(92 days)
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
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.
This document is a 510(k) premarket notification for the Utermöhlen Cryo Professional device. It is a correspondence from the FDA confirming the device's substantial equivalence to previously marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, there are no specific quantitative acceptance criteria or precise performance metrics reported in a table format. The performance data section broadly states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality (leakage) | Passed |
| Functionality (temperature probe testing) | Passed |
| Functionality (comparator functionality) | Passed |
| Biocompatibility (ISO 10993) | Passed |
The text indicates that "Based on the performance testing the product is equivalent to the predicate." However, it does not provide the specific numerical targets or results of these tests that would typically be found in a detailed study report.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any of the performance tests. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish a ground truth for a test set. The performance testing described relates to device functionality and biocompatibility, not diagnostic or treatment efficacy evaluated against expert consensus.
4. Adjudication method for the test set
There is no mention of an adjudication method, as the tests described are for device functionality and biocompatibility, not for subjective evaluation requiring adjudication.
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
No such study was conducted or reported. This device is a cryosurgical unit, not an AI-assisted diagnostic or treatment system involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the Utermöhlen Cryo Professional device, as it is a physical medical device (cryosurgical unit) and not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" as typically used in AI or diagnostic device evaluations is not directly applicable here. The "ground truth" for the performance tests would be the established engineering and biological standards for functionality (e.g., no leakage, accurate temperature reading) and biocompatibility (e.g., no adverse biological reactions as per ISO 10993).
8. The sample size for the training set
This question is not applicable, as the device is a physical cryosurgical unit and does not involve AI or machine learning algorithms that require a training set.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated in point 8.
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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
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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
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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)
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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, dispensersize, cryogencomposition;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.
§ 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.