The Dental Unit 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.

Device Description

The proposed devices Dental Unit are well equipped dental unit, which are intended to supply power to and serve as a base for dental devices and accessories. They are intended for use in the dental clinic/office environment and used by trained dentists and/or dental technicians and assistants. The products are attached with dental chair.

The proposed devices include two models. U300 and U500. Both of the two models mainly consist of instruments, instrument arm tray, cabinet group, operation light arm, assistant position, pedal switch, and patient chair.

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Dental Unit." It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. This type of document typically focuses on comparing the new device to existing ones based on technical specifications and safety standards, rather than clinical performance or diagnostic accuracy studies.

Therefore, the information regarding acceptance criteria and a study to prove the device meets these criteria is limited to non-clinical tests and compliance with safety and performance standards. There is no mention of studies involving human subjects, AI assistance, expert ground truth, or MRMC comparative effectiveness studies.

Here's the information extracted from the document:

1. A table of acceptance criteria and the reported device performance:

The document presents a comparison table between the proposed device (Dental Unit U300, U500) and the predicate device (Dental Unit with Chair S2310) across several technical characteristics and standards. The "acceptance criteria" can be inferred as compliance with the listed standards and achieving similar technical specifications to the predicate device.

Item	Acceptance Criteria (Predicate)	Reported Device Performance (Proposed)
Product Code	EIA	EIA
Regulation No.	21 CFR 872.6640	21 CFR 872.6640
Class	1	1
Intended Use	Supply power to and serve as a base for dental devices; and accessories. Intended for use in dental clinic/office environment by trained dentists/technicians/assistants. Attached with a dental chair.	Same as predicate.
Operating Light	Halogen	LED
Connection Joint	Comply with ISO9168	Comply with ISO9168
Water Heating	Yes	No
Operation Method	Control Panel / Assistant Control Panel / Foot Controller	Control Panel / Assistant Control Panel / Foot Controller
Power Supply	110V	110V
Frequency	50/60Hz	50/60Hz
Power (with dental chair)	900VA	400VA
Pressure of Water Supply	200 kPa ~ 400 kPa	0.2MPa-0.4MPa (200 kPa - 400 kPa)
Pressure of Air Supply	≥550 kPa	0.55MPa (550 kPa)
Dental Chair Loading Capacity	135Kg	200kg
Dental Chair Movement Range (Chair)	420-820 MM	390mm-740mm
Dental Chair Movement Range (Backrest)	0°~80°	1°~70°
Dental Chair Movement Range (Headrest)	200MM	150mm
Accessories can be attached to the device	Handpiece / Scaler / Curing Light / Syringe	Handpiece / Scaler / Curing Light / Three-way-Syringe
Performance Standards	Comply with ISO7494-1, ISO7494-2 and ISO6875	Comply with ISO7494-1, ISO7494-2 and ISO6875
Rate of Water Suction (Suction)	≥ 1L/min	1 L/min
Rate of Water Suction (Silva Ejector)	> 750mL/min	750ml/min
Electrical Safety	Comply with IEC 60601-1	Comply with IEC 60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Patient Contact Material	PU, PVC, Polyamide, ABS, Stainless steel	Armrest: PU, Leather for patient chair: PVC, Syringe: Stainless steel, Tubes: TPU

2. Sample size used for the test set and the data provenance:

The document describes non-clinical tests conducted to verify that the proposed device met design specifications and was substantially equivalent. It lists several international standards to which the device was tested for compliance (e.g., IEC 60601-1, IEC 60601-1-2, ISO7494-1, ISO7494-2, ISO 6875, ISO 10993-5, ISO 10993-10).

Sample size: Not applicable in the context of clinical test sets as no clinical study is mentioned. The tests were likely performed on a limited number of device units (e.g., prototypes or production samples).
Data provenance: Not explicitly stated as it's not a clinical data set. The tests were conducted by the manufacturer or accredited testing laboratories as part of verifying compliance with standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The "ground truth" for the non-clinical tests is established by the specified requirements of the international safety and performance standards themselves. There is no mention of experts establishing ground truth in a clinical sense.

4. Adjudication method for the test set:

Not applicable. This concept applies to clinical studies where different expert opinions on a case need to be resolved. For non-clinical device testing, the outcome is typically a pass/fail against a specific standard or specification.

