4.0bar | 410±140 kPa | Similar |
| Dental unithandpiece hose | Air flow rate:300Kpa,max.68NL/minSpray airflowrate:250Kpa,max.18NL/minWater flow rate:250Kpa,max.75mL/min | N/A | |
| Water System | City water supply | City water supply | Same |
| Water Heater | Max. (< 42 ° C) | Max. (< 42 ° C) | Same |
| Water SanitationSystem | Distilled water container added | Distilled water container added | Same |
| Suction | HVE (High Volume Evacuator) SalivaEjector | HVE (High Volume Evacuator)Saliva Ejector | Same |
| Patient Load | Max. 150kg | Max. 227kg | Similar |
| Chair Height | Max.780±10mm, Min.380±20mm | Max.780±10mm, Min.460±20mm | Similar |
| Backrest range | 110°-180° | N/A | |
| Head rest range | 0-100mm | N/A | |
| Lift Motor | Hydraulic electromotor | Electromotor | Similar |
| Dental light | Available | Available | Same |
| Foot control | Standard | Disc Type | Similar |
| Electrical Safety | Complied with IEC 60601- 1 | Complied with IEC 60601- 1 | Same |
| Electromagneticcompatibility | Complied with IEC 60601- 1-2 | Complied with IEC 60601- 1-2 | Same |
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Substantial Equivalence Discussion
The proposed BDC and predicate device are similar in all the items in the comparison chart except water pressure, patient load, chair height, back/head rest, lift motor, foot control and models. These differences do not affect substantial equivalence, also the subject device safety was verified with testing according to IEC 80601-2-60 and IEC 60601-1.
As the models/types do not differ significantly in purpose, design, materials, energy source, function or any other feature related to substantial equivalence.
On the basis of the discussion above, it is concluded that the subject device is substantially equivalent to the predicate device.
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VII. Non-Clinical Test Data
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the 3-way syringe , high-volume suction, saliva ejector, and tubing were conducted with the following performance standards:
ISO 10993-5: 2009 Biological evaluation of medical devices — Part 5: Tests for in vitro cvtotoxicity ISO 10993- 10: 2010 Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization
The 3-way syringe, high-volume suction, saliva ejector, and tubing of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
The tubing and syringes body are considered as indirect tissue contacting.
Such like armrest pad, dental operating light handles, upholstery seat, 3-way syringe, high volume evacuator and saliva ejector, we recommended using a barrier sleeves and barrier film which is non-sterile and intended for single patient use only.
Reprocessing Validation
Reprocessing validation was conducted per FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling - Guidance for Industry and Food and Drug Administration Staff (fda.gov)" including cleaning, disinfection, and sterilization validation for the components of the BDC Dental Unit.
As to the body/head of the 3-way syringe, high-volume evacuator, and saliva ejector, even though we conducted the Cleaning, intermediate disinfection testing on them, due to their connection which is fixed, the user can not disassembly them from the tubing, so we recommended in our IFU not only the cleaning and disinfection method, but also we recommend to wear compatible FDA-cleared disposable barriers when using them. Cleaning and Sterilization validation was conducted for the 3-way syringe tip.
In addition, cleaning and disinfection validation was provided for the surfaces of the subject device. Cleaning and disinfection vas conducted on the waterlines and water bottles of the subject device. Validation was conducted using the standard 16954:2015 Dentistry - Test methods for dental unit waterline biofilm treatment.
Electrical safety and electromagnetic compatibility (EMC)
The Electrical Safety and Electromagnetic compatibility tests were performed in accordance with the following standards. Comprehensive performance testing has been conducted on the BDC dental unit in accordance FDA recognized standards. EMC testing was conducted in accordance with Standard EN/IEC 60601- 1-2. Electrical, and environmental safety testing according to Standard EN/IEC 60601- 1 was performed and IEC 80601-2-60 Particular requirements for the basic safety and essential performance of dental equipment.
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Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions." The software for this device was considered as a "BASIC" level of concern, since a failure or latent flaw in the software would not directly result in serious injury or death to the patient or operator.
Performance Test
The performance tests were conducted as bench test and the test results met the pre-set criteria.
-
ISO 7494-1 Third edition 2018-06 - Dentistry - Dental units - Part 1: General requirements and test methods
-
ISO 7494-2 Second edition 2015-01 - Dental units - Part 2: Water and air supply - ISO 9168 - 2009-07- 15 - Dentistry - Hose connectors for air driven dental handpieces devices
Clinical Testing
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on well-established scientific and engineering principles. Clinical testing has not been conducted on this product.
VIII. CONCLUSIONS
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, the BDC dental unit is substantially equivalent to K3, the predicate device, in intended Use/indications for use, material composition, fundamental engineering technology, the principle of operation and basic design.
§ 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.