(28 days)
The Galil Medical 1.5 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The 1.5 CX Cryoablation Needles, when used with a Galil Medical Cryoablation System, are designed to destroy tissue by the application of extremely cold temperatures. A full list of specific indications can be found in the respective Galil Medical Cryoablation System User Manual.
For reference, the indications for use from Galil Medical Cryoablation Systems User Manuals are provided below.
The Galil Medical Cryoablation Systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, oncology, and urology, The systems are designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, skin lesions) by the application of extremely cold temperatures. The Galil Medical Cryoablation Systems have the following specific indications:
• Urology Ablation of prostate tissue in cases of prostate cancer and Benign Prostate 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; Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the evelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
- Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
- General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma
- ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
- Thoracic surgery (with the exception of cardiac tissue)
- Proctology Ablation of benign or malignant growths of the anus or rectum
Galil Medical's IceSphere 1.5 CX Cryoablation Needle is a sterile, single use, disposable component, used in conjunction with a Galil Medical Cryoablation System to perform cryoablative destruction of tissue. The needle is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. Galil Medical's IceSphere 1.5 CX Cryoablation Needle is a disposable 1.5 mm needle that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. The IceSphere 1.5 CX Cryoablation Needle offers a handle configured in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).
This document is an FDA 510(k) Premarket Notification for the "IceSphere 1.5 CX Cryoablation Needle." It does not describe a study involving an AI/machine learning device or a comparative effectiveness study involving human readers and AI. Instead, it details the substantial equivalence of a new medical device (a cryoablation needle) to existing predicate devices.
Therefore, many of the requested criteria regarding AI model performance, human expert adjudication, MRMC studies, and ground truth establishment for AI training/testing sets are not applicable to the information contained in this document.
The document focuses on demonstrating that the new cryoablation needle has the same technology, principle of operation, indications for use, and performance characteristics as previously cleared devices. The "performance data" referred to are related to the physical and functional aspects of the needle itself, not to the diagnostic or predictive performance of an AI algorithm.
Summary of what can be extracted based on the provided document:
There is no information in this FDA 510(k) Premarket Notification that pertains to the acceptance criteria or study design for an Artificial Intelligence or Machine Learning (AI/ML) device. This document is for a cryoablation needle, a physical medical device, not an AI software. Therefore, the requested information elements (acceptance criteria for AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are not applicable to this submission.
The "Summary of Performance Data and Substantial Equivalence" section in the document refers to:
- Functional testing: Assessed electrical heater requirements and functional requirements of the needle.
- System compatibility testing: Ensured the needle would operate with the Galil Medical Cryoablation System.
- Labeling verification: Evaluated instructions for use and labeling accuracy.
These tests prove the physical device (the cryoablation needle) meets its specifications and performs equivalently to predicate devices, not that an AI model meets performance criteria.
§ 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.