(92 days)
Not Found
No
The device description and performance studies focus on the physical mechanism of cryosurgery and do not mention any AI/ML components or data processing.
Yes
This device is intended to treat various skin lesions by freezing them, which aligns with the definition of a therapeutic device.
No
The device description clearly states its purpose is for the "removal of skin lesions" using cryosurgery, not for identifying or diagnosing medical conditions.
No
The device description clearly states it is comprised of a dispenser (canister) containing a cryogen and single-use foam-sticks, indicating it is a hardware device that uses a physical substance (cryogen) to perform its intended function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a cryosurgery system used for the physical removal of skin lesions by freezing. It acts directly on the body (in vivo) rather than analyzing a sample taken from the body (in vitro).
- Intended Use: The intended use clearly states the removal of skin lesions, not the diagnosis or analysis of them.
Therefore, this device falls under the category of a therapeutic device used for a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The product is indicated for the removal of the following skin lesions:
- Verrucae plantaris
- Verrucae Plana
- Verrucae vulgaris
- Mollescum contagiosum
- Skin tags
- = Actinic keratosis
- Genital warts "
- Lentigo
- . Seborrhoeic Keratosis
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The product is a portable cryosurqery system which is prescription only intended for medical professionals. It is indicated for removal of skin lesions. The product is comprised of a dispenser (canister) containing a cryogen (cryoliquid) which freezes the lesion. It is packaged with a box of single-use foam-sticks (buds). The foam-stick is placed in the front of the dispenser into the opening under the applicator cap. The applicator button is pressed to dispel cryogen on the foamstick (bud). The foam-stick is applied to the skin lesion for the designated time to freeze the skin lesion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals
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)
The device has been subject to performance testing including
-
- Functionality: leakage, temperature probe testing, comparator functionality;
-
- Biocompatibility testing to ISO 10993.
Based on the performance testing the product is equivalent to the predicate.
- Biocompatibility testing to ISO 10993.
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.
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.
Not Found
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized image of three human profiles facing right, with flowing lines that resemble ribbons or waves.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Koninklijke (Royal) Utermöhlen % Dr. K R Michael, Pharm.D., M.Sc. KRM Associates 17751 Frondosa Drive San Diego, California 92128
November 6, 2015
Re: K152203
Trade/Device Name: Utermöhlen Cryo Professional Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: October 12, 2015 Received: October 14, 2015
Dear Dr. Michael:
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. 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 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
Page 2 - Dr. K R Michael, Pharm.D., M.Sc.
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Joshua C. Nipper -S
For
Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number
Device Name
UTERMÖHLEN CRYO PROFESSIONAL
Indications for Use
The product is indicated for the removal of the following skin lesions:
- Verrucae plantaris
- Verrucae Plana
- Verrucae vulgaris
- Mollescum contagiosum
- Skin tags
- = Actinic keratosis
- Genital warts "
- Lentigo
- । Seborrhoeic Keratosis
Type of Use
● Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/3/Picture/0 description: The image shows the logo for Utermöhlen. The logo features the word "Utermöhlen" in blue letters inside of a red rounded rectangle. Above the word is a red crown-like design, and below the rectangle are the words "Since 1880".
Device name: Utermöhlen Cryo Professional Common Name: Portable Cryosurgery System for professional use Class: II Panel: GEH 510k K152203 page 1 / 2
1. Submitter
Koninklijke (Royal) Utermöhlen De Overweg 1 8471 ZA Wolvega Netherlands
2. US Contact
Dr Kenneth R Michael, KRM Associates 17751 Frondosa Drive San Diego, California 92128 Email: michael5416@gmail.com Fax: 858 485 0829 Tel: 858 487 5676
3. Device Name(s)
Utermöhlen Cryo Professional
4. Common Name
Portable cryosurgery system for professional use
5. Class: II
6. Panel: GEH
7. Predicate device
The following predicate devices are legally commercialised / marketed in the US.
| 510k | K982358 | K990877 | K982506 |
|---|---|---|---|
| Name of device | Histofreezer device | Histofreezer device | Verruca-Freeze |
| Manufacturer | STC Technologies, Inc | OraSure Technologies, Inc. | Cryosurgery Inc |
| Type of predicate | primary: | ||
| technical, dispenser | |||
| size, cryogen | |||
| composition; | |||
| claims; | |||
| labelling | primary: | ||
| claims, labelling | secondary: | ||
| professional use; | |||
| claims; | |||
| labelling; | |||
| buds |
510k Summary
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Image /page/4/Picture/24 description: The image shows the logo for Utermöhlen, a company that was founded in 1880. The logo features the company name in a red, stylized font, with the word "Utermöhlen" in a rounded rectangle. Above the name is a red crown-like design. Below the name, the text "Since 1880" is written in a smaller font.
510k Summary Device name: Utermöhlen Cryo Professional Common Name: Portable Cryosurgery System for professional use Class: II Panel: GEH 510k K152203 page 2 / 2
8. Device Description
The product is a portable cryosurqery system which is prescription only intended for medical professionals. It is indicated for removal of skin lesions. The product is comprised of a dispenser (canister) containing a cryogen (cryoliquid) which freezes the lesion. It is packaged with a box of single-use foam-sticks (buds). The foam-stick is placed in the front of the dispenser into the opening under the applicator cap. The applicator button is pressed to dispel cryogen on the foamstick (bud). The foam-stick is applied to the skin lesion for the designated time to freeze the skin lesion.
9. Indications for use
The product is indicated for the treatment of the following skin lesions:
- Verrucae plantaris
- Verrucae Plana
- Verrucae vulgaris
- Mollescum contagiosum ı
- -Skin tags
- Actinic keratosis -
- Genital warts -
- Lentigo .
- -Seborrhoeic Keratosis
10. Comparison of technological characteristics with predicate device
The product and the predicate are comprised of a dispenser (canister) with a cryogen used to freeze the skin lesion. The product is packaged with a box of foam-sticks (buds). The predicate and the submission device are used for the same indications, intended purpose and mode of operation; same specifications and same design. Both are for prescription only use.
11. Performance data
The device has been subject to performance testing including
-
- Functionality: leakage, temperature probe testing, comparator functionality;
-
- Biocompatibility testing to ISO 10993.
Based on the performance testing the product is equivalent to the predicate.
12. Conclusions
Based on the intended use, technical characteristics and performance testing, the device is equivalent to the predicate device.