(261 days)
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.
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 .
The provided text describes the Wartner Wart Removal System and focuses on its substantial equivalence to a predicate device rather than presenting a detailed study with specific acceptance criteria and performance metrics for the new device. Therefore, many of the requested elements (like sample size for test sets, number of experts for ground truth, MRMC study results, etc.) are not available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety and Effectiveness Equivalence: Functionally and operationally equivalent to predicate device. | The device is concluded to be safe and effective for its intended use and substantially equivalent to the primary predicate device (Wartner Wart Removal System for prescription use). It is also substantially equivalent in intended use, safety, and labeling to several labeling predicate devices. |
| Applicator Temperature (after saturation): Optimal for wart treatment. | Average temperature of the applicator surface after saturation is -56.4° C. |
| Applicator Effectiveness Duration: Maintain temperature below a certain threshold. | Foam applicator maintains a temperature of less than -50° C for up to five minutes. |
| Cryogen Composition: Same as predicate device. | Cryogen is a mixture of dimethylether and propane, identical to the predicate device. |
| Biocompatibility: Materials used are safe. | Cryogen and foam material (S616) are the same as the predicate device and well-characterized in published literature. |
| Safety Valve Functionality: Ensures safe operation. | Design incorporates a safety valve that cannot be actuated unless the foam applicator and holder are in place, identical to the predicate device. |
| Labeling Adequacy: Clear directions for use and safety, and information for self-diagnosis. | Labeling developed to ensure adequate directions for use, safety, self-diagnosis information, and instructions to contact a doctor if needed. Safety and warning statements are essentially similar to predicate devices. |
Missing Information for this Section: The document does not explicitly state quantitative "acceptance criteria" for clinical effectiveness (e.g., "X% of warts removed within Y weeks"). The focus is heavily on equivalence to the predicate.
2. Sample Size used for the Test Set and Data Provenance
- Sample Size: Not specified. The document describes laboratory testing and comparisons to predicate device characteristics, but no human clinical trial involving a "test set" of patients is detailed.
- Data Provenance: The document describes laboratory testing. It does not mention clinical data or its provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable as no clinical test set requiring expert-established ground truth is described. The safety and effectiveness claims are based on substantial equivalence to a predicate device and laboratory testing.
4. Adjudication Method for the Test Set
- Not applicable as no clinical test set requiring adjudication is described.
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 device is a cryosurgical wart removal system, not an AI or imaging diagnostic device. Therefore, no MRMC study or AI assistance is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable as this is a physical medical device, not an algorithm.
7. The type of ground truth used
- The "ground truth" for the claims in this submission appears to be derived from:
- Predicate Device Characteristics: Comparison of physical and chemical properties, design features, and intended use with the legally marketed predicate device.
- Laboratory Measurements: Explicit measurements of temperature (-56.4°C applicator surface, < -50°C for 5 minutes).
- Material Characterization: Reference to published literature for S616 foam.
- Labeling Review: Assessment of clarity and consistency with predicate device labeling.
8. The Sample Size for the Training Set
- Not applicable as this is a physical medical device, not an algorithm requiring a training set.
9. How the Ground Truth for the Training Set was established
- Not applicable as this is a physical medical device, not an algorithm requiring a training set.
Summary of Study (Based on Provided Document):
The document describes a substantial equivalence review for the Wartner Wart Removal System (Over-the-Counter use) against a predicate device (Wartner Wart Removal System for prescription use) and several other labeling predicates. The "study" presented here is primarily a comparative analysis of technological characteristics, safety features, and labeling between the proposed device and its predicates, supported by some laboratory testing of physical properties.
- Laboratory Testing: Conducted to determine the average temperature of the applicator surface after saturation (-56.4°C) and the duration it maintains a temperature below -50°C (up to five minutes). Foam characteristics (liquid retention, shape versatility) were also tested. The details of these lab tests (sample sizes, methods) are not provided beyond the results.
- Comparison to Predicate Devices: A detailed comparison was performed covering:
- Application Method: Identical applicators.
- Applicator Effectiveness Duration: Identical to predicate.
- Cryogen: Identical composition.
- Safety/Ease of Use: Identical safety valve design.
- Biocompatibility: Identical cryogen and foam material to predicate, with foam being well-characterized in literature.
- Indications for Use: OTC treatment of common warts (vs. prescription use by a physician for the primary predicate).
- Labeling: Developed for consumer clarity, safety, self-diagnosis, and similar to predicate device warnings.
The conclusion drawn from this comparative analysis and limited laboratory testing is that the proposed device is substantially equivalent to the predicate device in terms of safety and effectiveness, and identical in crucial technological characteristics, making it suitable for its intended OTC use. No clinical trials or expert-adjudicated test sets are described in this 510(k) summary.
{0}------------------------------------------------
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.
{1}------------------------------------------------
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.
{3}------------------------------------------------
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.
{4}------------------------------------------------
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
{5}------------------------------------------------
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)
§ 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.