Who is the manufacturer of Co-Ablation System with Sterile Co-Ablation Probe?

Hygea Medical Technology Co., Ltd. filed the 510(k) submission for Co-Ablation System with Sterile Co-Ablation Probe (K243042).

What is the FDA product code for Co-Ablation System with Sterile Co-Ablation Probe?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Co-Ablation System with Sterile Co-Ablation Probe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Co-Ablation System with Sterile Co-Ablation Probe?

CRYOCARE TOUCH™ System and Accessories (K201588); XSense Cryoablation System with CryoProbes (K240892); ISOLIS Cryoprobe (K230271).

Who can help prepare an FDA 510(k) submission like Co-Ablation System with Sterile Co-Ablation Probe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Co-Ablation System with Sterile Co-Ablation Probe

K243042 · Hygea Medical Technology Co., Ltd. · GEH · Jan 29, 2025 · General, Plastic Surgery

Device Facts

Record ID	K243042
Device Name	Co-Ablation System with Sterile Co-Ablation Probe
Applicant	Hygea Medical Technology Co., Ltd.
Product Code	GEH · General, Plastic Surgery
Decision Date	Jan 29, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-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 also 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 mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple 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 - 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 and rectum. - Ablation of hemorrhoids. Thoracic Surgery - Ablation of cancerous lesions.

Device Story

Co-Ablation System uses liquid nitrogen phase change to freeze/destroy solid tumors and lesion tissues; system includes host console (cryotank, valves, control/display) and single-use sterile probes. Probes inserted into lesion; liquid nitrogen flow freezes tissue; high-temperature steam (warm mode) melts ice for probe removal. Used in professional healthcare environments (OR/clinic) by trained physicians/nursing staff. System supports procedure planning and manual operation; integrates with imaging (e.g., CT) for real-time ice ball size control. Benefits include precise tumor ablation, reduced damage to surrounding tissue, and improved clinical efficiency. Temperature probes monitor surrounding tissue during treatment.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing (electrical safety, EMC, usability, software validation, sterilization, biocompatibility, shelf-life), ex-vivo ice ball characterization, and animal studies validating efficacy, safety, and operability.

Technological Characteristics

System uses liquid nitrogen for cryoablation and steam for warming. Probes made of 304 stainless steel with vacuum insulation and trocar tips. Connectivity: Standalone console with touchscreen/keyboard interface. Software: Procedure planning/manual control. Sterilization: EO. Biocompatibility: ISO 10993 compliant. Standards: ANSI/AAMI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366.

Indications for Use

Indicated for patients requiring cryoablation of solid tumors, benign/malignant growths, or nerve tissue in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Includes prostate/kidney tissue, liver metastases, skin lesions, warts, and pain management.

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

CRYOCARE TOUCH™ System and Accessories (K201588)
XSense Cryoablation System with CryoProbes (K240892)
ISOLIS Cryoprobe (K230271)

Related Devices

K260377 — XSense Cryoablation System with CryoProbes · IceCure Medical , Ltd. · Feb 24, 2026
K240892 — XSense Cryoablation System with Cryoprobes · IceCure Medical , Ltd. · Jun 28, 2024
K141110 — CRYOCARE CS SURGICAL SYSTEM · Healthtronics · Jun 25, 2015
K153489 — Cryocare CS Surgical System · Healthtronics · Feb 5, 2016
K993965 — CRYO-HIT · Galil Medical , Ltd. · Feb 18, 2000

