(334 days)
Not Found
No
The device description and performance studies focus on the cryosurgery mechanism and thermal properties, with no mention of AI or ML.
Yes
The device is used for the treatment of various benign and premalignant skin lesions by freezing cells to induce necrosis, which constitutes a therapeutic action.
No
The device is described as a "portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions." Its primary function is therapeutic (freezing cells to induce necrosis), not to diagnose a condition.
No
The device description clearly states it is a "portable aerosol cryosurgery device" with a "main device component [being] the aerosol canister containing cryogen spray." This indicates a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of various skin lesions by freezing them. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a cryosurgery device that uses a cryogen to freeze cells. This mechanism of action is for treatment, not for analyzing samples or providing diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic purposes. This device is used directly on the patient's skin for therapeutic purposes.
N/A
Intended Use / Indications for Use
Hydrozid Precise contains 1.1.1.2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of vertuca (warts), including plantar warts, seborrheic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatits, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
Hydrozid Precise™ is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells to induce 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, single-patient application templates which are disposed after use.
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)
As part of demonstrating safety and effectiveness of Hydrozid Precise™, and substantial equivalence to the predicate device, a bench test was performed to analyze the thermal profile (surface temperature, duration of the surface temperature and ice-ball) of the cryogen R134a. The bench test determined that Hydrozid Precise™ performed equivalently to the predicate device Hydrozid®. The temperature testing performed on Hydrozid Precise™ confirmed that the cryogen R134a was capable of reaching the minimum desired temperature for cell destruction and vascular stasis in both the minimum and maximum treatment time.
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
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May 30, 2023
BIBAWO Medical A/S Sandra Larsen Manager of Regulatory Affairs and Ouality Assurance Klintehøj Vænge 6 Birkerød, 3460 Denmark
Re: K221897
Trade/Device Name: Hydrozid Precise Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: April 24, 2023 Received: April 27, 2023
Dear Sandra Larsen:
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
1
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 (OS) 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 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,
Digitally signed Mark by Mark Trumbore Trumbore -s Date: 2023.05.30 -5 09:42:22 -04'00' Mark Trumbore, 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
2
Indications for Use
510(k) Number (if known) K221897
Device Name Hydrozid Precise
Indications for Use (Describe)
Hydrozid Precise contains 1.1.1.2-tetrafluoroethane (also known as R134A, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of vertuca (warts), including plantar warts, seborrheic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatits, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
| 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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510(k) Summary - Hydrozid Precise™
In accordance with 21 CFR Part 807, Section 807.92, this information serves as a 510(k) summary for Hydrozid Precise™ (K221897).
Date Prepared: May 24th, 2023 Submitted by: BIBAWO Medical A/S Klintehøj Vænge 6 3460 Birkerød Denmark
Contact Person:
Sandra Larsen Manager of Requlatory Affairs & Quality Assurance Sandra.larsen@bibawo-medical.com +45 81 40 18 43
Proprietary Name: Hydrozid Precise™ Common Name: Portable aerosol cryosurgery device Classification Name: Unit, Cryosurgical, Accessories Classification Requlation: 21 CFR 878.4350 Device: Class II Device Product Code: GEH Device Panel: General & Plastic Surgery Predicate Device: Hydrozid® (K201740) manufactured by BIBAWO Medical A/S is the predicate device.
5.1. Description of the Device
Hydrozid Precise™ is a portable aerosol cryosurgery device intended for the treatment of benign and premalignant skin lesions using a cryogen to freeze cells to induce 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
4
non-sterile, single-patient application templates which are disposed after use.
The mechanism of action for both Hydrozid Precise™ and the predicate device, Hydrozid®, 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 5.2.
Hydrozid Precise™ contains 1,1,2-tetrafluoroethane (also known as R134a, HFC-134a, HFA-134a or fluorocarbon 134a) and is to be used for the treatment of verruca (warts), including plantar warts, seborrheic keratosis, actinic keratosis, acrochordon (skin tags), molluscum contagiosum, age spots (lentigo), dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, granuloma pyogenicum, and pyogenic granuloma.
5.3. Substantial Equivalence Discussion
The Hydrozid Precise™ intended use, intended users, indications and clinical application as well as the overall technical characteristics are equivalent to the predicate device. The below table (table 5.3-1) compares the Hydrozid Precise™ to the predicate device with respect to intended use, technological characteristics and principles of operation.
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| Device Trade
Name | Hydrozid Precise™
Subject Device | Hydrozid®
Predicate Device | Significant
Differences |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | BIBAWO Medical A/S | BIBAWO Medical A/S | Same |
| 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 Precise™
contains 1,1,1,2-
tetrafluoroethane (also
known as R134a, HFC-
134a, HFA-134a or
fluorocarbon 134a) and
is to be used for the
treatment of verruca
(warts) including plantar
warts, seborrheic
keratosis, actinic
keratosis,
acrochordon (skin tags),
molluscum contagiosum,
age spots (lentigo), | 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, | Same |
| | dermatofibroma, small
keloids, granuloma
annulare, porokeratosis
plantaris, angiomas,
keratoacanthoma,
chondrodermatitis,
epithelial nevus,
leukoplakia, granuloma
pyogenicum, and
pyogenic granuloma. | 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 destruction due to:
• Direct effects of
freezing on the cells
• Vascular stasis
which develops after
thawing. | 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:
• Direct effects of
freezing on the cells
• Vascular stasis
which develops after
thawing. | Same |
| | | | |
| | The mechanism of | The mechanism of action | |
| | action in cryosurgery | in cryosurgery are divided | |
| | are divided into 3 | into 3 phases: | |
| | phases: | (1) heat transfer, | |
| | (1) heat transfer, | (2) Cell death, and | |
| | (2) Cell death, and | (3) inflammation. | |
| | (3) inflammation. | | |
| | R134a: 1,1,1,2- | R134a: 1,1,1,2- | Same |
| Cryogen | tetrafluoroethane | tetrafluoroethane | |
| | (CAS 354-33-6). | (CAS 354-33-6). | |
| Freezing time | Transient use;