(72 days)
Not Found
No
The device description and performance studies focus on cryosurgery and bench testing, with no mention of AI or ML.
Yes
The device is indicated for the "treatment of common warts and plantar warts" and provides "cryosurgery," which are therapeutic actions.
No
The device is described as a wart remover that treats warts using cryosurgery, and there is no mention of it being used to diagnose or identify warts. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly lists physical components: a pressurized canister and a custom application unit. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Dr. Yglo Wart Remover is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Dr. Yglo Wart Remover's Function: The Dr. Yglo Wart Remover is a cryosurgery product applied topically to the skin to freeze and remove warts. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for the "over-the-counter treatment of common warts and plantar warts," which is a direct therapeutic application, not a diagnostic one.
- Device Description: The description focuses on the physical components and the mechanism of action (cryosurgery) applied externally.
Therefore, the Dr. Yglo Wart Remover falls under the category of a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Dr. Yglo Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts.
Product codes
GEH
Device Description
The Dr. Yglo Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home.
Dr. Yglo Wart Remover consists of:
- A pressurized canister filled with 50ml of the compressed liquid gas dimethyl ether.
- A custom application unit used to administer the cold delivered by the cryogen to the ● wart.
- Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Topical - Wart.
Indicated Patient Age Range
adults and children 4 years of age and older.
Intended User / Care Setting
Dr. Yglo Wart Remover is to be applied by persons aged 18 years or older.
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
Non-Clinical Testing:
- The following tests were performed on the finished product:
- Stability testing
- Biocompatibility testing ●
- Usability Study--"Concept and Product Testing with 23 patients for In-Home Use" ●
- Comparative bench testing between Dr. Yglo Wart Remover and other predicate ● device using a biological tissue skin test model.
- Bench testing: Summary
- The following tests were performed on the finished product: ●
- . Comparative performance bench testing with predicate and other competitive devices including freezing performance and skin adherence testing.
The non-clinical and bench testing have supported the safety and efficacy of Dr. Yglo Wart Remover
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 6, 2021
The OTC Lab Healthcare B.V. % Ms. Kathleen Johnson, MSA V Official Correspondent Medical Device Approvals, Inc. 104 E. Harrison Ave. Fairfield, Iowa 52556
Re: K210529
Trade/Device Name: Dr. Yglo Wart Remover Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: February 15, 2021 Received: February 23, 2021
Dear Ms. Johnson:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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
1
542 of the Act); 21 CFR 1000-1050.
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): medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210529
Device Name Dr. Yglo Wart Remover
Indications for Use (Describe)
Dr. Yglo Wart Remover is indicated for the over-the-counter treatment of common warts and plantar warts.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for THEOTCLAB. The logo consists of a circular design on the left and the text "THEOTCLAB" on the right. The circular design features a dark blue circle with a light blue semi-circle at the top and a white "C" shape at the bottom. The text "THEOTCLAB" is in a light blue sans-serif font.
Premarket Notification 510(K) Summary (As Required by 21 CFR 807.92)
| 807.92(a)(1) | |
|---|---|
| Sponsor: | TheOTCLab Healthcare B.V. |
| Address: | Fred. Roeskestraat 115 |
| 1076 EE Amsterdam, The Netherlands | |
| T: 0031 (0)85 4444 202 | |
| www.theotclab.com | |
| Sponsor Contact Person: | Albert Swane- CEO |
| The OTC Lab | |
| Fred. Roeskestraat 115 | |
| 1076 EE Amsterdam | |
| The Netherlands | |
| info@theotclab.com | |
| 510(k) Contact Person: | Ms. Kathleen Johnson MSAV |
| Consultant | |
| Medical Device Approvals, Inc. | |
| 104 E. Harrison Ave. | |
| Fairfield, IA 52556 | |
| kathleen@mdapprovals.com | |
| 610-521-9469 | |
| Date Prepared: | 03-MAY-2021 |
| 807.92(a)(2) | |
| Device Trade Name: | Dr. Yglo |
| Proprietary Name: | Dr. Yglo Wart Remover |
| Common Name: | OTC Wart Removal System |
| Classification Name: | Cryosurgical units, accessories |
| Classification Panel: | General & Plastic Surgery |
| Classification Code: | GEH |
| Regulation Number: | 21 CFR 878.4350 |
807.92(a)(3)
Predicate Device: Substantial equivalence is claimed with the following devices:
| Name of Predicate
Device | Manufacturer | Predicate
Comparison | 510(k) Number |
|-----------------------------|-----------------|--------------------------------------------------|---------------|
| Wartie Wart
Remover | YouMedical B.V. | Intended use,
technology,
materials, label | K140314 |
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Image /page/4/Picture/0 description: The image shows the logo for THEOTCLAB. The logo consists of a circular emblem on the left and the text "THEOTCLAB" on the right. The emblem is a blue circle with a white "C" shape inside and a light blue "T" shape inside the "C". The text "THEOTCLAB" is in a light blue sans-serif font.
