(396 days)
Not Found
No
The document describes a cryoablation system that uses extreme cold temperatures to destroy tissue. The description focuses on the physical components, operational modes (single or multiple probes), and safety features. There is no mention of AI or ML in the intended use, device description, or performance studies. The use of ultrasound for visualization is mentioned, but this is a standard imaging modality and does not imply AI/ML processing.
Yes
The device is a cryoablation system intended for the destruction of tissue for various medical indications, which is a therapeutic purpose.
No
This device is a cryoablation system used for the destruction of tissue during surgical procedures by applying extreme cold temperatures. It is a therapeutic device, not a diagnostic one. While it may be used with an imaging device like ultrasound for visualization, the device itself performs a treatment (tissue destruction), not a diagnosis.
No
The device description clearly outlines hardware components such as a main chassis, cooling system, touch screen, foot pedal, and cryohandle, in addition to the software controller.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for the "cryogenic destruction of tissue during surgical procedures by the application of extreme cold temperatures." This describes a therapeutic intervention performed directly on the patient's body.
- Device Description: The device description details a system that delivers cold temperatures to targeted tissue using cryoprobes. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological samples.
The device is a surgical tool used for tissue ablation, which is a therapeutic procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The 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, 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, 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 turnors 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. MultiSenseTM System is indicated for three probe configuration only.
Product codes
GEH
Device Description
The IceCure Family of cryotherapy devices includes the IceSense™3 single-probe system (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
prostate, kidney, liver, skin, breast, anus, rectum, oral cavity, female genitalia, cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital - operating room; Office procedure
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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. Clinical testing was not required to demonstrate the safety and effectiveness of the device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.
0
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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)
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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 |
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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:
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- . 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.