(88 days)
Not Found
No
The document describes a cryoablation system that uses extreme cold temperatures to destroy tissue. The technology is based on the delivery of a low-temperature cryogen. There is no mention of AI or ML in the intended use, device description, or performance studies. The system is operated in conjunction with imaging, but the document does not suggest the system itself uses AI/ML for image processing or other functions.
Yes
Explanation: The device is intended for cryogenic destruction of tissue during surgical procedures by applying extreme cold temperatures, which is a therapeutic intervention. It is indicated for use as a cryosurgical tool in various medical fields to ablate or destroy tissues like cancerous or benign tumors, fibroadenomas, and lesions.
No
The device is a cryoablation system intended for the destruction of tissue using extreme cold, which is a therapeutic rather than a diagnostic function. While it can be used with an imaging device for visualization, the system itself does not diagnose conditions.
No
The device description clearly outlines hardware components such as a console, CryoProbes, an external dewar, and optional accessories like an introducer and holder. It also describes the physical mechanism of action involving the delivery of a cryogen. While software is mentioned in the performance studies, the device is fundamentally a hardware system with software control.
Based on the provided information, the XSense Cryoablation System with CryoProbes is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is for the "cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that delivers a cryogen to a probe tip to freeze and destroy tissue. This is a physical intervention, not a test performed on samples outside the body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform such analysis.
The device is a surgical tool used for tissue ablation, which is a therapeutic procedure.
N/A
Intended Use / Indications for Use
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, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, 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.
The system has the following specific indications:
-
· Urology Ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH).
-
· Oncology - Ablation of cancerous or malignant tissue and benign tumors and palliative intervention.
-
· Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Palliation of the skin. Destruction of warts or lesions.
-
· Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
-
· ENT (Ear, Nose, and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
-
· 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, mucocele cysts, multiple warts, plantar warts, 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 the oral cavity, rectum, and skin.
-
· Thoracic Surgery - Ablation of arrhythmic cardiac tissue and cancerous lesions.
-
· Proctology - Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.
Product codes
GEH
Device Description
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 IceCure Medical's technology. The device technology is based on the delivery of the lowtemperature 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 XSense Cryoablation System with CryoProbes is the next generation of its predicatethe already cleared ProSense™ Cryoablation System (K183213) and is part of the IceCure family of cryoablation products. The XSense Cryoablation System with CryoProbes operates in the same manner as the previous design of the ProSense™ Cryoablation System. The XSense Cryoablation System will include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder.
System Components: The system is comprised of three main subsystems: XSense (console), CryoProbes, External dewar. Optional accessories: Introducer, Holder.
Screen: Touch Screen mounted on the system's articulated arm. Tilt, swivel options and adjustable positioning. Screen size: 15.6".
Cooling System: Internal dewar of LN2.
Operating modes: Freeze Thaw Extraction Pause Stick. Automatic/Manual/ pre-programmed freezing cycles.
Procedure track record: Yes.
Number of CryoProbes controlled by the device: 1 CryoProbe.
CryoProbe pretest: Yes.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate, kidney, liver, skin, breast, genitalia, oral cavity, cardiac, anus, rectum
Indicated Patient Age Range
Not Found
Intended User / 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
IceCure Medical Ltd. conducted several performance tests to demonstrate that the XSense Cryoablation System with CryoProbes complies with performance standards and that it functions in a safe and effective manner, as intended.
The XSense Cryoablation System with CryoProbes underwent performance testing such as software verification and validation testing, biocompatibility, sterilization (EtO), shelf life, electrical safety, and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2 and IEC TR 60601-4-2) testing. These performance tests in addition to the bench tests and usability study, demonstrated that the differences in the technological characteristics between the subject and predicate devices do not raise any new types of safety or efficacy concerns. All tests were performed according to recognized standards and relevant FDA guidance.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
June 28, 2024
IceCure Medical Ltd. Maayan Levi Regulatory Affairs Director 7 HaEshel St. P.O. Box 3163 Caesarea, 3079504 Israel
Re: K240892
Trade/Device Name: XSense Cryoablation System with CryoProbes Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: March 31, 2024 Received: April 1, 2024
Dear Maayan Levi:
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.
