(127 days)
Dental Unit and Accessories are intended for the Dentists, Hygienists, and Dental assistants for traditional and normal patient treatment procedures in the dental operatory.
The Belmont QUOLIS 5000 SERIES DENTAL UNIT is a modification of the existing Belmont Dental Unit, Model 2000 series and Model 6000 series. It is a Dental Operative Unit and Accessories.
The provided text is a 510(k) premarket notification for a dental operative unit and accessories. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable in this context. The device is a physical dental unit, not an AI algorithm or diagnostic tool that would typically involve a test set, ground truth, expert adjudication, or MRMC studies.
Here's an analysis based on the information provided, highlighting what is applicable and what is not:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Performance Standards) | Reported Device Performance |
|---|---|
| IEC 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units, which presumably meet these standards. |
| ISO-7494-2:2003 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO-7494-1:2004 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
| ISO 60601-1 | Substantially Equivalent to Belmont 2000 Series and Model 6000 Series Dental Units. |
Explanation: The primary method for demonstrating that this device meets its performance "acceptance criteria" (which are outlined as specific international standards for medical electrical equipment and dental equipment) is by proving "Substantial Equivalence" to previously cleared predicate devices. The document states that a comparison (Attachment 2, not provided here) indicates the QUOLIS 5000 is substantially equivalent to the Belmont 2000 Series and Model 6000 Series Dental Units. This means that if the predicate devices meet these standards, then the new device, being substantially equivalent, is also considered to meet them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a substantial equivalence submission for a physical dental unit, not a study involving a test set of data for an algorithm. There is no "test set" in the context of an AI or diagnostic device performance evaluation. The "data provenance" would refer to the technical specifications and comparison data of the device itself and its predicate, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. As above, there is no "test set" or "ground truth" to be established by experts in the context of a dental operative unit's substantial equivalence. The "experts" involved would be regulatory reviewers (FDA) and potentially engineers/designers from the manufacturer who performed the comparison.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. There is no "test set" or "adjudication method" as this is not a diagnostic or AI performance study.
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 a physical dental unit and does not involve AI assistance for human readers/clinicians, nor does it involve a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a physical dental unit, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. There is no "ground truth" in the sense of clinical reference standards for an AI or diagnostic device. The "truth" in this context is that the device, through its design and specifications, adheres to relevant safety and performance standards equivalent to predicate devices.
8. The sample size for the training set
- Not Applicable. This is a physical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not Applicable. As above, no training set or ground truth in that context.
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SUMMARY
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| Dice Detail: | DEC 29 2007 | |
|---|---|---|
| Device Class: | CFR 872.6640 Identified device, DentalOperative Unit and Accessories asClass 1, Reserve. | |
| Trade or proprietary name: | BELMONT QUOLIS 5000 SERIESDENTAL UNIT | |
| Common or usual name: | Dentist's Unit | |
| Classification Name: | Dental Operative Unit and Accessories | |
| Device Listing No.: | 048314 | |
| Classification: | CFR 872.6640 Identified device, DentalOperative Unit and Accessories, asClass 1, Reserve. | |
| Performance Standards: | IEC 60601-1, ISO-7494-2:2003,ISO-7494-1:2004, ISO 60601-1 | |
| Labeling: | Copies are attached. | |
| Fablishment Detail: | ||
| Establishment Registration Number: 96114485 | ||
| TAKARA BELMONT USA, INC.BELMONT Equipment Division101 Belmont DriveSomerset, New Jersey 08873-1204 |
SUBMITTED BY SCHIFF & COMPANY, WEST CALDWELL, NJ
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performance compliance:
|EC 60601-1, ISO-7494-2:2003, ISO-7494-1-2004, ISO 60601-1
Substantially Equivalent:
This Dental Unit and accessories , based on being "Substantially Equivalent" to the Belmont Dental Unit , Model 2000 series and Model 6000 series, as indicated in the Belmont 510k, Pre-market notification submission dated March 7, 2000, K000799. Comparison of QUOLIS 5000 dental unit and Belmont 2000 Series Dental Unit as presented in attachment 2 indicates that both units are substantially equivalent.
Installation, Operating Instruction, Care and Maintenance are attached.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services, USA. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and science. The eagle is surrounded by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.
DEC 2 0 2007
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Takara Belmont USA, Incorporated C/O Robert Schiff, Ph.D., RAC, CQA President Schiff & Company, Incorporated 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re: K072273
Trade/Device Name: Belmont, Dental Unit & Accessories, Quolis 5000 Series Regulation Number: 21 CFR 872.6640 Regulation Name: Dental Operative Unit and Accessories Regulatory Class: I Product Code: NRD Dated: December 14, 2007 Received: December 17, 2007
Dear Dr. Schiff:
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 - Dr. Schiff
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 vours,
Susan Runoe
Chin Lin, Ph.D.
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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(K) PREMARKET NOTIFICATION FOR QUOLIS 5000 SERIES DENTAL UNIT TAKARA BELMONT USA, INC.
Indications for Use
510(k) Number (if known):
owice Name: BELMONT, DENTAL UNIT & ACCESSORIES, QUOLIS 5000 ERIES
dications For Use:
ntal Unit and Accessories are intended for the Dentists, Hygienists, and Dental sistants for traditional and normal patient treatment procedures in the dental atory.
iption Use CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
SE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Ruang
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
Page 1 of 1
510(k) Number: K1572273
§ 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.