(489 days)
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).
The provided text is a 510(k) Summary for a dental operative unit, the G7. This type of submission to the FDA focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device's performance against specific acceptance criteria for a novel AI/software function.
Therefore, the document does not contain the information requested regarding acceptance criteria and the detailed study that proves the device meets those criteria, specifically concerning advanced AI/software performance. The device mentioned (G7, Dental Operative Unit and Accessories) is a physical piece of medical equipment, not an AI-driven diagnostic or assistive tool.
The "Software Verification and Validation Testing" section on page 10 refers to firmware for controlling the dental chair, which is typical embedded software for device operation, not AI. The "moderate" level of concern mentioned is related to the potential impact of software failure on device function, not on diagnostic accuracy of an AI.
To directly answer your request based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not describe acceptance criteria for an AI/software performance study in the manner requested (e.g., sensitivity, specificity, AUC). It discusses compliance with general safety and performance standards for a dental operative unit.
| Acceptance Criteria (Not AI-related) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Basic safety & essential performance) | Fulfilled |
| IEC 60601-1-2 (EMC) | Fulfilled |
| IEC 80601-2-60 (Dental equipment specific) | Fulfilled |
| ISO 7494-1 (General requirements & test methods) | Pass |
| ISO 7494-2 (Water & air supply) | Pass |
| Software Verification & Validation | All test results were satisfactory |
2. Sample size used for the test set and the data provenance:
- Not Applicable. There is no "test set" in the context of an AI performance study. The testing refers to engineering and electrical safety compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI performance, is not established for this type of device and its described testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. This is not an AI performance study requiring adjudication of interpretations.
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:
- Not Applicable. This document covers a dental operative unit, not an AI-assistive diagnostic tool. No MRMC study was performed or is relevant to this device's regulatory review based on the provided information.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The device is a physical dental unit, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. Ground truth in the context of AI diagnostic performance is not relevant here. The "ground truth" for the device's performance relates to compliance with engineering and safety standards (e.g., voltage measurements, material properties, mechanical function).
8. The sample size for the training set:
- Not Applicable. This device does not involve a "training set" for an AI model.
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this device.
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April 3, 2023
Shinhung Company Ltd % Dave Kim Medical Device Regulatory Affairs Mtech Group 7505 Fannin St. Suite 610 Houston, Texas 77054
Re: K213749
Trade/Device Name: G7, Dental Operative Unit and Accessories Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit And Accessories Regulatory Class: Class I, reserved Product Code: EIA Dated: March 6, 2023 Received: March 6, 2023
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 (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 located 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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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) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/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 E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213749
Device Name G7 Dental System
Indications for Use (Describe)
The G7 Dental System and accessories are intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
| 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 K213749
510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
| Date 510k summary prepared: | 3/17/2022 |
|---|---|
| I.Submitter | |
| Submitter's Name : | Shinhung Co., Ltd. |
| Submitter's HQ Address: | Shinhung Bldg, 450, Cheongpa-ro, Jung-gu,Seoul, 100-858, Korea |
| Factory Address: | 42-25, 27beon-gil, Dongsan-ro, Danwon-gu, Ansan-siGyeonggi-Do, 425-852 Korea |
| Submitter's Telephone: | +82 (2) 6366-2175 |
| Contact person: | Mr. Sam Su Kyong sskyong@shinhung.co.kr /RA Manager |
| Official Correspondent: | Dave Kim (davekim@mtech-inc.net) |
| (U.S. Designated agent) | Mtech Group |
| Address: | 7505 Fannin St. Ste 610, Houston, TX 77054 |
| Telephone: | +713-467-2607 |
II. Subject Device
| Trade/proprietary name | : G7 |
|---|---|
| Regulation Name | : Dental Operative Unit and Accessories |
| Regulation Number | : 21 CFR 872.6640 |
| Product Code | : EIA |
| Regulatory Class | : Class I |
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Prescription Use.
III. Predicate Device
| 510(k) Number | K151996 (Jan. 22, 2016) |
|---|---|
| Primary Manufacturer | SHINHUNG. CO,.LTD |
| Device Name | TAURUS C1 |
| Regulation Name | Dental Operative Unit and Accessories |
| Regulation Number | 21 CFR 872.6640 |
| Product Code | EIA |
| Regulatory Class | Class I |
| Prescription Use |
This predicate has not been subject to a design-related recall.
Reference Device IV.
| 510(k) Number | K032756 (Dec. 04, 2003) |
|---|---|
| Primary Manufacturer | A-DEC, Inc |
| Device Name | A-DEC 532/533 |
| Regulation Name | Dental Operative Unit and Accessories |
| Regulation Number | 21 CFR 872.6640 |
| Product Code | EIA |
| Regulatory Class | Class I |
Prescription Use
V. Device Description
The G7 dental chair with operative unit is a dental chair with an operative unit attached for patient
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to sit during the dental diagnosis, treatment and /or operation. The dental chair has adjustable headrest, backrest, seat height and armrests. The proposed device also consists of dentist table with instrument holders, assistant table, water unit, arm system, cuspidor (spittoon), dental light and foot control. The instrument holder includes a 3-way syringe and salvia ejector supplied by DCI which are cleared by FDA (K151987).
