K Number

Device Name

Hydrozid

Manufacturer

MediLink A/S

Date Cleared

2021-07-07

(377 days)

Product Code

GEH

Regulation Number

878.4350

Intended Use

Hydrozid (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

Device Description

Hydrozid® is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction). The main device component is the aerosol canister containing cryogen spray. The device is provided in a kit containing a canister, application templates and Instructions for Use. The device is used with non-sterile, singlepatient application templates which are disposed after use.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K161296

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the cryogen and its physical effects, with no mention of AI or ML.

Therapeutic

Yes

The device is intended for the "treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma" using cryosurgery, which is a therapeutic intervention.

Diagnostic

The "Intended Use / Indications for Use" section clearly states that the device is to be "used for the treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma," indicating a therapeutic rather than diagnostic purpose. The "Device Description" further elaborates that it is a "cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction)."

SaMD (Software as a Medical Device)

The device description clearly states that the main component is an aerosol canister containing cryogen spray, which is a physical hardware component used for cryosurgery.

IVD (In Vitro Diagnostic)

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.
Hydrozid's Function: Hydrozid is a cryosurgery device that directly treats skin lesions by freezing them. It does not analyze samples taken from the body. Its purpose is therapeutic, not diagnostic.
Intended Use: The intended use clearly states it's for the "treatment of verruca (warts) including plantar warts, sebortheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma." This is a list of conditions it is used to treat, not diagnose.
Device Description: The description details a "portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells up to necrosis (cell destruction)." This further emphasizes its therapeutic function.

Therefore, Hydrozid is a therapeutic device used for the physical treatment of skin lesions, not an in vitro diagnostic device used for analyzing samples to aid in diagnosis.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

GEH

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

For professional use only.

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)

Non-Clinical Performance Data: A bench test was performed to analyze the thermal profile (surface temperature, duration of the surface temperature and iceball geometry and size) of the cryogen R134A and the predicate device cryogen. The bench test determined that Hydrozid® cryogen performed equivalently to the cryogen of the predicate device. A second temperature testing performed on Hydrozid® confirmed that the cryogen R134A could reach the minimum desired temperature for cell destruction and vascular stasis in both the minimum and maximum treatment time.

Clinical Performance Data: There was no clinical testing required to support the medical device as the indications for use are equivalent to those of the predicate devices. Portable aerosol cryosurgery devices have been on the market for decades and their clinical safety and efficacy has been established. The non-clinical testing detailed in this submission supports the substantial equivalence of the device.

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.

Cool Renewal® (K161296)

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

Regulation Number and Section

§ 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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

July 7, 2021

MediLink A/S Cristina Teixeira Director for Regulatory Affairs & Quality Assurance Gammelmosevej 176A Kgs. Lyngby. 2800 Denmark

Re: K201740

Trade/Device Name: Hydrozid Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: June 8, 2021 Received: June 9, 2021

Dear Cristina Teixeira:

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. 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 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 531-542 of the Act); 21 CFR 1000-1050.

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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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 Ouality Center for Devices and Radiological Health

Enclosure

Indications for Use

510(k) Number (if known) K201740

Device Name Hydrozid

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Traditional 510(k) Summary- Hydrozid®

In accordance with 21 CFR Part 807, Section 807.92, this information serves as a 510(k) summary for Hydrozid®.

Date Prepared: July 6, 2021

Submitted by: MediLink A/S Klintehøj Vænge 6

DK-3460 Birkerød Denmark +45 30 66 65 02

Contact Person: Cristina Teixeira

Director of Regulatory Affairs & Quality Assurance ct@medilink.dk

Proprietary Name: Hydrozid®

Common Name: Portable aerosol cryosurgery device Classification Name: Unit, Cryosurgical, Accessories Classification Regulation: 21 CFR 878.4350 Device: Class II Device Product Code: GEH Device Panel: General & Plastic Surgery Predicate Device: Cool Renewal® (K161296)

Description of the Device 1.

The mechanism of action for both Hydrozid® and the predicate device, Cool Renewal®, is based on the principles of cryosurgery (also referred as cryotherapy). Cryosurgery was first described in the 1800s and has since evolved into a wellestablished therapy within dermatology and other healthcare fields. Cryosurgery is performed using a cryogen to freeze the target tissue temperature to below the level that correlates with cell destruction also known as necrosis. The mechanism of action in cryosurgery are divided into 3 phases: (1) heat transfer, (2) cell death, and (3) inflammation. When the cryogen evaporates, it absorbs heat from its surroundings (heat transfer phase) causing cell destruction (cell death phase) due to:

. Direct effects of freezing on the cells
Vascular stasis which develops after thawing.

