(124 days)
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.
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.
The provided text is a 510(k) Summary for the Hygea Medical Technology Co., Ltd.'s Co-Ablation System with Sterile Co-Ablation Probe. It details comparisons to predicate devices and lists non-clinical performance data.
However, there is no information presented regarding acceptance criteria, reported device performance against those criteria, or a specific study proving the device meets those criteria in the context of an AI/algorithm's diagnostic performance. The document focuses on the substantial equivalence of the cryoablation system as a medical device based on its design, function, and non-clinical safety/effectiveness tests (electrical safety, EMC, usability, software, sterilization, biocompatibility, shelf life, ex-vivo, and animal testing).
Specifically, the document states:
- "No clinical data was necessary to determine the substantial equivalence of this device." This directly indicates that no clinical study, which would typically contain acceptance criteria and performance metrics for a diagnostic device, was conducted or submitted for this 510(k) clearance.
- The "Software Testing" section mentions "the software verification/validation met the acceptance criteria," but these acceptance criteria are related to general software development standards (IEC 62304, FDA guidance for software and cybersecurity) and not to the diagnostic performance of an AI/algorithm.
Therefore, I cannot provide the requested table and information because the provided text does not contain data related to:
- A table of acceptance criteria and reported device performance for an AI/algorithm's diagnostic capability.
- Sample size and data provenance for a test set for AI/algorithm performance.
- Number and qualifications of experts for ground truth establishment for AI/algorithm performance.
- Adjudication method for an AI/algorithm test set.
- MRMC comparative effectiveness study results for AI assistance.
- Standalone performance of an AI algorithm.
- Type of ground truth used for AI/algorithm performance.
- Sample size for the training set of an AI algorithm.
- How the ground truth for an AI training set was established.
This 510(k) summary is for a cryoablation system, which is a therapeutic device, not an AI-powered diagnostic device. The performance data presented refers to the physical and software functionalities of the system in performing cryoablation, not to the diagnostic accuracy of an AI.
{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}------------------------------------------------
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 DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | 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 SterileCo-Ablation Probe | Cryocare TOUCH™ System andAccessories | XSense Cryoablation System withCryoProbes | / | |
| Intended use | The Co-Ablation System withSterile Co-Ablation Probe isdesigned to destroy solid tumors,intended for use in open,minimally invasive or endoscopicsurgical procedures in the areas ingeneral surgery, urology,gynecology, oncology, neurology, | The Cryocare Touch™ System isintended for use in open, minimallyinvasive or endoscopic surgicalprocedures in the areas in generalsurgery, urology, gynecology,oncology, neurology, dermatology,ENT, proctology, pulmonary surgeryand thoracic surgery. The system is | XSense Cryoablation System withCryoProbes is intended for cryogenicdestruction of tissue during surgicalprocedures by the application ofextreme cold temperatures. XSenseCryoablation System with CryoProbesis indicated for use as a cryosurgicaltool in the fields of general surgery, | Same | |
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | Discussion | |
| dermatology, ENT, proctology,pulmonary surgery and thoracicsurgery. The system is designed toCo-Ablate tissue by the applicationof extreme cold temperaturesincluding prostate and kidneytissue, liver metastases, tumors,skin lesions, and warts. | designed to freeze/ablate tissue bythe application of extreme coldtemperatures including prostate andkidney tissue, liver metastases,tumors, skin lesions, and warts. | dermatology, neurology (includingcryoanalgesia), thoracic surgery, ENT,gynecology, oncology, proctology,and urology. The system is designedto destroy tissue by the applicationof extreme cold temperaturesincluding fibroadenomas, prostateand kidney tissue, liver metastases,tumors, skin lesions, and warts.XSense Cryoablation System withCryoProbes may be used with animaging device such as an ultrasoundto provide realtime visualization ofthe cryosurgical procedure. | |||
