Focused Cryotherapy System

{0} FDA U.S. FOOD & DRUG ADMINISTRATION December 9, 2025 Focused Cryo, Inc. Ryan Kruchten VP of Engineering 1205 Johnson Ferry Road Suite 136 - 336 Marietta, Georgia 30068 RE: K250742 Trade/Device Name: Focused Cryotherapy System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: November 7, 2025 Received: November 7, 2025 Dear Ryan Kruchten: 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 (the 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 available 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K250742 - Ryan Kruchten Page 2 Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts, are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/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-devices/device-advice-comprehensive-regulatory- {2} K250742 - Ryan Kruchten Page 3 assistance/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, JAMES H. JANG-S Digitally signed by JAMES H. JANG-S Date: 2025.12.09 00:08:28 -05'00" For Colin Kejing Chen, Ph.D. Acting 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 {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K250742 Device Name Focused Cryotherapy System Indications for Use (Describe) The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions. In addition, the system is intended for use in the following indications: Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders - Destruction of warts or lesions, angiomas, sebaceous hyperplasia, 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 Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas ENT - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth Thoracic Surgery {4} - (with the exception of cardiac tissue) Proctology - Ablation of benign or malignant growths of the anus or rectum Neurology - Freezing of nerve tissue in pain management/cryoanalgesia 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) # 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." {5} FOCUSED CRYO Focused Cryo, Inc. 101 Nerem St NW Suite 1000 Atlanta, GA 30313 # PREMARKET NOTIFICATION K250742 510(k) Summary Focused Cryotherapy System The following information is provided as required per 21 CFR 807.92 1. Submitter's Name: Focused Cryo, Inc. 101 Nerem St. NW Suite 1000 Atlanta, GA 30313 Contact Name: Mr. Ryan Kruchten, VP of Engineering Phone: 952-484-3166 E-mail: rkruchten@focusedcryo.com Date Prepared: December 4, 2025 2. Device Information: Proprietary Name: Focused Cryotherapy System Common/Usual Name: Cryosurgical unit and accessories Classification Name: Cryosurgical unit and accessories Regulation Number: 21 CFR 878.4350 Product Code: GEH 3. Predicate Devices: Primary: CRYOCARE TOUCH™ System and Accessories (K201588) Secondary: Visual-ICE Cryoablation System (K230551) 4. Device Description: The Focused Cryotherapy System is a cryoablation platform that contains the following components: - Probe (FC-2021CD01) - Console (FC-AR401) - Software The Focused Cryotherapy System is a cryoablation platform for use in the cryoablation of nerves and tumors. The Probe is a handheld, single use, cryosurgical instrument. The {6} Probe utilizes a high-pressure cryogen (argon gas) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. In use with tumors, temperatures below -40°C is the temperature at which intracellular ice formation occurs which is lethal for cells. When applied to nerves, temperatures below -20°C cause extracellular ice formation along axonal tubes which causes cessation of action potential conduction. When high pressure argon gas is supplied to the Probe via the Console, rapid cooling is achieved via the Joule-Thomson effect. The Probe incorporates a heating element to facilitate directional cryoablation. The Console has combination gas/electrical ports to handle 4 Probes in parallel. The Console contains the Firmware and Software. The System consists of a main chassis (Console) for the cooling system, Firmware, Software, controls, touch screen and Probe ports. Safety measures of the system include audible and visual alarms, safety valves, and emergency shutoff button. ## 5. Indications for Use: The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions. In addition, the system is intended for use in the following indications: ### Urology - Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) ### Oncology - Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy ### Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders - Destruction of warts or lesions, angiomas, sebaceous hyperplasia, 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, peri-anal condylomata, and palliation of tumors of the skin ### Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia {7} General surgery - Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas ENT - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth Thoracic Surgery - (with the exception of cardiac tissue) Proctology - Ablation of benign or malignant growths of the anus or rectum Neurology - Freezing of nerve tissue in pain management/cryoanalgesia 6. Comparison of Technological Characteristics with the Predicate Device: At a high level, the subject device differs from the predicate as a result of the following characteristics: - Electrical heating element - Directionally-biased ablation zones - Cryogen pressure utilized Length of the cryoprobe active region The table below includes a high level comparison of the Subject and Predicate Devices: Table 1 - Predicate and Subject Device Comparison - Focused Cryotherapy System | Characteristic | Subject Device: Focused Cryotherapy System | Secondary Predicate Device: Visual-ICE Cryoablation System | Primary Predicate Device: Cryocare Touch System | Comparison Between Subject and Predicate Devices | | --- | --- | --- | --- | --- | | 510(k) Number | K250742 | K230551 | K201588 | N/A | | Manufacturer | Focused Cryo, Inc. | Boston Scientific | Varian Medical Systems | N/A | | Regulation | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | Same | | Product Code | GEH | GEH | GEH | Same | | Classification | Class II | Class II | Class II | Same | | Device Type | Cryosurgical Unit and Accessories | Cryosurgical Unit and Accessories | Cryosurgical Unit and Accessories | Same | | Intended Use | Freeze/ablate tissue by the application of extreme cold temperatures | Freeze/ablate tissue by the application of extreme cold temperatures | Freeze/ablate tissue by the application of extreme cold temperatures | Same | | Indications for Use | The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a | The Visual-ICETM Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICETM Cryoablation System is indicated for use as | The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, | The Subject Device has the same indications for use as the Secondary Predicate, except for the addition | {8} | | cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, nerves, tumors, and skin lesions. In addition, the system is intended for use in the following indications: Urology • Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) Oncology • Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy Dermatology • Ablation or freezing of skin cancers and other cutaneous disorders • Destruction of warts or lesions, angiomas, sebaceous hyperplasia, 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, peri-anal condylomata, and palliation of tumors of the skin Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, and skin lesions. The Visual-ICE Cryoablation System has the following specific indications: • Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia (BPH) • Oncology Ablation of cancerous or malignant tissue and benign tumors, and palliative intervention. