(102 days)
Not Found
No
The document describes a cryosurgical device and its physical components and functionality. There is no mention of AI, ML, or any computational analysis of data for decision-making or control beyond basic system monitoring and safety features.
Yes
The device is intended for the destruction of tissue during surgical procedures by applying extreme cold, which is a therapeutic action.
No
The device is described as a cryosurgical tool used for the destruction of tissue, not for diagnosis. While it may be used with an ultrasound for visualization, the ultrasound is a separate diagnostic tool, and the IceSense3 itself performs tissue ablation.
No
The device description clearly outlines hardware components such as a main chassis, controller, touch screen, foot pedal, cryohandle, and disposable cryoprobe, indicating it is a physical medical device, not software-only.
Based on the provided information, the IceSense3 device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the cryogenic destruction of tissue during surgical procedures. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a tool that delivers cold temperatures to targeted tissue using a cryoprobe. This is a physical intervention on the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide diagnostic information.
IVD devices are used to perform tests on samples taken from the human body to diagnose diseases or conditions. The IceSense3 is a surgical tool used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the crvosurgical procedure.
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 ● benign prostatic hyperplasia
Oncology
- The system may be used for ablation of cancerous or malignant tissue. .
- The system may be used for ablation of benign tumors. .
- The system may be used for palliative intervention. .
Dermatology
- The system may be used for the ablation or freezing of skin cancers and other coetaneous . disorders.
Gynecology
- The system may be used for the ablation of malignant neoplasia or benign dysplasia of the ● female genitalia.
General Surgery - The system may be used for the ablation of 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, cavemous hemangiomas, recurrent cancerous lesions.
- The system may be used for the destruction of warts or lesions.
- The system may be used for the palliation of tumors of the oral cavity, rectum, and skin. .
- The system may be used for Ablation of breast fibroadenomas .
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. .
Product codes
GEH
Device Description
The IceSense3 device is used to destroy unwanted tissue by application of extreme cold to the selected sites. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available.
The device consists 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
prostatic tissue, prostate, skin, female genitalia, mouth, eyelid, canthus area, oral cavity, rectum, breast, cardiac tissue, anus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Performance testing of IceSense3, 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. Performance testing of IceSense3 versus the Sanarus Visica2 system that are both based on liquid nitrogen technology were conducted and gave very similar metrics of iceball formation versus time; the temperatures at the tip of the probe were very similar as well.
In all instances, the IceSense3 functioned as intended and the performance observed was as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The IceSense3 system probes can create an iceball of at least 40mm diameter.
Predicate Device(s)
Reference Device(s)
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
NOV 2 9 2010
5. 510(K) SUMMARY
lceCure's IceSense3 device
Name and Address of Applicant:
iceCure 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: November 21, 2010
Name of Device
Trade/Proprietary Name: IceCure Medical, IceSense3 device
Common Name: Cryosurgical unit and accessories
Classification Name: Cryosurgical unit and accessories (21 C.F.R. § 878.4350).
Manufacturing Facility
IceCure Medical LTD.
Haeshel 7, Caesarea I.P. 38900, Israel
lceCure Medical LTD. lceCure IceSense™ 3 510(k) Submission
(
Section 5 510(k) Summary Page 1 of 4
1
Predicate Devices
The IceSense3 System is substantially equivalent to the cleared IceSense™ System (K072883), the cleared Galil Medical Seednet family (K052530) and Sanarus Medical's V2 Treatment System (K062896).
Intended Use / Indications for Use
The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the crvosurgical procedure.
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 ● benign prostatic hyperplasia
Oncology
- The system may be used for ablation of cancerous or malignant tissue. .
- The system may be used for ablation of benign tumors. .
- The system may be used for palliative intervention. .
Dermatology
- The system may be used for the ablation or freezing of skin cancers and other coetaneous . disorders.
Gynecology
- The system may be used for the ablation of malignant neoplasia or benign dysplasia of the ● female genitalia.
General Surgery
- The system may be used for the ablation of 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, cavemous hemangiomas, recurrent cancerous lesions.
- The system may be used for the destruction of warts or lesions.