807.92(a)(4) Description of the Device:
The Dr. Yglo Wart Remover is effective in the treatment of warts by providing an over the counter cryosurgery product (for the treatment of warts), to be used at home.
Dr. Yglo Wart Remover consists of:
- A pressurized canister filled with 50ml of the compressed liquid gas dimethyl ether.
- A custom application unit used to administer the cold delivered by the cryogen to the ● wart.
- Instructions for use in which you can read about the product how it works, how to use the product to treat warts, warnings and limitations.
Dr. Yglo Wart Remover contains the following materials:
| Location | Material |
|---|---|
| Cone | POM |
| Nose Piece | Bronze coated with Nickel |
| Ring | POM |
| Can | Aluminum |
Dr. Yglo Wart Remover is intended for topical treatment of common and plantar warts. using the following application times, which vary on the basis of the wart diameter:
| WART DIAMETER | TREATMENT TIME | |
|---|---|---|
| Common warts and plantar | ||
| warts on toes and arch of | ||
| foot | Smaller than 3/32 in | |
| (2.5mm) | 10 seconds | |
| Common warts and plantar | ||
| warts on toes and arch of | ||
| foot | 3/32 – 3/16 in (2.5 – 5.0 | |
| mm) | 15 seconds | |
| Common warts and plantar | ||
| warts on toes and arch of | ||
| foot | Larger than 3/16 in (5.0mm) | 20 seconds |
| Calloused Plantar warts on | ||
| heels and balls of feet | All sizes | 40 seconds or less |
807.92(a)(5)
Indication for Use for the Subject Device:
Dr. Yglo Wart Remover is indicated for over-the-counter treatment of common warts and plantar warts.
Intended Users of the Subject Device:
Dr. Yqlo Wart Remover is intended to be used in adults and children 4 years of age and older. Dr. Yglo Wart Remover is to be applied by persons aged 18 years or older.
807.92(a)(6) Technological Characteristics:
Dr. Yglo Wart Remover is a portable cryosurgical system comprised of a canister containing a cryogen and an applicator that applies the cold to the wart to be treated for the over-thecounter treatment of common and plantar warts. The Dr. Yglo Wart Remover employs a metal applicator used as cold retraction vehicle. This allows for pin-pointed accuracy in
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Image /page/5/Picture/0 description: The image shows the logo for THEOTCLAB. The logo consists of a blue circle with a white and light blue design inside, followed by the text "THEOTCLAB" in a light blue sans-serif font. The letters "THE" and "LAB" are in a lighter shade of blue than the letters "OTC".
freezing the skin. Finally, the product uses thermal energy removed from skin at the anatomical site of a common wart and/or plantar wart.
807.92(b) Non-Clinical Testing:
1.The following tests were performed on the finished product:
- Stability testing
- Biocompatibility testing ●
- Usability Study--"Concept and Product Testing with 23 patients for In-Home Use" ●
- Comparative bench testing between Dr. Yglo Wart Remover and other predicate ● device using a biological tissue skin test model.
2. Bench testing: Summary
- The following tests were performed on the finished product: ●
- . Comparative performance bench testing with predicate and other competitive devices including freezing performance and skin adherence testing.
