XSense Cryoablation System with CryoProbes is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures.

XSense Cryoablation System with CryoProbes 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 fibroadenomas prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.

XSense Cryoablation System with CryoProbes may be used with an imaging device such as an ultrasound to provide real-time visualization of the cryosurgical procedure.

The system has the following specific indications:

• Urology - ablate prostate tissue in cases of prostate cancer and benign prostatic 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. Pallation of tumors of the skin. Destruction of warts or lesions.
• Gynecology - ablation of malignant neoplasia or benign dysplasia of the female genitalia.
• ENT (Ear, Nose and Throat) - Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth.
• General Surgery - Ablation of breast fibroadenomas, leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and seborrheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of tumors of the oral cavity, rectum, and skin.
• Thoracic Surgery - ablation of arrhythmic cardiac tissue and cancerous lesions.
• Proctology - ablation of benign or malignant growths of the anus and rectum and hemorrhoids.

The XSense Cryoablation System with CryoProbes is operated in conjunction with an imaging system, such as ultrasound, to provide real-time visualization of the cryosurgical procedure, used in a professional healthcare environment for cryotherapy according to IceCure Medical's technology. The device technology is based on the delivery of the low-temperature cryogen under pressure from the internal dewar to the CryoProbe's tip, enabling it to reach very low temperature, due to the thermal energy transfer principle that occurs as a result of phase transfer from liquid to gas of nitrogen at the tip of the CryoProbe, and thus freeze and destroy the treated tissue that the CryoProbe comes in contact with.

The XSense Cryoablation System with CryoProbes cleared under (K240892) is the predicate device of the subject device XSense Cryoablation System with CryoProbes, which is part of the IceCure family of cryoablation products. No change other than the Shelf-life of two (2) years was introduced since last cleared under (K240892). The XSense Cryoablation System include the following additional accessories: (1) CryoProbes that are available in two configurations, (2) an external 25 liters dewar with a supporting cart, (3) an Introducer, and (4) a Holder.

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The CoolCryo cryoapplicator is a single use, sterile device indicated for the cryosurgical treatment for ablation of arrhythmic cardiac tissue by freezing target tissues, inducing an inflammatory response (cryonecrosis) that blocks the electrical conduction pathway.

The CoolCryo cryoapplicator can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.

The CoolCryo control console is a nonsterile, reusable device which delivers cryogenic energy, namely liquid nitrogen, to the CoolCryo cyroapplicator. The CoolCryo control console can be used in adults and is intended for use in the clinical environment by trained healthcare professionals.

The CoolCryo is a sterile, single-use cryogsurgical device to freeze target tissue, blocking electrical conduction pathways by creating an inflammatory response or cyronecrosis.

The CoolCryo comprises a cryoapplicator and a control console with a liquid nitrogen reservoir:

• CC01-01 Cryoapplicator for cardiac cryoablation,
• CC01-21 Control console for cardiac cryoablation with liquid nitrogen reservoir.

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The Focused Cryotherapy System is intended for cryoablative destruction of tissue during surgical procedures. The Focused Cryotherapy System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), 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, nerves, tumors, and skin lesions.

In addition, the system is intended for use in the following 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. Palliation of pain associated with metastatic lesions involving bone in patients who have failed or are not candidates for standard radiation therapy

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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal 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, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas

ENT

• Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth

Thoracic Surgery

• (with the exception of cardiac tissue)

Proctology

• Ablation of benign or malignant growths of the anus or rectum

Neurology

• Freezing of nerve tissue in pain management/cryoanalgesia

The Focused Cryotherapy System is a cryoablation platform that contains the following components:

• Probe (FC-2021CD01)
• Console (FC-AR401)
• Software

The Focused Cryotherapy System is a cryoablation platform for use in the cryoablation of nerves and tumors. The Probe is a handheld, single use, cryosurgical instrument. The Probe utilizes a high-pressure cryogen (argon gas) to freeze target tissues, creating an inflammatory response, and ultimately, cryonecrosis. In use with tumors, temperatures below -40°C is the temperature at which intracellular ice formation occurs which is lethal for cells. When applied to nerves, temperatures below -20°C cause extracellular ice formation along axonal tubes which causes cessation of action potential conduction. When high pressure argon gas is supplied to the Probe via the Console, rapid cooling is achieved via the Joule-Thomson effect. The Probe incorporates a heating element to facilitate directional cryoablation. The Console has combination gas/electrical ports to handle 4 Probes in parallel. The Console contains the Firmware and Software. The System consists of a main chassis (Console) for the cooling system, Firmware, Software, controls, touch screen and Probe ports. Safety measures of the system include audible and visual alarms, safety valves, and emergency shutoff button.