| Indications for Use | General Surgery Destruction of warts or lesions Palliation of tumors of the oralcavity, rectum, and skin Ablation of breastfibroadenomas Ablation of leukoplakia ofmouth, angiomas, sebaceoushyperplasia, basal cell tumors of | General Surgery Destruction of warts or lesions Palliation of tumors of the oralcavity, rectum and skin Ablation of breast fibroadenomas Ablation of leukoplakia of themouth, angiomas, sebaceoushyperplasia, basal cell tumors of theeyelid or canthus area, ulcerated | General Surgery Ablation of breast fibroadenomas,leukoplakia of mouth, angiomas,sebaceous hyperplasia, basal celltumors of the eyelid or canthus area,ulcerated basal cell tumors,dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts, | The subject device isthe same as thepredicate device A,and compare topredicate device B,"Ablation ofarrhythmic cardiactissue" is not included. | |
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | Discussion | |
| the eyelid or canthus area,ulcerated basal cell tumors,dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,hemorrhoids, anal fissures,perianal condylomata, pilonidalcysts, actinic and seborrheickeratoses, cavernoushemangiomas, recurrentcancerous lesions | basal cell tumors, dermatofibromas,small hemangiomas, mucocelecysts, multiple warts, plantar warts,hemorrhoids, anal fissures, perianalcondylomata, pilonidal cysts, actinicand seborrheic keratoses, cavernoushemangiomas, recurrent cancerouslesions | hemorrhoids, anal fissures, perianalcondylomata, pilonidal cysts actinicand seborrheic keratoses, cavernoushemangiomas, recurrent cancerouslesions. Palliation of tumors of therectum, hemorrhoids, anal fissures,pilonidal cysts, and recurrentcancerous lesions. Destruction ofwarts or lesions. Palliation of tumorsof the oral cavity, rectum, and skin. | |||
| Urology• Ablation of prostate tissue incases of prostate cancer andbenign prostatic hyperplasia | Urology• Ablation of prostate tissue incases of prostate cancer and benignprostatic hyperplasia | Urology• Ablate prostate tissue in cases ofprostate cancer and benign prostatichyperplasia (BPH) | |||
| Gynecology• Ablation of malignant neoplasiaor benign dysplasia of the femalegenitalia | Gynecology• Ablation of malignant neoplasiaor benign dysplasia of the femalegenitalia | Gynecology• Ablation of malignant neoplasia orbenign dysplasia of the femalegenitalia | |||
| Oncology• Ablation of cancerous ormalignant tissue• Ablation of benign tumors | Oncology• Ablation of cancerous ormalignant tissue• Ablation of benign tumors• Palliative interventionNeurology• Freezing of nerve tissue in pain | Oncology• Ablation of cancerous ormalignant tissue and benign tumorsand palliative interventionDermatology | |||
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | 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 healthcareenvironment | Professional healthcareenvironment | 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 DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System with CryoProbes | Discussion | |
| use of this system are prohibitedfrom operating or maintaining thesystem. | Radiologists. Technicians must be atleast high school graduates who aresubsequently trained in theoperations of the EndocareCryocare CS system. The technicianworks under the direction of thephysician to operate the machine,including tank-set up, machinestart-up, and operating the userinterface. | cryoablation system training course.You have read and understood allrelevant material accompanyingthelceSense3 cryoablation system. | |||
| Principles of Operation | Phase Change Effect | Joule-Thomson Effect | Phase Change Effect | The Subject Device isthe same as thePredicate Device B, butthey differ from thePredicate Device A. | |
| Operation Mode | Freeze, Warm, Pause | Freeze, Thaw, Stick, Stop | Freeze, Thaw, Stick, Pause, Extraction | The subject Devicesdon't have stick mode. | |
| Software Control | Procedure planning/ManualOperation. | Auto/Manual Freeze. | Automatic/Manual/Pre-programmedfreezing cycles | SameThree devices have thesame model, just onlythe description isminor difference. | |
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | Discussion | |
| Freeze Temperature at theProbe Tip | -186 ℃ ± 10 ℃ | -150 ℃± 10 ℃ | -196 ℃ | The Subject Deviceand Predicate Device Bhave the sameminimumtemperature, which islower than thePredicate Device A. | |
| Cryogen | Liquid Nitrogen | Argon | Liquid Nitrogen | The Subject Deviceand Predicate Device Bhave the sameCryogen, LiquidNitrogen. ThePredicate Device Auses Argon as thecryogen. | |
| Warm Temperature at theProbe Tip | 75 ℃±10 ℃ | 40 ℃ | 40 ℃ | The temperature ofthe Subject Device ishigher than that ofboth Predicate Devices | |
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | Discussion | |
