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K Number
K012733
Device Name
CARIES DETECTOR
Manufacturer
KURARAY MEDICAL INC.
Date Cleared
2001-09-14

(31 days)

Product Code
LFC
Regulation Number
872.1740
Type
Traditional
Panel
DE
Reference & Predicate Devices
K951813,K913405
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CARIES DETECTOR is indicated for the following applications: Detection of carious dentin

Device Description

This product is classified into Caries Detection Device, CFR 21 Section 872. 1740. Two of the predicate devices listed in section 3 operate by means of applying dyes to teeth to stain areas of decay. They do not involve chemical reactions, nor use electrical current or optical instruments. The methods of operation of these devices is similar to that of plaque disclosing agents in that they stain the affected areas.

AI/ML Overview

The provided text is a 510(k) summary for the "CARIES DETECTOR" device by Kuraray Medical Inc. It explicitly states that the submission is for an alteration of the name and address of the manufacturer and not to intend other changes to the device itself.

It further clarifies that the "technological characteristics, chemical ingredients and safety of this device are completely the same as CARIES DETECTOR manufactured by Kuraray Co., Ltd. (K951813)."

This means that a new study to prove device performance or establish new acceptance criteria was not conducted for this specific 510(k) submission (K012733). The substantial equivalence is based on the predicate device (K951813), which presumably had its performance proven at the time of its own clearance.

Therefore, the requested information regarding acceptance criteria and the study proving the device meets them cannot be directly extracted from this document for K012733, as no such new study was performed for this submission. The document relies on the previous clearance of the predicate device.

To answer your request, one would need to refer to the original 510(k) submission for the predicate device, K951813 (CARIES DETECTOR by Kuraray Co., Ltd.), if that information is publicly available.

Based solely on the provided text for K012733:

  1. Table of acceptance criteria and the reported device performance:

    • No new acceptance criteria or reported device performance studies are included in this 510(k) summary for K012733, as it is a manufacturer name/address change and not a device modification. The device is stated to be "completely the same" as the predicate K951813.

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

    • Not applicable to this 510(k) submission, as no new performance study was conducted.

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

    • Not applicable to this 510(k) submission, as no new performance study was conducted.

  4. Adjudication method:

    • Not applicable to this 510(k) submission, as no new performance study was conducted.

  5. Multi-reader multi-case (MRMC) comparative effectiveness study:

    • No MRMC study was conducted or reported in this 510(k) submission.

  6. Standalone performance study:

    • No standalone performance study was conducted or reported in this 510(k) submission for K012733.

  7. Type of ground truth used:

    • Not applicable to this 510(k) submission, as no new performance study was conducted.

  8. Sample size for the training set:

    • Not applicable to this 510(k) submission, as it is a dye-based caries detection device and typically does not involve algorithm training in the context of AI.

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

    • Not applicable to this 510(k) submission.

§ 872.1740 Caries detection device.

(a)
Identification. The caries detection device is a device intended to show the existence of decay in a patient's tooth by use of electrical current.(b)
Classification. Class II.