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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 leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, 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 CRYOcare V-probe is a CRYOprobe accessory to be used in conjunction with the CRYOcare CS Surgical System. The indications for use have not changed. The V-Probe delivers cold temperatures via Argon gas utilizing the Joules Thompson principle to targeted tissue. The patient contact V-Probe (an accessory item to the CRYOcare CRYOsurgical CS System) is supplied as a single use Sterile Disposable item.

The provided document is a 510(k) summary for the Endocare Cryocare CS Surgical System. This type of regulatory submission establishes substantial equivalence to a predicate device rather than proving performance against specific acceptance criteria through a de-novo study.

Therefore, the document does not contain any information regarding specific acceptance criteria, a study proving the device meets those criteria, or the details of such a study (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance data).

The "SUMMARY OF SUBSTANTIAL EQUIVALENCE" section explicitly states that the device is considered substantially equivalent to predicate devices due to similarities such as:

• Same intended use
• Same operating principle
• Same system design
• Same patient contacting materials
• Same manufacturing materials
• Same packaging and sterilization processes

Since the device is claiming substantial equivalence, a detailed performance study as outlined in your request is typically not required unless there are significant changes that raise new questions of safety and effectiveness.

In summary, the information requested in your prompt is not available in the provided 510(k) summary.

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