Who is the manufacturer of IceSense 3, ProSense, MultiSense?

IceCure Medical , Ltd. filed the 510(k) submission for IceSense 3, ProSense, MultiSense (K183213).

What is the FDA product code for IceSense 3, ProSense, MultiSense?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for IceSense 3, ProSense, MultiSense?

510(k) clearance (submission type: Traditional).

What are the predicate devices for IceSense 3, ProSense, MultiSense?

IceSense 3 System (K102360); Galil Medical Seednet family (K052530).

Who can help prepare an FDA 510(k) submission like IceSense 3, ProSense, MultiSense?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

IceSense 3, ProSense, MultiSense

K183213 · IceCure Medical , Ltd. · GEH · Dec 20, 2019 · General, Plastic Surgery

Device Facts

Record ID	K183213
Device Name	IceSense 3, ProSense, MultiSense
Applicant	IceCure Medical , Ltd.
Product Code	GEH · General, Plastic Surgery
Decision Date	Dec 20, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. 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, 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 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. Palliation of turnors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and sebortheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). 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 system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only.

Device Story

Cryoablation system; delivers extreme cold via pressurized liquid nitrogen to disposable cryoprobes; destroys targeted tissue. Components: main chassis, controller, touch screen, foot pedal, cryohandle. Used in OR or clinic by physicians. MultiSense model supports up to three probes in parallel; IceSense 3/ProSense support single probe. System monitors pressure, flow, temperature, and microswitches; provides real-time status/error displays. Optional ultrasound integration for visualization. Benefits: precise tissue ablation for oncology, urology, and general surgery applications. Safety features: alarms, emergency stop, automatic procedure abortion on malfunction.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via electrical/EMC testing and bench studies comparing iceball size (40mm single, 94mm triple) and thermal profiles against predicates.

Technological Characteristics

Closed-loop liquid nitrogen system. Probes made of 304/316 stainless steel. Active thawing via electrical heating element (up to 35°C). Touch screen interface. Connectivity: standalone. Sterilization: Ethylene Oxide (ISO 11135). Standards: ES60601-1, IEC 60601-1-2. Software-controlled valves, pump, and heaters.

Indications for Use

Indicated for patients requiring cryosurgical tissue destruction in general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology. Specific conditions include prostate cancer, BPH, malignant/benign tumors, liver metastases, skin cancers, warts, cutaneous disorders, female genital dysplasia, oral leukoplakia, arrhythmic cardiac tissue, hemorrhoids, and breast fibroadenomas.

Regulatory Classification

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.

Predicate Devices

IceSense 3 System (K102360)
Galil Medical Seednet family (K052530)

