Model note · Cryotherapy System
IceCure ProSense Cryoablation System
ProSense is a single probe cryoablation console that freezes tissue with liquid nitrogen held in an internal dewar and fed in a closed circuit to a disposable cryoprobe. It is cleared in the US as a general cryosurgical tool and, since a 2025 De Novo grant, for local treatment of low risk breast cancer in patients aged 70 or over. Under ultrasound guidance an elliptical ice ball forms around the probe tip, and active nitrogen gas thawing releases the probe.
The model
Maker, model and type.
- Maker
- IceCure Medical Ltd.
- Model
- ProSense Cryoablation System (FAS3000000)
- Device type
- Cryotherapy System
- Main document
- Open the public document
Key specifications
What the public record says.
| Item | Value | Source |
|---|---|---|
| Cryogen and cooling system | Pressurised liquid nitrogen in an internal small dewar, closed system | Source |
| Thawing method | Active thawing with nitrogen gas | Source |
| Minimum cooling zone temperature | -170 degrees C at the cryoprobe cooling zone centre | Source |
| Cryoprobe range | 10 G or 13 G, spherical or elliptical ice ball, shafts 124 to 185 mm | Source |
| Breast cancer probe | 10 G elliptical, 140 mm shaft (FAP7200000), the only probe validated for that indication | Source |
| Default breast protocol | Two freezes of 9 minutes with an 8 minute thaw between; up to seven freeze and thaw steps allowed | Source |
| Probe extraction temperature | Tip no warmer than 35 degrees C | Source |
| Supply voltage (US models) | 100 to 127 VAC (FAS3000000 and FAS3000000-2) | Source |
| Sterile accessories | Probes, introducers and temperature sensor are EtO sterilised, 5 year shelf life | Source |
| FDA status | K183213 general cryosurgery (2019); De Novo DEN220077, product code QXW, 21 CFR 878.4355 (2025) | Source |
Recalls
Known FDA recalls.
- Z-2650-20232019-09-16
User manual updated (DSR3200000 Rev. E) with safety guidance for mechanically damaged cryoprobes.
FDA record
Safety
Safety warnings from the record.
- For breast use, practice in patients with implants is not established; the distance between lesion and implant must be documented as adequate. Source
- The breast indication is limited to biologically low risk tumours of 1.5 cm or less in patients 70 or older on adjuvant endocrine therapy. Source
- FDA lists electrical, thermal or mechanical injury and incomplete ablation needing further treatment among the risks to health. Source
- MAUDE records include use of incorrect control or treatment settings, so protocol settings should be checked before freezing. Source
Sources
Where this note comes from.
- FDA De Novo DEN220077 decision summary, ProSense Cryoablation System
- FDA 510(k) K183213 summary, IceSense3, ProSense, MultiSense
- FDA recall Z-2650-2023, ProSense
- openFDA MAUDE problem counts, brand PROSENSE
Not covered: The ProSense user manual (DSR3200000) is not public, so no alarm or error codes, dewar capacity, fill procedure or part numbers beyond those quoted by FDA are given. The manufacturerUrl is the IceCure corporate site and was not opened. MAUDE counts are small.
BMEssentia knowledge drafted from public information, reviewed by Hasan Khaled Ismail on 2026-10-24. Always follow the manufacturer's instructions for use and service manual.
Cryotherapy System
Other models of this device.
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