Indications for Use VI.
The G7 dental chair with operative unit is intended for use in general dental applications by providing the dental practitioner a user interface to control operation of the dental chair and attached dental devices. The system delivers air, water, vacuum and electricity to allow the dental practitioner an intuitive control center for all common and normal patient treatment procedures performed in the dental operatory.
| Model | TAURUS C1 (K151996) | G7 (K213749) | |
|---|---|---|---|
| Indications forUse | The TAURUS C1 DentalSystem and accessories areintended for use in generaldental applications byproviding the dentalpractitioner a user interface tocontrol operation of the dentalchair and attached dentaldevices. The system deliversair, water, vacuum andelectricity to allow the dentalpractitioner an intuitivecontrol center for all commonand normal patient treatmentprocedures performed in thedental operatory. | The G7 dental chair withoperative unit is intended foruse in general dentalapplications by providing thedental practitioner a userinterface to control operation ofthe dental chair and attacheddental devices. The systemdelivers air, water, vacuum andelectricity to allow the dentalpractitioner an intuitive controlcenter for all common andnormal patient treatmentprocedures performed in thedental operatory. | |
| Construction | CHAIR / UNIT / DOCTORTABLE /ASSISTANTTABLE / OPERATINGLIGHT / FOOT CONTROL /STOOL | CHAIR /UNIT/ DOCTORTABLE /ASSISTANTTABLE / OPERATINGLIGHT / FOOT CONTROL /STOOL | |
| Power Supply | AC110V/115V, 50/60Hz | AC110V/115V,50/60Hz | |
| Description | Power ShockProtection | Class 1 | Class 1 |
| ElectricProtection | B Type | B Type | |
| EMC Standard | EN 60601-1-2IEC 61000-3-2IEC 61000-3-3 | EN 60601-1-2IEC 61000-3-2IEC 61000-3-3 | |
| Dental unitsStandard | ISO 7494-1ISO 7494-2 | ISO 7494-1ISO 7494-2 | |
| Dental unit&chair particularstandard | - | IEC 80601-2-60 | |
| Safety Standard | IEC 60601-1 | IEC 60601-1 | |
| Chair Operatingsystem | Hydraulic system | Hydraulic system | |
| UNIT/CHAIRform type | Over-arm Contour type | Over-arm Contour type | |
| Inlet AirPressure (Mpa) | 0.6 ~ 0.78MPa | 0.6 ~ 0.78MPa | |
| Inlet WaterPressure (Mpa) | 0.2 ~ 0.59MPa | 0.2 ~ 0.59MPa | |
| AllowablePatient Load | 150 Kgf | 150Kgf | |
| Vacuum system | Central Vacuum system orAir Vacuum system | DCI vacuum system with HVEand saliva ejectors (K151987) | |
| Flushing system | N/A | Included | |
| Water treatmentwith ICX tablet | N/A | Included | |
| 3-Way Syringe | Adjusting the Water / Air /Spray function in the syringe | Adjusting the Water / Air /Spray function in the syringewith DCI tip (K151987) | |
| Vacuum syringetip | Disposable tip | Not provided | |
| Vacuum syringe | POLY AMID, Durr | Aluminum, DCI | |
| Saliva-ejector | POLY AMID, Durr | Aluminum, DCI | |
| Low-speed /High-speedhandpiece | Not provided | Not provided | |
| Scaler | Piezon kit, EMS | Piezon kit, EMS | |
| Cuspidor | Spittoon bowl / Rinsing pipe /Tumbler filler | Spittoon bowl / Rinsing pipe /Tumbler filler | |
| Water System | City Water / Distilled Water | City Water / Distilled Water | |
| OperatingLight | Type | Halogen (Shin Hung) | EDI LED |
| Light headstructure | 3-axis head adjustmentmethod | 3-axis head adjustmentmethod | |
| ON/OFF Control | Auto and manual ON/OFF | Auto and manual ON/OFF | |
| Brightnesscontrol | 2 stage control | Continuous control | |
| Light pattern | 130mmX70mm @ 700mm | 130mmX70mm @ 700mm | |
| LoadingCapacity | 150kgf | 150kgf | |
| DentalChair | MovementRange (Chair) | 530 ~825mm(± 20 mm) | 400~760mm(± 20 mm) |
| MovementRange (Backrest) | $0° ~ 63° (± 3°)$ | $0° ~ 70° (± 3°)$ | |
| Headrest | Double-articulating headrest | Double-articulating headrest | |
| Table arm | Manual system | Air brake system | |
| Safety switchfunction | BACKREST and auxiliaryarm, 2 safety switches | Rink cover and swing coversafety switch, emergency stopbutton located on the back ofthe chair seat, 3 safetyswitches. | |
| The safety switch stops thechair operation. | The safety switch stops thechair operation. | ||
| Programmablechair position | Programmable chair position:Total 5 positions | Programmable chair position:Total 5 positions | |
| Deliverysystem | Handpieceholder | 6 integrated rotation typeholder | 6 integrated rotation typeholder |
| Handle | Fixed handle | Fixed handle | |
| Touchpad | Membrane panel | Membrane Panel | |
| Handpiece water | Manually adjustable | Manually adjustable handpiecewater / air cooling. | |
| Flexarm tension | Control the tension to adjustthe shift of TABLE ARMrotation. | Control the tension to adjustthe shift of TABLE ARMrotation. | |
| Accessories | Instrumentholders | HVE, SE, 3-WAYsyringeattached | HVE, SE, 3-WAYsyringeattached |
| Foot control | Standard, all-in-one | Standard, all-in-one, | |
| Cuspidor | Attach/detachable GLASSdisassemble for cleaning. | Magnetic cuspidor disassemblefor cleaning | |
| Solids collector | Equipped | Equipped | |
| Supportcenter | Distilled waterreservoir | Equipped | Equipped |
