Cry-Ac®, Cry-Ac-3®, Cry-Baby

K193619 · Brymill Cryogenic Systems · GEH · Mar 25, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K193619
• Device Name: Cry-Ac®, Cry-Ac-3®, Cry-Baby
• Applicant: Brymill Cryogenic Systems
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Mar 25, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for: · Ablation or freezing of skin cancers and other cutaneous disorders · Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

Device Story

Hand-held, refillable cryosurgical devices (Cry-Ac®, Cry-Ac-3®, Cry-Baby®) used in dermatology clinics by physicians. Devices store liquid nitrogen in insulated, double-walled metal vacuum reservoirs (125 mL, 300 mL, or 500 mL). Operation involves finger-trigger release of pressurized liquid nitrogen through either open spray applicators (apertures, extensions, cryochambers) for direct tissue contact or closed probe applicators (mini, conical, ball, flat) for conductive cooling. Devices feature vent-based pressure relief. Output is localized cryogenic cooling for tissue ablation or destruction. Benefits include precise removal of cutaneous lesions and tumors. No electronic processing or software involved.

Clinical Evidence

Bench testing only. Validation included cleaning, sterilization (ANSI/AAMI/ISO 17665-1:2006), shelf-life, biocompatibility (ISO 10993-5:2009, ISO 10993-10:2012), reservoir/collar bond integrity, finger trigger functionality, and temperature performance testing.

Technological Characteristics

Self-pressurizing, untethered liquid nitrogen delivery system. Materials: brass apertures, stainless steel/brass probes with Teflon coating, silicon extension tubing. Reservoir: double-walled metal vacuum bottle. Sterilization: steam (autoclavable). Connectivity: none. Energy source: mechanical pressure.

Indications for Use

Indicated for dermatological patients requiring ablation or destruction of skin lesions, including skin cancers (basal cell carcinoma/tumors), warts, skin tags, angiomas, sebaceous hyperplasia, dermatofibromas, mucocele cysts, actinic/seborrheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of skin tumors.

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

• Cry-Ac B-700 and B-800 and Accessories (Pre-Amendments Devices)
• SeedNet™ System and SeedNetGold™ System (K031117)
• CryoPro® Mini and CryoPro® Maxi (K982280)
• Wallach Ultra Freeze (K935010)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 25, 2020

Brymill Cryogenic Systems % Roshana Ahmed Sr. Consultant, Regulatory Affairs, Medical Devices G&L Scientific, Inc. 25 Independence Blvd.. Suite 404 Warren, New Jersey 07059

Re: K193619

Trade/Device Name: Cry-Ac®, Cry-Ac-3®, Cry-Baby Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: December 19, 2019 Received: December 26, 2019

Dear Roshana Ahmed:

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.

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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 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.

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 Quality Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2020

See PRA Statement below.

## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K193619

Device Name Cry-Ac(R) Cry-Ac-3(R) Cry-Baby(R)

Indications for Use (Describe)

The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for:

· Ablation or freezing of skin cancers and other cutaneous disorders

· Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

Type of Use (Select one or both, as applicable)

| <div> <span style="font-size: 10pt;"> <span style="font-family: Symbol;"> <span style="font-weight: bold;">☑</span> </span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span style="font-size: 10pt;"> <span style="font-family: Symbol;">□</span> </span> Over The Counter Use (21 CFR </div> |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|

|X Prescription Use (Part 21 CFR 801 Subpart D)

Dver-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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# 510(k) Summary

#### I. Submitter

Brymill Cryogenic Systems 105 Windermere Avenue, Suite 2B Ellington, CT 06029 Phone: [phone] x 103

Contact Person: Paul Sideleau, Senior Quality Assurance and Regulatory Manager Date Prepared: March 13, 2020

#### II. Device

| Device Proprietary Names: | Cry-Ac®, Cry-Ac-3®, Cry-Baby® |
|---------------------------|-----------------------------------|
| Common or Usual Name: | Cryosurgical Unit and Accessories |
| Classification Name: | Cryosurgical Unit and Accessories |
| Regulation Number: | 21 CFR 878.4350 |
| Product Code: | GEH |
| Device Classification | II |

#### III. Predicate Device

Substantial equivalence is claimed to the following devices:

- Primary predicate
- Cry-Ac B-700 and B-800 and Accessories, Pre-Amendments Devices, Brymill о Corporation
- Secondary predicates ●
- O SeedNet™ System and SeedNetGold™ System, K031117, Galil Medical Ltd.
- CryoPro® Mini and CryoPro® Maxi, K982280, Cortex Technology ApS O
- Wallach Ultra Freeze, K935010, Wallach Surgical Devices Inc. O

#### Device Description IV.

The Cry-Ac® Cryosurgical Devices (Cry-Ac-38, and Cry-Baby®) are hand-held, refillable, cryosurgical devices which dispense pressurized liquid nitrogen via open spray and closed probe applicators.

The cryosurgical devices are provided in three (3) sizes: 4 oz (125 mL; Cry-Baby®), 10 oz (300 mL, Cry-Ac-3®), and 16 oz (500 mL; Cry-Ac®). The open spray applicators include apertures, bent and straight spray extensions (1 in and 3 in), and cryochambers (6 mm to 18 mm) in various gauges. The probe applicators include mini probes (1 mm to 6 mm), conical probes (1 mm to 6

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mm), ball probes (6 mm to 3 cm) and flat probes (8 mm to 3 cm). Additional accessories include a back-vent adapter, luer lock adapter, malleable extension, and right-angle and 45° adapters. The apertures are manufactured from brass, the probes are manufactured from stainless steel and brass, and coated with Teflon. Extension tubing is manufactured from silicon.

