(396 days)
The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. It is 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 system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. The system has the following specific indications: Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Palliation of tumors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and sebortheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). Thoracic Surgery (ablation of arrhythmic cardiac tissue and cancerous lesions). Proctology (ablation of benign or malignant growths of the anus and rectum and hemorrhoids). The system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only.
The IceCure Family of cryotherapy devices includes the IceSense™3 single-probe system (cleared under 510(k) #K102360 and rebranded as ProSense™), and MultiSense™ – a new system that accommodates up to three cryoprobes operating in parallel. The systems are used to destroy unwanted tissue by application of extreme cold to the selected sites. The devices deliver cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The devices consist of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction.
This document is a 510(k) premarket notification for the IceCure Family Cryoablation System, specifically K183213. It details the device's characteristics and compares it to predicate devices to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:
Important Note: This submission is for a medical device (cryoablation system) and not an AI/software device that would typically involve a multi-reader multi-case (MRMC) study or complex AI performance metrics like sensitivity, specificity, etc., established against expert ground truth for image interpretation. The "acceptance criteria" here relate to the engineering and performance specifications of the physical device and its cryoablation capabilities, compared to its predicates.
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (cryoablation system), the acceptance criteria are based on functional performance, safety standards, and equivalence to predicate devices, rather than diagnostic accuracy metrics of an AI.
| Acceptance Criteria Category | Specific Criteria/Tests | Reported Device Performance |
|---|---|---|
| Safety & Performance Standards Conformance | Electrical testing (ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012) | Compliant |
| Electromagnetic Compatibility (EMC) (IEC 60601-1-2 Edition 4.0 2014-02) | Compliant | |
| Software Validation and Verification | Functioned as intended; met acceptance criteria | |
| Sterilization | Validated per ISO 11135 (Ethylene Oxide cycle) for accessories (probes, introducers, temperature sensor) | Accessories were sterilized in accordance with ISO 11135 |
| Biocompatibility | Evaluation per FDA's "Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1" (for patient-contacting materials) | Not required as no changes in patient contacting materials were made compared to predicates. |
| Bench Testing (MultiSense performance) | Ability to create an iceball of at least 40 mm diameter for a single probe (in 15 min freeze) | Achieved; "at least 40 mm diameter" for single probe |
| Ability to create an iceball of at least 94 mm diameter for a three-probe system (in 15 min freeze) | Achieved; "at least 94 mm" for a three-probe system | |
| Shaft temperature remained within device specifications during freeze, thaw, and warm phases. | Demonstrated; "remained within the device's specifications" | |
| Time change of iceball size and probe tip temperature similar to predicate devices. | Similar to predicate devices | |
| Iceball isotherm measurements met device's specifications. | Results met the device's specifications | |
| Comparison to Predicate Devices | Same intended uses and indications | Yes |
| Same technological characteristics | Yes | |
| Same principles of operation | Yes | |
| Minor technological differences do not raise different issues of safety or effectiveness. | Performance data demonstrate safety and effectiveness similar to predicates. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a "sample size" in terms of number of cases or patients for a test set, as this was not a clinical performance study in the way an AI diagnostic device would require.
- Test Set: The "test set" here refers to the physical devices and their components undergoing bench testing, electrical safety, EMC, and sterilization validation. The number of units tested is not specified but would follow standard engineering and quality assurance protocols for device validation.
- Data Provenance: The data provenance is from bench testing and validation activities performed by the manufacturer (IceCure Medical LTD.), likely at their facility in Israel, in accordance with international and FDA standards. This is prospective testing as it's part of the device development and regulatory submission process. There is no mention of patient data (retrospective or prospective) for performance evaluation, as clinical testing was not deemed necessary for this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable in the context of this device and submission. "Ground truth" in this submission refers to:
- Established engineering specifications and performance targets (e.g., specific cryotemperature, iceball size, electrical safety limits).
- Compliance with recognized industry standards (e.g., ISO, IEC).
- Comparison to the performance of legally marketed predicate devices.
These are validated through engineering measurements, not via expert interpretation of data like in an image-based AI diagnostic study.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used for consensus reading in clinical studies, particularly for human ground truth establishment in diagnostic accuracy studies. For device performance testing, results are quantitative measurements against predefined specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A MRMC study was not conducted because:
- This is a physical cryoablation system, not an AI or diagnostic imaging device that assists human readers in interpretation.
- The FDA determined that "Clinical testing was not required to demonstrate the safety and effectiveness of the device."
Therefore, no effect size of human readers improving with AI assistance is applicable or reported.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance)
Not applicable. This device is a cryoablation system, which is a surgical tool, not a diagnostic algorithm. Its performance is evaluated on its ability to generate an iceball, maintain temperatures, and conform to safety standards, not on an algorithm's diagnostic output.
7. Type of Ground Truth Used
The "ground truth" for this device's performance acceptance is based on:
- Engineering Specifications: Predefined quantitative targets for device function (e.g., iceball size, temperature ranges, operational parameters).
- Compliance with Recognized Standards: Meeting requirements of international standards for electrical safety (IEC 60601-1, IEC 60601-1-2), sterilization (ISO 11135), and biocompatibility (ISO 10993-1).
- Equivalence to Predicate Device Performance: Demonstrating that the performance characteristics (e.g., iceball formation, temperature control) are "similar" to or "as safe and effective as" those of the already cleared predicate devices.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
§ 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.