(124 days)
Not Found
Yes
The device description explicitly mentions "The Co-Ablation System has model number with AI Epic S40U and AI Epic S20U." While the summary doesn't detail the AI functionality, the model numbers strongly suggest the incorporation of AI technology.
Yes.
The device is intended to destroy solid tumors, ablate tissues, and manage pain, directly addressing health conditions and symptoms.
No
This device is designed for the destruction or ablation of tissue using extreme cold or heat, which is a therapeutic function, not a diagnostic one. While it may be used to treat conditions that were previously diagnosed, the device itself does not provide diagnostic information.
No
The device description clearly outlines hardware components including a Co-Ablation System (with tanks, valves, pipes, etc.), a Sterile Co-Ablation Probe, and a Sterile Temperature Probe. While there is a "control/display system" which likely involves software, the device is fundamentally a hardware system for cryoablation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Co-Ablation System with Sterile Co-Ablation Probe is a therapeutic device. Its intended use is to destroy tissue (tumors, lesions, etc.) through the application of extreme temperatures (freezing and heating). It is used during surgical procedures directly on the patient's body.
- No Sample Analysis: The device does not analyze samples taken from the body to provide diagnostic information. It is a tool for physical intervention on tissue.
Therefore, the device's function and intended use clearly place it outside the scope of an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / 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, 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.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. Specific anatomical sites mentioned include:
- prostate and kidney tissue
- liver
- skin
- oral cavity
- rectum
- breast
- eyelid or canthus area
- anus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended User: This system is only restricted to use in specific surgeries by qualified medical professionals and nursing staffs properly trained. Those who have not received adequate training on the use of this system are prohibited from operating or maintaining the system.
Care Setting: Professional healthcare environment
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)
Non-Clinical Testing:
- Electrical Safety: The Co-Ablation System with Sterile Co-Ablation Probe meets the basic safety and essential performance for the intended use and use environment in accordance with ANSI/AAMI ES60601-1.
- Electromagnetic Compatibility (EMC): The Co-Ablation System with Sterile Co-Ablation Probe meets the EMC requirement for the intended use and use environment in accordance with IEC 60601-1-2.
- Usability Testing: The usability testing of Co-Ablation System with Sterile Co-Ablation Probe is to evaluate the user interface in accordance with IEC 60601-1-6 and IEC 62366.
- Software Testing: The software development is in accordance with IEC 62304, FDA guidance for the content of premarket submissions for software contained in Medical devices and FDA guidance for Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. And the software verification/validation met the acceptance criteria.
- Sterilization Testing: The Sterile Co-Ablation Probe and Sterile Temperature Probe are sterilized by EO, the validation was performed in accordance with ISO 11135, ISO 11737-1,ISO 11737-2,ISO11607-1, ISO 11607-2.
- Biocompatibility Testing: The applied parts of Sterile Co-Ablation Probe and Sterile Temperature Probe are inserted into the tissue and limited contact is less than 24 hours, the biocompatibility testing was performed in accordance with ISO 10993 related standards.
- Shelf Life Testing: The aging testing and packaging testing were performed to verity the validity of shelf life and packaging of Co-Ablation System with Sterile Co-Ablation Probe.
- Ex-vivo Testing: The Co-Ablation System with Sterile Co-Ablation Probe were performed the ex-vivo testing, co-ablation volume correlates with treatment area length, tip diameter, and freezing time. The longer the treatment area, the larger the probe diameter, and the longer the duration of cryogenics, the larger the volume of ice ball formed and the larger the area of tumor that can be clinically covered, without increasing inadvertent damage to surrounding tissue.
- Additional Performance Testing:
- The Co-Ablation System with Sterile Co-Ablation Probe ice ball verification testing.
- Sterile Temperature Probe measurement accuracy verification testing.
- Animal Testing: The Co-Ablation System with Sterile Co-Ablation Probe were performed the animal testing, which indicated that Sterile Co-Ablation Probe of different diameters corresponding to different cold zones could produce ice balls of different sizes under the same ablation scheme, providing a basis for clinicians to treat tumors of specific sizes, different specifications can better meet clinical needs. And throughout all ablation treatments, the ECG monitoring results showed stable vital signs in the animals, all the subject devices could be used with the desired functions, no abnormalities of the device was observed, and the operability was good. It was validated fully the efficacy, safety and usability of the product, without the additional safety and performance risk.
Clinical Testing:
No clinical data was necessary to determine the substantial equivalence of this device.
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.
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 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
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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
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
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 | practitioner licensed in your country. | | |
| | received adequate training on the | either Urologists or Interventional | You have taken a certified IceSense3 | | |
| Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
Cryosurgical unit and accessories | Predicate Device B
XSense Cryoablation System with CryoProbes | Discussion | |
| | use of this system are prohibited
from operating or maintaining the
system. | Radiologists. Technicians must be at
least high school graduates who are
subsequently trained in the
operations of the Endocare
Cryocare CS system. The technician
works under the direction of the
physician to operate the machine,
including tank-set up, machine
start-up, and operating the user
interface. | cryoablation system training course.
