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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental device called "D/Sense 1-Step." This document primarily addresses the regulatory approval of the device based on its substantial equivalence to a legally marketed predicate device.
The document does not contain the information requested in your prompt regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study details.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This type of information would typically be found in a clinical study report or a more detailed section of the 510(k) submission itself, which is not provided in the given text. The letter only confirms that the FDA reviewed the submission and found the device substantially equivalent.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL = 2 2002
Mr. John Discko Executive Vice President Centix, Incorporated 770 River Road Shelton, Connecticut 06484-5458
Re: K021146
Trade/Device Name: D/Sense 1-Step Regulation Number: 872.3250 Regulation Name: Calcium Hydroxide Cavity Liner Regulatory Class: II Product Code: EJK Dated: April 3, 2002 Received: April 9, 2002
Dear Mr. Discko:
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.
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.
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Page 2 - Mr. Discko
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 (OS) 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html
Sincerely yours,
Timothy Ulatowski
Tim Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page of
510(k) NUMBER (IF KNOWN): [K021146](https://510k.innolitics.com/search/K021146)
DEVICE NAME: `DI Sense 1-step
INDICATIONS FOR USE:
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter-Use (Optional Format 1-2-96
Suen Runa
(Division Sign-Off) (Division Sign-On)
Division of Dental, Infection Control,
Division of Dental, Infection Devices Divisional Hospital Devices 510(k) Number -
§ 872.3250 Calcium hydroxide cavity liner.
(a)
Identification. A calcium hydroxide cavity liner is a device material intended to be applied to the interior of a prepared cavity before insertion of restorative material, such as amalgam, to protect the pulp of a tooth.(b)
Classification. Class II.