| Warming working fluid | Ethyl alcohol | Helium | Nitrogen gas | The three devices usedifferent materials asthe warming workingfluid based on theirown operatingprinciple. | |
| Safety | Under CT guidance, the tumortissue boundary is clear,Co-Ablation System can controlthe ice ball size according to theimage in real time to achieve theprecise ablation. | Under CT guidance, the tumortissue boundary is clear, CryocareTouch™ System can control the iceball size according to the image inreal time to achieve the preciseablation. | Under CT guidance, the tumor tissueboundary is clear, XSenseCryoablation System can control theice ball size according to the image inreal time to achieve the preciseablation. | Same | |
| Human Machine Interface | Touchscreen/Keyboard | Touchscreen/Remote Keyboard | Touchscreen/Cryohandle | Same | |
| Probe Channel | S40U: Configure 1 to 4S20U: Configure 1 to 2 | 1 to 8 | 1 | The maximum numberof channels isdifferent. | |
| TemperatureProbe | Channel | 1 to 4 | 1 to 8 | 1 | The maximum numberof channels isdifferent. |
| Disposable/Single use | Single use | Single use | Single use | Same | |
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device ACryosurgical unit and accessories | Predicate Device BXSense Cryoablation System withCryoProbes | Discussion | |
| Sterility | EO | EO | EO | Same | |
| BiocompatibilityClassification | Patient contact materials complywith ISO 10993-1 | Patient contact materials complywith ISO 10993-1 | Patient contact materials complywith ISO 10993-1 | Same | |
| PatientContactingMaterials | 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 DeviceSterile Co-Ablation Probe | Predicate Device AISOLIS Cryoprobe | Predicate Device BXSense Cryoablation Systemwith CryoProbes | Discussion |
|---|---|---|---|---|
| 510(k) Number | K243042 | K230271 | K240892 | / |
| Manufacturer | Hygea Medical TechnologyCo.,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 havedifferent diameters. |
| Disposable /Single use | Single use | Single use | Single use | Same |
{17}------------------------------------------------
| Feature | Subject DeviceSterile Co-Ablation Probe | Predicate Device AISOLIS Cryoprobe | Predicate Device BXSense Cryoablation Systemwith CryoProbes | Discussion |
|---|---|---|---|---|
| Sterility | EO | Gamma Irradiation | EO | The Subject Device andPredicate Device B aresterilized using the samesterilization method as EO.The Predicate Device B usesGamma Irradiation. |
| Biocompatibilityclassification | Patient contact materials complywith ISO 10993-1 | Patient contact materials complywith ISO 10993-1 | Patient contact materialscomply with ISO 10993-1 | Same |
| Patient ContactingMaterials | 304 Stainless steels. Contactduration<24 hours | 304 Stainless steels. Contactduration<24 hours | 304 Stainless steels. Contactduration<24 hours | Same |
| Probe Pretest | Yes | Yes | Yes | Same |
The intended uses and indications for use of Substantially the same as the predicate devices, and the Subject Device has the similar technological characteristics, and principles of opedicate devices. The minor technological differences between the Subject Device and the Primary Predicate Device raise no new issues of safety or effectiveness. Performance that the Subject Device is as safe and effective as the cleared the cleared the cleared XSense Cryoablation System (K240892), the cleared Cyocare TOUCH™ System(K201588) and the cleared ISOLIS Cryoprobe (K230271).
{18}------------------------------------------------
8. Performance Data (Non-Clinical Testing)
Hygea completed the following non-clinical tests. The Co-Ablation System with Sterile Co-Ablation Probe passed the testing in accordance with internal requirements, national standards, and international standards shown below. The test results support the device substantial equivalence to the predicate device:
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
{19}------------------------------------------------
• 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.
9. Performance Data (Clinical Testing)
No clinical data was necessary to determine the substantial equivalence of this device.
10. Conclusion
The intended uses and indications for use are substantially the same as the predicate devices, and the Co-Ablation System with Sterile Co-Ablation Probe has the similar technological characteristics, and principles of operation as the predicate devices. The minor technological differences do not raise new or different questions of safety and effectiveness, the non-clinical performance testing has demonstrated the Co-Ablation System with Sterile Co-Ablation Probe is as safe and effective as the predicate devices. Therefore, the Co-Ablation System with Sterile Co-Ablation Probe are substantially equivalent to the predicate devices.
§ 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.