Search Results

The CRYO-HITTM 200 System, like the already cleared CRYO-HITTM System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumor, lesions and warts.

In addition the CRYO-HIT™ 200 System has the following specific indications:

Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia ("BPH"))

Oncology (ablation of cancerous or malignant tissue, 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 female 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 hemangilomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, 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 rectum and ablation of hemorrhoids)

The CRYO-HIT™ 200 System is the exact same device as Galil Medical LTD's cleared CRYO-HIT™ System (K980913) except for the following tochnological modifications: (1) Additional accessories are made available (1.5 mm probe, multiprobe distribution panel). (2) disposable probes are added as an option; (3) an additional method of controlling the freeze process is offered; and (4) minor changes to the software that are necessary for the display of the screen information have been made: and (5) the probes are available in chrome-coated brass and the flexible hose is available in two additional materials.

The provided text describes the Galil Medical CRYO-HIT™ 200 System, a cryosurgical tool, and its substantial equivalence to previously cleared devices. However, it does not contain any information regarding acceptance criteria, device performance studies, sample sizes, expert involvement, ground truth establishment, or any other details typically found in a study proving device meet acceptance criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance metrics.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input.

To answer your request, I would need a document that describes:

1. Specific performance metrics (e.g., cooling rate, minimum temperature achieved, ice ball size, tissue necrosis depth).
2. Pre-defined acceptance criteria for these metrics.
3. A study protocol and results demonstrating how the CRYO-HIT™ 200 achieved these criteria.
4. Details on the study design, including sample sizes, data provenance, ground truth methods, and expert involvement.

Ask a specific question about this device

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.

Ask a specific question about this device