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:

No, an MRMC comparative effectiveness study was not done. The device is a "Dental Unit," which is a physical piece of equipment for dental procedures, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, a standalone performance study in the context of an algorithm or AI was not done. The device is a traditional dental unit.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the technical specifications outlined in the international standards (e.g., IEC 60601-1 for electrical safety, ISO7494-1 for general dental unit requirements, ISO 10993 for biocompatibility). The device either complies with these standards or it does not.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

Not applicable.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 13, 2015

Zhuhai Siger Medical Equipment Co., Ltd. c/o Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd. P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K142206

Trade/Device Name: Dental Unit Regulation Number: 21 CFR 872.6640 Regulation Name: Dental operative unit and accessories Regulatory Class: I Product Code: EIA Dated: January 21, 2015 Received: February 12, 2015

Dear Ms. Hong:

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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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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142206

Device Name Dental Unit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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K142206

510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K142206

1. Date of Submission: 01/20/2015

2. Sponsor Identification

Zhuhai Siger Medical Equipment Co., Ltd Building 2, No. 1 Chuangxin Yi Road, Tangjiawan Town, Zhuhai City, Guangdong, China

Establishment Registration Number: Not yet registered

Contact Person: Huisheng Wang Position: General Manager Tel: 86 13802677946 Fax: 86 756 3881011 Email: wanghs@siger.cn

3. Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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4. Proposed Device Identification

Proposed Device Name: Dental Unit Proposed Device Model: U300, U500 Proposed Device Common Name: operative dental unit

Regulatory Information: Classification Name: Unit, Operative Dental Classification: I Product Code: EIA Regulation Number: 21 CFR 872.6640 Review Panel: Dental

Intended Use Statement:

to The Dental Unit 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."

5. Predicate Device Identification

510(k) Number: K130410 Product Name: Dental Unit with Chair S2310 Manufacturer: Xianyang North West Medical Instrument (Group) Co., Ltd

6. Device Description

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

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IEC 60601-1: 2005 +COOR.1 (2006) + CORR.2 (2007), Medical electrical equipment Part 1: General requirements for basic safety and essential performance
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
ISO7494-1: 2004, Dentistry Dental units Part 1: General requirements and test methods. ISO7494-2: 2003, Dentistry - Dental units - Part 2: Water and air supply.
ISO 6875: 2011, Dentistry -- Patient chair
ISO 10993-5: 2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity.
ISO 10993-10: 2010, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization.

8. Substantially Equivalent (SE) Conclusion

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Devices	Predicate Device
Product Code	EIA	EIA
Regulation No.	21 CFR 872.6640	21 CFR 872.6640
Class	1	1
Intended Use	The Dental Unit is intended to supplypower to and serve as a base for dentaldevices; and accessories. It is intendedfor use in the dental clinic /officeenvironment and used by traineddentists and/or dental technicians andassistants. This product is attached witha dental chair.	The Dental Unit with Chair is intendedto supply power to and serve as a basefor dental devices and accessories. It isintended for use in the dentalclinic/office environment and used bytrained dentists and/or dentaltechnicians and assistants. This productis attached with a dental chair.
Features	OperatingLight	Halogen	LED
	ConnectionJoint	Comply with ISO9168	Comply with ISO9168
	WaterHeating	Yes	No
Operation Method	Control Panel / Assistant Control Panel/ Foot Controller	Control Panel / Assistant Control Panel/ Foot Controller
Power Supply	110V	110V
Frequency	50/60Hz	50/60Hz

Table 3-1 Comparison of Technology Characteristics

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Power (with dental chair)			900VA	400VA
Pressure of Water Supply			200 kPa ~ 400 kPa	0.2MPa-0.4MPa
Pressure of Air Supply			≥550 kPa	0.55MPa
DentalChair	LoadingCapacity		135Kg	200kg
	MovementRange(Chair)		420-820 MM	390mm-740mm
	MovementRange(Backrest)		0°~80°	1°~70°
		MovementRange(Headrest)	200MM	150mm
Accessories can beattached to the device			Handpiece / Scaler / Curing Light /Syringe	Handpiece / Scaler / Curing Light /Three-way-Syringe
Performance Standards			Comply with ISO7494-1, ISO7494-2and ISO6875	Comply with ISO7494-1, ISO7494-2and ISO6875
Rate of WaterSuction	Suction		≥ 1L/min	1 L/min
	SilvaEjector		> 750mL/min	750ml/min
Electrical Safety			Comply with IEC 60601-1	Comply with IEC 60601-1
EMC			Comply with IEC 60601-1-2	Comply with IEC 60601-1-2
Patient Contact Material			Armrest: PULeather for patient chair: PVCSyringe: Stainless steel Tubes:TPU	PU, PVC, Polyamide, ABS, Stainlesssteel

The proposed devices, Dental Unit U300 and U500, are determined to be Substantially Equivalent (SE) to the predicate device, Dental Unit with Chair S2310 (K130410), with respect to intended use, technological characteristics and principles of operation.

Regulation Number and Section

§ 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.