(28 days)
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families 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 by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needle families 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, mucocele cysts, multiple warts, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
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· 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)
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· Thoracic surgery (with the exception of cardiac tissue)
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· Proctology (ablation of benign or malignant growths of the anus or rectum)
Galil Medical's IcePearl 2.1 CX, IceFORCE 2.1 CX, IcePearl 2.1 CX L, and IceFORCE 2.1 CX L Cryoablation Needles (collectively referred to as the 2.1 CX Cryoablation Needles) are sterile, single use, disposable components, when used in conjunction with Galil Medical's commercially available cryoablation systems, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application.
The 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both the IcePearl and IceFORCE needle families offer handles configured as straight and in a 90-degree angled configuration (to aid positioning of the needle within the CT imaging system gantry). Additionally, both needle families offer a long version of the needle that contains a longer needle shaft and a 90-degree angled handle configuration (IcePearl 2.1 CX L and IceFORCE 2.1 CX L).
The change presented in this Special 510(k) is an internal component change. There are no changes to the intended use, indications for use, or technological characteristics.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles.
Overall Assessment:
The provided document is a 510(k) Summary for a Special 510(k) submission. This type of submission is used when there are modifications to a legally marketed device that do not affect its intended use or fundamental scientific technology. The primary purpose of the testing described is to confirm that the changes made to the device (a component change) do not negatively impact its existing safety and performance characteristics and that it remains substantially equivalent to its predicate.
Therefore, the document does not contain information about a comprehensive clinical study to establish initial efficacy or performance against new acceptance criteria. Instead, it focuses on demonstrating that the modified device still meets the established performance specifications of the predicate devices.
Detailed Breakdown of Requested Information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Specification) | Reported Device Performance (Modified Device) |
|---|---|
| Needle temperatures met specifications for freezing and thawing | Met specifications |
| Electrical insulation requirements | Verified electrical insulation |
| Durability requirements | Verified durability |
| Freezing performance specifications | Met freezing performance specifications |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes or the data provenance (e.g., country of origin, retrospective/prospective) for any of the performance tests. It states that "Verification and performance testing was conducted on needles built with the modified component." Given it's a Special 510(k) for a component change, the testing would likely involve a statistically appropriate number of units to demonstrate consistent performance within a manufacturing batch, rather than a large clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of submission. The ground truth for this device's performance is based on engineering specifications and physical measurements (e.g., temperature, electrical resistance, freezing rates), not on expert clinical assessment or consensus.
4. Adjudication method for the test set
This information is not applicable. Since the testing is based on direct physical measurements against engineering specifications, there is no need for expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This information is not applicable. The device is a cryosurgical needle, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical cryosurgical needle, not an algorithm.
7. The type of ground truth used
The ground truth for the performance testing of this cryoablation needle is based on engineering specifications and physical measurements. These specifications would have been established during the development and initial clearance of the predicate devices, covering aspects like target temperatures, freezing rates, electrical integrity, and material durability.
8. The sample size for the training set
This information is not applicable. The device is a physical medical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable for the same reason as above.
§ 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.