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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Long H. Chen -S Digitally signed by Long H. Chen -S
Date: 2024.06.28 16:44:31 -04'00'
Long Chen. Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K240892
Device Name XSense Cryoablation System with CryoProbes
Indications for Use (Describe)
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, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, 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.
The system has the following specific indications:
- · Urology Ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH).
· Oncology - Ablation of cancerous or malignant tissue and benign tumors and palliative intervention.
· Dermatology - Ablation or freezing of skin cancers and other cutaneous disorders. Palliation of the skin. Destruction of warts or lesions.
· Gynecology - Ablation of malignant neoplasia or benign dysplasia of the female genitalia.
· ENT (Ear, Nose, and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
· 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, mucocele cysts, multiple warts, plantar warts, 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 the oral cavity, rectum, and skin.
· Thoracic Surgery - Ablation of arrhythmic cardiac tissue and cancerous lesions.
· Proctology - Ablation of benign or malignant growths of the anus and rectum and hemorrhoids.
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
Image /page/5/Picture/0 description: The image shows the IceCure logo, which features the company name in a stylized font with the tagline "Innovating Cryotherapy Solutions" underneath. The logo is set against a blue background. Below the logo, the text "Page 1 of 7" is displayed, indicating that this image is the first page of a document.
XSense Cryoablation System with CryoProbes 510(K) Summary
| Applicant Name: | IceCure Medical Ltd.
7 HaEshel St.
P.O.B 3163
Caesarea, 3079504, Israel
Telephone: +972-4-6230333 |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Maayan Levi,
Regulatory Affairs Director
IceCure Medical Ltd.
MaayanL@icecure-medical.com |
| Date Prepared: | March 31, 2024 |
| Trade Name: | XSense Cryoablation System with CryoProbes |
| Classification Name: | 21 CFR 878.4350 |
| Product Codes: | GEH |
| Classification: | Class II Medical Device |
| Review Panel: | General and Plastic Surgery |
| Predicate Device: | ProSense™ Cryoablation System which was cleared as part of
IceCure Family Cryoablation System (IceSense™3, ProSense™
and MultiSense™) (K183213) |
Intended Use/Indication for Use:
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, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology.
6
Image /page/6/Picture/0 description: The image shows the IceCure logo, which is a stylized image of an ice crystal with the text "IceCure" next to it. Below the logo, the text "Innovating Cryotherapy Solutions" is visible. The text "Page 2 of 7" is at the bottom of the image.
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 real-time visualization of the cryosurgical procedure.
| Field | Indication |
|---|---|
| Urology | Ablate prostate tissue in cases of prostate cancer and |
| benign prostatic hyperplasia (BPH). | |
| Oncology | Ablation of cancerous or malignant tissue and |
| benign tumors and palliative intervention. | |
| Dermatology | Ablation or freezing of skin cancers and other |
| cutaneous disorders. Palliation of tumors of the skin. | |
| Destruction of warts or lesions. | |
| Gynecology | Ablation of malignant neoplasia or benign dysplasia |
| of the female genitalia. | |
| ENT (Ear, Nose, and Throat) | Palliation of tumors of the oral cavity and ablation |
| of leukoplakia of the mouth. | |
| 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, | |
| 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. | |
| Thoracic Surgery | Ablation of arrhythmic cardiac tissue and cancerous |
| lesions. | |
| Proctology | Ablation of benign or malignant growths of the anus |
| and rectum and hemorrhoids. |
The system has the following specific indications:
7
Image /page/7/Picture/1 description: The image shows the IceCure logo, which includes a stylized white graphic to the left of the text "IceCure Innovating Cryotherapy Solutions" on a blue background. Below the logo, the text "Page 3 of 7" is displayed in a larger, black font. The page number indicates that this is part of a larger document or presentation.
1.1 Device Description and Technological Characteristics:
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 IceCure Medical's technology. The device technology is based on the delivery of the lowtemperature 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 XSense Cryoablation System with CryoProbes is the next generation of its predicatethe already cleared ProSense™ Cryoablation System (K183213) and is part of the IceCure family of cryoablation products. The XSense Cryoablation System with CryoProbes operates in the same manner as the previous design of the ProSense™ Cryoablation System. The XSense Cryoablation System will include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder.
Performance Data: 1.2
IceCure Medical Ltd. conducted several performance tests to demonstrate that the XSense Cryoablation System with CryoProbes complies with performance standards and that it functions in a safe and effective manner, as intended.
