(99 days)
Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
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 eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucccele cysts, multiple warts, plantar warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
- . Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
- t General surgery (palliation of the rectum, hemorrhoids, 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 (ablation of arrhythmic cardiac tissue cancerous lesions)
- t Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The IceEDGE 2.4 Cryoablation Needle is a sterile, single use, disposable component used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. It is intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The disposable cryoablation needle has a sharp cutting tip, a 2.4 mm shaft, a color-coded handle, gas tubing, and a connector. Additionally, the needle shaft exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceEDGE needle differs from the predicate devices in that it contains modified heat exchanger and a larger shaft diameter to enable the needle to produce a larger iceball size.
This document is a 510(k) summary for the IceEDGE 2.4 Cryoablation Needle. It describes the device, its intended use, and claims substantial equivalence to predicate devices based on performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Dimensional Specifications for needle | Met defined specifications (implies passing dimensional testing) |
| Functional Performance (e.g., gas flow, sealing) | Met defined specifications (implies passing functional testing) |
| Freezing Performance (e.g., iceball size, temperature) | Met defined specifications (implies passing freezing performance testing). Specific mention of "larger iceball size" compared to predicates due to design modifications. |
| Biocompatibility | Meets ISO 10993 requirements |
| Safety & Effectiveness (overall) | "Test results demonstrated that the IceEDG namedie meets defined specifications and does not raise any new safety or effectiveness issues." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Performance testing was conducted on IceEDGE Cryoablation Needle," but does not specify the sample size used for any of the tests (dimensional, functional, freezing performance, or in vivo ablation zone characterization).
The data provenance is not explicitly stated. However, the testing was conducted in-house by Galil Medical Ltd., and it is implied to be prospective as it was conducted specifically for this 510(k) submission. There is no mention of country of origin for the data beyond that it was conducted by the submitter (Galil Medical Ltd. in Israel).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided in the document. The document refers to "in vivo ablation zone characterization," which would typically involve expert interpretation (e.g., by pathologists or radiologists). However, the number and qualifications of such experts are not detailed.
4. Adjudication Method for the Test Set:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This study was not done. The document describes performance testing of the device itself and compares its technical specifications and intended use to predicate devices, but it does not involve human readers for comparative effectiveness.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
This concept does not apply to this device. The IceEDGE 2.4 Cryoablation Needle is a physical medical device (a cryoablation needle), not an algorithm or AI software. Therefore, a standalone algorithm performance study is not relevant.
7. Type of Ground Truth Used:
For the in vivo ablation zone characterization, the ground truth would likely be histopathological or imaging-based assessment by experts (e.g., pathology reports or radiological interpretations of ablation zones). However, the document only broadly states "in vivo ablation zone characterization" without specifying the precise method of ground truth establishment. For other tests (dimensional, functional, freezing), the "ground truth" would be the device specifications themselves (e.g., a specific length, a certain gas flow rate, a measured iceball diameter).
8. Sample Size for the Training Set:
This information is not applicable as this is a physical medical device and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as this is a physical medical device and not an AI/ML algorithm.
§ 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.