(82 days)
The CryOmega is a disposable device intended for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. The list below shows examples of the type of lesions that can be treated.
-Genital Lesions -Molluscum Contagiosum -Seborrheic Keratoses -Skin Tags -Verruca Plantaris -Verruca Vulgaris -Verruca Plana -Actinic Keratosis -Lentigo
The CryOmega device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device contains a 16g cartridge of nitrous oxide that is dispensed once the device is activated. Physicians or medical professionals can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide (-89°C). Unlike the predicate device, the CryOmega is designed to be self contained and disposable after all of the liquefied gas has been dispensed.
The provided text is a 510(k) Premarket Notification Summary for the CryOmega device. It focuses on demonstrating substantial equivalence to a predicate device (Cryoprobe-C) rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device (SaMD) clearances.
Therefore, much of the requested information regarding AI device testing (such as sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone performance for an algorithm) is not applicable to this document. The CryOmega is a physical cryosurgical unit, not an AI/software device.
However, I can extract information related to the device's characteristics and the basis for its substantial equivalence.
Here's a breakdown of the requested information based only on the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a physical device, the "acceptance criteria" are not framed as statistical performance metrics for an algorithm but rather as characteristics demonstrating substantial equivalence to a predicate device. The "reported device performance" is essentially a comparison of its characteristics to the predicate.
| Characteristic / "Acceptance Criteria" | Predicate Device (Cryoprobe-C K024009) | CryOmega (Reported Device Performance) |
|---|---|---|
| Intended Use | To destroy tissue during surgical procedures by applying extreme cold. | Disposable device intended for surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures. Examples of treatable lesions listed: Genital Lesions, Molluscum Contagiosum, Seborrheic Keratoses, Skin Tags, Verruca Plantaris, Verruca Vulgaris, Verruca Plana, Actinic Keratosis, Lentigo. |
| Cryogen Characteristics | Nitrous Oxide, N2O at 50 bar pressure. 8g or 16g cartridges. | Nitrous Oxide, N2O at 50 bar pressure. 16g cartridge. |
| Materials | Housing: Aluminum; Micro-Applicator: unknown; Lock Cap: Plastic; Filter: Unknown; O-rings: Unknown; Cartridge: Metal. | Housing: Plastic; Filter: Plastic; O-rings: Butadiene-rubber; Cartridge: Metal. |
| Mode of Use | Apply Spray Topically. | Apply Spray Topically. |
| Mechanism of action | N2O gas is delivered to the treatment site at -89°C to effect cellular destruction. | N2O gas is delivered to the treatment site at -89°C to effect cellular destruction. |
| Storage Conditions |
§ 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.