Hydrozid Precise

K221897 · Bibawo Medical A/S · GEH · May 30, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K221897
• Device Name: Hydrozid Precise
• Applicant: Bibawo Medical A/S
• Product Code: GEH · General, Plastic Surgery
• Decision Date: May 30, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Portable aerosol cryosurgery device; utilizes 1,1,1,2-tetrafluoroethane (R134a) cryogen to induce tissue necrosis via freezing. Input: cryogen spray from aerosol canister; Output: localized freezing of target skin lesion. Used in clinical settings by healthcare professionals. Mechanism: heat transfer during cryogen evaporation causes rapid freezing, leading to direct cell destruction and vascular stasis. Device includes application templates to guide treatment. Benefits: provides controlled cryotherapy for various benign/premalignant skin conditions. Healthcare provider applies spray approximately 1 cm from lesion for < 1 minute to achieve therapeutic temperature.

Clinical Evidence

Bench testing only. Thermal profile analysis (surface temperature, duration, ice-ball formation) compared subject device to predicate. Results confirmed subject device reaches minimum temperatures required for cell destruction and vascular stasis equivalent to predicate.

Technological Characteristics

Portable aerosol cryosurgery device. Cryogen: 1,1,1,2-tetrafluoroethane (CAS 354-33-6). Spray head design: 0.1 mm outlet, fixed tip, black color. Non-sterile, single-patient use application templates. Transient use (< 1 minute).

Indications for Use

Indicated for professional use in the treatment of benign and premalignant skin lesions including warts, seborrheic keratosis, skin tags, molluscum contagiosum, age spots, dermatofibroma, small keloids, granuloma annulare, porokeratosis plantaris, angiomas, keratoacanthoma, chondrodermatitis, epithelial nevus, leukoplakia, and pyogenic granuloma.

Regulatory Classification

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.

Predicate Devices

• Hydrozid (K201740)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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 [e-mail] [phone]

