(73 days)
Not Found
No
The document describes a computer-controlled system for cryoablation based on the Joule-Thomson effect. It mentions a touch screen interface and software control but does not include any terms or descriptions indicative of AI or ML technology being used for decision-making, image analysis, or other functions. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes
The device is described as a "Cryoablation System" intended for "cryoablative destruction of tissue during surgical procedures" across various medical fields to treat conditions like cancer, lesions, and warts. This clearly indicates its use in medical treatment and intervention.
No
This device is a therapeutic device used for tissue destruction through cryoablation, not for diagnosing medical conditions.
No
The device description explicitly states it is a "mobile console system" and uses "high-pressure argon gas" and "helium gas" circulating through "cryoablation needles" for tissue freezing and thawing. This indicates significant hardware components beyond just software.
Based on the provided information, the Visual-ICE™ Cryoablation System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states the system is for "cryoablative destruction of tissue during surgical procedures." This involves direct interaction with the patient's body to treat tissue in vivo.
- Device Description: The description details a system that uses gases and needles to freeze and thaw tissue within the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Visual-ICE system performs a therapeutic procedure in vivo.
N/A
Intended Use / Indications for Use
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE 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 metastases, lesions, and warts.
The Visual-ICE 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, 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
- Thoracic surgery Ablation of arrhythmic cardiac tissue cancerous lesions
- Proctology Ablation of benign or malignant growths of the anus or rectum, and hemorrhoids
Product codes
GEH
Device Description
The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, prostate, cancerous or malignant tissue, benign tumors, prostate, skin, eyelid, canthus area, female genitalia, rectum, 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 Cyroablation System to ensure that the design, functionality, and performance met the requirements. Testing was conducted according to protocols based on international standards and in-house requirements. Testing included system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing. Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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
GALILMEDICAL
A New Vision of Precision
Section 5. 510(k) Summary J
Page 1 of ②
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. Amy McKinney Director, Regulatory Affairs Galil Medical Inc. 651-287-5096 Phone: 651-287-5097 Fax: Email: amy.mckinney@galilmedical.com
Sr. Regulatory Affairs Advisor
Alternate Contact:
- Galil Medical Inc. 651-287-5098 Phone: Fax: 651-287-5099 Email: lynne.davies@galilmedical.com
| Device Name: | Visual-ICE™ Cryoablation System |
|---|---|
| Device Classification Name: | Cryosurgical unit and accessories (GEH) |
| 21 CFR 878.4350 | |
| Predicate Devices: | Presice Cryosurgical System (K060390) |
Lynne Davies
Device Description:
The Visual-ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface that allows the user to control and monitor the procedure. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or alternatively, by the use of Galil Medical i-Thaw technology in which a heating element inside the cryoablation needle can be energized to cause thawing.
Intended Use:
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE 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
1
A New Vision of Precision
CONFIDENTIAL
extreme cold temperatures including prostate and kidney tissue, liver metastases, lesions, and warts.
The Visual-ICE 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, 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 |
| • Thoracic surgery | Ablation of arrhythmic cardiac tissue cancerous lesions |
| • Proctology | Ablation of benign or malignant growths of the anus or rectum, and
hemorrhoids |
Summary of Performance Data and Substantial Equivalence:
The Visual-ICE System uses the same technology and has the same intended use and indications for use as the predicate, Galil Medical's Presice Cryoablation System (K060390).
A full battery of verification and validation testing was conducted on the Visual-ICE Cyroablation System to ensure that the design, functionality, and performance met the requirements. Testing was conducted according to protocols based on international standards and in-house requirements. Testing included system testing, electrical testing, mechanical testing, packaging and labeling testing, software testing, design and usability testing, and animal cadaver testing. Test results demonstrated that the Visual-ICE Cryoablation System meets defined specifications, is substantially equivalent to the predicate device, and does not raise any new issues of safety and effectiveness.
Conclusion:
The information and data provided in this 510(k) Notification establish that the Visual-ICE Cryoablation System is substantially equivalent to the legally marketed predicate device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird-like figure with three distinct lines forming its body and wings. The bird is oriented diagonally, facing towards the upper right. Encircling the bird is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Galil Medical, Inc. % Ms. Amy McKinney Director, Regulatory Affairs 63 Chicory Court Lake Jackson, Texas 77566
MAR 1 2 2012
Re: K113860
Trade/Device Name: Visual-ICE Cryoablation System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: December 29, 2011 Received: December 30, 2011
Dear Ms. McKinney:
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
3
Page 2 - Ms. Amy McKinney
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/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mark A. Mcllvaine
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" with a small circle inside, followed by the text "GALILMEDICAL" in bold, sans-serif font. Below the company name is the tagline "A New Vision of Precision" in a smaller, lighter font.
Indications for Use Statement
K12XXXXX 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Visual-ICE Cryoablation System
Indications For Use:
The Visual-ICE™ Cryoablation System is intended for cryoablative destruction of tissue during surgical procedures. The Visual-ICE System is indicated for use as a cryssurgical 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 metastases, turnors, skin lesions, and warts.
The Visual-ICE 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 turnors 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 malignant 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 fibroadenoma)
- ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth) .
- Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions) .
- Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids) .
Prescription Use X (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Neil P. O'Brien for mka
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K113860