(82 days)
Not Found
No
The description focuses on the mechanical function of dispensing cryogenic gas and does not mention any computational or data-driven processes indicative of AI/ML.
Yes
The device is intended for the surgical destruction of tissue for various lesions, which is a therapeutic purpose.
No
The device description states its purpose is for "surgical destruction of target tissue by applying cryogenic gases," which indicates a therapeutic rather than diagnostic function. The intended use also lists various lesions that "can be treated," further supporting its therapeutic role.
No
The device description clearly states it is a physical device containing a cartridge of nitrous oxide and designed to dispense it, indicating it is a hardware device, not software-only.
Based on the provided information, the CryOmega device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "surgical destruction of target tissue by applying cryogenic gases". This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device dispenses a gas for direct application to tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. The CryOmega is a surgical tool used for treatment.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
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. It is believed that this feature increases the safety of the device since operators cannot replace or access the high pressure gas cartridge. Additionally because the device is disposable there is no servicing or maintenance of the CryOmega device.
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
Physician or Licensed Practitioner
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.
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
CryOmega
PREMARKET NOTIFICATION SUMMARY
I. Device Name:
Proprietary Name - CryOmega Usual Name - Cryosurgical unit and accessories Classification Name - Class II, GEH
QCT 6 2010
II. Establishment Registration Number:
This 510(k) is submitted by STC Consulting LLC. The product will be manufactured by CryoConcepts LLP, a company owned by STC Consulting LLC.
III. Device Classification:
The CryOmcga is a Class II device according to Cryosurgical unit and accessories (21 CFR 878.4350) and has been assigned a product code of GEH.
IV. Performance Standards:
To date, no performance standards have been finalized which affect the CryOmega device.
. .
V. Proposed Labels, Labeling, Advertisements and Enginecring Drawings:
This document contains the proposed Instruction Manual for the CryOmega device
VI. Statement of Similarities and Differences to Legally Marketed Devices:
A summary of the substantial equivalence ("SE") analysis for the CryOmega versus the Cryoprobe-C is provided in the following table.
| 510k Predicate
Characteristic | Cryoprobe-C
Predicate
K024009 | CryOmega-
Substantial
Equivalence |
|------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cryoprobe-C
K024009
-Intended Use
Statement | Intended use: To
destroy tissue
during surgical
procedures by
applying extreme
cold | 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 |
| | | |
| | | |
| Cryoprobe-C | Nitrous Oxide, N20 | Nitrous Oxide, N20 |
| K024009 | at 50 bar pressure. | at 50 bar |
| -Cryogen | 8g or 16g | pressure. 16g |
| Characteristics | cartridges | cartridge |
| | | |
| Cryoprobe-C | Housing: Aluminum | Housing: Plastic |
| K024009 | Micro-Applicator: | Filter: Plastic |
| -Materials | unknown | O-rings: |
| | Lock Cap: Plastic | Butadiene-rubber |
| | Filter: Unknown | Cartridge: Metal |
| | O-rings: Unknown | |
| | Cartridge: Metal | |
| Cryoprobe-C | Apply Spray | Apply Spray |
| K024009 | Topically | Topically |
| -Mode of Use | | |
| | | |
| Cryoprobe-C | N20 qas is | N20 gas is |
| K024009 | delivered to the | delivered to the |
| -Mechanism of | treatment site at - | treatment site at |
| action | 89C to effect | -89C to effect |
| | cellular | cellular |
| | destruction | destruction |
| Cryoprobe-C |