The XSense Cryoablation System with CryoProbes underwent performance testing such as software verification and validation testing, biocompatibility, sterilization (EtO), shelf life, electrical safety, and electromagnetic compatibility (IEC 60601-1, IEC 60601-1-2 and IEC TR 60601-4-2) testing. These performance tests in addition to the bench tests and usability study, demonstrated that the differences in the technological characteristics between the subject and predicate devices do not raise any new types of safety or efficacy concerns. All tests were performed according to recognized standards and relevant FDA guidance.
8
Image /page/8/Picture/0 description: The image shows the IceCure logo, which features a stylized white graphic next to the word "IceCure" in a blue box. Below the logo is the text "Innovating Cryotherapy Solutions". Underneath the blue box is the text "Page 4 of 7", indicating this is a page number within a document.
1.3 Substantial Equivalence:
The following table compares the subject XSense Cryoablation System with CryoProbes to the predicate device (ProSense™ Cryoablation System which was cleared as part of IceCure Family of Cryoablation System (IceSense™3, ProSense™, and MultiSense™) (K183213)) with respect to its intended use, technological characteristics and principles of operation, providing detailed information regarding the basis for the determination of substantial equivalence.
| Subject Device | Predicate Device | |
|---|---|---|
| Device Name | XSense Cryoablation System with | |
| CryoProbes | Ice Cure Family Cryoablation | |
| System (IceSense™3, ProSense™ | ||
| and MultiSense™) | ||
| 510(k) Number | K240892 | K183213 |
| Product Code | GEH | GEH |
| Device | Cryotherapy system | Cryotherapy system |
| Intended Use | The system is intended for cryogenic | |
| destruction of tissue during surgical | ||
| procedures. | The system is intended for | |
| cryogenic destruction of tissue | ||
| during surgical procedures. | ||
| Indications for | ||
| Use | XSense cryoablation system is | |
| intended for cryogenic destruction of | ||
| tissue during surgical procedures by | ||
| the application of extreme cold | ||
| temperatures. | ||
| XSense cryoablation system is | ||
| indicated for use as a cryosurgical | ||
| tool in the fields of general surgery, | ||
| 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 may be | ||
| used with an imaging device such as | ||
| an ultrasound to provide real-time | IceCure Family (IceSense™3, | |
| ProSense™, and MultiSense™) | ||
| cryoablation system is intended for | ||
| cryogenic destruction of tissue | ||
| during surgical procedures by the | ||
| application of extreme cold | ||
| temperatures. | ||
| It is indicated for use as a | ||
| cryosurgical tool in the fields of | ||
| general surgery, 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 prostate | ||
| and kidney tissue, liver metastases, | ||
| tumors, skin lesions, and warts. | ||
| The system has the following | ||
| specific indications: | ||
| Subject Device | Predicate Device | |
| Device Name | XSense Cryoablation System with | |
| CryoProbes | Ice Cure Family Cryoablation | |
| System (IceSenseTM3, ProSenseTM, | ||
| and MultiSenseTM) | ||
| visualization of the cryosurgical | ||
| procedure. | ||
| The system has the following specific | ||
| indications: | ||
| • Urology - ablate prostate tissue in | ||
| cases of prostate cancer and benign | ||
| prostatic hyperplasia (BPH). | ||
| • Oncology - ablation of cancerous or | ||
| malignant tissue and benign tumors | ||
| and palliative intervention. | ||
| • Dermatology - ablation or freezing | ||
| of skin cancers and other cutaneous | ||
| disorders. Palliation of tumors of the | ||
| skin. Destruction of warts or lesions. | ||
| • Gynecology - ablation of malignant | ||
| neoplasia or benign dysplasia of the | ||
| female genitalia. | ||
| • ENT -Palliation of tumors of the | ||
| oral cavity and ablation of | ||
| leukoplakia of the mouth. | ||
| • 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, | ||
| 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 (ablate prostate tissue in | |
| cases of prostate cancer and benign | ||
| prostatic hyperplasia (BPH)). | ||
| Oncology (ablation of cancerous or | ||
| malignant tissue and benign tumors | ||
| and palliative intervention). | ||
| Dermatology (ablation or freezing of | ||
| skin cancers and other cutaneous | ||
| disorders. Palliation of tumors of the | ||
| skin. Destruction of warts or | ||