The Cry-Ac® Cryosurgical Devices, open spray and closed probe applicators, and adapters are provided non-sterile and are autoclavable.

#### V. Indications for Use

The Cry-Ac® Cryosurgical Devices and Accessories are intended for use as cryosurgical tools in the field of dermatology. The Cry-Ac® Cryosurgical Devices and Accessories are indicated for:

- Ablation or freezing of skin cancers and other cutaneous disorders ●
- . Destruction of skin tags, warts or lesions, angiomas, sebaceous hyperplasia, basal cell carcinoma, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin

#### VI. Comparison of Technological Characteristics

The Cry-Ac® Cryosurgical Devices and Accessories have the same intended use as the SeedNet™ System and SeedNetGold™ System (K031117) and CryoPro® Mini and CryoPro® Maxi (K982280). Slight differences in the indications for use statements do not alter the overall intended use of the subject devices with respect to the predicate devices.

The Cry-Ac® Cryosurgical Devices and Accessories are technologically similar to the Cry-Ac B-700 and B-800 and Accessories (Pre-Amendments Devices), CryoPro® Mini and CryoPro® Maxi (K982280), and Wallach Ultra Freeze (K935010).

The Cry-Ac® Cryosurgical Devices and the predicate devices share the following technological characteristics:

- use of a self-pressurizing, untethered cryosurgical liquefied gas coolant delivery system; ●
- use of insulated bottles and inclusion of relief valves; ●
- delivery of liquid nitrogen;
- use of metal reservoir to store liquid nitrogen;
- use of a finger trigger to release liquid nitrogen;
- use of a soldered reservoir/collar connection for Cry-Baby®, and
- use of a vent in the reservoir cap as a fail-safe mechanism for pressure relief.

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The Cry-Ac® Cryosurgical Devices are technologically different from the predicate devices as follows:

- provision of smaller reservoir volumes to provide for different storage capacities, and .
- use of adhesive (instead of soldering) for the Cry-Ac-3® reservoir/collar . connection.

The Cry-Ac® Cryosurgical Accessories and the predicate devices share the following characteristics:

- . provision of open sprays (apertures, straight sprays, and cryochambers) and closed probes (mini probes, conical probes, ball probes, and flat probes);
- same materials of construction;
- same sizes; and
- reprocessing via steam sterilization. ●

There are no technological differences between the Cry-Ac® Cryosurgical Accessories and the predicate devices.

| | Cry-Ac®<br>Cryosurgical<br>Devices and<br>Accessories | Cry-Ac®<br>Cryosurgical<br>Devices and<br>Accessories<br>(Pre-Amendment<br>Device) | Wallach Ultra Freeze<br>(K935010) | CryoPro® Mini<br>and CryoPro®<br>Maxi<br>(K982280) |
|-----------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Manufacturer | Brymill Cryogenic<br>Systems | Brymill Corporation | Wallach Surgical<br>Devices, Inc. (now<br>Cooper Surgical) | Cortex<br>Technology ApS |
| Delivery System | Self-pressurizing,<br>untethered<br>cryosurgical<br>liquified gas coolant<br>delivery system | Self-pressurizing,<br>untethered<br>cryosurgical<br>liquified gas coolant<br>delivery system | Self-pressurizing,<br>untethered<br>cryosurgical liquified<br>gas coolant delivery<br>system | Self-pressurizing,<br>untethered<br>cryosurgical<br>liquified gas<br>coolant delivery<br>system |
| Gas | Liquid nitrogen | Liquid nitrogen | Liquid nitrogen | Liquid nitrogen |
| Volume | 4 oz (125 mL; Cry-<br>Baby®)<br>10 oz (300 mL, Cry-<br>Ac-3®) | 16 oz (500 mL) | .3 L (300 mL)<br>.5 L (500 mL) | .35 L (350 mL)<br>.5 L (500 mL) |

# Technological comparison

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K193619

Brymill Cryogenic Systems

| Cry-Ac® Cryosurgical Devices and Accessories |
|----------------------------------------------|
| Traditional 510(k): K193619 |

| | 16 oz (500 mL; Cry-<br>Ac®) | | | |
|---------------|-------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------|
| Reservoir | Reusable double<br>walled metal vacuum<br>bottle | Metal canister to<br>hold liquid nitrogen | Reusable insulated<br>metal pressure vessel | Reusable insulated<br>metal pressure vessel |
| Open Sprays | Apertures<br>Straight Sprays<br>Bent Sprays<br>Cryochambers | Apertures<br>Straight Sprays<br>Bent Sprays<br>Cryochambers | Apertures | Apertures<br>Straight Spray<br>Bent Spray<br>Soft Peel Spray |
| Closed Probes | Mini probes<br>Conical probes<br>Ball probes<br>Flat probes | Mini probes<br>Conical probes<br>Ball probes<br>Flat probes | Closed Tips (4) | Mini probes<br>Conical probes<br>Flat probes |

#### VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

- cleaning validation;
- sterilization validation per ANSI/AAMI/ISO 17665-1:2006;
- shelf-life testing;
- biocompatibility testing per ISO 10993-5:2009 and ISO 10993-10:2012; ●
- reservoir/collar bond verification and validation test;
- finger trigger validation; and ●
- . temperature testing.

#### VIII. Conclusion

The information provided above supports that the Cry-Ac® Cryosurgical Devices and Accessories are as safe and effective as the predicate devices. Although minor differences in design and technology exist between the subject and predicate devices, the testing supports that these differences do not raise any new questions of safety and effectiveness. Therefore, it is concluded that the Cry-Ac® Cryosurgical Devices and Accessories are substantially equivalent to the predicate devices.

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