(261 days)
Wartner Wart Removal System
Compound W Gel, Compound W Pads for Kids, Clear Away Gel, Clear Away Liquid, Rite Aid Wart Liquid, Suave Hairspray
No
The device description and performance studies focus on a cryosurgical system using compressed gases and foam applicators, with no mention of AI or ML.
Yes
Explanation: The device is intended for the "treatment of common warts" using cryosurgery, which is a therapeutic intervention.
No
The device is described as a "Wart Removal System" and its intended use is for "treatment of common warts," indicating it is a therapeutic device, not a diagnostic one.
No
The device description explicitly lists physical components such as a canister, foam applicators, and an applicator stick/key, indicating it is a hardware-based medical device.
Based on the provided information, the Wartner Wart Removal System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "over-the-counter treatment of common warts." This is a therapeutic purpose, directly treating a condition on the body.
- Device Description: The device is a cryosurgical system that applies a cold gas mixture to the wart. This is a physical treatment method.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information for diagnosis, monitoring, or screening. The Wartner system does not involve the analysis of any biological specimens.
Therefore, the Wartner Wart Removal System is a therapeutic device used for the physical removal of warts, not an IVD.
N/A
Intended Use / Indications for Use
Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
Wartner Wart Removal System is indicated for OTC treatment of common warts.
Wartner Wart Removal System is intended for the treatment of common warts.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- . Ten foam applicators
- . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
- An illustrated description of how to use the product .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Laboratory Testing: The average temperature of the applicator surface after saturation is -56.4° C. Several lengths, sizes, and shapes of foam were tested to identify the optimum characteristics of liquid retention (minimal dripping) and versatile shape for treating various sizes of warts.
Biocompatibility: The cryogen used is a mixture of dimethylether and propane, which is the same as cryogen used in the predicate device, Wartner Wart Removal System for prescription use. The material used to transfer the cold to the patient in both Wartner Wart Removal System OTC and the predicate device is a foam material. The foam used in Wartner which has contact with the wart is S616 foam which is well characterized chemically and physically in the published literature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Wartner Wart Removal System
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Compound W Gel, Compound W Pads for Kids, Clear Away Gel, Clear Away Liquid, Rite Aid Wart Liquid, Suave Hairspray
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Wartner Medical Products Wartner Wart Removal System
FEB 2 0 2002
Safety and Effectiveness Summary
1. Submitter's Name, Address and Contact Person
Submitter
Contact Person
| Wartner Medical Products | Nancy Lum-Wilson |
|---|---|
| Europark 20 | N. Wilson Consulting Inc. |
| 4904 SX Oosterhout | 25 Bellini Ave. |
| Netherlands | Brampton, Ontario |
| L6T 3Z8 CANADA | |
| Telephone: 00 31 162 437 268 | Telephone: 905-794-3339 |
| Facsimile: 00 31 162 437 269 | Facsimile: 905-794-0633 |
Date Summary Prepared: May 25, 2001
2. Name of Device
Wartner Wart Removal System
3. Name of Predicate Device(s)
Wartner Wart Removal System, by Wartner Medical Products (Primary Predicate) Compound W Gel, by Medtech (labeling only) Compound W Pads for Kids, by Medtech (labeling only) Clear Away Gel, by Schering-Plough HealthCare Products, Inc., (labeling only) Clear Away Liquid, by Schering-Plough HealthCare Products, Inc., (labeling only) Rite Aid Wart Liquid, by Rite Aid Corporation (labeling only) Suave Hairspray, by Helene Curtis (Flammability label only)
4. Description of Device
Wartner Wart Removal System is a cryosurgical system for the treatment of warts. It consists of
- A canister filled with 35 ml of a liquid mixture of the compressed gases . dimethyl ether and propane. This gas mixture does not harm the ozone layer, and has a four-year shelf life.
- . Ten foam applicators
- . An applicator stick/key for holding a foam applicator, required to dispense the liquid to the applicator, and held by the person during treatment
- An illustrated description of how to use the product .
5. Statement of Intended Use
Wartner Wart Removal System is intended for the over-the-counter treatment of common warts.
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6. Statement of Technological Characteristics of the Device
- a) Laboratory Testing:
The average temperature of the applicator surface after saturation is -56.4° C.
Several lengths, sizes, and shapes of foam were tested to identify the optimum characteristics of liquid retention (minimal dripping) and versatile shape for treating various sizes of warts.
- b) Biocompatibility:
The cryogen used is a mixture of dimethylether and propane, which is the same as cryogen used in the predicate device, Wartner Wart Removal System for prescription use.
The material used to transfer the cold to the patient in both Wartner Wart Removal System OTC and the predicate device is a foam material. The foam used in Wartner which has contact with the wart is S616 foam which is well characterized chemically and physically in the published literature.
- c) Comparison to Predicate Device(s):
Application
Wartner for OTC use provides an applicator, which is removed from the tube of cryogen after saturation and can be easily manipulated to treat warts of various sizes.
The Wartner prescription use predicate device applicator is identical.
Applicator Effectiveness Duration
Wartner's foam applicator maintains a temperature of less than minus 50℃ for up to five minutes.
The Wartner predicate device effectiveness is identical
Cryogen
Wartner uses a cryogen composed of dimethylether and propane.
The Wartner predicate device cryogen is identical.
2
Safety/Ease of Use:
Wartner's design incorporates the use of a safety valve that cannot be actuated unless the foam applicator and holder are in place. The Wartner prescription use predicate device has an identical safety valve.
Indications for Use:
Wartner Wart Removal System is indicated for OTC treatment of common warts. The predicate device, Wartner Wart Removal System for prescription use is indicated for the treatment of common warts by a physician.
Labeling:
The labeling of Wartner Wart Removal System has been developed to ensure the consumer has adequate directions for use and for safety. Wartner labeling has also been developed to provide adequate information for the consumer to make a self diagnosis and to ensure they contact their doctor if in any doubt, if stinging or aching persists after treatment or if the wart does not improve after three treatments.
The safety and warning statements for the primary predicate device (Wartner Wart Removal System for prescription use) and for all of the labeling predicate devices (Compound W Gel, Compound W pads, Clear Away Gel, Clear Away Liquid, Rite Aid Wart Liquid) is essentially similar. In addition, Wartner contains an essentially similar flammability statement to Suave Hairspray (Flammability label predicate), which uses an aluminum container and contains dimethyl ether and alcohol for use by the general public.
7. Conclusion
Based on the information presented above it is concluded that the proposed Wartner 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/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 0 2002
Wartner Medical Products c/o Ms. Nancy Lum-Wilson N. Wilson Consulting, Inc. 25 Bellini Avenue Brampton, Ontario L6T 3Z8 Canada
Re: K011708
Trade/Device Name: Wartner Wart Removal System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: January 18, 2002 Received: January 22, 2002
Dear Ms. Lum-Wilson:
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. 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. Nancy Lum-Wilson
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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 Division of Small 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.
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Wartner Medical Products Wartner Wart Removal System
STATEMENT OF INDICATIONS FOR USE
510(k) Number:
Device Name:
Wartner Wart Removal System
Indications for Use : Wartner Wart Removal System is intended for the treatment of common warts.
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
(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
X Over-the-Counter Use (Optional Format 1-2-96)