(88 days)
For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-thecounter removal of common warts and plantar warts on the bottom of the foot. The device consists of the following:
- Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane
- Reusable activator that releases the cryogen into the applicators
- Disposable applicators
- Information booklet
The Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-the-counter removal of common warts and plantar warts. The device was evaluated for substantial equivalence to predicate devices, namely the Wartner Wart Removal System (K011708) and the Histofreezer Wart Removal System (K023487, K924114).
The acceptance criteria for this device are primarily based on demonstrating substantial equivalence to its predicate devices in terms of technological characteristics, safety, and effectiveness. A formal study report with detailed numerical acceptance criteria and a corresponding performance report is not provided in the given text. Instead, the submission relies on direct comparisons to the predicate devices and general statements about the device's performance.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit numerical acceptance criteria are not presented in the document, the table below is constructed based on the comparisons made to the predicate devices, indicating what was deemed "similar" or "sufficient."
| Feature/Characteristic | Acceptance Criteria (Implied) | Reported Device Performance (Dr. Scholl's Freeze Away) |
|---|---|---|
| Applicator Temperature | Similar to predicate devices (e.g., -36°C to -42°C) | -42°C (average after saturation) |
| Applicator Effectiveness Duration | Sufficient length of time for use per instructions (e.g., 75-230 seconds) | ~170 seconds (maintains -42°C on Teflon surface), ~230 seconds for Histofreezer predicate |
| Cryogen | Same as or similar to predicate devices | Mixture of dimethyl ether and propane (same as Wartner) |
| Biocompatibility | Meet ISO 10993 for limited surface contact with breached skin | Studies conducted on applicator material (assumed to meet standard) |
| Safety Features | At least comparable to predicate devices | Cryogen released only after applicator attached and pressed; includes luer lock (additional safety) |
| Indications for Use (Common Warts) | Same as Wartner predicate device | Over-the-counter removal of common warts |
| Indications for Use (Plantar Warts) | Same as Histofreezer predicate device | Over-the-counter removal of plantar warts |
| Labeling | Adequate directions for safe use, self-diagnosis support, doctor consultation guidance | Developed to ensure adequate directions, self-diagnosis, and contact doctor if needed |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information about any clinical studies or sample sizes for a "test set" in the traditional sense (e.g., patient data). The evaluation appears to be based on laboratory testing of the device's physical characteristics (temperature, duration, cryogen composition) and comparisons to established predicate devices. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable or provided in the given text. The "ground truth" for this type of submission is likely derived from established scientific principles for cryotherapy and the performance characteristics of previously cleared predicate devices, rather than expert consensus on individual cases.
4. Adjudication Method
This information is not applicable or provided as there is no mention of a human-read or human-interpreted test set requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done as this approval is for a physical device (cryosurgical wart remover) rather than an AI-powered diagnostic or interpretive tool. There is no mention of human readers or AI assistance in this context.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This device is a physical product, not an algorithm. Therefore, a standalone algorithm performance study was not conducted. The performance described relates to the physical properties and efficacy of the cryosurgical process itself.
7. Type of Ground Truth Used
The "ground truth" for this submission primarily relies on:
- Physical and Chemical Properties: Laboratory measurements of temperature, duration, and cryogen composition.
- Established Efficacy of Cryotherapy: The underlying principle that cryotherapy is an effective method for wart removal (as demonstrated by the predicate devices).
- Predicate Device Performance: The demonstrated safety and effectiveness of the Wartner and Histofreezer devices in removing common and plantar warts.
8. Sample Size for the Training Set
There is no mention of a training set as this device does not involve machine learning or AI models that require data for training.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set, this information is not applicable.
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K031697
113
PREMARKET NOTIFICATION 510(k) SUMMARY
-
- Submitter's Name: Schering-Plough HealthCare Products, Inc. Address: 3030 Jackson Avenue, Memphis, TN 38151 Telephone Number: (901) 320-2917 Contact Person: John M. Clayton, PhD Date Prepared: August 8, 2003
-
- Device Name:
Proprietary Name: Dr. Scholl's® Freeze Away™ Wart Remover Usual Name: OTC Wart Removal System Classification Name: Cryosurgical Unit, Accessories
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- Description of Device:
Dr. Scholl's Freeze Away Wart Remover is a cryosurgical system for the over-thecounter removal of common warts and plantar warts on the bottom of the foot. The device consists of the following:
- Pressurized canister with a cryogen mixture of liquid dimethyl ether and propane a.
- b. Reusable activator that releases the cryogen into the applicators
- Disposable applicators C.
