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The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), 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, tumors, skin lesions, and warts.

The SeedNet System has the following specific indications:

• Urology (ablation of prostate tissue in cases of prostate cancer and t Benign Prostate Hyperplasia "BPH")
• Oncology (ablation of cancerous or malignant tissue and benign I tumors, and palliative intervention)
• Dermatology (ablation or freezing of skin cancers and other cutaneous . disorders. Destruction of warts or lesions, 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, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin.)
• Gynecology (ablation of malignant neoplasia or benign dysplasia of I the female genitalia)
• General surgery (palliation of tumors of the rectum, hemorrhoids, ı anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
• ENT (Palliation of tumors of the oral cavity and ablation of . leukoplakia of the mouth)
• Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous . lesions)
• Proctology (ablation of benign or malignant growths of the anus or # rectum, and hemorrhoids)

Cryosurgical unit with argon-cooled probes. The SeedNet Family System includes the SeedNet®/SeedNetGold® System, CryoThera® System, and Cryo-Hit® System. Modifications include the addition of a longer 17G (1.5mm) needle, a 90° needle, a needle/TS holder stand, and the addition of CT as an imaging modality to the device labeling, in addition to MRI and ultrasound.

Please find below the requested information based on the provided text.

Acceptance Criteria and Device Performance:

The document indicates that the modified SeedNet Family underwent a "comprehensive testing process as part of the design verification process." This implies that specific acceptance criteria were defined for these tests. However, the document does not explicitly state what these acceptance criteria were or provide detailed quantitative performance results against them. It broadly states that the device is "substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet Family."

Therefore, for the table, since specific numerical acceptance criteria and reported performance values are not provided, I will use the descriptive information available.

• Longer 17G (1.5mm) needle (modification of cleared 1.5mm stainless steel cryoneedle).
• 90° needle (modification of cleared 1.5mm stainless steel cryoneedle).
• Needle/TS holder stand.
• CT as an imaging modality in labeling (in addition to MRI and ultrasound).
  Deemed substantially equivalent to predicate devices, indicating these modifications did not alter fundamental technological characteristics negatively. |
  | Mode of Operation: Substantially equivalent to predicate devices. | No changes in the fundamental mode of operation (cryogenic destruction of tissue by applying extreme cold temperatures) reported, maintaining substantial equivalence. |
  | Performance Characteristics: Substantially equivalent to predicate devices. | The device underwent "comprehensive electrical, mechanical and biocompatibility testing." The submission concludes that it "does not raise any new safety and/or effectiveness issues," implying performance characteristics are consistent with the predicate devices. Specific quantitative performance metrics (e.g., cooling rates, ice ball dimensions, mechanical strength) are not provided in this summary. |
  | Intended Use: Identical to predicate devices, for cryogenic destruction of tissue across specified medical fields. | The intended use statement for the modified SeedNet Family is identical to the original SeedNet System, covering general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology, with specific indications including ablation of prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. |
  | Safety: No new safety issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new safety issues. |
  | Effectiveness: No new effectiveness issues raised. | Comprehensive electrical, mechanical, and biocompatibility testing conducted. The device was found not to raise any new effectiveness issues. |

Detailed Study Information:

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • The provided text does not specify a sample size for a test set, nor does it describe a study involving patient data (retrospective or prospective) for performance evaluation in the context of substantial equivalence. The "testing process" mentioned refers to design verification, including electrical, mechanical, and biocompatibility tests of the device itself, rather than a clinical performance study using patient data.
   • No country of origin for such data is mentioned.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • The document does not describe a study that involved establishing ground truth by human experts for a test set of medical images or patient outcomes. The testing reported is for device verification (electrical, mechanical, biocompatibility).

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • No adjudication method is mentioned as there is no described study involving expert review or a test set requiring adjudication in the context of clinical performance.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study is mentioned. This device is a cryosurgical unit, not an AI-assisted diagnostic tool for image interpretation, so such a study would not be relevant in this context.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a medical device (cryosurgical unit), not a software algorithm or AI. The performance discussed is about the physical device and its components.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the device verification mentioned (electrical, mechanical, biocompatibility testing), the "ground truth" would be established by engineering and laboratory standards, specifications, and reference materials. No clinical outcomes data, pathology, or expert consensus on clinical cases are mentioned as part of the evidence for substantial equivalence, beyond the broad claim that the device raises no new safety or effectiveness issues for its intended use.

7. The sample size for the training set:

   • Not applicable. This is a physical medical device, not an AI or software algorithm that undergoes machine learning training.

