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K Number
K032271
Device Name
WARTNER WART REMOVAL SYSTEM, MODEL 66715 82000 (PRODUCT CODE NUMBER 52E022)
Manufacturer
WARTNER USA B.V.
Date Cleared
2003-09-10

(49 days)

Product Code
GEH
Regulation Number
878.4350
Type
Traditional
Panel
SU
Reference & Predicate Devices
K032271
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

WARTNER® Wart Removal System is indicated for the over-the-counter treatment of common warts and plantar warts.

Device Description

Not Found

AI/ML Overview

This document, a 510(k) summary, does not contain the information requested about acceptance criteria and a study proving a device meets those criteria.

The provided text is a summary prepared for the FDA's 510(k) premarket notification process for the WARTNER® Wart Removal System. Its primary purpose is to demonstrate substantial equivalence to legally marketed predicate devices, not to present detailed performance study results against specific acceptance criteria.

Therefore, I cannot extract the following information from the given text:

  1. A table of acceptance criteria and the reported device performance
  2. Sample size used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or its effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

The document focuses on:

  • Contact information of the submitter.
  • Device name.
  • Predicate devices used for comparison.
  • The FDA's letter granting substantial equivalence.
  • The intended indications for use.

These elements are standard for a 510(k) summary and do not delve into the specifics of performance studies as you've requested.

§ 878.4350 Cryosurgical unit and accessories.

(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.