| Cup watersystem | Automatic and manual watersupply system. | Automatic and manual watersupply system. | |
| Watering time can be set bythe user. | Watering time can be set bythe user. | ||
| OperationMethod | Control panel / Assistant control panel / Foot controller |
VII. Comparison of Technological Characteristics with the Predicate Device
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VIII. Comparison of Technological Characteristics with the Reference Device
| Model | A-DEC 532/533 (K032756) | G7 (K213749) | |
|---|---|---|---|
| Indications forUse | The A-dec 532/533 DeliverySystem Dental Unit andaccessories are intended foruse in general dentalapplications by providing thedental practitioner a userinterface to control operationof the dental chair andattached dental devices. Thesystem delivers air, water,vacuum and electricity toallow the dental practitioneran intuitive control center forall common and normalpatient treatment proceduresperformed in the dentaloperatory. | The G7 dental chair withoperative unit is intended foruse in general dentalapplications by providing thedental practitioner a userinterface to control operation ofthe dental chair and attacheddental devices. The systemdelivers air, water, vacuum andelectricity to allow the dentalpractitioner an intuitive controlcenter for all common andnormal patient treatmentprocedures performed in thedental operatory. |
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| Construction | CHAIR / UNIT / DOCTORTABLE / ASSISTANTTABLE / OPERATINGLIGHT / FOOT CONTROL /STOOL | CHAIR /UNIT/ DOCTORTABLE / ASSISTANTTABLE / OPERATINGLIGHT / FOOT CONTROL /STOOL | |
|---|---|---|---|
| Vacuum syringe | Aluminum, DCI | Aluminum, DCI | |
| Saliva-ejector | Aluminum, DCI | Aluminum, DCI | |
| Flushing system | After each patient treatment,discharge water from thetubes of all handpieces for 20to 30 seconds by using theflushing system. The flushswitch is located at the bottomleft of the doctor's table. Pullthe flush switch and hold ituntil the waste is completelydrained from the tubing.When only air comes out,release the flush switch. | After each patient treatment,discharge water from the tubesof all handpieces for 20 to 30seconds by using the flushingsystem. The flush switch islocated at the bottom left of thedoctor's table. Pull the flushswitch and hold it until thewaste is completely drainedfrom the tubing. When onlyair comes out, release the flushswitch. | |
| Water treatmentwith ICX tablet | A-dec ICX tablets arespecially formulated tomaintain dental unitwaterlines and preventaccumulation of odor and foultaste bacteria. Maintainsdental unit waterline effluent<10 CFU/ml. | A-dec ICX tablets are speciallyformulated to maintain dentalunit waterlines and preventaccumulation of odor and foultaste bacteria. Maintains dentalunit waterline effluent ≤10CFU/ml. |
The technological characteristics between the proposed device and the predicate device are similar physically and technically. Both the subject device, the predicate device and the reference device share the same indications for use as well as equivalent material composition, fundamental engineering technology, principles of operation and basic design. Moreover, G7, the subject device, and A-DEC 532/533, the reference device (K032756) share the same vacuum syringe, saliva-ejector, flushing system and the water treatment regime.
PERFORMANCE DATA IX.
The G7 dental chair with operative unit complies with the following performance standards.
Non Clinical testing:
ISO 10993-1:209/(R) 2013 Biological evaluation of medical devices-Part1: Evaluation and
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testing within a risk management process.
IEC 60601-1 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance. The requirements of specified standards were fulfilled.
IEC 60601-1-2 Test for Medical Electrical Equipment was performed for General Requirements for basic safety and essential performance (collateral standards: electromagnetic compatibility. The requirements of specified standards were fulfilled.
IEC 80601-2-60 Test for Particular requirements for the basic safety and essential performance of dental equipment. The requirements of specified standards were fulfilled.
ISO 7494-1 Test was performed for general requirements and test methods: Pass
ISO 7494-2 Test was performed for general requirements for water and air supply: Pass
Software Verification and Validation Testing
Firmware for G7 includes PCB Foot Blu Slave MPU and Master MPU board to receive and transmit wireless foot controller signals. Software verification and validation testing were conducted and documented as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" 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.
All test results were satisfactory.
CONCLUSIONS X.
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Shinhung Co. Ltd. concludes that The G7 dental operative unit is substantially equivalent to TAURUS C1, the predicate device, and A-DEC 532/533, the reference device, in 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.