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION". January 29, 2025 Hygea Medical Technology Co., Ltd. Xingtong Jiang Deputy General Manager Floor 6&7, West Area of Building No. 8, No.30 YuHua Road, Shunyi Beijing, Beijing 101318 China Re: K243042 Trade/Device Name: Co-Ablation System with Sterile Co-Ablation Probe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: September 27, 2024 Received: December 30, 2024 Dear Xingtong Jiang: 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. {1}------------------------------------------------ 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 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-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 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-device-advicecomprehensive-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-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-regulatory {2}------------------------------------------------ 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, Digitally signed by Long H. Chen Long H. Chen -S -s Date: 2025.01.29 13:46:22 -05'00' 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 {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K243042 #### Device Name Co-Ablation System with Sterile Co-Ablation Probe Indications for Use (Describe) The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open. minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-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 also 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 mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple 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 - · 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 and rectum. - · Ablation of hemorrhoids. Thoracic Surgery - · Ablation of cancerous lesions. 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. {4}------------------------------------------------ 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}------------------------------------------------ # 510(k) Summary ## Co-Ablation System with Sterile Co-Ablation Probe ## 1. Submission Sponsor Hygea Medical Technology Co., Ltd. Floor 6&7, West Area of Building No. 8, No.30 YuHua Road, Shunyi, 101318 Beijing PEOPLE'S REPUBLIC OF CHINA Contact Name: Mr.Xingtong Jiang, Deputy General Manager Email: djq@hygeamed.com Phone:+86-010-82158025 ## 2. Date Prepared Sep 25th 2024 ## 3. Device Identification | Trade/Proprietary Name: | Co-Ablation System with Sterile Co-Ablation Probe | |-------------------------|---------------------------------------------------| | Regulation Number: | 21 CFR 878.4350 | | Regulation Name: | Cryosurgical Unit And Accessories | | Regulatory Class: | Class II | | Regulatory Class: | GEH | ## 4. Predicate Device(s): CRYOCARE TOUCH™ System and Accessories (k201588) Manufacturer: Varian Medical Systems, Inc. XSense Cryoablation System with CryoProbes(K240892) Manufacturer: IceCure Medical Ltd. ISOLIS Cryoprobe(K230271) Manufacturer: Varian Medical Systems, Inc. The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures. The CRYOCARE TOUCH System is a standalone surgical system, it consists of a compact, easy to-operate console and associated accessories that include Endocare™ Cryoprobe devices to {6}------------------------------------------------ K243042 deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using high pressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft. The XSense Cryoablation System with CryoProbes is operated in conjunction with an imaging system, such as ultrasound, to provide real-time visualization of the cryosurgical procedure, used in a professional healthcare environment for cryotherapy according to lceCure Medical's technology. The device technology is based on the delivery of the low temperature cryogen under pressure from the internal dewar to the CryoProbe's tip, enabling it to reach very low temperature, due to the thermal energy transfer principle that occurs as a result of phase transfer from liquid to gas of nitrogen at the tip of the CryoProbe, and thus freeze and destroy the treated tissue that the CryoProbe comes in contact with. The ISOLIS cryoprobe is a single use, disposable device designed for use with CryoCare® Systems. ISOLIS cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The refrigerative and warming capability is limited to the distal end of the probe shaft that is comprised of stainless steel and is designed with a pointed tip to facilitate cryoprobe insertion and placement. #### 5. Device Description The Co-Ablation System with Sterile Co-Ablation Probe is a device designed to freeze/ablate tissue. It utilizes phase change effect to generate extremely low temperature and high temperature to destroy lesion tissues with a combined working mode, to achieve better clinical efficacy, safety and efficiency. Main components: Co-Ablation System, Sterile Co-Ablation Probe. Accessory: Sterile Temperature Probe. The Co-Ablation System is a mobile medical equipment. The Co-Ablation System consists a host of Co-Ablation System including liquid nitrogen storage tank (referred to as cryotank), cryo-valve, warm working medium storage tank (referred to as warmtank), warm-valve, waste bottle,insulated pipe and control/display system, etc. The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U. The Sterile Co-Ablation Probe is a single-use sterile product, consisting of a handle, quick release connector, probe tip and probe shaft. It must be used in conjunction with the Co-Ablation System. During treatment, the Sterile Co-Ablation Probe is inserted into the lesion to be ablated. The freezing channel is opened, and the freeze working medium (liquid nitrogen) rapidly flows to the probe and evaporates to absorb heat, rapidly freezing and {7}------------------------------------------------ K243042 destroying tissue near the probe tip. When the system is switched from the freeze mode to warm mode, high temperature steam passes to the tip of the Sterile Co-Ablation Probe, rapidly heating the tip portion of the Sterile Co-Ablation Probe so that the frozen tissue around the Sterile Co-Ablation Probe is quickly melted, and the Sterile Co-Ablation Probe is easily pulled out. The Sterile Co-Ablation Probe consists of right-angle and straight configurations with model number Elite, and comprises 20 specifications as listed below: | Model | Specifications | Structural Form | |-------|----------------|---------------------| | Elite | ACL17 | Straight shaped | | | ACS17 | | | | ACX17 | | | | ABL20 | Right-angled shaped | | | ABS20 | | | | ABX20 | | | | ADL26 | | | | RCL17 | | | | RCS17 | | | | RCX17 | | | | RBL20 | | | | RBS20 | | | | RBX20 | | | | RBL26 | | | | RBS26 | | | | RBX26 | | | | RAL26 | | | | RAS26 | | | | RAL30 | | | | RAS30 | | The Sterile Temperature Probe is designed for use with