(90 days)
The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ System is intended for cryogene as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, general surgery, oncology, and urology, and urology, The system is designed to gynecology, oncology, proctorogy, and aronegy of temperatures including prostate and kidney tissue, liver metastascs, turnors, skin lesions, and warts.
In addition the modified CRYO-HIT™ System has the following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hynernlasia "BPH")
Oncology (ablation of cancerous or malignant tissue, and ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the fomale genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or recturn, and ablation of hemorrhoids)
The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe got a available in each model (1-probe, 2-probe, 3-probe, 4-probe, 5-probe, 5-probe, 7-probe and 8-probe configurations) and the number of temperature sensor ports, to meet the needs of different customers.
The probes that can be used in the different configurations are exactly the same. The modified CRYO-HIT™ System is the exact same device as Galil Medical I.TD's cleared CRYO-HIT™ System (K980913) except for the following technological modifications: (1) Additional probes are made available; (2) single use probes are added as an option; (3) a foot pedal is added as an operating option; (4) the number of probes and external thermocouples is more varied; (5) the modified CRYO-HIT™ System allows an additional method of controlling the freeze process; and (6) minor changes to the software that are necessary for the display of the screen informations
The provided document is a 510(k) summary for the Galil Medical CRYO-HIT™ System, which is a cryosurgical unit. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.
Therefore, I cannot provide the requested information from the given text.
The information includes:
- Company Name: Galil Medical Ltd.
- Trade/Proprietary Name: CRYO-HIT™ System
- Classification Name: CRYOSURGICAL UNIT
- Predicate Devices: ENDOcare CRYO-HIT™ System
- Indications for Use: Cryogenic destruction of tissue during surgical procedures in various fields (general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology). Specifically for ablating prostate and kidney tissue, liver metastases, tumors, skin lesions, warts, and other specified conditions.
- Device Description: Multiple models with varying numbers of probe ports (1-8), but same performance, technology, and intended use. Modified version includes additional probes, single-use probes option, foot pedal, more varied probe/thermocouple numbers, an additional freeze process control method, and minor software changes.
- Claim of Substantial Equivalence to previously cleared CRYO-HIT™ System (K980913) and ENDOcare system.
- FDA 510(k) clearance letter (K991272) dated February 21, 2008 (correcting a previous letter from July 12, 1999).
To answer the questions, information on clinical or non-clinical performance testing would be necessary, which is not present in this 510(k) summary. Usually, a 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results as an IDE or PMA submission would.
§ 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.