(23 days)
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.
Bari-Kad™ Packing Device
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets, data provenance.
- Number or qualifications of experts for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results (human readers improvement with/without AI).
- Standalone (algorithm-only) performance.
- Type of ground truth used.
- Sample size for the training set.
- 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).
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 4 - 2005
BioEnvelop Agro, Incorporated C/O Robert Schiff, PhD President Schiff & Company 1129 Bloomfield Avenue West Caldwell, New Jersey 07006
Re: K050318
Trade/Device Name: Bari-Kad™ Packing Device Regulation Number: 21 CFR 872.6300 Regulation Name: Rubber Dam and Accessories Regulatory Class: I Product Code: EIE Dated: February 08, 2005 Received: February 11, 2005
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 Eederal Register.
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Page 2 - Robert Schiff, PhD
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 lease be advised that 1 271 b seian that your device complies with other requirements of the Act or that I Drin has mude a acceministered by other Federal agencies. You must comply with all 1 cacial success and regulading, but not limited to: registration and listing (21 CFR Part 807); an the Ave requirements) ; good manufacturing practice requirements as set forth in the quality labeling (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) I mis letter will and my your e FDA finding of substantial equivalence of your device to a legally prematicated notified on " 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 n you attire office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small general informational 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,
Chiu S. Liu, Ph.D.
Chiu S. Lin, PhD 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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2050318
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): Device Name:
Not yet assigned. Packing Device
Indications for 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.
Prescription Use_X
Over-The-Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Pearce
Mision Sign-Off) asion of Anesthesiology, General Hospital, rection Control, Dental Devices
Number: K050318
§ 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.