You have read and understood all
relevant material accompanying
thelceSense3 cryoablation system. | | |
| Principles of Operation | Phase Change Effect | Joule-Thomson Effect | Phase Change Effect | The Subject Device is
the same as the
Predicate Device B, but
they differ from the
Predicate Device A. | |
| Operation Mode | Freeze, Warm, Pause | Freeze, Thaw, Stick, Stop | Freeze, Thaw, Stick, Pause, Extraction | The subject Devices
don't have stick mode. | |
| Software Control | Procedure planning/Manual
Operation. | Auto/Manual Freeze. | Automatic/Manual/Pre-programmed
freezing cycles | Same
Three devices have the
same model, just only
the description is
minor difference. | |
| Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
Cryosurgical unit and accessories | Predicate Device B
XSense Cryoablation System with
CryoProbes | Discussion | |
| Freeze Temperature at the
Probe Tip | -186 ℃ ± 10 ℃ | -150 ℃± 10 ℃ | -196 ℃ | The Subject Device
and Predicate Device B
have the same
minimum
temperature, which is
lower than the
Predicate Device A. | |
| Cryogen | Liquid Nitrogen | Argon | Liquid Nitrogen | The Subject Device
and Predicate Device B
have the same
Cryogen, Liquid
Nitrogen. The
Predicate Device A
uses Argon as the
cryogen. | |
| Warm Temperature at the
Probe Tip | 75 ℃±10 ℃ | 40 ℃ | 40 ℃ | The temperature of
the Subject Device is
higher than that of
both Predicate Devices | |
| | Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
Cryosurgical unit and accessories | Predicate Device B
XSense Cryoablation System with
CryoProbes | Discussion |
| | Warming working fluid | Ethyl alcohol | Helium | Nitrogen gas | The three devices use
different materials as
the warming working
fluid based on their
own operating
principle. |
| | Safety | Under CT guidance, the tumor
tissue boundary is clear,
Co-Ablation System can control
the ice ball size according to the
image in real time to achieve the
precise ablation. | Under CT guidance, the tumor
tissue boundary is clear, Cryocare
Touch™ System can control the ice
ball size according to the image in
real time to achieve the precise
ablation. | Under CT guidance, the tumor tissue
boundary is clear, XSense
Cryoablation System can control the
ice ball size according to the image in
real time to achieve the precise
ablation. | Same |
| | Human Machine Interface | Touchscreen/Keyboard | Touchscreen/Remote Keyboard | Touchscreen/Cryohandle | Same |
| | Probe Channel | S40U: Configure 1 to 4
S20U: Configure 1 to 2 | 1 to 8 | 1 | The maximum number
of channels is
different. |
| Temperature
Probe | Channel | 1 to 4 | 1 to 8 | 1 | The maximum number
of channels is
different. |
| | Disposable
/Single use | Single use | Single use | Single use | Same |
| Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
Cryosurgical unit and accessories | Predicate Device B
XSense Cryoablation System with
CryoProbes | Discussion | |
| Sterility | EO | EO | EO | Same | |
| Biocompatib
ility
Classification | Patient contact materials comply
with ISO 10993-1 | Patient contact materials comply
with ISO 10993-1 | Patient contact materials comply
with ISO 10993-1 | Same | |
| Patient
Contacting
Materials | 304 Stainless steels | 304 Stainless steels | 304 Stainless steels | Same | |
10
11
12
13
14
15
16
Table 2 – Predicate and Subject Device Comparison - Sterile Co-Ablation Probe
| Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
ISOLIS Cryoprobe | Predicate Device B
XSense Cryoablation System
with CryoProbes | Discussion |
|------------------------|---------------------------------------------|----------------------------------------|---------------------------------------------------------------------|------------------------------------------------|
| 510(k) Number | K243042 | K230271 | K240892 | / |
| Manufacturer | Hygea Medical Technology
Co.,
Ltd. | Varian Medical Systems | IceCure Medical Ltd | / |
| Probe Shaft | 304 Stainless steels | 304 Stainless steels | 304 Stainless steels | Same |
| Probe Shaft Insulation | Vacuum | Vacuum | Vacuum | Same |
| Probe Shaft Tip | Trocar | Trocar | Trocar | Same |
| Outer Diameter
(mm) | 1.7/1.98/2.6/3.0 | 1.7/2.4/3.8 | 2.4/3.4 | The three devices have
different diameters. |
| Disposable /Single use | Single use | Single use | Single use | Same |
17
| Feature | Subject Device
Sterile Co-Ablation Probe | Predicate Device A
ISOLIS Cryoprobe | Predicate Device B
XSense Cryoablation System
with CryoProbes | Discussion |
|------------------------------------|------------------------------------------------------|------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Sterility | EO | Gamma Irradiation | EO | The Subject Device and
Predicate Device B are
sterilized using the same
sterilization method as EO.
The Predicate Device B uses
Gamma Irradiation. |
| Biocompatibility
classification | Patient contact materials comply
with ISO 10993-1 | Patient contact materials comply
with ISO 10993-1 | Patient contact materials
comply with ISO 10993-1 | Same |
| Patient Contacting
Materials | 304 Stainless steels. Contact
duration