(78 days)
The CryOmega Flexx is intended for the surgical destruction of tissue by applying cryogenic gases at extreme low temperatures.
The List below shows examples of the types of lesions that may be treated:
- Molluscum Contagiosum
- · Skin Tags
- · Actinic Keratosis
- Lentigo
- · Verruca Plana
- · Verruca Vulgaris
- Verruca Plantaris
- · Genital Lesions
- · Seborrheic Keratosis
The CryOmega Flexx device is designed to dispense a continuous stream of liquid nitrous oxide when actuated. The device uses a 16g or 25g cartridge of nitrous oxide that is sprayed once the gas cartridge has been screwed onto the applicator. Licensed Practitioners can then dispense the gas for use in procedures requiring the destruction of tissue using the extreme cold of nitrous oxide, N2O (-89ºC).
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the CryOmega Flexx device:
The document is a 510(k) premarket notification summary for the CryOmega Flexx, a cryosurgical unit. It focuses on demonstrating substantial equivalence to a predicate device (CryOmega-K102006) rather than defining and proving new acceptance criteria for novel performance claims. Therefore, the "acceptance criteria" here are essentially the performance characteristics of the predicate device, which the new device must meet or be substantially equivalent to.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from Predicate Device Performance) | Reported CryOmega Flexx Performance |
|---|---|
| Cryogen Temperature at Treatment Site: -89°C | "replicate measurements of gas sprayed onto a thermocouple from each device were all less than -90°C" (This indicates it meets or exceeds the predicate's reported temperature.) |
| Amount of Gas Dispensed: (Implied by predicate) | **"replicate sprays of each device were performed, weighing the devices before and after a 5 second spray. The amount dispensed for the CryOmega Flexx and CryOmega were calculated and found to be |
§ 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.