Related Devices

K102360 — ICESENCE 3 · IceCure Medical , Ltd. · Nov 29, 2010
K240892 — XSense Cryoablation System with Cryoprobes · IceCure Medical , Ltd. · Jun 28, 2024
K260377 — XSense Cryoablation System with CryoProbes · IceCure Medical , Ltd. · Feb 24, 2026
K072883 — ICE-SENSE · Arbel Medical , Ltd. · Dec 10, 2007
K980110 — ENDOCRE CRYOCARE CRYOSURGICAL SYSTEM · Endocare, Inc. · Apr 10, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, and the text on the right is in blue. The text is arranged in three lines, with "FDA" on the first line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line. December 20, 2019 IceCure Medical LTD. % Zvi Ladin Principal Boston MedTech Advisors Inc. 990 Washington Street Suite #204 Dedham, Massachusetts 02026 Re: K183213 Trade/Device Name: IceCure Family Cryoablation System (IceSense 3, ProSense, MultiSense) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: November 20, 2019 Received: November 21, 2019 Dear Zvi Ladin: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal {1}------------------------------------------------ statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K183213 #### Device Name IceCure Family Cryoablation System #### Indications for Use (Describe) The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. 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, 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 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. Palliation of turnors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts actinic and sebortheic keratoses, cavernous hemangiomas, recurrent cancerous lesions. Palliation of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or lesions. Palliation of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). 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 system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only. Type of Use (Select one or both, as applicable) X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) | CONTINUE ON A SEPARATE PAGE IF NEEDED. | |----------------------------------------| |----------------------------------------| This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 1. 510(K) SUMMARY # lceCure's Family Cryoablation System # Name and Address of Applicant: lceCure Medical LTD. Haeshel 7, Caesarea I.P. 38900, Israel Elisabeth Sadka, VP RA QA clinical Telephone: 972-4-6230333 Fax: 972-4-6230222 # Contact Person and Phone Number: Zvi Ladin, Ph.D., Principal, Boston MedTech Advisors Telephone: 781-407-0900 Fax: 781-407-0901 E-mail: zladin@bmtadvisors.com Date Prepared: December 19, 2019 ## Name of Device Trade/Proprietary Name: IceCure Family (IceSense™3, ProSense™ and MultiSense™) Cryotherapy Systems Common Name: Cryosurgical unit and accessories Classification Name: Cryosurgical unit and accessories (21 C.F.R. § 878.4350) Product Code: GEH # Manufacturing Facility IceCure Medical LTD. Haeshel 7, Caesarea I.P. 3079504, Israel {4}------------------------------------------------ ### Predicate Devices The IceCure Family of Cryotherapy Systems is substantially equivalent to the cleared IceSense™3 System (K102360) and the cleared Galil Medical Seednet family (K052530). ### Intended Use / Indications for Use The IceCure Family (IceSense™3, ProSense™, and MultiSense™) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery, ENT, gynecology, 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 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. Palliation of tumors of the skin. Destruction of warts or lesions). Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia). ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). General Surgery (ablation of leukoplakia of mouth, angjomas, 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 hemanqiomas, 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. Ablation of breast fibroadenomas). 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 system may be used with imaging device like ultrasound to provide real-time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only. {5}------------------------------------------------ ## Technological Characteristics The IceCure Family of cryotherapy devices includes the IceSense™3 single-probe system (cleared under 510(k) #K102360 and rebranded as ProSense™), and MultiSense™ – a new system that accommodates up to three cryoprobes operating in parallel. The systems are used to destroy unwanted tissue by application of extreme cold to the selected sites. The devices deliver cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available. The devices consist of a main chassis for the cooling system, a controller, a touch screen, a foot pedal and a cryohandle that controls the system and holds the probe. Safety measures of the system include alarms, safety valve, emergency button and automatic abortion of the procedure in case of technical malfunction. # Comparison with the Predicate Device Cryoablation is the fundamental technological principle for both the subject IceCure Family of cryotherapy devices and the predicate lceSense™3 System (K102360) and Galil Medical Seednet family (K052530). The subject and marketed predicate devices are used to ablate unwanted tissue by application of extreme cold. The subject and predicate devices are based on the same technological principles: - . Delivery of cryogen from a dewar to a cryoprobe tip - Application of cryogen to ablate (freeze) the unwanted tissue . - Heat transfer at the tip of the cryoprobe for quick release of the probe - User-controlled (trigger/foot pedal) to release cryogen . - Software activated Controller . ProSense™ is a mere rebranding of the cleared IceSense™3 single-probe system (K102360). Therefore, the ProSense™ System has the same hardware and software components as the lceSense™3 System. Hardware and software changes introduced since the device was originally cleared on November 29, 2010, were analyzed following FDA's Guidance Documents – "Deciding When to Submit a 510(k) for a Change to an Existing Device" (K97-1) dated January 10, 1997 and "Deciding When to Submit 510(k) for a Software Change to an Existing Device," dated October 25, 2017. All changes were determined not to require new 510(k) premarket notifications and were {6}------------------------------------------------ therefore documented and released based on the company's standard operating procedures. This submission includes the current configuration of the system. The MultiSense™ System has the same principle