the Co-Ablation System to monitor temperatures in the surrounding tissue. The Sterile Temperature Probe with model number Ease, and comprises 4 specifications: TSS08, TSL08, TMS15 and TML15. ## 6. Intended Use and Indications for Use The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-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 also intended for use in the following indications: {8}------------------------------------------------ ## 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 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 - 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 and rectum. - Ablation of hemorrhoids. Thoracic Surgery - Ablation of cancerous lesions. ## 7. Comparison of Technological Characteristics with the Predicate Device The following table compares the Co-Ablation System with Sterile Co-Ablation Probe to the predicate devices with respect to indications for use, principles of operation, technological characteristics, materials, and performance, and forms the basis for the determination of substantial equivalence. The subject device does not raise any new questions of safety or effectiveness as compared to the predicate device. {9}------------------------------------------------ | Feature | Subject Device Sterile Co-Ablation Probe | Predicate Device A Cryosurgical unit and accessories | Predicate Device B XSense Cryoablation System with CryoProbes | Discussion | | |----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K243042 | K201588 | K240892 | / | | | Regulatory Class | Class II | Class II | Class II | Same | | | Regulation Name | Cryosurgical unit and accessories | Cryosurgical unit and accessories | Cryosurgical unit and accessories | Same | | | Product Code | GEH | GEH | GEH | Same | | | Regulation No. | 21 CFR 878.4350 | 21 CFR 878.4350 | 21 CFR 878.4350 | Same | | | Manufacturer | Hygea Medical Technology Co., Ltd. | Varian Medical Systems | IceCure Medical Ltd | / | | | Trade/Device Name | Co-Ablation System with Sterile Co-Ablation Probe | Cryocare TOUCH™ System and Accessories | XSense Cryoablation System with CryoProbes | / | | | Intended use | The Co-Ablation System with Sterile Co-Ablation Probe is designed to destroy solid tumors, intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, | The Cryocare Touch™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is | XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. XSense Cryoablation System with CryoProbes is indicated for use as a cryosurgical tool in the fields of general surgery, | Same | | | Feature | Subject Device Sterile Co-Ablation Probe | Predicate Device A Cryosurgical unit and accessories | Predicate Device B XSense Cryoablation System with CryoProbes | Discussion | | | | dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to Co-Ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. | designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. | dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including fibroadenomas, prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide realtime visualization of the cryosurgical procedure. | | | | Indications for Use | 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 mouth, angiomas, sebaceous hyperplasia, basal cell tumors of | 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 | General Surgery Ablation of breast fibroadenomas, leukoplakia of 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, | The subject device is the same as the predicate device A, and compare to predicate device B, "Ablation of arrhythmic cardiac tissue" is not included. | | | Feature | Subject Device Sterile Co-Ablation Probe | Predicate Device A Cryosurgical unit and accessories | Predicate Device B XSense Cryoablation System with CryoProbes | Discussion | | | | 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 | 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 | hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of tumors of the oral cavity, rectum, and skin. | | | | | Urology • Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia | Urology • Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia | Urology • Ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH) | | | | | Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia | Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia | Gynecology • Ablation of malignant neoplasia or benign dysplasia of the female genitalia | | | | | Oncology • Ablation of cancerous or malignant tissue • Ablation of benign tumors | Oncology • Ablation of cancerous or malignant tissue • Ablation of benign tumors • Palliative intervention Neurology • Freezing of nerve tissue in pain | Oncology • Ablation of cancerous or malignant tissue and benign tumors and palliative intervention Dermatology | | | | Feature | Subject Device Sterile Co-Ablation Probe | Predicate Device A Cryosurgical unit and accessories | Predicate Device B XSense Cryoablation System with CryoProbes | Discussion | | | | • Palliative intervention | management/cryoanalgesia | • Ablation or freezing of skin cancers | | | | | Neurology | Dermatology | and other cutaneous disorders. | | | | | • Freezing of nerve tissue in pain | • Ablation or freezing of skin | Palliation of tumors of the skin. | | | | | management/cryoanalgesia | cancers and other cutaneous | Destruction of warts or lesions | | | | | Dermatology | disorders | ENT (Ear, Nose, and Throat) | | | | | • Ablation or freezing of skin | Proctology | • Palliation of tumors of the oral | | | | | cancers and other cutaneous | • Ablation of benign or malignant | cavity and ablation of leukoplakia of | | | | | disorders | growths of the anus or rectum | the mouth. | | | | | Proctology | • Ablation of hemorrhoids | Proctology | | | | | • Ablation of benign or malignant | Thoracic Surgery | • Ablation of benign or malignant | | | | | growths of the anus and rectum | • Ablation of cancerous lesions | growths of the anus and rectum and | | | | | • Ablation of hemorrhoids | | hemorrhoids | | | | | Thoracic Surgery | | Thoracic Surgery | | | | | • Ablation of cancerous lesions | | • Ablation of arrhythmic cardiac | | | | | | | tissue and cancerous lesions | | | | Use Environment | Professional healthcare environment | Professional healthcare environment | Professional healthcare environment | Same | | | Intended User | This system is only restricted to | The users of the system must be | The user of the XSense cryoablation | | | | | use in specific surgeries by | physicians trained in their | system only if you meet all the | | | | | qualified medical professionals | respective fields, supported by | following criteria: | | | | | and nursing staffs properly | technicians trained in the operation | You are a board certified medical | Same | | | | trained. Those who have not | of the system. Physicians should be…