(28 days)
No
The document describes a cryoablation system with updated needles and software, but there is no mention of AI or ML capabilities in the intended use, device description, or performance studies. The software update appears to be for supporting the new needles and enhancing programming robustness, not for implementing AI/ML algorithms.
Yes
The device is described as a "cryoablation needle" intended for "cryoablative destruction of tissue during surgical procedures" for various medical conditions, indicating its therapeutic purpose.
No
The device is a cryoablation needle intended for the destruction of tissue, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states that the submission is for "IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles," which are described as sterile, single-use, disposable hardware components. While the submission also includes changes to the Visual-ICE System software, the primary device being cleared is a physical needle.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "cryoablative destruction of tissue during surgical procedures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a "Cryoablation Needle" used to "destroy tissue by the application of extreme cold temperatures." This describes a surgical tool used for treatment.
- 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 information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide diagnostic information. This device is a surgical instrument used for treatment.
N/A
Intended Use / Indications for Use
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles are 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, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have 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 cvsts, 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 (with the exception of cardiac tissue)
- . Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
Product codes
GEH
Device Description
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System Software Revision 1.4.0, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles offer handles configured as straight and in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).
The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles were designed to provide the same cryoablation functionality with similar iceball shapes on a 2.1 mm shaft as compared to Galil Medical's predicate needles, IceRod CX (1.5 mm) needle and IceEDGE 2.4 mm needle.
The IcePearl 2.1 CX and IceFORCE 2.1 CX Crvoablation Needles differ from the predicate devices in that the reconfigured heat exchanger has been relocated from the needle shaft to the needle handle and an additional vacuum insulated tube has been incorporated into the handle. The changes were made to ensure optimal freezing performance utilizing a 2.1 mm shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, rectum, anus, breast, oral cavity, female genitalia
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 was conducted on the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles with Visual-ICE Software Revision 1.4.0 to verify safety and performance characteristics and to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional testing, functional testing, freezing performance, and in vivo needle track ablation, based on depth of tissue necrosis characterization. Test results demonstrated that the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles when used with Visual-ICE Software Revision 1.4.0 meet defined specifications and do not raise any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K121251, K140584, K111859, K113860, K123865, K143564
Reference Device(s)
IceRod CX Cryoablation Needles (K121251 and K140584), IceEDGE 2.4 Cryoablation Needle (K111859), Visual-ICE Cryoablation System (K113860, K123865, K143564)
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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 28, 2015
Galil Medical Ltd. % Ms. Lynne Davies Galil Medical Incorporated 4364 Round Lake Road Arden Hills, Minnesota 55112
Re: K152133
Trade/Device Name: IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 31, 2015 Received: July 28, 2015
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-related
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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.
for
Sincerely yours,
David Krause -S
- 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
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Image /page/2/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter G with a green dot inside, followed by the text "GALIL MEDICAL" in a bold, sans-serif font. Below the company name is the tagline "Leading Through Innovation" in a smaller, lighter font.
K152133
Indications for Use Statement
510(k) Number (if known): K152133
Device Name: IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles
Indications For Use:
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles are 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, oncology, proctology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have 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 cvsts, 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 (with the exception of cardiac tissue)
- . 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)
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Image /page/3/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" with a green dot inside, followed by the text "GALIL MEDICAL" in a bold, sans-serif font. Below the logo is the tagline "Leading Through Innovation" in a smaller, lighter font.
Section 5. 510(k) Summary
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 Ltd.
Tavor 1 Building
Shaar Yokneam
Yokneam Industrial Park 20692
Israel |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Company Contact Person: | Ms. Lynne A Davies
Sr. Manager, Regulatory Affairs
Galil Medical Ltd.
Phone: 651-287-5098
Fax: 651-287-5099
Email: lynne.davies@galilmedical.com |
| Alternate Contact Person: | Ms. Amy E McKinney
VP, Regulatory Affairs and Quality
Galil Medical Ltd.
Phone: 651-287-5096
Fax: 651-287-5097
Email: amy.mckinney@galilmedical.com |
| Device Name: | IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation
Needles |
| Device Classification Name: | Cryosurgical unit and accessories (GEH)
21 CFR 878.4350 |
| Predicate Devices / Reference
510(k): | IceRod CX Cryoablation Needles (K121251 and
K140584)
IceEDGE 2.4 Cryoablation Needle (K111859)
Visual-ICE Cryoablation System (K113860, K123865,
K143564) |
| Date of Preparation: | July 28, 2015 |
Device Description:
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are sterile, single use, disposable components, when used in conjunction with Galil Medical's Visual-ICE Cryoablation System Software Revision 1.4.0, to perform cryoablative destruction of tissue. The needles are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are disposable 2.1 mm needles that have a sharp cutting tip, a color-coded handle, a gas tube, and a connector. Both IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles offer handles configured as straight and in a 90° angled configuration (to aid positioning of the needle within the CT imaging system gantry).
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 green dot inside, followed by the text "GALILMEDICAL" in a bold, sans-serif font. Below the logo is the tagline "Leading Through Innovation" in a smaller font.
K152133
The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles were designed to provide the same cryoablation functionality with similar iceball shapes on a 2.1 mm shaft as compared to Galil Medical's predicate needles, IceRod CX (1.5 mm) needle and IceEDGE 2.4 mm needle.
