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

Device Description

Yoboshi dental units with chairs are driven by imported low-voltage DC motor with imported air spring auxiliary balance to keep a safe and stable operation of equipment and low noise. With two pieces of NSK high speed H.P and one piece of NSK lowspeed H.P, it is easy and credible for working. The single-form seamless leather cushion provides comfort for the patient to sit and for the doctor to clean and disinfect more easily. It is applicable for the dental clinic. The unit is composed of integral ceramic spittoon, air-controlled balanced instrument-arm, newlydesigned cold light.

The models include A8000, A8000-I, A8000-II. All of these types follow the same design principle and intended use, and comply with ISO7494-1:2004, ISO7494-2:2003. The hose connectors of these types comply with ISO9168:1991. The air-motors of these types comply with ISO13294: 1997. Dental patient chair complies with ISO 6875:1995.

All of these types of applicant devices consist of similar components with similar function and different appearance, these components include:

Electric pedal switch ●
Control key for mouth lamp
Wash cuspidor
Gargle water control
Pedal switch
Handrail
Backrest
Headrest
Cuspidor
Rising pipe
Lamp arm
Operation light
Seat cushion for child

AI/ML Overview

The K103550 submission for the Yoboshi Dental Unit with Chair describes a traditional 510(k) submission, indicating that the device's safety and effectiveness are established by demonstrating substantial equivalence to a predicate device. This type of submission relies on comparative data rather than a de novo clinical study with specific acceptance criteria and performance metrics for the new device alone.

Therefore, the information typically found in an AI/software device submission regarding detailed acceptance criteria, a standalone study proving those criteria, expert ground truth adjudication, MRMC studies, or training set details is not present in this document.

Instead, the submission focuses on demonstrating that the Yoboshi Dental Unit with Chair (Models A8000, A8000-I, A8000-II) is substantially equivalent to the legally marketed predicate device, the North West Medical Instrument (Group) Co., Ltd. Dental Unit with Chair, Model: S2300 (K080438).

Here's an analysis of the provided information, addressing the requested points where applicable, and highlighting what is not available due to the nature of this 510(k) submission type:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is generally not found in a traditional 510(k) submission for a physical medical device like a dental unit, especially when demonstrating substantial equivalence. The "acceptance criteria" here implicitly refer to meeting the recognized standards and having comparable specifications to the predicate device.

Category	"Acceptance Criteria" (Implicit)	Reported Device Performance (Compliance)
Effectiveness	Compliance with relevant ISO standards for dental units and chairs.	Complies with: - ISO 7494-1:2004 - ISO 7494-2:2003 - ISO 9168:1991 - ISO 6875:1995 - ISO 13294:1997
Safety	Compliance with relevant IEC standards for medical electrical equipment.	Complies with: - IEC 60601-1 - IEC 60601-1-2
	Compliance with biocompatibility standards (for applied materials).	Complies with: - ISO 11138-1:2006 (for BI material) - ISO 11737-1:2006 (for disposable anesthesia channel) - ISO 10993-5 & -10 (for Single-use anesthesia tube)
	Software Validation (if applicable).	In compliance with FDA Guidance for Content of Pre-Market Submissions for Software Contained in Medical Devices.
Comparison to Predicate	Same classification, indications, intended use, similar product design, technical, biological, and safety specifications.	Verified as "Substantially Equivalent" to predicate device K080438. Differences (e.g., optional video system) do not raise new questions of safety or effectiveness.

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

Sample Size for Test Set: Not applicable. This submission relies on engineering and performance testing against recognized standards, and a comparison to a predicate device, not a "test set" of clinical data in the context of an AI algorithm.
Data Provenance: Not applicable. The "data" here refers to test results against international standards and design specifications, not country-of-origin specific clinical data.

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

Not applicable. This device is a physical dental unit, not an AI algorithm that requires expert consensus for ground truth on a test set of images or patient data. Its performance is assessed against engineering standards and comparison to a predicate device.

4. Adjudication method for the test set

Not applicable for the reasons stated above.

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 is not an AI device. An MRMC study is irrelevant for a dental operative unit.

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

Not applicable. This is not an AI device or software algorithm in that context. The "software validation" mentioned relates to any embedded software controlling basic functions of the dental unit, not a standalone AI diagnostic or assistive tool.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the typical AI/diagnostic sense. The "ground truth" for this device's safety and effectiveness is established by its adherence to internationally recognized performance and safety standards (e.g., ISO, IEC) and by demonstrating substantial equivalence to a previously cleared device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. This is not an AI/machine learning device.

Summary of the Study/Evidence:

The "study" demonstrating that the Yoboshi Dental Unit with Chair meets acceptance criteria for 510(k) clearance is not a clinical trial or AI performance study. Instead, it is a Substantial Equivalence (SE) determination based on:

Compliance with Recognized Standards: The device was tested and found to comply with a comprehensive set of international standards for dental equipment, medical electrical equipment, biocompatibility, and hose connectors (ISO 7494-1:2004, ISO 7494-2:2003, ISO 9168:1991, ISO 6875:1995, ISO 13294:1997, IEC 60601-1, IEC 60601-1-2, ISO 11138-1:2006, ISO 11737-1:2006, ISO 10993-5 & -10).
Comparison to a Predicate Device: A detailed comparison was made between the Yoboshi Dental Unit (A8000, A8000-I, A8000-II) and the predicate device (North West Medical Instrument (Group) Co., Ltd. Dental Unit with Chair, Model: S2300, K080438). The applicant asserted, and the FDA agreed, that the devices share the same classification information, indications for use, intended use, and similar product design, technical specifications, biological specifications, and safety specifications. The differences (e.g., optional video system) were deemed not to raise new questions of safety or effectiveness.
Software Validation: Any embedded software within the device underwent validation in compliance with FDA guidance.