During cryosurgery, both extracellular and intracellular ice formation occur, with fast freezing in the center of the lesion, and slow freezing on the outside border. The loss of blood supply to the treated area eradicates the likelihood of survival of the cells in the frozen tissue (inflammation phase).

Indications for Use Statement 2.

Hydrozid® (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or HFA-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angjomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.

3. Substantial Equivalence Discussion

The Hydrozid® intended use, indications and clinical application as well as the overall technical characteristics are substantially equivalent to the predicate device. The below table (table 5.3-1) compares the Hydrozid® to the predicate device with respect to intended use, technological characteristics and principles of operation. Differences between Hydrozid® and the predicate device are related to minor material and design elements.

Table 5.3-1: Substantial Equivalence Summary

Device Trade Name	Hydrozid®	Cool Renewal®	Significant Differences
Manufacturer	MediLink A/S	Cool Renewal LCC	N/A
Common Name	Portable aerosol cryosurgery device	Portable aerosol cryosurgery device	Same
Classification name	Unit, Cryosurgical, Accessories	Unit, Cryosurgical, Accessories	Same
Regulation number	21 CFR 878.4350	21 CFR 878.4350	Same
Class	II	II	Same
Device Product Code	GEH	GEH	Same
Device Panel	General & Plastic Surgery.	General & Plastic Surgery.	Same
Sterile	No	No	Same
Indications for Use	Hydrozid® (also known as R134A or 1,1,1,2-tetrafluoroethane or HFC-134a or HFA-134a or fluorocarbon 134a) is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin	1,1,1,2-tetrafluoroethane, Pentafluoroethane, and 1,1,1-trifluoroethane is to be used for the treatment of verruca (warts) including plantar warts, seborrheic keratosis, actinic keratosis, achrochordon (skin tags), molluscum contagiosum, age spots,	Same
	tags), molluscum
contagiosum, age
spots,
dermatofibroma,
small keloids,
granuloma
annulare,
porokeratosis
plantaris, angiomas,
keratoacanthoma,
chondrodermatitis,
epithelial nevus,
leukoplakia,
granuloma
pyogenicum, and
pyogenic
granuloma.	dermatofibroma,
small keloids,
granuloma annulare,
porokeratosis
plantaris, angiomas,
keratoacanthoma,
chondrodermatitis,
epithelial nevus,
leukoplakia,
granuloma
pyogenicum, and
pyogenic
granuloma.
Intended Users	For professional use only.	For professional use only	Same
Mechanism of Action	Cryosurgery: freeze the target tissue temperature to below the level that correlates with cell destruction (necrosis). When the cryogen evaporates, it absorbs heat from its surroundings causing cell	Cryosurgery: freeze the target tissue temperature to below the level that correlates with cell destruction (necrosis). When the cryogen evaporates, it absorbs heat from its surroundings causing cell destruction due to:	Same
	Direct effects of freezing on the cells Vascular stasis which develops after thawing. The mechanism of action in cryosurgery are divided into 3 phases: (1) heat transfer, (2) Cell death, and (3) inflammation.	Direct effects of freezing on the cells Vascular stasis which develops after thawing. The mechanism of action in cryosurgery are divided into 3 phases: (1) heat transfer, (2) Cell death, and (3) inflammation.
Cryogen	R134A: 1,1,1,2-tetrafluoroethane (CAS 354-33-6).	R404A: 1,1,1,2-tetrafluoroethane (CAS 354-33-6);
Pentafluoroethane (CAS 420-46-2);
1,1,1,- trifluoroethane (CAS 811-97-2)	Similar.
Hydrozid® contains only 1 cryogen which is also part of the Cool Renewal® mixture. The cryogen is already used in the predicate device as well as well-established in other medical application (e.g., asthma inhalers and
			skin
applications).
Furthermore,
performance
data show
Hydrozid®
achieves a
thermal profile
comparable to
the predicate
device. Hence,
no new safety
or efficacy
concerns are
raised.
Freezing time	Transient use;