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy • Dermatology Ablation or freezing of skin cancers and other cutaneous disorders Destruction of warts or lesions, angiomas, sebaceous hyperplasia, 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, peri-anal condylomata, and palliation of tumors of the skin • Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia • General surgery | gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. In addition, the system is intended for use in the following indications: General Surgery • Destruction of warts or lesions • Palliation of tumors of the oral cavity, rectum and skin • Ablation of breast fibroadenomas • Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions Urology • Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia Oncology • Ablation of cancerous or malignant tissue • Ablation of benign tumors • Palliative intervention Neurology | of the neurology indication, which it shares with the Primary Predicate. | | --- | --- | --- | --- | {9} | | General surgery • Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas ENT • Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth Thoracic Surgery • (with the exception of cardiac tissue) Proctology • Ablation of benign or malignant growths of the anus or rectum Neurology • Freezing of nerve tissue in pain management/cryoanalgesia | Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas • ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth • Thoracic Surgery (with the exception of cardiac tissue) • Proctology Ablation of benign or malignant growths of the anus or rectum | • Freezing of nerve tissue in pain management/cryoanalgesia Dermatology • Ablation or freezing of skin cancers and other cutaneous disorders Proctology • Ablation of benign or malignant growths of the anus or rectum • Ablation of hemorrhoids Thoracic Surgery • Ablation of cancerous lesions | | | --- | --- | --- | --- | --- | | Mechanism of Action / Principle of Operation | Joule-Thomson Effect | Joule-Thomson Effect | Joule-Thomson Effect | Same | | Freeze Gas | Argon | Argon | Argon | Same | | Operating Pressure (psi) | 3500 | 3500 | 3200 | Same as Secondary Predicate | | Thaw Mechanism | Heating element based | Heating element based | Helium | Same as Secondary Predicate | | Number of Simultaneously Active Probes / Channels | 4 channels/active needle ports | 8 channels/active needle ports | 8 channels/active needle ports | The Subject Device supports fewer cryoprobes for simultaneous operation. | | Console Freeze Modes | Circumferential, Directional | Circumferential | Circumferential | The Subject Device has a second operating mode that produces a directionally biased ablation zone. | | User Interface | Touchscreen | Touchscreen | Touchscreen and remote keypad | Same as Secondary Predicate | | Probe Temperature Sensor | Internal Thermocouple at Tip | Internal Thermocouple at Tip | Internal Thermocouple at Tip | Same | | Temperature Feedback | Software Enabled | Software Enabled | Software Enabled | Same | | Probe Diameter | 2.1 mm | 1.5 and 2.1 mm | 1.7 and 2.4 mm | Same as one configuration of | {10} | | | | | Secondary Predicate. | | --- | --- | --- | --- | --- | | Probe Length | 20 cm | 10, 17.5, and 23 cm | 7, 15, and 23 cm | Similar to Predicate devices. Probe Length is within the bounds of predicate probe lengths. | | Probe Tip | Trocar | Trocar | Trocar | Same | | Probe Material | Stainless Steel | Stainless Steel | Stainless Steel | Same | | Probe Sterility | Sterile, Single-Use | Sterile, Single-Use | Sterile, Single-Use | Same | 7. Performance Data (Non-Clinical Testing): Verification and validation testing was conducted in accordance with applicable international standards and internal requirements to ensure safety, effectiveness, and compliance. Verification testing included the following: - System Verification: Confirmed proper functionality of Probes, Console, and Software - Mechanical Testing: Evaluated gas components, Probe integrity, and packaging durability - Electrical Safety & EMC Testing: Conducted per IEC 60601-1 and IEC 60601-1-2 standards - Software Verification & Validation: Developed per IEC 62304 and FDA software guidance, verified all software requirements - Biocompatibility Testing: Conducted per ISO 10993 series Validation testing included the following: - Human Factors Testing: Assessed usability per IEC 60601-1-6, IEC 62366 and FDA human factors guidance - Sterilization Validation: Ensured compliance with ISO 11135 and related standards. - Ex-Vivo Tissue Testing: Testing was performed in porcine tissue samples to validate device tissue effects and quantify thermal performance and temperature-time histories. - Isotherm Comparative Testing: Head-to-head comparison testing was performed with the predicate device to demonstrate substantially equivalent isothermal contours. All performance tests met predefined acceptance criteria, demonstrating that the Focused Cryotherapy System is as safe and effective as the predicate device. No new risks to safety or effectiveness were identified. No animal or clinical studies were included in this submission. 8. Determination of Substantial Equivalence to the Predicate Device: {11} A subset of technological characteristics and features of the subject device differs from the predicate device. However, these differences do not raise different questions of safety and effectiveness when compared to the predicate devices. Performance data demonstrate that the subject device is as safe and effective as the predicate devices for the same intended use, thereby supporting a determination of substantial equivalence. The subject device has the same intended use as the predicate devices. 9. Conclusion: The assessment following the outcomes observed in the performance testing and design verification and design validation determines that the Focused Cryotherapy System conforms to the defined user needs and intended uses in both circumferential and directional ablation modes. Focused Cryo, therefore, considers the Focused Cryotherapy System to be safe and effective and to perform at least as well as the predicate devices.