- d. Information booklet
-
- Intended Use Statement:
Dr. Scholl's Freeze Away Wart Remover is indicated for the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
-
- Comparison of Technological Characteristics:
Dr. Scholl's Freeze Away Wart Remover is substantially equivalent to the Modification to Wartner Wart Remover System by Wartner Medical Products. The only significant difference between the two products is that the Freeze Away Wart Remover product is additionally indicated for the removal of plantar warts. For the over-the-counter plantar wart indication, we are claiming substantial equivalence to the Histofreezer Wart Removal System.
- Comparison of Technological Characteristics:
All 3 devices (Freeze Away, Wartner, Histofreezer) are portable cryosurgical systems comprised of a canister containing cryogen and an applicator that is saturated with cryogen and then applied to the wart to be treated.
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K031697
a. Laboratory Testing
The average temperature of the Dr. Scholl's Freeze Away Wart Remover applicator surface after saturation is -42°C and is similar to that of the predicate devices (see below).
b. Biocompatibility
The cryogen used is a mixture of dimethyl ether and propane, which is the same as the cryogen used in the primary predicate device (Wartner).
The standard biocompatibility studies recommended under ISO 10993 for a medical device with limited surface contact duration to breached/compromised skin were conducted on the applicator material and are included in this 510(k).
c. Comparison to Predicate Devices:
Application
Dr. Scholl's Freeze Away Wart Remover includes an applicator that is saturated with cryogen and then applied to the wart to be treated.
The primary predicate device (Wartner) uses a similar applicator constructed of a different material.
Applicator Effectiveness Duration
Dr. Scholl's Freeze Away Wart Remover maintains a temperature of -42°C at the applicator tip for approximately 170 seconds when tested using a temperature probe resting on a room temperature Teflon surface. A temperature of -57°C [similar to that listed in 510(k)s K011708 and K924114] is measured if tested using a temperature probe held in mid-air. The method that employs a Teflon surface under the temperature probe is a more appropriate method for simulation of actual use conditions and was used for the substantial equivalence comparison.
The primary predicate device (Wartner) maintains a similar temperature (-36℃) for approximately 75 seconds, while the Histofreezer device maintains the same temperature as Freeze Away (-42°C) for approximately 230 seconds. All devices maintain the freezing temperature for a sufficient length of time to allow the product to be used according to the instructions for use.
Crvogen
Dr. Scholl's Freeze Away Wart Remover uses a cryogen composed of dimethyl ether and propane.
The primary predicate device (Wartner) uses the same cryogen.
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Safety / Ease of Use
Dr. Scholl's Freeze Away Wart Remover includes a safety feature whereby the cryogen will be released into the applicator only after the applicator is attached to the pressurized can and pressed onto the activator. The applicator on the Freeze Away product also contains a luer lock which allows the applicator to be twisted onto the can, preventing accidental detachment during activation or treatment.
The primary predicate device (Wartner) utilizes the first safety feature listed above but does not contain the second safety feature.
Indications for Use
Dr. Scholl's Freeze Away Wart Remover is indicated for the over-the-counter removal of common warts and plantar warts.
The primary predicate device (Wartner) is indicated for the over-the-counter removal of common warts, while a second predicate device (Histofreezer) is indicated for the over-the-counter removal of common warts and plantar warts.
Labeling
The labeling of Dr. Scholl's Freeze Away Wart Remover has been developed to ensure the consumer has adequate directions for safe use. Freeze Away labeling has also been developed to provide adequate information for the consumer to make a self diagnosis 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.
The safety and warning statements for the OTC predicate device (Modification to Wartner Wart Removal System) are essentially similar.
7. Conclusion
Based on the information presented above, it is concluded that the proposed Dr. Scholl's Freeze Away Wart Remover is safe and effective for its intended use when used in accordance with label directions and is substantially equivalent to the predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
AUG 2 9 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Philip Johnson Manager, Regulatory Affairs Schering-Plough Healthcare Products 3 Connell Drive Berkeley Heights, New Jersey 07922
Re: K031697
Trade/Device Name: Dr. Scholl's Freeze Away™ Wart Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: May 30, 2003 Received: June 3, 2003
Dear Mr. Johnson:
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 - Mr. Philip Johnson
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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
(W 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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Statement of Indications for Use
510(k) Number (if known): KO31697
Device Name: Dr. Scholl's® Freeze Away™ Wart Remover
Indications for Use: For the over-the-counter removal of common warts and plantar warts on the bottom of the foot.
(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)
Over-The-Counter Use
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number K031697
§ 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.