OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01 by CLOSURE MEDICAL CORP.

The provided text is a 510(k) clearance letter for the Octyldent® (2-octyl cyanoacrylate) device. This type of document primarily confirms that a new medical device is substantially equivalent to a legally marketed predicate device, allowing it to be marketed. It does not typically contain detailed information about acceptance criteria, specific device performance data from a clinical study, or the methodology of such a study.

Therefore,Based on the provided text, I cannot furnish the requested information regarding acceptance criteria and the study that proves the device meets them because this document is a 510(k) clearance letter and does not contain that level of detail.

Specifically, the following information is not present in the provided text:

A table of acceptance criteria and the reported device performance: The document only states the device is "substantially equivalent" to predicate devices for its stated indications for use. It does not provide specific performance metrics or acceptance criteria.
Sample size used for the test set and the data provenance: This information is not included.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not included.
Adjudication method for the test set: This information is not included.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: This information is not included.
If a standalone performance study was done: This information is not included.
The type of ground truth used: This information is not included.
The sample size for the training set: This information is not included.
How the ground truth for the training set was established: This information is not included.

The document's purpose is to grant clearance for marketing based on substantial equivalence, not to detail the results of performance studies. Such details would typically be found in the 510(k) submission itself, which is not provided here.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR - 9 1998

Mr. Joe B. Barefoot Vice President, Quality Assurance and Regulatory Affairs CLOSURE Medical Corporation™ 5265 Capital Boulevard Raleigh, North Carolina 27616

Re : K980159 Octyldent® (2-octyl cyanoacrylate) Trade Name: Requlatory Class: II Product Code: EMA Dated: January 15, 1998 Received: January 16, 1998

Dear Mr. Barefoot:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of

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the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 marice and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fdaygov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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7. Statement of Indications for Use

510(k) Number (if known):_

Device Name: Octyldent® (2-octyl cyanoacrylate)

Indications For Use:

Octyldent® is intended for use as an adhesive for the temporary fixing of periodontal polymer or fibers in periodontal pockets.

(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)

Susan Runnes

(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number

CLOSURE Medical Corporation

004

Regulation Number and Section

§ 872.3275 Dental cement.

(a)
Zinc oxide-eugenol —(1)Identification. Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
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.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.(2)
Classification. Class II.