of operation and technological features as the single-probe IceSense™3 (K102360) and the multi-probe Galil Medical Seednet (K052530) systems. It can accommodate up to three cryoprobes operating in parallel. The submission was focused on two key elements: - IceCure Medical's multi-probe system design is similar to the Galil Medical Seednet . (K052530) predicate. - . Streamline the Indications for Use of the IceCure Family cryoablation system in accordance with those of the predicate devices. | | IceCure Family | IceSense3 | Seednet family | |------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510k Number | K183213 | K102360 | K052530 | | Company | IceCure Medical, Ltd. | IceCure Medical, Ltd. | Galil Medical | | Device | Cryotherapy system | Cryotherapy system | Cryotherapy system | | Intended use | The system is intended for cryogenic destruction of tissue during surgical procedures. | The IceSense3 System is intended for cryogenic destruction of tissue during surgical procedures. | The system is intended for cryogenic destruction of tissue during surgical procedures. | | Indications for Use | IceCure Family (IceSenseTM3, ProSenseTM, and MultiSenseTM) cryoablation system is intended for cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures. 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 | The IceSense3 System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in a number of specific fields which include the following: Urology The system may be used to ablate prostatic tissue. The system may be used for the ablation of prostate tissue in cases of prostate cancer and | The system is intended for cryogenic destruction of tissue during surgical procedures. The 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 | {7}------------------------------------------------ | application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts. | benign prostatic hyperplasia Oncology The system may be | |-----------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------| | The system has the following specific indications: | used for ablation of cancerous or malignant tissue. The system may be | | Urology (ablate prostate tissue in cases of prostate cancer and benign prostatic hyperplasia (BPH)). | used for ablation of benign tumors. The system may be used for palliative intervention. | | Oncology (ablation of cancerous or malignant tissue and benign tumors and palliative intervention). | Dermatology The system may be used for the ablation or freezing of skin cancers | | Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. | and other cutaneous disorders. | | Palliation of tumors of the skin. Destruction of warts or lesions). | Gynecology The system may be used for the ablation of malignant neoplasia or | | Gynecology (ablation of malignant neoplasia or benign dysplasia of the | benign dysplasia of the female genitalia. General Surgery | | female genitalia). ENT (Palliation of tumors of the oral cavity and ablation | The system may be used for the ablation of leukoplakia of mouth, | | of leukoplakia of the mouth). General Surgery (ablation of | angiomas, sebaceous hyperplasia, basal cell | | leukoplakia of mouth, angiomas, sebaceous hyperplasia, basal cell | tumors of the eyelid or canthus area, ulcerated basal cell tumors, | | tumors of the eyelid or canthus area, ulcerated basal cell tumors, | dermatofibromas, small hemangiomas, mucocele cysts, multiple | | dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar | warts, plantar warts, hemorrhoids, anal fissures, perianal | | warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts | condylomata, pilonidal cysts, actinic and seborrheic keratoses, | | actinic and seborrheic keratoses, cavernous hemangiomas, recurrent | cavernous hemangiomas, recurrent cancerous lesions, ablation of breast | | cancerous lesions. Palliation of tumors of the rectum, hemorrhoids, anal | fibroadenoma. The system may be used for the destruction | | fissures, pilonidal cysts, and recurrent cancerous lesions. Destruction of warts or | of warts or lesions. The system may be | | lesions. | used for the palliation of warts or lesions. | metastases, tumors, skin lesions, and warts. The 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 maliqnant 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, ablation of breast fibroadenomas) ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth). {8}------------------------------------------------ | of the oral cavity, rectum, and skin. Ablation of breast fibroadenomas). 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 system may be used with imaging device like ultrasound to provide real- time visualization of the cryosurgical procedure. MultiSense™ System is indicated for three probe configuration only. | tumors of the oral cavity, rectum, and skin. Thoracic Surgery The system may be used for the ablation of arrhythmic cardiac tissue. The system may be used for the ablation of cancerous lesions Proctology The system may be used for the ablation of benign or malignant growths of the anus and rectum. The systems may be used for the ablation of hemorrhoids. The system may be used with an ultrasound device to provide real- time visualization of the cryosurgical procedure | Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids) The system may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cooling system location and refrigerant | Internal small [1 or 3] dewar(s) of liquid nitrogen. [1 or 3] dewar(s) used per procedure | Internal small dewar of liquid nitrogen. 