The IcePearl 2.1 CX and IceFORCE 2.1 CX Crvoablation Needles differ from the predicate devices in that the reconfigured heat exchanger has been relocated from the needle shaft to the needle handle and an additional vacuum insulated tube has been incorporated into the handle. The changes were made to ensure optimal freezing performance utilizing a 2.1 mm shaft.
The table below provides a summary comparison of the submitted devices compared to the predicate devices.
| Description of Submitted Device: | Comments related to Predicates: |
|---|---|
| IcePearl 2.1 CX and IceFORCE 2.1 | |
| CX Cryoablation Needles | IceRod CX Cryoablation Needles (K121251, K140584); and |
| IceEDGE 2.4 (K111859) | |
| Design and Construction | |
| Needle Tip | Same as predicate |
| Needle Shaft | Shaft size (diameter) is in-between the shaft sizes of the predicates |
| Gas Pathway Tubing | Same as predicate |
| Handle | Same as the predicates with the exception of a larger diameter resulting |
| from the incorporation of: | |
| • the reconfigured heat exchanger located in the proximal end of the handle toward the connector versus being in the needle shaft; and | |
| • the addition of a vacuum insulation tube | |
| Needle Connector | Same as predicate |
| Performance and Function | |
| Freezing/Thawing Technology | Same as predicate |
| Function | Same as predicate |
| Freezing Parameters | Same as predicate |
| Thaw Parameters | Same as predicate |
| Track Ablation | Same as predicate |
| Indications for Use | Same as predicate |
In summary, the submitted IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have the same technology, principle of operation and indications for use as the predicate devices.
This Special 510(k) also contains changes to the Visual-ICE System software denoted as Software Release 1.4.0. Software Release 1.4.0 is an updated version of the Visual-ICE software previously cleared. There are no changes to the system hardware required as a result of the changes being made in the software. The following modifications were incorporated based on the added software support of the proposed IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles as well as customer and sales feedback to enhance the robustness of the software programming.
| User Interface
Changes | Updated the needle selection dialog to display marketing names and to default to the
currently selected needle type. |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Service and | Added features for service personnel to diagnose and troubleshoot issues in the field. |
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Image /page/5/Picture/0 description: The image shows the logo for Galil Medical. The logo consists of a stylized letter "G" with a green dot inside, followed by the text "GALIL MEDICAL" in a bold, sans-serif font. Below the logo, the tagline "Leading Through Innovation" is written in a smaller font.
| Maintenance
Changes | These changes include:
Ability to access and troubleshoot to needle memory parameters from diagnostic screen Ability to export multiple log files to USB Stick Modified the Visual ICE message to accommodate for 2 year service intervals. |
|---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Functional
Changes | Added support for needles that have been calibrated with heater wire temperature information during production. This allows for a lower needle shaft temperature display. Added support for the 2.1 CX Cryoablation Needles to the software. Added reporting of timeline when channel is disconnected. Modified the software to display lowest temperature during freezing and to display temperatures in the MTS graphs without first having to test a needle. |
| User Interface and
Functional
Changes | Added support and dialog messages related to real time feedback of power consumption by needles in i-Thaw, FastThaw, and cautery modes. The big timers on the system are now easier to activate from different screens and display needle temperature. Streamlined the channel controls by removing the redundant advanced features on the freeze and thaw dialogs. Added the ability to FastThaw directly from the channel controls instead of having to filter through multiple menu options. Added the ability to save and load multiple programmed cycles. |
Intended Use:
Galil Medical's IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles are intended for cryoablative destruction of tissue during surgical procedures. The IcePearl 2.1 CX and lceFORCE 2.1 CX Cryoablation Needles are 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, oncology, and urology. The systems are designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
The Galil Medical IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles have 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 malignant neoplasia or benign dysplasia of the female genitalia)
- . General surgery (palliation 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 (with the exception of cardiac tissue)
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Image /page/6/Picture/0 description: The image shows the logo for Galil Medical. The logo features a stylized letter "G" with a green dot inside, followed by the text "GALILMEDICAL" in a bold, sans-serif font. Below the logo, the tagline "Leading Through Innovation" is displayed in a smaller, lighter font.
- Proctology (ablation of benign or malignant growths of the anus or rectum, and ● hemorrhoids)
Summary of Performance Data and Substantial Equivalence:
The IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles use the same technology and have the same intended use and method of operation as compared to the predicate devices.
Performance testing was conducted on the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles with Visual-ICE Software Revision 1.4.0 to verify safety and performance characteristics and to establish substantial equivalence. Testing was conducted according to protocols based on international standards and in-house requirements and included dimensional testing, functional testing, freezing performance, and in vivo needle track ablation, based on depth of tissue necrosis characterization. Test results demonstrated that the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles when used with Visual-ICE Software Revision 1.4.0 meet defined specifications and do not raise any new safety or effectiveness issues.
Conclusion:
The information and data provided in this Special 510(k) Notification establish that the IcePearl 2.1 CX and IceFORCE 2.1 CX Cryoablation Needles when used with Visual-ICE Software Revision 1.4.0 are substantially equivalent to the legally marketed predicate devices.