PISCES PLUS (DW286 C) by IVOCLAR VIVADENT, INC.

I am sorry, but the provided text from the FDA 510(k) K020183 document for "Pisces Plus" does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This document is a marketing clearance letter, which means the FDA has determined the device is "substantially equivalent" to legally marketed predicate devices. This letter primarily focuses on:

Trade/Device Name: Pisces Plus
Regulation Number and Name: 872.3710, Base Metal Alloy
Regulatory Class: Class II
Product Code: EJH
Submission Date: January 15, 2002
Approval Date: March 13, 2002
Indications For Use: For onlay, ¼ crowns, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.
General Controls: Mentions annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

It does not include:

A table of acceptance criteria or reported device performance.
Details about a sample size for a test set, data provenance, or a study.
Information on experts used to establish ground truth or their qualifications.
Adjudication methods.
MRMC comparative effectiveness study results or effect sizes.
Standalone algorithm performance.
Type of ground truth used.
Sample size for a training set.
How ground truth for a training set was established.

This type of information, particularly detailed performance data and study design, would typically be found in the 510(k) submission document itself, which is often much more extensive and not usually fully included in the public clearance letter. The clearance letter confirms the substantial equivalence but does not elaborate on the specific testing performed to demonstrate that equivalence.

Summary

{0}------------------------------------------------

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like bird with three curved lines representing its wings or feathers. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2002

Mr. Anderjeet Gulati Quality Assurance Manager Ivoclar Vivadent, Incorporated 175 Pineview Drive Amherst, New York 14228

Re: K020183

Trade/Device Name: Pisces Plus Regulation Number: 872.3710 Regulation Name: Base Metal Alloy Regulatory Class: Class II Product Code: EJH Dated: January 15, 2002 Received: January 18, 2002

Dear Mr. Gulati:

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.

{1}------------------------------------------------

Page 2 - Mr. Anderjeet Gulati

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 (QS) 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) rms lotet notification. The FDA finding of substantial equivalence of your device to a legally premaince in a classification for your device and thus, permits 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 O inter grief and 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 A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

K020183 Not yet assigned 510(k) Number (if known): _

Device Name:

Pisces Plus (DW286 C C _______________________________________________________________________________________________________________________________________________________

Indications For Use:

Pisces Plus (DW286 C) alloy intended to be used for onlay, ¼ crows, telescope crowns, conus crowns, posts, short and long span bridges, PFM crowns.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)


(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number	K202083

Prescription Use X (Per 21 CFR 801.109)	OR	Over-The-Counter Use ____
-----------------------------------------	----	---------------------------

(Optional Format 1-2-96)

Regulation Number and Section

§ 872.3710 Base metal alloy.

(a)
Identification. A base metal alloy is a device composed primarily of base metals, such as nickel, chromium, or cobalt, that is intended for use in fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Dental Base Metal Alloys.” The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.