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TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures

• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Lesions
• Genital Lesions
• Seborrheic Keratosis

TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

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The CryoFreeze Wart and Skin Tag Remover is intended for the over-the-counter treatment of common warts and plantar warts in individuals ages 4 years and older and the over-the-counter treatment of skin tags in individuals ages 22 and older.

The CryoFreeze Wart and Skin Tag Remover is an over-the-counter (OTC) cryotherapy device designed for the treatment of common warts, plantar warts, and skin tags. The device includes:

• A pressurized aerosol canister filled with a liquid mixture of compressed gases
• Applicator swabs
• Detailed instructions, including illustrated descriptions

To use the device, the user must insert an applicator swab into the actuator, saturate the swab with cryogen, and apply the foam tip of the swab directly onto the lesion, holding it in place for 40 seconds. After removal, the frozen tissue will appear white and begin to thaw, typically taking 20-40 seconds. The device is non-sterile and intended for home use by laypersons. No special training or sterilization is required for operation.

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TargetCool-e (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

TargetCool-e (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures

• Molluscum Contagiosum
• Skin Tags
• Actinic Keratosis
• Lentigo
• Verruca Plana
• Verruca Vulgaris
• Verruca Lesions
• Genital Lesions
• Seborrheic Keratosis

TargetCool-e is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool-e device consists of a main device, nozzle, a guard and a cartridge.

The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool-e displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

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The Verruca-Freeze H Plus cryosurgical system is intended for use by trained medical professionals to treat the following benign skin lesions:

• Actinic Keratosis
• Genital Warts
• Lentigo
• Molluscum Contagiosum
• Seborrheic Keratosis
• Skin Tags
• Verruca Plantaris
• Verruca Vulgaris
• Verruca Plana

The main component of the Verruca-Freeze® H Plus cryosurgical system is the pressurized aerosol canister containing cryogen spray. The canister is used with foam swabs, which are non-sterile, single-use applicators that are disposed of after each use. The foam swabs allow the cryogen to be localized to a target lesion.

The procedure begins by saturating a foam swab with cryogen and then placing it directly onto the lesion for 15–40 seconds. Upon removal of the swab from the skin, the frozen tissue appears white and begins thawing. The typical thaw time is 20–40 seconds. This treatment methodology is simple and has been an accepted practice used by physicians for decades. It utilizes a cryogen formulation to freeze lesions and destroy the underlying tissue through evaporative cooling. On the cellular level, both extracellular and intracellular ice formation occur. This submission includes a modification to the cryogen formulation. No other changes were made to the device design, intended use, or operating principle.

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The Skin Clinic Freeze Point product is intended for the treatment of common warts, plantar warts, and skin tags by OTC consumers. Treat skin tags in adults age 22 years or older

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This 510(k) clearance letter details the clearance of a medical device, "Skin Clinic Freeze Point for Warts and Skin Tags," which is a cryosurgical unit. However, the provided document does not contain any information about the acceptance criteria or the study that proves the device meets the acceptance criteria.

The 510(k) process is primarily focused on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy and safety in the same way a PMA (Premarket Approval) application would. While a 510(k) submission does include performance data, this particular clearance letter only states that the device is substantially equivalent and provides regulatory information, such as:

• Device Name: Skin Clinic Freeze Point for Warts and Skin Tags
• Regulation Number: 21 CFR 878.4350
• Regulation Name: Cryosurgical Unit And Accessories
• Regulatory Class: Class II
• Product Code: GEH
• Indications for Use: Treatment of common warts, plantar warts, and skin tags by OTC consumers; treat skin tags in adults age 22 years or older.
• Type of Use: Over-The-Counter Use

Therefore, I cannot provide the requested information regarding acceptance criteria and study details based solely on this document.

To answer your prompt, I would need a different type of document, such as a summary of safety and effectiveness data (SSED) or a detailed study report that would typically be part of a 510(k) submission but is not included in the clearance letter itself.

Without that information, I cannot fill in the table or address the points about sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details, or ground truth establishment.

