(14 days)
The ERBECRYO 2 Cryosurgical Unit and Accessories are intended for (destruction) of tissue during surgical procedures by the application of extreme cold and for removal of foreign bodies, mucous plugs, necrotic tissue, and tissue biopsy by cryoadhesion.
Clinical Indications for Cryosurgery:
| Gynecology: | Cervical Erosions, Cervical Polyps, Condylomas, Chronic Cervicitis, Vulva Carcinoma (palliative),
Neoplasia |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Dermatology: | Leukoplakia, Fibroma, Condylomas, Basal Cell Carcinoma, Skin Tumor (palliative), Warts, Naephus |
| Ophthalmology: | Ablatio Retinae, Glaucoma, Lid Tumor |
| ENT: | Leukoplakia, Inoperable Tumor (palliative), Laryngeal Papilloma, Fibroma, Angioma, Haemangioma |
| Thoracic Surgery: | Post-Operative |
| Urology: | Prostate Tumor (palliative), Condylomas, Penile Tumor (palliative) |
| Phlebology: | Varicose Veins of the Lower Limbs (Cryo Stripping) |
| Proctology: | Hemorrhoids (1st and 2nd Degree), Pari-Anal Condylomas, Anal Tumor (palliative), Rectal Tumor
(palliative), Acute Anal Fissures |
| Pulmonology: | Tumors, Granulomatous Tissue, Malignant Lesions (palliative) |
| Pneumology: | Tracheobronchial Stenoses (Cryo re-canalization) |
The ERBECRYO 2 Cryosurgical Unit and Accessories consists of a cryosurgical unit, probes with a cryosurgical tip, a connecting hose to be connected to a CO2 (Carbon Dioxide) gas bottle and a footswitch for activation. The system is mounted on a cart, which also carries up to two CO2 gas bottles.
The ERBECRYO 2 Cryosurgical Unit and Accessories is used to apply extreme cold to tissue during surgical procedures. The system uses the Joule-Thomson principle where pressurized gas expands through a fine orifice inside the tip of the cryosurgical probe producing a rapid drop in temperature and freezing the probe tip and the surrounding tissue.
The unit and accessories are provided non sterile. The cryoprobes are reusable and directions for cleaning and sterilizing the cryosurgical probes are provided in the Notes on Use.
Design and materials of the ERBECRYO 2 Cryosurgical probes are very similar to the predicate probes.
I am sorry, but based on the provided text, there is no information about a study that describes acceptance criteria and proves the device meets those criteria. The document is a 510(k) premarket notification for a medical device (ERBE ERBECRYO 2 Cryosurgical Unit and Accessories), which focuses on demonstrating substantial equivalence to a predicate device.
The document mentions "Physical and Performance Testing" and states that "The system conforms with the following standards" and lists several international standards (e.g., EN ISO 14971, ANSI/AAMI ES60601-1). It also notes that "The intended use was validated in comparative tissue studies against the predicate system. The performance was similar for both systems." However, it does not provide:
- A table of specific acceptance criteria.
- Reported device performance against such criteria.
- Details about sample sizes for test sets, data provenance, or ground truth establishment.
- Information on expert involvement or adjudication methods.
- Any multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them from the given text.
§ 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.