(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 intended use of the 10LAP4 probe, when used as a part of the Cryocare CS Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the human body and is a subset of the uses cleared under K043278, and is documented in Section 4.3 of this submission.
The Cryocare CS 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 Surgical system 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.
The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated 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 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows:
Frequency: 7.0 MHz
Elements: 128
Array type: Linear
Pitch (mm): 0.30
Elevation width (mm): 5.0
Geometric focus (mm): 25
Azimuth radius (mm): N/A
Azimuth length (mm): 38.4
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 describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices. It does not present any clinical study data or acceptance criteria for a device's performance, as would be found in a study demonstrating the efficacy or safety of a new medical device.
Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided document.
The document indicates that the device has the "same intended use" and "same operating principle and has not altered the fundamental technology" as its predicate devices (K032333 and K043278). This suggests that substantial equivalence was established primarily through comparison to existing devices rather than new clinical performance data.
§ 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.