(90 days)
Not Found
Not Found
Unknown
The provided 510(k) summary is incomplete and lacks information about the device description, intended use, and any mention of AI/ML or related technologies. The presence of a predicate device (K030303) doesn't inherently indicate the presence or absence of AI/ML in the new device.
No
There is no information provided in the input that indicates this device is a therapeutic device. The only information available is the K number for a reference device.
No.
The provided text does not contain enough information to determine if the device is a diagnostic device. All fields are marked as "Not Found" except for a reference device with a K number, which alone doesn't clarify the device's diagnostic nature.
Unknown
The provided 510(k) summary is incomplete and lacks crucial information about the device description and intended use, making it impossible to determine if it is a software-only medical device.
Based on the information provided, it is not possible to definitively determine if this device is an IVD (In Vitro Diagnostic).
Here's why:
- The "Intended Use / Indications for Use" section is "Not Found". This is the most crucial section for determining if a device is an IVD. IVDs are specifically intended for use in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. Without the intended use, we cannot assess if it fits this definition.
- All other relevant sections are also "Not Found". Information about the device description, image processing, AI/ML, input modality, anatomical site, patient age, user/setting, training/test sets, performance studies, and key metrics would provide context about the device's function and how it is used. The absence of this information makes it impossible to infer its nature.
- The presence of a "Reference Device(s)" (K030303) is not sufficient to classify the device. While K030303 might be an IVD, a reference device is simply a device used for comparison or context, not necessarily a direct indication of the device's own classification.
In summary, without the intended use and other descriptive information, we cannot determine if this device is an IVD.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
K030303 has been converted to P020045/S5, approved on June 10, 2004.