The FDA's letter (K103550) confirms the substantial equivalence determination, allowing the device to be marketed.

Summary

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K103550

Yoboshi Dental Unit- 510(K): Sec. 5

510(K) SUMMARY

JAN - 4 2011

This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92

1.0 Submitter's Information

Establishment Registration Name:

Foshan Yoboshi Medical Equipment Co., Ltd.

4 Simple Workshop, East city road, (Fuwan) hecheng city street, Gaoming, Foshan, Guangdong China 528500

Contact Person of applicant Mr. Jianjun Zhong - Management Representative ' 4 Simple Workshop, East city road, (Fuwan) hecheng city street, Gaoming, Foshan, Guangdong China 528500

TEL: +86-757-2885 3333 FAX: +86-757-2890 1866 Email:

Contact Person of the Submission:

Ms. Sabrina Wei

MEDLAB (Shenzhen) Information Service Co., LTD

Room 2706, Block A, ZhongFang JinYuan Buiding, Xinwen Road Shenzhen, Guangdong, P.R. China, 518034

TEL: +86-755-83089699 FAX: +86-755-83089760

Email: sabrinawei(@hotmail.com; ; please CC lingbensuo@gmail.com,

2.0 Device Information

Type of 510(k) submission: Traditional Device Common Name: · Dental Unit with Chair Trade Name: Yoboshi Dental Unit Model: A8000, A8000-I, A8000-II Classification name: · Dental operative unit and accessories

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Review Panel:	Dental
Product Code:	EIA
Regulation Class:	I
Regulation Number:	872.6640

3.0 Predicate Device Information

Sponsor:	North West Medical Instrument (Group) Co., Ltd
Device:	Dental Unit with Chair, Model: S2300
510(K) Number:	K080438

4.0 Device description

All of these types of applicant devices consist of similar components with similar function and different appearance, these components include:

Electric pedal switch ●
Control key for mouth lamp
Wash cuspidor
Gargle water control
Pedal switch
Handrail
Backrest
Headrest
Cuspidor
Rising pipe
Lamp arm
Operation light
Seat cushion for child

Intended Use 5.0

The Dental Unit with Chair is intended to supply power to and serve as a base for

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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

6.0 Effectiveness and Safety Considerations

Effectiveness:

The Dental Unit with Chair complies with ISO7494-1:2004, ISO7494-2:2003, ISO9168: 1991, ISO 6875:1995 and ISO13294: 1997.

Safety Considerations:

The applicant devices comply with IEC60601-1, Medical electrical equipment - Part 1: General requirements for safety and IEC60601-1-2, Medical electrical equipment - Part 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility - Requirements and tests.

For all hose connectors and air motors, the applicant devices comply with ISO 9168: 1991 and ISO 13294: 1997.

For dental patient chair, the applicant devices comply with ISO 6875:1995.

In regard to biocompatibility evaluation, the applicant devices comply with ISO 111381-1: 2006 for BI material, ISO 11737-1: 2006 for disposable anesthesia channel; ISO 10993-5 & -10 for Single-use anesthesia tube.

The Software Validation is in compliance with FDA Guidance for the Content of Pre-Market Submissions for Software Contained in Medical Devices.

Comparison to predicate device and conclusion 7.0

Comparison Analysis

The applicant device has same classification information, same indications and intended use, similar product design, similar technical specification, biological specification and safety specification. The video system of the applicant device is optional for Model A8000 & A8000-I, and it is substantially equivalent to the predicate device in other parts.

Conclusion:

The applicant device is Substantially Equivalent (SE) to the predicate device which is US legally marketed device. Therefore, the applicant device is determined as safe and effectiveness.

Compare with predicate device, they are very similar in design principle, intended use, functions, material and the adopting applicable standards. The differences between applicant device and predicate device do not raise any new questions of safety or effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing essential human services. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA", which is arranged in a circular fashion around the eagle.

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

Fosham Yoboshi Medical Equipment Company, Limited C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

JAN - 4 2011

Re: K103550

Trade/Device Name: Yoboshi Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: December 21, 2010 Received: December 22, 2010

Dear Mr. Job:

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- Mr. Job

Enclosure

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/ ucm 1 1 5809.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 yours,

Susan Russer

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

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Statement of Indications for Use

510(k) Number (if known):

K103556

Device Name: Model:

Yoboshi Dental Unit with Chair A8000, A8000-I, A8000-II

JAN - 4 2011

Indications for Use:

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 OF NEEDED) is use Stidfer

Division Sign-Off) iivision of Anesthesiology, General Hospital nfection Control, Dental Devices

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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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.