IceCure Medical LTD. IceCure IceSense™ 3 510(k) Submission
Section 5 510(k) Summary Page 2 of 4
2
- The system may be used for the palliation of tumors of the oral cavity, rectum, and skin. .
- The system may be used for Ablation of breast fibroadenomas .
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. .
Technological Characteristics
· The IceSense3 device is used to destroy unwanted tissue by application of extreme cold to the selected sites. The device delivers cold temperatures to targeted tissue by pressurized liquid nitrogen closed system and a disposable cryoprobe. Various cryoprobes are available.
The device consists 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.
Performance Data
The performance of the IceSense3 is in the range of metrics performance of the predicate devices, in the range of up to 15 minutes freeze, the IceSense3 system probes can create an iceball of at least 40mm diameter. Performance testing of IceSense3, 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. Performance testing of IceSense3 versus the Sanarus Visica2 system that are both based on liquid nitrogen technology were conducted and gave very similar metrics of iceball formation versus time; the temperatures at the tip of the probe were very similar as well.
In all instances, the IceSense3 functioned as intended and the performance observed was as expected.
IceCure Medical LTD. lceCure lceSense™ 3 510(k) Submission
Section 5 510(k) Summary Page 3 of 4
3
Substantial Equivalence
The IceSense3 device is as safe and effective as the cleared IceSense™ System (K072883), the cleared Galil Medical Seednet family (K052530) and the cleared Sanarus Medical's V2 Treatment System (K062896).
The IceSense3 device has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the IceSense3 device and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the IceSense3 device is as safe and effective as the cleared IceSense™ System (K072883), the cleared Galil Medical Seednet family (K052530) and the cleared Sanarus Medical's V2 Treatment System (K062896).
Thus, the IceSense3 is substantially equivalent.
lceCure Medical LTD. lceCure IceSense™ 3 510(k) Submission
Section 5 510(k) Summary Page 4 of 4
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with its wings spread, facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
NOV 2 9 2010
IceCure Medical, Ltd. % Boston MedTech Advisors Zvi Ladin, Ph.D. 990 Washington Street, Suite 204 Dedham, Massachusetts 02026
Re: K102360
Trade/Device Name: IceCure Medical IceSense3 Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: October 28, 2010 Received: October 29, 2010
Dear Dr. 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. The general controls provisions of the Act include requirements for annual registration. Iisting 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 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
5
Page 2 - Zvi Ladin, Ph.D.
CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Mulkern
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Gynecology
- The system may be used for the ablation of malignant neoplasia or benign dysplasia of ● the female genitalia.
General Surgery
- The system may be used for the ablation of leukoplakia of mouth, angiomas, sebaceous . hyperplasia, basal cell tumors of the eyelid or canthus area, uicerated 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.
- The system may be used for the destruction of warts or lesions. .
- The system may be used for the palliation of tumors of the oral cavity, rectum, and skin. �
- The system may be used for Ablation of breast fibroadenomas t
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. .
Over-The-Counter Use AND/OR (21 CFR 801 Subpart C) Prescription Use (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nulke Qelm for min.
Page 3 of 3
Division of Surgical, Orthopedic, and Restorative Devices
IceCure Medical LTD. IceCure iceSense™ 3 510(k) Submission
Section 4 Section 4
Indications for Use StatemEA(0(k) Number
7
Indications for Use Statement
K 102360 510(k) Number (if known):
Device Name: IceCure Medical IceSense3
Indications for Use:
The IceSense3 is intended for cryogenic destruction of tissue during surgical procedures. The IceSense3 is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, thoracic surgery, gynecology, oncology, proctology, and urology. The IceSense3 may be used with an ultrasound device to provide real-time visualization of the cryosurgical procedure.
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 . benign prostatic hyperplasia
Oncology
- The system may be used for ablation of cancerous or malignant tissue. .
- The system may be used for ablation of benign tumors. .
- The system may be used for palliative intervention. .
Dermatology
- The system may be used for the ablation or freezing of skin cancers and other coetaneous . disorders.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Net Rl. Oble. Co. nxtn.
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K02360
Page _ of _
IceCure Medical LTD. IceCure IceSense™ 3 510(k) Submission
Section 4 Indications for Use Statement Page 2 of 3