(45 days)
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.
The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.
All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.
The provided text is for a 510(k) summary for a "Dental Unit with Chair" (K080438). This type of device is a Class I product, and the submission primarily focuses on demonstrating substantial equivalence to a predicate device based on common design principles, adherence to recognized standards, and safety considerations. It does not involve a study proving performance against specific acceptance criteria in the way a medical imaging AI or diagnostic device would.
Therefore, many of the requested categories (like sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of regulatory submission. The "acceptance criteria" here are compliance with recognized standards and demonstration of substantial equivalence.
Here's a breakdown based on the available information:
Acceptance Criteria and Device Performance for K080438 (Dental Unit with Chair)
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance/Compliance |
|---|---|---|
| Effectiveness | Compliance with ISO 7494-1 (Dental equipment — Dental unit), ISO 7494-2 (Dental equipment — Dental patient chairs), ISO 6875 (Dental equipment — Patient's chair), and ISO 9168 (Dental equipment — hose connectors) | Device complies with all listed ISO standards. |
| Safety (Biological) | Compliance with ISO 10993 (Biological evaluation of medical devices) for biocompatibility of skin-contact materials. | Device's skin-contact component material meets biocompatibility requirements. |
| Safety (Electrical) | Compliance with IEC 60601-1 (Medical electrical equipment - General requirements for safety) and IEC 60601-1-2 (Electromagnetic compatibility). | Device complies with both IEC 60601-1 and IEC 60601-1-2. |
| Safety (Software) | Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices. | Software validation is in compliance with FDA guidance. |
| Substantial Equivalence | Same classification, indications, intended use, similar product design, technical, biological, and safety specifications as the predicate device (K032543 C8+DENTAL OPERATIVE UNIT). | The applicant device is substantially equivalent to the predicate device, excluding a video system feature not present in the applicant device. |
2. Sample size used for the test set and the data provenance:
- Not Applicable. This is a hardware device submission focused on compliance with recognized standards and substantial equivalence, not performance against clinical test data. No specific "test set" in the context of clinical or algorithmic performance data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. See point 2. Ground truth in the context of clinical data is not relevant here. Compliance with standards is assessed through engineering tests and documentation.
4. Adjudication method for the test set:
- Not Applicable. See point 2.
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 device is a dental unit and chair, not an AI or diagnostic tool that would involve human readers or image interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device, not an algorithm.
7. The type of ground truth used:
- Engineering Standards and Predicate Device Characteristics: The "ground truth" for this submission is based on the requirements of recognized international and national standards (ISO, IEC, FDA guidance) and the specifications/performance of a previously cleared predicate device.
8. The sample size for the training set:
- Not Applicable. See point 2.
9. How the ground truth for the training set was established:
- Not Applicable. See point 2.
Summary Explanation:
This 510(k) submission (K080438) for a "Dental Unit with Chair" is a Class I medical device. For such devices, particularly those that are not complex diagnostic tools or AI-driven, the regulatory pathway primarily involves demonstrating substantial equivalence to an existing legally marketed predicate device. This demonstration is achieved by showing that the new device has the same intended use, similar design principles, and, crucially, complies with relevant recognized national and international consensus standards for safety and effectiveness (e.g., ISO, IEC).
The "study that proves the device meets the acceptance criteria" in this context refers to the manufacturer's internal testing and documentation verifying that the device (and its components, including software where applicable) meets the specifications outlined in the standards (e.g., electrical safety, biocompatibility, mechanical properties) and aligns with the design and features of the predicate device. There is no clinical trial, performance study with patient data, or AI algorithm validation involved.
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 9807.92.
The Assigned 510(k) Number is:
1. Applicant Device Information
Trade/Proprietary Name: Dental Unit with Chair Model: S2300, S2305, S2308, S2315, S2318, S2320 Common Name: Dental Unit with Chair Classification Name: Unit, Operative Dental Device Class: I Product Code: EIA Regulation Number: 872.6640 Review Panel: Dental Intended Use:
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.
2. Submitter Information
Sponsor and Manufacturer:
North West Medical Instrument (Group) Co., Ltd No.3 Biyuan Road, Xianyang, 712000 Shaanxi, China
Contact Person of the Submission:
Ms. Diana Hong Mr. Eric Chen Shanghai Mid-Link Business Consulting Co., Ltd Suite 8D, Zhongxin Zhongshan Mansion, No.19, Lane 999, Zhong Shan Nan Er Road, 200230 Shanghai, China Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809
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Email: Diana.hong@mid-link.net
3. Predicate Device
K Number: K032543 C8+DENTAL OPERATIVE UNIT Classification Name: Unit, Operative Dental Product Code: EIA Manufacturer: SIRONA DENTAL SYSTEMS GMBH.
4. Device Description
The applicant device of Dental Unit with Chair contains 6 types: S2300, S2305, S2308, S2315, S2318 and S2320. All of these types follow the same design principle and intended use, and comply with ISO7494-1, ISO7494-2 and ISO6875. The connection of these types complies with ISO9168.
All of these types of applicant device consist of similar components with similar function and different appearance, these components include: main box, connection box, assistant holder, foot control, telescopic tray arm, instrument tray, operating light.
5. Effectiveness and Safety Considerations
Effectiveness:
The Dental Unit with Chair comply with ISO7494-1, ISO7494-2, ISO6875 and ISO9168.
Safety Considerations:
The Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of the skin-contact component material in the finished product meets the requirement of Biocompatibility.
The applicant device is compliance 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
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The Software Validation is in compliance with FDA Guidance to Compliance with FDA Guidance for the Content of PreMarket Submissions for Software Contained in Medical Devices.
6. Substantially Equivalence Determination
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 applicant device doesn't provide the video system, but 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 market device. Therefore, the applicant device is determined as safe and effectiveness.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
North West Medical Instrument (Group) Company, Limited C/O Ms. Laura Danielson Responsible Third Party Official TUV SUD America, Incorporated 1775 Old Highway 8NW New Brighton, Minnesota 55112
APR - 4 2008
Re: K080438
Trade/Device Name: Dental Unit with Chair Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: EIA Dated: March 20, 2008 Received: March 21, 2008
Dear Ms. Danielson:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 - Ms. Danielson
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Susan Quong
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Y.Indications for Use
510(k) Number: KOSO438 ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
Device Name: Dental Unit with Chair
Indications for Use:
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 (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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Russo
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
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510(k) Number: K080438
§ 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.