The non-clinical and bench testing have supported the safety and efficacy of Dr. Yglo Wart Remover
Substantial Equivalence Information:
| Subject Device | Predicate Device | |
|---|---|---|
| Dr. Yglo Wart Remover | Wartie Wart Remover | |
| FDA 510(K) number | K210529 | K140314 |
| Intended use | ||
| comparison | OTC treatment of common | |
| warts and plantar warts. | OTC treatment of common warts | |
| and plantar warts. | ||
| indications for use | ||
| comparison | OTC treatment of common | |
| and plantar warts. | OTC treatment of common and | |
| plantar warts. | ||
| anatomical sites | Topical - Wart. | Topical - Wart. |
| energy used and/or | ||
| delivered | Thermal energy removed | |
| from skin via a metal | ||
| interface. | Thermal energy removed from | |
| skin via a metal interface. | ||
| design | Device requiring activation | |
| and application. Metal tip | ||
| provides pin- pointed | ||
| accuracy. | Device requiring activation and | |
| application. Metal tip provides | ||
| pin- pointed accuracy. | ||
| materials | DME from aerosol can | |
| applied to the skin through a | ||
| metal core via a Nickel tip | ||
| providing pin- point | ||
| accuracy. | DME from aerosol can applied to | |
| the skin through a metal core via | ||
| a Nickel tip providing pin- point | ||
| accuracy. | ||
| biocompatibility | Established according to | |
| ISO 10993. | Established according to ISO |
-
|
| Usability | Concept and Product
Testing | Unknown |
. Comparison of Technological Characteristics:
The Dr. Yglo Wart Remover is substantially equivalent to the Wartie Wart Removal System device for the same indications. Both devices are portable cryosurgical systems comprised of a canister containing a cryogen and an applicator that applies the cold to the wart to be treated for the over-the-counter treatment of common and
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Image /page/6/Picture/0 description: The image shows the logo for "THE OTCLAB". The logo consists of a circular icon on the left and the text "THE OTCLAB" on the right. The circular icon is blue with a white "C" shape and a light blue "T" shape inside. The text "THE OTCLAB" is light blue, with the "OTC" portion in a darker blue.
plantar warts. The Dr. Yglo Wart remover and Wartie Wart Remover employs both a metal applicator. Therefore, Wartie Wart Remover is selected as equivalent product. In fact, the predicate product Wartie Wart Remover has been presented to show the precision freezing performance involved a metal applicator.
This difference in technology has been evaluated in bench testing to determine the equivalence of the products. The equivalent device Wartie Wart Remover has been presented which also uses metal core technology for the cryosurgery of benign skin lesion. Though this product, utilizes a similar technology to cool the metal, it shows that the heat transfer via a metal core is a used and approved technology.
The method of freezing skin via a metal applicator is equivalent to the Wartie Wart Remover predicate device, in that both devices allow for pen-pointed accuracy in freezing the skin. The knowledge of the patient as well as results of the bench testing were taken into consideration.
As mentioned earlier, bench testing has shown the performance of Dr. Yglo Wart Remover to be equivalent with other OTC technologies in terms of safety and efficacy, thereby supporting its OTC status.
The technology employed by Dr. Yglo Wart Remover is similar to its predicate in that the product uses pure DME gas and is applied via a metal applicator, bench testing has shown equivalent performance for safety and efficacy on biological tissue.
. Summary of Similarities:
The Dr. Yglo Wart Remover has the following similarities with the Wartie Wart Removal:
- The same intended use and indication for use. ●
- The same metal-tip applicator .
- The same DME gas ●
- The same warnings and contraindications. ●
- Available for Over-The-Counter use. ●
- Destroy common warts and plantar warts by cryoablation. ●
- Dr. Yglo Wart Remover and Wartie Wart Removal are intended for over- the-counter treatment of common warts and plantar warts.
- . Wartie Wart Removal and Dr. Yglo Wart Remover use a cryogen filled into an aerosol can to transform kinetic energy into thermal energy in order to remove a common wart or plantar wart by cryosurgery.
- Dr. Yglo Wart Remover makes use of a secured locking ring in order to assure mechanical safety of the product. A similar feature is also employed by the Wartie Wart Removal.
- . In both the predicate device identified above (Wartie Wart Removal System) as well as Dr. Yqlo Wart Remover, thermal safety precautions are associated with activation of the aerosol.
- Dr. Yglo Wart Remover, and the predicate device, use thermal energy removed from skin at the anatomical site of a common wart and/or plantar wart.
- . The label of the Dr. Yglo Wart Remover has been developed to ensure consumer safety and is equivalent to the predicate devices identified for this purpose.
- The safety and warning statements for the predicate devices and for all the other predicate labeling device are similar.
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Image /page/7/Picture/0 description: The image shows the logo for "THE OTCLAB". The logo consists of a circular icon on the left and the text "THE OTCLAB" on the right. The circular icon contains the letters "T" and "C" in a stylized design, with the "T" in a light blue color and the "C" in a dark blue color. The text "THE OTCLAB" is written in a combination of light blue and dark blue colors.
- Dr. Yglo Wart Remover employs a metal applicator, which is equivalent to the Wartie . Wart Remover predicate device, as both devices allow for pin-pointed accuracy in freezing the skin.
3. Conclusion:
Based on the information presented, it is concluded that the proposed product, Dr. Yglo Wart Remover is safe and effective for its intended use and is substantially equivalent to the predicate device. It can be therefor considered substantially equivalent in intended use, indication for use, safety and affectivity profile, and labeling.