(88 days)
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.
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.
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.
The system is comprised of three main subsystems: XSense (console), CryoProbes, External dewar. Optional accessories: Introducer, Holder.
The provided text is a 510(k) Summary for the XSense Cryoablation System with CryoProbes. It compares the subject device to a predicate device (ProSense™ Cryoablation System) to demonstrate substantial equivalence, rather than providing a performance study of an AI/ML powered device.
Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance for an AI/ML model.
- Details on sample size, data provenance, expert adjudication, MRMC studies, or standalone algorithm performance.
- Information on ground truth establishment or training set details relevant to AI/ML.
The provided text focuses on the device's intended use, technological characteristics, and safety and effectiveness relative to a traditional medical device predicate, not an AI-powered one.
§ 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.