(101 days)
After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.
Smartburs
This document is a 510(k) premarket notification letter from the FDA for a dental device called "Smartburs". It confirms that the device is substantially equivalent to legally marketed predicate devices. It does not contain information about acceptance criteria or a study proving device performance as typically expected for complex AI/ML-based medical devices.
Therefore, I cannot provide the requested information for the following reasons:
- No Acceptance Criteria or Performance Study: The provided text is a regulatory clearance letter, not a scientific study report. It states that the device is substantially equivalent to a predicate device, which is a regulatory determination, not a performance validation against specific acceptance criteria.
- Device Type: "Smartburs" is a dental bur, a mechanical instrument for removing decay. It is not an AI/ML-based device that would typically involve acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance, nor would it involve training sets, test sets, or expert adjudication for ground truth.
Because the document does not contain the specifics of a performance study for an AI/ML device, I cannot fill in the requested table or answer the questions regarding sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 0 2008
Mr. Derek Gladden Management Representative S.S. White Burs, Incorporated 1145 Towbin Avenue Lakewood, New Jersey 08701
Re: K080687
Trade/Device Name: Smartburs Regulation Number: 21 CFR 872.3240 Regulation Name: Dental Bur Regulatory Class: I Product Code: EJL Dated: May 23, 2008 Received: June 9, 2008
Dear Mr. Gladden:
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- Mr. Gladden
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.
Suite Y. Michie Omd.
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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Indications for Use
510(k) Number (if known): K080687
Device Name: Smartburs
Indications for Use:
After primary access using another instrument, Smartburs is intended to selectively remove decayed dentin, without removal of healthy dentin from tooth surfaces. Smartburs is not designed to cut or remove enamel, composite, amalgam, cementum, or healthy dentin.
Prescription Use × (21 CFR Part 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Plummer
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K080652
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§ 872.3240 Dental bur.
(a)
Identification. A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.