(54 days)
No
The summary describes a computer-controlled cryoablation system for tissue destruction, but there is no mention of AI or ML in the intended use, device description, or performance studies. The control and monitoring are described as user-controlled via a touch screen interface.
Yes
The device is indicated for medical procedures such as the destruction of various tissues, including cancerous or malignant tissue, benign tumors, and skin lesions, for therapeutic purposes (e.g., ablation of prostate tissue in cases of prostate cancer, palliation of tumors).
No
The device is described as a "cryosurgical tool" and is "designed to destroy tissue" by applying extreme cold temperatures. Its indications for use include "ablation" of various tissues and tumors, which are therapeutic rather than diagnostic actions.
No
The device description explicitly states that the system is comprised of a Console, Mobile Connection Panel (MCP), and a Junction Box Assembly, which are hardware components. The performance studies also mention electrical and mechanical testing, further indicating the presence of hardware.
Based on the provided information, the Visual-ICE MRI Cryoablation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue samples) taken from the human body to provide information about a person's health. This testing is done outside the body (in vitro).
- Visual-ICE System Function: The Visual-ICE MRI Cryoablation System is a surgical tool used directly on the human body to destroy tissue using extreme cold temperatures. It is a therapeutic device, not a diagnostic one.
- Intended Use: The intended use clearly states it is a "cryosurgical tool" designed to "destroy tissue." This is a therapeutic action, not a diagnostic one.
- Device Description: The description details a system for "cryoablative tissue destruction using a minimally invasive procedure," performed "under visual guidance in an MR environment." This confirms its use within the body for treatment.
Therefore, the Visual-ICE MRI Cryoablation System falls under the category of a surgical or therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Visual-ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
The Visual-ICE MRI Cryoablation 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
- Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
- . General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
- ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
- Thoracic surgery (with the exception of cardiac tissue) •
- Proctology Ablation of benign or malignant growths of the anus or rectum
Product codes
GEH
Device Description
The Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has been designed to permit the delivery of cryoablation treatments under visual guidance in an MR environment. The Visual-ICE MRI System is comprised of a Console, Mobile Connection Panel (MCP) and a Junction Box Assembly. The system is computercontrolled with a touch screen user interface that allows the user to control and monitor the procedure. The console is located in the control room, while the Mobile Connection Panel is located in the magnet room. Junction boxes mounted in the two rooms, and connection of the gas and signal lines between the junction boxes occurs via a penetration panel. The Mobile Connection Panel is constructed of non-ferromagnetic materials to allow for placement within the magnet room close to the scanner. The Visual-ICE MRI Cryoablation System was designed for compatibility with Galil Medical's previously cleared IceRod MRI and IceSeed MRI cryoablation needles (K051052).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR
Anatomical Site
prostate, kidney, liver, skin, prostate, cancerous or malignant tissue, benign tumors, skin cancers, cutaneous disorders (warts, lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata), female genitalia, rectum, anal fissures, pilonidal cysts, recurrent cancerous lesions, breast, oral cavity, heart, 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)
A full battery of verification and validation testing was conducted on the Visual-ICE MRI Cyroablation System to ensure that the design, functionality, and performance met all the specified requirements and that the features of the system satisfy its intended use. Testing was conducted according to protocols based on international standards and in-house requirements. Verification testing included system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing. System testing assessed whether the functional requirements of the system as a whole were satisfied by the design. Mechanical testing evaluated the mechanical robustness of the system and sub-systems. functional testing of the gas system, and tests of mechanical safety requirements. Electrical testing assessed the functional aspects of the circuit assemblies, tests of electromagnetic compatibility and immunity (EMC/EMI), and tests of electrical safety requirements. Software testing exercised individual units of software as well as tests of the functionality of the entire software package. Validation testing included design and usability testing and animal testing. Test results demonstrated that the Visual-ICE MRI Cryoablation System meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Visual-ICE Cryoablation System (K113860), SeedNet MRI Cryoablation System (K021261)
Reference Device(s)
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
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern. Inside the circle is a stylized image of three human profiles facing right, with a triple-line design above them, resembling a stylized human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2017
Galil Medical Incorporated Ms. Lynne Davies Senior Manager, Regulatory Affairs 4364 Round Lake Road Arden Hills, Minnesota 55112
Re: K173037
Trade/Device Name: Visual-ICE MRI Cryoablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: September 27, 2017 Received: September 28, 2017
Dear Ms. Davies:
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, 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 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
1
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.
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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
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510(k) SUMMARY
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92.
| Submitter: | Galil Medical Inc.