8. How the ground truth for the training set was established:

   • Not applicable as there is no training set for an AI algorithm.

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The SeedNet 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 (including cryoanalgesia), 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, tumors, skin lesions, and warts. The SeedNet 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 and benign tumors and palliative intervention), Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, 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, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin), Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia), General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.), ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth)., Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,), Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids). The SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.

The SeedNet System is a cryosurgical unit with argon-cooled probes. The modified SeedNet System includes cryoneedles and cryoprobes of different sizes, shapes, or made of different materials, a remote MRI Compatible Mobile Distribution Panel (MDP) for the MRI compatible system, functional features added to the software to indicate the user when no signal is detected from specific temperature sensors or thermocouples, a New General Use Template for use with the IceRod Cryoneedles, and IceRod Prostate and Renal Kits. The trade names CryoThera, Cryo-Hit, and SeedNet/SeedNetGold are associated with the system.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galil Medical LTD. SeedNet System.

Important Note: The provided document is a 510(k) summary for a medical device. 510(k) summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting de novo clinical trial data with acceptance criteria for novel performance. Therefore, the information typically found in a clinical study report regarding specific acceptance criteria and detailed performance metrics might be limited or absent, as is the case here.

This submission argues for substantial equivalence primarily based on technological characteristics, mode of operation, performance characteristics, and intended use being similar to existing cleared devices. The "performance data" mentioned refers to design verification testing, not a clinical study to prove efficacy against specific, pre-defined acceptance criteria.

Acceptance Criteria and Device Performance

Based on the provided text, there are no explicitly stated quantitative acceptance criteria for a study designed to prove the device's performance against specific metrics of diagnostic accuracy (like sensitivity, specificity, accuracy) that are commonly seen in AI/diagnostic device submissions.

The document's "Performance Data & Substantial Equivalence" section emphasizes the modified SeedNet System's equivalence to predicate devices and outlines a "comprehensive testing process as part of the design verification process," including electrical, mechanical, and biocompatibility testing. This type of testing ensures the device functions as intended and safely, but it does not evaluate its diagnostic or therapeutic efficacy against a defined clinical "ground truth" with statistical measures.

The core argument for clearance is substantial equivalence. The "performance" being evaluated implicitly is that the modified device performs comparably to the predicate devices in its intended use, which is cryogenic tissue destruction.

Table of Acceptance Criteria and Reported Device Performance

• Ability to perform cryogenic destruction of tissue.
• Safety (electrical, mechanical, biocompatibility). | - "The modified SeedNet System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet System."
• "The modified SeedNet System and its modified accessories were subjected to a comprehensive testing process as part of the design verification process. This included electrical, mechanical and biocompatibility testing."
• "The modified SeedNet System does not raise any new safety and/or effectiveness issues." |
  | Specific Indications for Use:
• Effective ablation for prostate tissue, cancerous/malignant tissue, skin lesions, etc. (as per predicate device's established efficacy). | - The modified device retains the same indications for use as the predicate SeedNet System, implying that its ability to perform these functions is considered equivalent. |

Study Information

Given the nature of a 510(k) summary for a cryosurgical unit, the "study" referred to is a series of engineering verification and validation tests, not a clinical trial in the sense of evaluating diagnostic or therapeutic efficacy with patient data. Therefore, many of the requested points below (e.g., sample size for test sets, ground truth, experts for ground truth, MRMC studies) are not applicable or not detailed in this document.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable in the context of a clinical test set from patient data. The "test set" would refer to the device units and components undergoing design verification. No specific numerical sample size for components or systems is provided, nor is patient data involved.
   • Data Provenance: Not applicable for clinical data. The testing is internal design verification and validation.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there is no mention of "ground truth" being established by experts for clinical performance in this submission. The "ground truth" for electrical, mechanical, and biocompatibility testing would be adherence to engineering specifications and relevant standards, verified by qualified engineers and testers.

3. Adjudication method for the test set:

   • Not applicable. There's no mention of an adjudication process for clinical outcomes, as this is not a clinical efficacy study.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging interpretation tool. There are no "human readers" or AI in the context of improving interpretation.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a hardware cryosurgical system, not a standalone algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • For the design verification testing mentioned, the "ground truth" would be adherence to defined engineering specifications, industry standards, and regulatory requirements (e.g., for electrical safety, mechanical integrity, biocompatibility). It is not clinical "ground truth" like pathology or outcomes data.

7. The sample size for the training set:

   • Not applicable. This device does not involve AI or machine learning models that require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.