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

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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<br>Name | Hydrozid Precise™<br>Subject Device | Hydrozid®<br>Predicate Device | Significant<br>Differences |
|---------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Manufacturer | BIBAWO Medical A/S | BIBAWO Medical A/S | Same |
| Common Name | Portable aerosol<br>cryosurgery device | Portable aerosol<br>cryosurgery device | Same |
| Classification<br>name | Unit, Cryosurgical,<br>Accessories | Unit, Cryosurgical,<br>Accessories | Same |
| Regulation<br>number | 21 CFR 878.4350 | 21 CFR 878.4350 | Same |
| Class | II | II | Same |
| Device Product<br>Code | GEH | GEH | Same |
| Device Panel | General & Plastic<br>Surgery. | General & Plastic<br>Surgery. | Same |
| Sterile | No | No | Same |
| Indications<br>for Use | Hydrozid Precise™<br>contains 1,1,1,2-<br>tetrafluoroethane (also<br>known as R134a, HFC-<br>134a, HFA-134a or<br>fluorocarbon 134a) and<br>is to be used for the<br>treatment of verruca<br>(warts) including plantar<br>warts, seborrheic<br>keratosis, actinic<br>keratosis,<br>acrochordon (skin tags),<br>molluscum contagiosum,<br>age spots (lentigo), | Hydrozid® (also known as<br>R134A or 1,1,1,2-<br>tetrafluoroethane or HFC-<br>134a or HFA-134a or<br>fluorocarbon 134a) is to be<br>used for the treatment of<br>verruca (warts) including<br>plantar warts, seborrheic<br>keratosis, actinic<br>keratosis, achrochordon<br>(skin tags), molluscum<br>contagiosum, age spots,<br>dermatofibroma, small<br>keloids, | Same |
| | dermatofibroma, small<br>keloids, granuloma<br>annulare, porokeratosis<br>plantaris, angiomas,<br>keratoacanthoma,<br>chondrodermatitis,<br>epithelial nevus,<br>leukoplakia, granuloma<br>pyogenicum, and<br>pyogenic granuloma. | granuloma annulare,<br>porokeratosis plantaris,<br>angiomas,<br>keratoacanthoma,<br>chondrodermatitis,<br>epithelial nevus,<br>leukoplakia, granuloma<br>pyogenicum, and<br>pyogenic granuloma. | |
| Intended Users | For professional<br>use only. | For professional use<br>only | Same |
| Mechanism<br>of Action | Cryosurgery: freeze the<br>target tissue<br>temperature to below<br>the level that correlates<br>with cell destruction<br>(necrosis). When the<br>cryogen evaporates, it<br>absorbs heat from its<br>surroundings causing<br>cell destruction due to:<br>• Direct effects of<br>freezing on the cells<br>• Vascular stasis<br>which develops after<br>thawing. | Cryosurgery: freeze the<br>target tissue temperature<br>to below the level that<br>correlates with cell<br>destruction (necrosis).<br>When the cryogen<br>evaporates, it absorbs<br>heat from its<br>surroundings causing<br>cell destruction due to:<br>• Direct effects of<br>freezing on the cells<br>• Vascular stasis<br>which develops after<br>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; < 1 minute.<br>Specific freeze time<br>determined by the type,<br>size and location of the<br>lesion being treated | Transient use; < 1 minute.<br>Specific freeze time<br>determined by the type,<br>size and location of the<br>lesion being treated | Same |
| Treatment<br>distance | Approximately 1 cm (0.4<br>in) from the lesion. | 2 to 3 cm (0.79 to 1.18 in)<br>from the lesion. | Similar |
| Accessories | Application Templates | Application Templates | Same |
| Technical<br>characteristics<br>Device | Portable cryosurgery<br>device to be applied directly<br>on the indication. | Portable cryosurgery<br>device to be applied directly<br>on the indication. | Same |
| Technical<br>characteristics<br>Spray head design | Spray head has a spray<br>outlet that is 0.1 mm. | Spray head has a spray<br>outlet that is 0.25 mm. | Similar |
| Technical | Consist of a spray head | Consist of a spray head | Similar |
| characteristics | with<br>a fixed tip/tube | with a somewhat flexible | |
| Spray head design | | tip/tube | |
| Technical<br>characteristics<br>Spray head design | Color: black | Color: white | Similar |

Table 5.3-1: Substantial Equivalence Summary

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Image /page/6/Picture/1 description: The image shows the logo for BIBAWO Medical. The text "BIBAWO" is in large, bold, blue letters. Below that, the word "Medical" is in smaller, blue letters. The logo is simple and professional.

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Image /page/7/Picture/1 description: The image shows the logo for BIBAWO Medical. The word "BIBAWO" is in large, bold, blue letters on the top line. Below that, the word "Medical" is in smaller, bold, blue letters. The logo is simple and clean, with a focus on the company name.

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Image /page/8/Picture/1 description: The image shows the logo for BIBAWO Medical. The text "BIBAWO" is in large, bold, blue letters. Below that, the word "Medical" is in smaller, bold, blue letters. The logo is simple and professional.

Testing and arqumentation rationale were provided to support the equivalence of the Hydrozid Precise™ and shows that no new questions of safety and effectiveness have been introduced with this device. The safety and effectiveness of the Hydrozid Precise™ are adequately supported by the testing rationale, substantial equivalence information, materials information, and comparison of technical characteristics provided within this premarket notification.

## Non-Clinical Performance Data 5.4.

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.

## Statement of Substantial Equivalence 5.5.

By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the previously cleared predicate device. Hydrozid Precise™ does not raise new questions regarding safety and effectiveness as compared to the predicate device.

#### 5.6. Conclusion

The Hydrozid Precise™ device is determined, based on comparison test to the predicate device, to be substantially equivalent to the predicate device, Hydrozid®.