(14 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 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 CS (Combo System) Surgical System consists of a compact, easy-to- operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).
The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.
The Cryocare CS unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.
An added feature to the Cryocare CS Surgical System is integration of the Terason 2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound module utilizes the Terason Model 2000 Handheld Ultrasound System using Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital views, and operates in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. This use includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or from the integrated Terason 2000 ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.
The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM-compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.
The provided text is a 510(k) summary for the Endocare Cryocare CS Surgical System. This document focuses on establishing substantial equivalence to previously cleared predicate devices, rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance metrics.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, ground truth establishment, expert qualifications, adjudication methods, and MRMC studies is not available in the provided text.
The document primarily describes the device, its intended use, and argues for its substantial equivalence to predicate devices (K023757, K002615, and K030191) based on shared:
- Intended use
- Operating principle
- Fundamental technology
- CryoProbes
- System design
- Patient contacting materials
- Manufacturing materials
- Packaging and sterilization methods
The information needed to fill out the table and answer the questions about performance studies is not part of a 510(k) summary focused on substantial equivalence for this type of device (a cryosurgical unit). Performance data for such devices typically revolves around safety and functional aspects (e.g., cooling rates, temperature accuracy), which are generally demonstrated through bench testing and, if applicable, pre-clinical animal studies, rather than clinical studies with "acceptance criteria" and "reported performance" in the way one might see for an AI/ML diagnostic device.
§ 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.