(63 days)
The Cryocare CS Surgical 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 designed to freeze/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 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 the 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 or rectum
- Ablation of hemorrhoids
Thoracic Surgery
- Ablation of arrhythmic cardiac tissue
- Ablation of cancerous lesions
The Endocare™ Cryocare CS® Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe® devices to monitor temperatures in the surrounding tissue.
The provided document is a 510(k) summary for the Cryocare CS Surgical System. It describes the device, its intended use, and its equivalence to predicate devices, but does not contain details about acceptance criteria, a specific study proving device performance against those criteria, or clinical study specifics like sample sizes, ground truth establishment, or expert involvement.
Therefore, I cannot provide the requested information. The document explicitly states "NON-CLINICAL TESTING" was performed, including "Isotherm Testing," but these are not clinical studies with patients and diagnostic performance metrics. The conclusion states that the devices "have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use," based on a comparison of indications for use, technological characteristics, and isotherm data, rather than a clinical study.
§ 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.