| lesions). | ||
| Gynecology (ablation of malignant | ||
| neoplasia or benign dysplasia of the | ||
| female genitalia). | ||
| ENT (Palliation of tumors of the | ||
| oral cavity and ablation of | ||
| leukoplakia of the mouth). | ||
| General Surgery (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. 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. | ||
| Ablation of breast fibroadenomas). | ||
| Thoracic Surgery (ablation of | ||
| arrhythmic cardiac tissue and | ||
| cancerous lesions). | ||
| Subject Device | Predicate Device | |
| Device Name | XSense Cryoablation System with | |
| CryoProbes | Ice Cure Family Cryoablation | |
| System (IceSense™3, ProSense™, | ||
| and MultiSense™) | ||
| Thoracic Surgery - ablation of arrhythmic cardiac tissue and cancerous lesions. Proctology - ablation of benign or malignant growths of the anus and rectum and hemorrhoids. | Proctology (ablation of benign or malignant growths of the anus and rectum and hemorrhoids). The system may be used with imaging device like ultrasound to provide realtime visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only. | |
| Use Environment | Professional healthcare environment | Professional healthcare environment |
| System Components | The system is comprised of three main subsystems: | |
| XSense (console) | ||
| CryoProbes | ||
| External dewar |
Optional accessories:
Introducer
Holder | The system is comprised of three main subsystems:
ProSense (console)
CryoProbes
External dewar
Optional accessories:
Introducer
Holder |
| Screen | Touch Screen mounted on the system's articulated arm.
Tilt, swivel options and adjustable positioning.
Screen size: 15.6" | Touch Screen mounted on the system.
Tilt and swivel options.
Screen size: 15.6" |
| Cooling System | Internal dewar of LN2 | Internal dewar of LN2 |
| Operating modes | Freeze Thaw Extraction Pause Stick | Freeze Thaw Extraction Pause |
| | Automatic/Manual/ pre-programmed freezing cycles | Automatic/Manual/pre-programmed freezing cycles |
| Procedure track record | Yes | Yes |
| Number of CryoProbes | 1 CryoProbe | 1 CryoProbe for ProSense™;
2 CryoProbes for MultiSense™ |
| | Subject Device | Predicate Device |
| Device Name | XSense Cryoablation System with
CryoProbes | Ice Cure Family Cryoablation
System (IceSense™3, ProSense™
and MultiSense™) |
| controlled by
the device | | |
| CryoProbe
pretest | Yes | Yes |
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Image /page/9/Picture/0 description: The image shows the logo for IceCure, a company that specializes in innovating cryotherapy solutions. The logo is set against a blue background. The word "IceCure" is written in a sans-serif font, with the "I" stylized to include a dot above it that resembles a water droplet. Below the company name is the tagline "Innovating Cryotherapy Solutions" in a smaller font.
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Image /page/10/Picture/0 description: The image is a logo for IceCure. The logo is set on a blue background. The text "IceCure" is in a sans-serif font, and below it is the text "Innovating Cryotherapy Solutions" in a smaller font. To the left of the text is a stylized image of a drop of liquid.
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Image /page/11/Picture/0 description: The image shows the IceCure logo, which features a stylized letter "U" with a dot above it, followed by the text "IceCure" in a clean, sans-serif font. Below "IceCure" is the tagline "Innovating Cryotherapy Solutions" in a smaller font. Underneath the logo is the text "Page 7 of 7" in a larger, serif font, indicating it is the last page of a document.
As described in the comparison table above, the subject XSense Cryoablation System with CryoProbes has the same intended use and indications for use, similar technological characteristics, and principles of operation as its predicate device. This is supported by performance testing deemed as required. Consequently, the technological differences between the XSense Cryoablation System with CryoProbes and its predicate device do not raise any new issues of safety or effectiveness.
1.4 Conclusions:
The XSense Cryoablation System with CryoProbes is substantially equivalent in terms of safety and effectiveness for requested indications for use to its predicate device, the ProSense™ Cryoablation System that was already cleared as part of the IceCure Medical Ltd's Family Cryoablation System (IceSense™3, ProSense™, and MultiSense™) (K183213).