4364 Round Lake Road
Arden Hills, MN 55112 |
|-----------------------------|---------------------------------------------------------------------------------------|
| Company Contact Person: | Ms. Lynne A Davies, BS
Sr. Manager, Regulatory Affairs
Galil Medical Inc. |
| Phone: | 651-287-5098 |
| Fax: | 651-846-4516 |
| Email: | lynne.davies@btgplc.com |
| Alternate Contact Person: | Rebeka Stoltman, BS, MBA
Director, Regulatory Affairs
Galil Medical Inc. |
| Phone: | 651-287-5020 |
| Fax: | 877-510-7757 |
| Email: | Rebeka.stoltman@btgplc.com |
| Device Name: | Visual-ICE™ MRI Cryoablation System |
| Device Classification Name: | Cryosurgical unit and accessories |
| Regulation Number: | 21 CFR 878.4350 |
| Product Code: | GEH |
| Predicate Devices 510(k): | Visual-ICE Cryoablation System (K113860)
SeedNet MRI Cryoablation System (K021261) |
| Date of Preparation: | September 27, 2017 |
Device Description:
The Visual-ICE™ MRI Cryoablation System is a mobile system intended for cryoablative tissue destruction using a minimally invasive procedure. The Visual-ICE MRI Cryoablation System has been designed to permit the delivery of cryoablation treatments under visual guidance in an MR environment. The Visual-ICE MRI System is comprised of a Console, Mobile Connection Panel (MCP) and a Junction Box Assembly. The system is computercontrolled with a touch screen user interface that allows the user to control and monitor the procedure. The console is located in the control room, while the Mobile Connection Panel is located in the magnet room. Junction boxes mounted in the two rooms, and connection of the gas and signal lines between the junction boxes occurs via a penetration panel. The Mobile Connection Panel is constructed of non-ferromagnetic materials to allow for placement within the magnet room close to the scanner. The Visual-ICE MRI Cryoablation System was designed for compatibility with Galil Medical's previously cleared IceRod MRI and IceSeed MRI cryoablation needles (K051052).
The table below provides a summary comparison of the submitted device compared to the predicate devices.
4
K173037
| Description of Submitted
Device:
Visual-ICE MRI Cryoablation
System | Comments related to Predicates:
SeedNet MRI and Visual-ICE Cryoablation Systems
(K021261,K113860) |
|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design and Construction | |
| Console, MCP and Junction
Boxes | Similar to predicate; Visual-ICE MRI is comprised of
updated components to address more stringent ESD
requirements in the 4th edition of Medical Electrical
Equipment EMC standard IEC 60601-1-2 |
| Needle ports | Same as predicate |
| Channel Lock | Same as predicate |
| User interface | Same as predicate |
| Performance and Function | |
| Principles of Operation:
Freezing / Thawing | Same as predicate |
| Needle Compatibility | Same as predicate |
| Signals between Console and
MCP | Similar to predicate; Fiberoptic lines were selected for
Visual-ICE MRI to minimize interference as compared
to the electrical conductor lines for the legacy SeedNet
MRI System |
In summary, the submitted Visual-ICE MRI Cryoablation System has the same technology and principle of operation as the predicate devices.
Indications for Use / Intended Use:
The Visual-ICE MRI Cryoablation System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology (including cryoanalgesia), thoracic surgery (with the exception of cardiac tissue), ENT, gynecology, proctology, and urology. This system is designed to destroy tissue (including prostate and kidney tissue, liver metastases, tumors, and skin lesions) by the application of extremely cold temperatures.
The Visual-ICE MRI Cryoablation 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 hemangiomas, mucocele cysts, multiple warts, plantar warts, actinic and seborrheic keratosis, cavernous hemangiomas, peri-anal condylomata, and palliation of tumors of the skin
- Gynecology Ablation of malignant neoplasia or benign dysplasia of the female genitalia
- . General surgery Palliation of tumors of the rectum, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas
- ENT Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth
- Thoracic surgery (with the exception of cardiac tissue) •
- Proctology Ablation of benign or malignant growths of the anus or rectum
5
K173037
The intended use and indications for use are the predicates with the exception that warts, hemorrhoids and ablation of cardiac tissue have been excluded for international indication alignment and marketing reasons. Galil Medical contends that there are no differences to the intended therapeutic, diagnostic, prosthetic, or surgical use of the device, and that the device is safe and effective when used as labelled.
Summary of Performance Data and Substantial Equivalence:
A full battery of verification and validation testing was conducted on the Visual-ICE MRI Cyroablation System to ensure that the design, functionality, and performance met all the specified requirements and that the features of the system satisfy its intended use. Testing was conducted according to protocols based on international standards and in-house requirements. Verification testing included system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing. System testing assessed whether the functional requirements of the system as a whole were satisfied by the design. Mechanical testing evaluated the mechanical robustness of the system and sub-systems. functional testing of the gas system, and tests of mechanical safety requirements. Electrical testing assessed the functional aspects of the circuit assemblies, tests of electromagnetic compatibility and immunity (EMC/EMI), and tests of electrical safety requirements. Software testing exercised individual units of software as well as tests of the functionality of the entire software package. Validation testing included design and usability testing and animal testing. Test results demonstrated that the Visual-ICE MRI Cryoablation System meets defined specifications, is substantially equivalent to the predicate devices, and does not raise any new issues of safety and effectiveness for its intended use.
Conclusion:
The information and data provided in this Traditional 510(k) Premarket Notification establish that the Visual-ICE MRI Cryoablation System is substantially equivalent to the legally marketed predicate devices with regard to performance, safety, and effectiveness for its intended use.