1 dewar used per procedure | Internal cylinders of argon. | | Thawing | Active thawing: nitrogen gas is heated by an electrical heating element. Reaching up to 35 degrees Celsius. | Active thawing: nitrogen gas is heated by an electrical heating element. Reaching around 35 degrees Celsius. | Active thawing: electric element or helium gas reaching 35 degrees Celsius. | | Operating mode | Freeze, thaw, active thaw. Manual/pre-programmed freezing cycles | Freeze, thaw, active thaw. Manual/pre-programmed freezing cycles | Freeze, low freeze, active thaw, off, stick | | Parameters controlled by the user | Automatic or manual treatment mode; freeze or thaw time and active thaw mode. Operated from the touch screen control panel, and in addition for the IceSense™3 model only: the cryohandle buttons or the foot pedal | Automatic or manual treatment mode; freeze or thaw time and active thaw mode. Operated from the touch screen control panel, the cryohandle buttons or the foot pedal. | Probe temperature, freeze thaw stick and active thaw mode. Operated from the probe handle buttons, remote control unit. | | Software controls | Valves, pump, heaters | Valves, pump, heaters | Valves, pump, heater | | Parameters monitored by the software | The controller constantly monitors the status of: | The controller constantly monitors the status of: | The controller constantly monitors the status of: | | | Microswitches, pressure and flow gauges, temperature sensors, buttons. | Microswitches, pressure and flow gauges, temperature sensors, buttons. | Gauges, temperature sensors, buttons. | | System display | Online display: time, mode, status, messages, errors. | On line display: time, mode, status, messages, errors. | On line display: time, pressure, temperature, status, errors, messages. | | Procedure track record | Yes | Yes | Yes | | Number of probes controlled by the device | 1 probe for ProSense™; 3 probes for MultiSense™ | 1 probe | 1-5 probes | | Probes characteristics | 2.4 mm, 3.4 mm pencil or trocar tips, for small or medium, elliptical or spheric iceball. Shaft lengths for 2.4 mm probes include 124 mm and 134 mm; Shaft lengths for 3.4 mm probes include 127 mm, 140mm, and 185 mm. Made from 304 and 316 stainless steel. | 2.0 mm, 2.7 mm, 3.0 mm, 3.4 mm sharp or blunt tips, for small or medium iceball. Made from 304 and 316 stainless steel. | 1.5 mm, 2.0 mm, 3.2 mm, 3.4 mm, 5.0 mm, 6.0 mm for small medium or large iceball, sharp or blunt and surface probes. Made from 304 and 316 stainless steel. | | Probe connection to the system | Probe is screwed to the handle | Probe is screwed to the handle | Quick connection of the pipe to the system or screwing the probe to the handle | | Safety measures | Alarms, pretest, microswitch. Safety valve, pressure relief valves, Emergency stop button. Automatic abortion of the procedure in case of technical malfunction. One dewar content is for up to 15 minutes of continuous operation of freeze. | Alarms, pretest, microswitch. Safety valve, pressure relief valves, Emergency stop button. Automatic abortion of the procedure in case of technical malfunction. One dewar content is for up to 16 minutes of continuous operation of freeze. | Emergency stop button Safety valve, pressure relief valves, Emergency stop button, alarms. | | Screen | Touch Screen mounted on the system. Tilt and swivel as needed | Touch Screen mounted on the system. Tilt and swivel as needed | Screen mounted on the system. Tilt and swivel as needed | | Dimensions | Height: 120cm/47.24" Depth: 50cm /19.68" // 70 cm / 27.56" Width: 50 cm /19.68" Weight: 70 Kg / 154 lb (with 1 dewar) // 150 Kg / 330 lb (with 3 dewars) | Height: 120cm/47.24" Depth: 50cm /19.68" Width: 50 cm /19.68" Weight: 70 Kg / 154 lb | Height: 58" Depth: 34" Width: 23" Weight (without gas cylinders): 265 lb. | | Cryoprobe pretest | Yes | Yes | Yes | | Use Environment | Hospital - operating room Office procedure | Hospital - operating room Office procedure | Hospital - operating room Office procedure | {9}------------------------------------------------ {10}------------------------------------------------ ### Performance Data Performance data were provided in support of the substantial equivalence determination. System was tested for conformance with relevant safety and performance standards, such as electrical testing, electromagnetic compatibility and software validation and verification, formulated in the device specifications. In all instances, the systems functioned as intended and the performance observed met acceptance criteria for all tests. ### Sterilization The IceCure Family cryoablation system accessories (probes, introducers and temperature sensor) are all sterilized utilizing an Ethylene Oxide sterilization cycle validated in accordance with ISO 11135 - Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization. ### Biocompatibility The biocompatibility evaluation of patient contacting materials of the IceCure Family cryoablation system accessories was conducted in accordance with FDA's "Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"". Biocompatibility testing was not required as there were no changes in patient contacting materials. ### EMC and Electrical Safety Electromagnetic compatibility (EMC) and electrical safety (ES) of the Ice Cure Family cryoablation system were tested and determined to be compliant with the following standards: {11}------------------------------------------------ - . ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD). - IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment Part 1-2: General . requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests. ### Bench testing Bench testing focused on demonstrating the performance of the MultiSense system using multiple probes. The performance of the MultiSense devices was found to be similar to that of the predicate devices IceSense™3 System (K102360) and Gall Medical Seednet family (K052530). Specifically, testing documented that in the range of up to 15 minutes freeze, the probes can create an iceball of at least 40 mm diameter for a single probe, and 94 mm for a three-probe system. Performance testing included testing of the shaft temperature during freeze, thaw and warm phases. Results demonstrated that temperatures along the shaft remained within the device's specifications during all phases. The time change of iceball size and probe tip temperature were similar for the candidate and predicate devices. Iceball isotherm measurements were conducted and the results met the device's specifications. ### Performance Testing - Clinical Clinical testing was not required to demonstrate the safety and effectiveness of the device. ### Substantial Equivalence The IceCure Family devices are as safe and effective as the cleared IceSense™3 System (K102360) and the cleared Galil Medical Seednet family (K052530). The IceCure Family devices have the same intended uses and indications, technological characteristics, and principles of operation as the predicate devices. The minor technological differences between the IceCure devices and their predicate devices do not raise different issues of safety or effectiveness. Performance data demonstrate that the IceCure devices are as safe and effective as the cleared IceSense™ System (K102360) and the cleared Galil Medical Seednet family (K052530). Thus, the IceCure Family of cryotherapy systems is substantially equivalent to its predicate devices.