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The CRYO-HIT™ 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 (including cryoanalgesia), 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, tumors, skin lesions, and warts. The CRYO-HIT™ 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 and benign tumors and palliative intervention), Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, 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, actinic and seborrheic keratoses, cavernous hemanglomas, perianal condylomata, and palliation of tumors of the skin), Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia), General surgery (palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.), ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth), Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions), Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids). The CRYO-HIT™ System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.

The Galil Medical's Cryo-Hit™ System for Cryoanalgesia is a modification of Galil Medical LTD's cleared Cryo-Hit™ (K993965). The modified Cryo-Hit™ System is the exact same device as the Cryo-Hit™ except for the addition of the 4.5 mm surface probe.

The provided document is a 510(k) summary for the Galil Medical Cryo-Hit™ System, focusing on a modification for cryoanalgesia. It does not present specific acceptance criteria or a formal study designed to "prove the device meets acceptance criteria" in the way one would expect for a diagnostic or AI-driven medical device. Instead, it relies on demonstrating substantial equivalence to predicate devices and referencing existing medical literature and two clinical studies to support the safety and effectiveness of the device for cryoanalgesia.

Therefore, many of the requested elements (like a table of acceptance criteria, sample sizes for training/test sets, expert adjudication methods, MRMC studies, or standalone performance) are not applicable or explicitly stated in this type of regulatory submission for a simple device modification.

Below is an attempt to address the requested information based on what is available in the document, with explicit notes about what is not provided.

Description of Acceptance Criteria and Study to Prove the Device Meets Acceptance Criteria

The Galil Medical Cryo-Hit™ System is a cryosurgical unit. The specific submission is for a modification focusing on its use for cryoanalgesia, with the addition of a 4.5 mm surface probe. The acceptance criteria are implicitly tied to demonstrating substantial equivalence to predicate devices by showing the modified device is as safe and effective for its intended use.

The study supporting this claim consists of reviewing existing medical literature on cryoanalgesia and presenting two recent clinical studies conducted using the Cryo-Hit™ system.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a cryosurgical unit modification and not a diagnostic device, explicit "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, etc.) are not defined. Instead, the "acceptance" is based on demonstrating safety and effectiveness compared to predicate devices for the specified indications. The reported device performance is described in terms of clinical outcomes, primarily pain reduction and absence of major complications.

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The CRYO-HIT™ System for MRI 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, tumors, skin lesions, and warts.

The CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ 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, 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 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 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 rectum, and ablation of hemorrhoids)

The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.

The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).

The provided text describes the CRYO-HIT™ System for MRI and its indications for use, but it does not contain specific information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, or any comparative effectiveness studies.

The document is a 510(k) summary and a subsequent correction letter from the FDA, focusing on substantial equivalence to a predicate device (CRYO-HIT™ 200 System, K991517) based on similar intended use, principle of operation, and technological characteristics. It highlights the modifications (MRI kit and additional probe types) that distinguish the new device from the predicate.

Therefore, I cannot fulfill the request for information regarding acceptance criteria, study details, and sample sizes as this information is not present in the provided text.

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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.

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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.

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CRYO-HIT™ 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, neurosurgery, thoracic surgery, ENT, gynecology, oncology, proctology, and urology for the ablation of tissue, including liver metastases, skin lesions, warts, and prostate tissue.

CRYO-HIT™ is a cryosurgical system that consists of:

• 1, a structural enclosure (The CRYO-HIT™ system is housed in a rack assembly mounted on four cater wheels for ease of transport),
• 2. a power control panel,
• 3. a computer and control assembly,
• 4, a gas supply system: Argon (cooling) and Helium (thawing) gas reservoirs,
• 5. a gas distribution system (valve assembly ),
• 6. Accessories: cryoprobes (named galil-eo probes), temperature sensors and a remote control unit.
     The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe ports available in each model (3-probe, 5-probe, 7-probes and 8-probe configurations) and the number of temperature sensor ports ( to meet the needs of different customers).
     The probes used for the 3-probe, 7-probes and 8-probe configurations are exactly the same.

This is a 510(k) premarket notification for a medical device (CRYO-HIT™ System) and as such does not contain a study section with acceptance criteria and a description of a study to prove the device meets those criteria. 510(k) submissions typically demonstrate substantial equivalence to a predicate device rather than conducting new clinical performance studies with acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. The document primarily focuses on establishing the substantial equivalence of the CRYO-HIT™ system to existing cryosurgical devices based on intended use, technology, and operating principles.

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