(90 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a cryosurgical device, with no mention of AI or ML.
Yes
The device is described as "cryosurgical tools" intended for "ablation or freezing of skin cancers and other cutaneous disorders" and "destruction of skin tags, warts or lesions," which are therapeutic actions.
No
The device is described as a cryosurgical tool used for the ablation, freezing, or destruction of various skin conditions and lesions. Its function is therapeutic, not diagnostic.
No
The device description clearly details physical hardware components (hand-held devices, applicators, probes, adapters) and performance studies related to hardware (cleaning, sterilization, shelf-life, biocompatibility, bond verification, trigger validation, temperature testing). There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cryosurgical tools in the field of dermatology" for "Ablation or freezing of skin cancers and other cutaneous disorders" and "Destruction of skin tags, warts or lesions," etc. This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a hand-held device that dispenses liquid nitrogen for freezing tissue. This is a physical intervention, not a diagnostic test performed on a sample taken from the body.
- IVD Definition: In vitro diagnostics are tests performed on samples (like blood, urine, tissue) taken from the human body to detect diseases, conditions, or infections. This device does not perform such tests.
Therefore, the Cry-Ac® Cryosurgical Devices and Accessories are therapeutic devices used for cryosurgery, not in vitro diagnostic devices.
N/A
Intended Use / 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, mucocele cysts, multiple warts, plantar warts, actinic and sebortheic keratosis, cavernous hemangiomas, perianal condylomata, and palliation of tumors of the skin
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The Cry-Ac® Cryosurgical Devices (Cry-Ac-3®, 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
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.
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.
Cry-Ac B-700 and B-800 and Accessories, Pre-Amendments Devices, Brymill о Corporation, K031117, K982280, K935010
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
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.
1
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 (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 Quality Center for Devices and Radiological Health
Enclosure
2
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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over The Counter Use (21 CFR |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------- |
|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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
I. Submitter
Brymill Cryogenic Systems 105 Windermere Avenue, Suite 2B Ellington, CT 06029 Phone: 800-777-2796 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 ●
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
4
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.
5
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®
Cryosurgical
Devices and
Accessories | Cry-Ac®
Cryosurgical
Devices and
Accessories
(Pre-Amendment
Device) | Wallach Ultra Freeze
(K935010) | CryoPro® Mini
and CryoPro®
Maxi
(K982280) |
|-----------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Manufacturer | Brymill Cryogenic
Systems | Brymill Corporation | Wallach Surgical
Devices, Inc. (now
Cooper Surgical) | Cortex
Technology ApS |
| Delivery System | Self-pressurizing,
untethered
cryosurgical
liquified gas coolant
delivery system | Self-pressurizing,
untethered
cryosurgical
liquified gas coolant
delivery system | Self-pressurizing,
untethered
cryosurgical liquified
gas coolant delivery
system | Self-pressurizing,
untethered
cryosurgical
liquified gas
coolant delivery
system |
| Gas | Liquid nitrogen | Liquid nitrogen | Liquid nitrogen | Liquid nitrogen |
| Volume | 4 oz (125 mL; Cry-
Baby®)
10 oz (300 mL, Cry-
Ac-3®) | 16 oz (500 mL) | .3 L (300 mL)
.5 L (500 mL) | .35 L (350 mL)
.5 L (500 mL) |
Technological comparison
6
Brymill Cryogenic Systems
| Cry-Ac® Cryosurgical Devices and Accessories |
|---|
| Traditional 510(k): K193619 |
| | 16 oz (500 mL; Cry-
Ac®) | | | |
|---------------|-------------------------------------------------------------|-------------------------------------------------------------|---------------------------------------------|--------------------------------------------------------------|
| Reservoir | Reusable double
walled metal vacuum
bottle | Metal canister to
hold liquid nitrogen | Reusable insulated
metal pressure vessel | Reusable insulated
metal pressure vessel |
| Open Sprays | Apertures
Straight Sprays
Bent Sprays
Cryochambers | Apertures
Straight Sprays
Bent Sprays
Cryochambers | Apertures | Apertures
Straight Spray
Bent Spray
Soft Peel Spray |
| Closed Probes | Mini probes
Conical probes
Ball probes
Flat probes | Mini probes
Conical probes
Ball probes
Flat probes | Closed Tips (4) | Mini probes
Conical probes
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.
----------------------This space intentionally left blank------------------------------------------------------