(62 days)
Urology
- The system may be used to ablate prostatic tissue. .
- . The system may be used for the ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Oncology
- The system may be used for ablation of cancerous or malignant tissue. .
- The system may be used for ablation of benign tumors. .
- The system may be used for palliative intervention. .
Dermatology
- The system may be used for the ablation or freezing of skin cancers and other . cutaneous disorders.
Gynecology
- The system may be used for the ablation of malignant neoplasia or benign . dysplasia of the female genitalia.
General Surgery
- The system may be used for the ablation of leukoplakia of mouth, 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, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions.
- The system may be used for the destruction of warts or lesions. .
- . The system may be used for the palliation of tumors of the oral cavity, rectum, and skin.
Thoracic Surgery
- The system may be used for the ablation of arrhythmic cardiac tissue. .
The system may be used for the ablation of cancerous lesions .
Proctologv
- . The system may be used for the ablation of benign or malignant growths of the anus and rectum
- . The systems may be used for the ablation of hemorrhoids.
The ICE-SENSE™ Device is used to destroy unwanted tissue by application of extreme cold to the selected site. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable sharp or blunt probes. The device consists of a main chassis for the cooling system, a controller with a screen and key pad, a cryohandle that controls and holds the probe and a foot pedal.
The Arbel Medical Ltd. ICE-SENSE® Device is a cryosurgical unit that destroys unwanted tissue by applying extreme cold. It uses a closed system with pressurized liquid nitrogen and disposable sharp or blunt probes.
Here's an analysis of the provided information regarding its acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria & Reported Device Performance:
The provided 510(k) summary does not explicitly state specific quantitative acceptance criteria or reported device performance metrics in a tabular or detailed format. Instead, it relies on demonstrating substantial equivalence to predicate devices.
The core "acceptance criterion" indirectly stated is that the device must be "substantially equivalent" to legally marketed predicate devices in terms of intended use, indications for use, principles of operation, and technological characteristics, without raising new issues of safety and effectiveness.
- Acceptance Criterion (Implied): Substantial equivalence to predicate devices (Cryomedical Sciences Cryolite (K970995), Cryomedical Sciences Accuprobe 610 (K964366, K973190), and Galil Medical Cryo-Hit (K980913)) in:
- Intended Use
- Indications for Use
- Principles of Operation
- Technological Characteristics
- No new issues of safety and effectiveness.
- Reported Device Performance (as claimed by manufacturer): "The ICE-SENSE™ has the same intended use and indications for use, principles of operation and technological characteristics as its predicate devices. The slight differences between ICE-SENSE™ and its predicate devices do not raise any new issues of safety and effectiveness. Arbel's ICE-SENSE™ is substantially equivalent to a combination of the above named predicate devices and the minor differences detailed in the discussion do not raise additional concerns of safety or efficacy."
2. Sample Size Used for the Test Set and Data Provenance:
The document does not mention any specific "test set" in the context of a clinical performance study using patient data. The primary approach for demonstrating safety and effectiveness for this 510(k) relies on substantial equivalence to predicate devices, not on a new clinical study with a patient test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
This information is not applicable as the submission does not describe a clinical study with a test set requiring expert-established ground truth.
4. Adjudication Method for the Test Set:
This information is not applicable as the submission does not describe a clinical study with a test set requiring an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The submission focuses on technological equivalence rather than human-in-the-loop performance with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No, a standalone algorithm performance study was not done or described. The device is a cryosurgical unit, a hardware device, not an AI/algorithm-based diagnostic or therapeutic system.
7. The Type of Ground Truth Used:
Ground truth, in the context of a clinical study, is not explicitly mentioned or used in this submission, as the approval route is based on substantial equivalence to existing predicate devices, not on proving effectiveness through new clinical data requiring ground truth.
8. The Sample Size for the Training Set:
This information is not applicable as the submission does not describe an AI/algorithm-based system that would require 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; there is no AI/algorithm training set described.
§ 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.