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The Skin Clinic Nitro Clear Wart Remover is intended for the OTC treatment of common warts and plantar warts in adults and children 4 years of age and older.

The Skin Clinic Nitro Clear Wart Remover device utilizes extreme cold to facilitate the removal of common and plantar warts by freezing. Each device contains a container of cryogen gas in a plastic holder along with instructions for use. The Skin Clinic Nitro Clear Wart Remover device is for OTC use and utilizes Nitrous Oxide cryogen delivered from the cartridge into a tip which acts as a reservoir for the cryogen gas. The applicator tip is cooled to as low as -89°C. Depending on the location and size, the applicator is placed against the common wart or plantar wart between 10-40 seconds which freezes the targeted area. The frozen wart falls away over time and new epidermis grows in its place. One to four treatments with intervals of two weeks may be required.

Acceptance Criteria and Study Details for Skin Clinic NitroClear

Based on the provided FDA 510(k) clearance letter for the Skin Clinic NitroClear Wart Remover, here's a breakdown of the acceptance criteria and the studies conducted:

1. Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state quantitative "acceptance criteria" for the device's performance in terms of efficacy (e.g., a specific percentage of wart clearance). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices. This equivalence is established by:

• Comparable technological characteristics: The subject device operates on the same principle (cryotherapy to destroy tissue with extreme cold) and has similar design and safety features to its predicates.
• Achieving equivalent or lower temperatures: Through bench testing, the device demonstrated its ability to reach temperatures comparable to or lower than the predicate devices. This implies it can achieve the intended cryotherapeutic effect.
• Demonstrated cell killing efficacy (in vitro): The in vitro test showed that the device is capable of effectively destroying cells, aligning with its mechanism of action for wart removal.
• Human factors usability: The device's usability was deemed acceptable for over-the-counter use by consumers based on a dedicated study.

2. Sample Size for Test Set and Data Provenance

The document does not specify a quantitative "test set sample size" for a clinical efficacy study. The performance data primarily relies on:

• Bench Testing: This would involve laboratory setups to measure temperature, not human subjects.
• In vitro Test: This was conducted on cells in an agar matrix, not human subjects.
• Human Factors Usability Study: While not explicitly stated, this study would involve human participants to assess usability. The document does not provide the sample size, country of origin, or whether it was retrospective or prospective.

Given the nature of the clearance (510(k) for substantial equivalence), a large-scale clinical efficacy trial with a dedicated test set of patients for wart clearance is usually not required if the technology is deemed sufficiently similar to a predicate.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth for a clinical test set from a diagnostic or efficacy perspective. The testing described (bench, in vitro, usability) does not typically involve expert consensus for ground truth on patient outcomes.

• For Biocompatibility: Experts in biocompatibility testing (toxicologists, material scientists) would have been involved in the evaluation against ISO 10993 standards.
• For Human Factors: Experts in human factors engineering would have designed and evaluated the usability study.

No specific number or qualifications are provided in the document.

4. Adjudication Method for the Test Set

Since there is no mention of a clinical test set with patient outcomes requiring adjudication (e.g., for diagnostic accuracy of an AI or efficacy of treatment), there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. This type of study is typically performed for diagnostic imaging devices involving multiple readers interpreting cases, often with and without AI assistance, to measure changes in diagnostic performance. The Skin Clinic NitroClear is a cryosurgical treatment device, not a diagnostic imaging AI.

6. Standalone Algorithm Performance Study

No standalone (algorithm only without human-in-the-loop) performance study was done. The device is a physical cryosurgical unit, not a software algorithm that operates independently. Its performance is inherent in its physical function and interaction with a user.

7. Type of Ground Truth Used

• For Biocompatibility: The ground truth would be established by the requirements of the ISO 10993 standard.
• For Temperature Attainment: The ground truth would be objective temperature measurements using calibrated equipment.
• For Cell Killing (in vitro): The ground truth would be the observed viability of cells in the agar matrix after treatment, typically assessed through laboratory methods.
• For Human Factors Usability: The ground truth would be observations of user interaction and performance against predefined usability objectives or tasks.

There is no mention of pathology, expert consensus on images, or long-term outcomes data as "ground truth" in the context of this 510(k) submission, as it focuses on substantial equivalence for a physical treatment device rather than a diagnostic or AI-driven system.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the Skin Clinic NitroClear is a physical device, not an AI or machine learning model that requires training data.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for a machine learning model.

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