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K Number
K050318
Device Name
BARI-KAD PACKING DEVICE
Manufacturer
BIOENVELOP AGRO, INC.
Date Cleared
2005-03-04

(23 days)

Product Code
EIE
Regulation Number
872.6300
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Bari-Kad™ is a device intended to protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening.

Device Description

Bari-Kad™ Packing Device

AI/ML Overview

The provided document is an FDA 510(k) clearance letter for the BioEnvelop Agro, Incorporated's "Bari-Kad™ Packing Device". This device is a dental product (rubber dam and accessories) intended to "protect soft tissue and isolate a tooth or a series of teeth from paste in the mouth during dental procedures, such as teeth whitening."

Based on the content of this regulatory letter, it is not a study report or clinical trial documentation. It primarily states:

  • The FDA has reviewed the 510(k) premarket notification.
  • The device is found substantially equivalent to legally marketed predicate devices.
  • It outlines regulatory compliance requirements.
  • It includes an "Indications for Use Statement."

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving the device meets those criteria.

Specifically, the document does not provide any of the following information:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes used for test sets, data provenance.
  3. Number or qualifications of experts for ground truth.
  4. Adjudication method.
  5. MRMC comparative effectiveness study results (human readers improvement with/without AI).
  6. Standalone (algorithm-only) performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This is a regulatory clearance notice, not a scientific study report. To find the information you're looking for, you would typically need to consult the original 510(k) submission summary or any clinical studies referenced within it (if any were required, which is less common for Class I devices like this one).

§ 872.6300 Rubber dam and accessories.

(a)
Identification. A rubber dam and accessories is a device composed of a thin sheet of latex with a hole in the center intended to isolate a tooth from fluids in the mouth during dental procedures, such as filling a cavity preparation. The device is stretched around a tooth by inserting a tooth through a hole in the center. The device includes the rubber dam, rubber dam clamp, rubber dam frame, and forceps for a rubber dam clamp. This classification does not include devices intended for use in preventing transmission of sexually transmitted diseases through oral sex; those devices are classified as condoms in § 884.5300 of this chapter.(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 § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180 of this chapter, with respect to general requirements concerning records, and § 820.198 of this chapter, with respect to complaint files.