(175 days)
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No
The description focuses on the mechanical and thermal aspects of the device (Stirling cooler, temperature control) and does not mention any AI/ML components or functions.
Yes
The device is used to treat diseased, viral, premalignant, and malignant tissue, and to necrose unwanted tissue, which are therapeutic functions.
No
The device is described as a "Cryosurgical unit used for ablative type surgical technique" and an "instrument used to necrose unwanted tissue," indicating its primary function is therapeutic (tissue destruction/ablation), not diagnostic (identifying or characterizing disease).
No
The device description clearly outlines hardware components including pen cores, a Stirling cooler, reusable tips, and an external power supply. It is a physical cryosurgical unit, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "Cryosurgical unit used for ablative type surgical technique on multiple organ systems... to necrose unwanted tissue". This describes a surgical procedure performed on the patient's body, not a test performed on a sample taken from the patient.
- Device Description: The description details a system for freezing tissue in situ using a Stirling cooler and various tips. This is consistent with a surgical instrument, not a diagnostic device that analyzes biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), detecting analytes, or providing diagnostic information based on laboratory testing.
Therefore, this device falls under the category of a surgical instrument used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
Cryosurgical unit used for ablative type surgical technique on multiple organ systems, wide range of disease, viral, premalignant and malignant tissue.
Cryosurgical instrument used to necrose unwanted tissue in the gynecological and dermatological practice
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The CryoPen system provides a safe means of freezing tissue without the use of cryogenic liquids or greenhouse gases. The system consists of multiple pen cores, a Stirling cooler which rejects heat, and a variety of reusable tips for dermatologic and gynecology applications. When used properly, the system will deliver effective temperature for tissue ablation. The model number of this Cryosurgical system is CT-2000.
The Stirling cooler is used to lower the temperature of the CryoPen units to temperatures of -105 degrees Celsius. It operates on a 24 V DC external power supply powered by 115 (or 220) V AC obtained from conventional convenience outlets. The housing of the cooler provides necessary electrical safety features and electromagnetic compatibility. A temperature indicator indicates the readiness of the CryoPen units during cool down,
There are currently four different size tips for use in general surgery and dermatological applications as well as four different size tips for use in gynecology applications. They are:
| Application | Tip Sizes |
|---|---|
| General/Dermatology | 3mm, 5mm, 7mm, 10mm |
| Gynecology | 3mm, 10mm, 19mm, 25mm |
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
multiple organ systems, gynecological and dermatological practice
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The CryoPen cryosurgical system is substantially equivalent to the Wallach LL100 Predicate Device, approved on February 4, 1981, (reference K803311) based on the nonclinical bench testing performed on ballistic gelatin. Data generated from bench testing shows the CryoPen is able to freeze the same volume and mass as the Wallach LL100.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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