A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane
12 Disposable Applicators O
1 Pumice Stone o
o 12 Foot Comfort Pads
1 Reusable Activator that releases the cryogen into the applicator O
An illustrated description of how to use the product with common and o plantar warts

This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated.

AI/ML Overview

The provided text is a 510(k) summary for the Compound W® Freeze Off™ Plantar Wart Removal System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo study with specific performance acceptance criteria and a detailed study report. Therefore, much of the requested information about acceptance criteria, detailed study design, and performance metrics for this specific device is not available in the provided text.

Here's an attempt to address the points based on the available information:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or a direct performance study for the new device (Compound W® Freeze Off™ Plantar Wart Removal System). Instead, it relies on demonstrating substantial equivalence to previously approved devices.

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance (Implicit from SE)
Intended Use	Same as predicate devices	"The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts. There is no change to the intended use of this device."
Technological Characteristics	Similar to predicate devices (Cryogen, applicator materials, method of application)	"The Compound W® Freeze Off™ Plantar Wart Removal System...is substantially equivalent to both the Compound W Freeze Off™ Wart Removal System by OraSure Technologies, Inc. and the Wartner Wart Removal System by Wartner USA b.v. The primary predicate device (Compound W® Freeze Off™) uses the same applicator constructed of the same material. There is no change to the method of application to the wart."
Safety and Effectiveness	Established in predicate device 510(k) (K023487)	"The safety and ease of use have been established in the 510k for this product - K023487."
Labeling	Adequate directions, warnings, and consistent with predicate devices for safe OTC use, especially regarding pumice stone and seeking medical advice.	"The labeling of the Compound W® Freeze Off™ Plantar Wart Removal System has been developed to ensure the consumer has adequate directions for safety... has been modified to provide adequate information for the consumer to use the pumice stone safely with plantar warts and to ensure that they contact their doctor if in any doubt, if stinging or aching persists after treatment, or if the wart does not improve after four, treatments to seek physician advice. This direction is consistent with the existing warning and cautions regarding medical advice in our instructions for use." "The safety and warning statements for the OTC predicate device... and for the labeling predicate device is essentially similar."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not describe a specific "test set" for the new device. The submission relies on the established safety and effectiveness data of the predicate devices. Therefore, no information on sample size, data provenance, or study type for a test set of this specific device is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No specific test set for the new device is described, and thus no expert ground truthing process is mentioned in this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No specific test set for the new device is described, and thus no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a cryosurgical device for wart removal, not an imaging or diagnostic AI device. Therefore, MRMC studies and AI assistance metrics are not relevant or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device, not an algorithm, and its use inherently involves human interaction for application.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the predicate devices, the ground truth for establishing safety and effectiveness would have been based on clinical outcomes data (e.g., wart clearance rates, adverse events) from their original clinical studies. However, the provided document does not detail these for the predicates, only states that their safety and effectiveness were established.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device that utilizes a training set in the conventional sense.

9. How the ground truth for the training set was established

Not applicable. This is not an AI/algorithm-based device.

Summary

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OraSure Technologies, Inc. 150 Webster St. Bethlehem, PA 18015 610/882-1820

(060859

JUL 1 8 2006

Compound W® Freeze Off™ Plantar Wart Removal System Special 510k Summary

1. Submitter's Name: OraSure Technologies, Inc. Address: 150 Webster St., Bethlehem, PA 18015 Telephone Number: (610) 882-1820 ext. 5043 Contact Person: Sue Sutton-Jones Date Prepared: 31 January 2006
1. Device Name: Compound W® Freeze Off™ Plantar Wart Removal System Proprietary Name: or other proprietary name Usual Name: OTC wart removal system Classification Name: Cryosurgical unit, accessories (21 CFR 878.4350), Product Code GEH.
1. Device to Which Substantial Equivalence Is Claimed: Compound W® Freeze Off™ Wart Removal System - K023487 Wartner Wart Removal System, by Wartner Medical Products – K011708 (labeling only)
1. Description of Device:

The Compound W® Freeze Off™ Plantar Wart Removal System is a cryosurgical system for the treatment of common warts and plantar warts. It consists of:

A canister filled with a liquid mixture of the compressed gases dimethyl O ether, propane and isobutane
12 Disposable Applicators O
1 Pumice Stone o
o 12 Foot Comfort Pads
1 Reusable Activator that releases the cryogen into the applicator O
An illustrated description of how to use the product with common and o plantar warts
ട്. Intended Use Statement:

The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common warts and plantar warts. There is no change to the intended use of this device.

6. Comparison of Technological Characteristics to Predicate Devices:

The Compound W® Freeze Off™ Plantar Wart Removal System for over-thecounter treatment of common and plantar warts is substantially equivalent to both the Compound W Freeze Off™ Wart Removal System by OraSure Technologies, Inc. and the Wartner Wart Removal System by Wartner USA b.v.. The primary predicate device (Compound W® Freeze Off™) uses the same applicator constructed of the same material. There is no change to the method of application to the wart.

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This device is a portable cryosurgical system comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied tan the wart to be treated. Both devices are approved for the OTC treatment of common warts and plantar warts.

The labeling of the Compound W® Freeze Off™ Plantar Wart Removal System has been developed to ensure the consumer has adequate directions for var eyotofor safety. Compound Wo Freeze Off™ Wart Removal System labeling has been modified to provide adequate information for the consumer to use the pumice stone safely with plantar warts and to ensure that they contact their doctor if in any Joubt, if stinging or aching persists after treatment, or if the wart does not improve after four, treatments to seek physician advice. This direction is consistent with the existing warning and cautions regarding medical advice in our instructions for use.

The safety and warning statements for the OTC predicate device (Compound W Freeze Off™ Wart Removal System - K023487) and for the labeling predicate device is essentially similar.

1. Significant Changes or Modifications to the Device:
  There are no changes or modifications to the device.
Indications for use have not been changed or modified. ו
The safety and ease of use have been established in the 510k for this product -। K023487.
The only modification to the Compound We Freeze Off™ Wart Removal System is the addition of a small pumice stone that is optional for use in the treatment of plantar warts.
Instructions for use have been modified to include the use of the pumice stone । in the treatment of plantar warts. This labeling change is consistent with the labeling of the predicate device, Wartner Wart Removal System, by Wartner Medical Products - K011708.

8. Conclusion:

Based on the information presented above, it is concluded that the proposed Compound W® Freeze Off™ Plantar Wart Removal System is safe and effective for its intended use and is substantially equivalent to the primary predicate device. It is also substantially equivalent in intended use, safety, and labeling to the labeling predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure with three lines extending upwards, resembling a bird in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 18 2006

OraSure Technologies, Inc. % Ms. Sue Sutton-Jones Senior, VP, Regulatory Affairs & Quality 220 East First Street Bethlehem, Pennsylvania 18015-1360

Re: K060859

Trade/Device Name: Compound W® Freeze Off™ Plantar Wart Removal System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: June 22, 2006 Received: June 23, 2006

Dear Ms. Sutton-Jones:

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 mav 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. 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.

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Page 2 – Ms. Sue Sutton-Jones

This letter will allow you to begin marketing your device as described in your Section 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 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Raubaus Buehm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K060859

Device Name: Compound W® Freeze Off™ Plantar Wart Removal System

Indications For Use: The Compound W® Freeze Off™ Plantar Wart Removal System is indicated for over-the-counter treatment of common and plantar warts.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Barbara Builid R. MKL)

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

Page 1 of

510(k) Number Kol.08551

Regulation Number and Section

§ 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.