(84 days)
No
The description focuses on the mechanical and thermal aspects of the cryosurgical system and probes, with no mention of AI or ML capabilities.
Yes
The device is designed for the ablation of tissue for various medical conditions and procedures, which is a therapeutic intervention.
No
This device is a cryosurgical system designed for the ablation (removal) of tissue, which is a therapeutic function, not a diagnostic one. It uses thermocouples to monitor temperature during the ablation procedure, but this monitoring is for controlling the treatment, not for diagnosing a condition.
No
The device description explicitly states it consists of a control unit, cryoprobes, and thermocouple inputs, which are all hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "ablation of tissue" in various surgical specialties. This is a direct therapeutic intervention performed on the patient's body.
- Device Description: The description details a cryosurgical system that uses cryoprobes to freeze and destroy tissue. This is a surgical tool used during a medical procedure.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The ENDOcare CRYOcare™ Cryotherapy System is a surgical device used for tissue ablation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ENDOcare CRYOcare™ Cryotherapy System is designed for use in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology and urology for the ablation of tissue, including liver metastases, skin lesions, warts and removal of prostate tissue.
Product codes
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Device Description
The current ENDOcare CRYOcare™ Cryosurgical System is a cryosurgical system that consists of a control unit and eight cryoprobes. The Cryosurgical System also incorporates independent thermocouple inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power. The control units for the 2 and 5-probe models will have the same performance characteristics as the 8-probe model. The only difference will be in the outer case which will be smaller and more cost effective to meet the needs of different customers.
At the heart of the ENDOcare CRYOcare™ Cryosurgical System is the Cryoprobe. The Cryoprobes limit the extreme cold zone to a small active area at the tip, which results in an overall more efficient surgical tool. The probes are supplied sterile and individually packaged. The probes used for the 2-probe and 5-probe output configurations are exactly the same as those for the 8-probe output configuration. The ENDOcare Cryoprobe is a single use cryostat. Cryostats have been used as refrigerant devices for the past one hundred years. The Cryoprobe has no moving parts and is made of standard surgical stainless steel. The ENDOcare Cryoprobe is small enough in diameter to used medically, yet generates enough cooling capacity to effectively ablate tissue
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
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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
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Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
Section 2.0 - SMDA 1990 Requirements
2.1 510(K) Summary
DEC 1 8 1996
Device Description
The current ENDOcare CRYOcare™ Cryosurgical System is a cryosurgical system that consists of a control unit and eight cryoprobes. The Cryosurgical System also incorporates independent thermocouple inputs to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power. The control units for the 2 and 5-probe models will have the same performance characteristics as the 8-probe model. The only difference will be in the outer case which will be smaller and more cost effective to meet the needs of different customers.
At the heart of the ENDOcare CRYOcare™ Cryosurgical System is the Cryoprobe. The Cryoprobes limit the extreme cold zone to a small active area at the tip, which results in an overall more efficient surgical tool. The probes are supplied sterile and individually packaged. The probes used for the 2-probe and 5-probe output configurations are exactly the same as those for the 8-probe output configuration. The ENDOcare Cryoprobe is a single use cryostat. Cryostats have been used as refrigerant devices for the past one hundred years. The Cryoprobe has no moving parts and is made of standard surgical stainless steel. The ENDOcare Cryoprobe is small enough in diameter to used medically, yet generates enough cooling capacity to effectively ablate tissue
Substantial Equivalence Support
The ENDOcare CRYOcare™ Cryotherapy System is designed for use in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology and urology for the ablation of tissue, including liver metastases, skin lesions, warts and removal of prostate tissue. The current ENDOcare CRYOcare™ Cryotherapy System includes an 8-probe output model which was originally determined to be substantially equivalent on January 19, 1995 (reference K942299). The system will also be marketed in smaller, more cost effective models that utilize less probes. In addition to the 8-probe output model, ENDOcare will market a 2-probe output and a 5-probe output model. The additional models are substantially equivalent to the previously cleared device. The performance characteristics and technology will remain the same. The primary difference is that the number of probes will be less and the control units will be smaller to meet the different needs of customers.
Sterilization Methodology
The following sterilization information is applicable to the Cryoprobes only. Sterilization validation will be conducted utilizing an overkill method based on the recommendations in the current American Association for the Advancement of Medical Instrumentation (ANSUAAMI/ISO 11135-1994) Guideline for Industrial Ethylene Oxide.
1
Sterilization of Medical Devices. A minimum Sterility Assurance Level (SAL) of 104 will be achieved. Sterile barrier packaging will consist of standard disposable medical device packaging containing a plastic film and a coated paper side. This is the same sterile barrier packaging that is used with the 8-Probe model. Maximum levels of EtO residuals will not exceed:
25 ppm for ethylene oxide 25 ppm for ethylene chlorohydrin 250 ppm for ethylene glycol