(125 days)
The Galil Medical IceRod CX Cryoablation Needle is intended for cryoablative destruction of tissue during surgical procedures. The IceRod CX Cryoablation Needle is 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, 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.
The Galil Medical IceRod CX Cryoablation Needle has 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, mucocele 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)
- . General surgery (palliation of tumors 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 (with the exception of cardiac tissue)
- . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The IceRod CX Cryoablation Needle is a sterile, single use, disposable component used in conjunction with Galil Medical's Visual-ICE 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 IceRod CX disposable cryoablation needle has a 17G shaft, a sharp cutting tip, a color-coded handle, a gas tube, and a connector containing a small PCB board capable of relaying needle information such as needle type, lot number, and expiration date information to Galil's Visual-ICE Cryoablation System. Additionally, the needle exhibits markings to aid in positioning the needle in tissue. The IceRod CX needle differs from the predicate devices in that the distal shaft of the needle contains a non-stick coating and Galil's i-Thaw electrical thaw technology can be used for FastThaw and/or Track Ablation following a cryoablation procedure when used with Galil's Visual-ICE Cryoablation System.
The provided text describes the IceRod CX Cryoablation Needle and its substantial equivalence to predicate devices, focusing on design differences and intended use rather than specific acceptance criteria or a detailed study plan to demonstrate device performance against such criteria. Therefore, much of the requested information cannot be extracted directly from the given document.
Here's a breakdown of what can be inferred and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results in a quantitative manner. It states that "Performance testing was conducted on IceRod CX Cryoablation Needle to verify safety and performance characteristics and to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional testing, functional testing, freezing performance, and in vivo needle track ablation, based on depth of tissue necrosis characterization." It concludes that "Test results demonstrated that the IceRod CX needle meets defined specifications and does not raise any new safety or effectiveness issues."
However, specific acceptance criteria values (e.g., maximum freezing temperature, ice ball size, thaw rate) and the measured performance metrics are not provided.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Dimensional Testing | Meets defined specifications |
| Functional Testing | Meets defined specifications |
| Freezing Performance | Meets defined specifications |
| In Vivo Needle Track Ablation (depth of tissue necrosis characterization) | Meets defined specifications |
| Biocompatibility | Meets requirements outlined in ISO 10993 |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "in vivo needle track ablation" which implies an animal or cadaver study, but the number of needles or test subjects is not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective). The in vivo nature suggests prospective experimental testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not mentioned in the document.
4. Adjudication Method for the Test Set
Not mentioned in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study is not mentioned. This type of study is more relevant for diagnostic imaging devices where human readers interpret output, not for a cryoablation needle's performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable as the device is a cryoablation needle, not an algorithm or AI system. Its performance is related to its physical and thermodynamic properties, not an algorithm's output.
7. The Type of Ground Truth Used
The "ground truth" for the performance testing cited appears to be based on:
- Defined specifications: For dimensional, functional, and freezing performance.
- Depth of tissue necrosis characterization: For in vivo needle track ablation, likely determined through histological examination or similar scientific assessment in a lab setting.
- ISO 10993 requirements: For biocompatibility, involving standardized tests.
8. The Sample Size for the Training Set
This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable as the device is a cryoablation needle, not an AI or machine learning model that requires a training set.
§ 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.