(27 days)
Not Found
No
The summary describes a cryoablation needle, a physical device used for tissue destruction. There is no mention of software, algorithms, image processing, or any terms related to AI/ML. The performance studies focus on the physical properties and equivalence to a predicate device.
Yes
The device is intended for "cryoablative destruction of tissue during surgical procedures" for various medical conditions, indicating a direct therapeutic action on the body.
No
The device is described as a cryoablation system intended for the destruction of tissue during surgical procedures, not for diagnosing conditions.
No
The device description clearly states it is a sterile, single-use, disposable device with physical components like a sharp cutting tip, shaft, handle, gas tubing, and connector. It is used in conjunction with cryoablation systems, which are also hardware.
Based on the provided text, 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 "sterile, single use, disposable device used in conjunction with Galil! Medical's cleared cryoablation systems... for cryoablative destruction of tissue during surgical procedures." It's a tool used in surgery.
- Lack of In Vitro Activity: The description does not mention any testing or analysis of samples (blood, tissue, etc.) outside of the body. IVD devices are used to examine specimens in vitro (in glass, or outside the living organism) to provide information for diagnosis, monitoring, or screening.
This device is a surgical tool used for a therapeutic purpose, not for diagnostic testing of samples.
N/A
Intended Use / Indications for Use
The intended use for Galil's proposed insulated IceSphere cryoablation needles has not changed as a result of the modification described in this Special 510(k). The intended use and indications for use are the same as the predicate indications for use of Galil Medical Cryoablation Systems and associated needles.
Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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.
Galil Medical Cryoablation Systems 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 evelid 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 (ablation of arrhythmic cardiac tissue cancerous lesions)
- Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement.
Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and kidney tissue, liver, skin, prostate, kidney, breast, rectum, anus, oral cavity, heart, 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 Galil's non-insulated predicate and the proposed insulated lceSphere Cryoablation Needles 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. The insulated IceSphere successfully passed all the design properties testing in accordance with the established acceptance criteria compared to the non-insulated leeSphere predicate. Test results demonstrated that the proposed insulated IceSphere needles meet defined specifications and do not raise any new safety or effectiveness issues as compared to the predicate.
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.
Cryoablation Probe (IceSphere Cyroablation Needle)
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.
K060390, K021261, K113860, K110946
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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 "Leading Through Innovation" in a smaller, lighter font.
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. Regulatory Affairs and Quality Advisor
Galil Medical Inc. |
| Phone: | 651-287-5098 |
| Fax: | 651-287-5099 |
| Email: | lynne.davies@galilmedical.com |
| Alternate Contact Person: | Ms. Amy E McKinney
Sr Director, Global Regulatory Affairs and Quality
Galil Medical Inc. |
| Phone: | 651-287-5096 |
| Fax: | 651-287-5097 |
| Email: | amy.mckinney@galilmedical.com |
| Device Name: | IceSphere Cryoablation Needle |
| Device Classification Name: | Cryosurgical unit and accessories (GEH)
21 CFR 878.4350 |
| Predicate Devices /
Referenced 510(k): | Cryoablation Probe (IceSphere Cyroablation Needle) Referenced
Galil 510(k): K060390, K021261, K113860, K110946 |
| Date of Preparation | June 4, 2014 |
Device Description:
Galil Medical's predicate IceSphere needles and Galil's proposed IceSphere needles are sterile, single use, disposable devices used in conjunction with Gali! Medical's cleared cryoablation systems (SeedNet, SeedNet Gold; Presice; Visual-ICE) for cryoablative destruction of tissue during surgical procedures. The needles have a sharp cutting tip, a 1.5mm (17G) shaft, a color-coded handle, gas tubing, and a connector. Galil's predicate and proposed iceSphere needles are available in 2 handle configurations: straight and 90°. The needles contain shaft markings to aid the physician in needle placement.
Galil is requesting clearance of the proposed vacuum insulated IceSphere needles. The vacuum insulated modification represents a one-for-one component exchange within the internal non-patient contacting lumen of the cryoablation needle shaft.
1
Table 1 provides a comparison of the predicate and the proposed device.
| Description of Device | Comments related to the predicate |
|---|---|
| Design and Construction | |
| Needle Tip | Same |
| Needle Shaft | Internal one-for-one component exchange |
| Needle Shaft Marks | Same |
| Gas Pathway Tubing | Same |
| Handle | Same |
| Needle Connector | Same |
| Performance and Function | |
| Indications for Use | Same |
| Freezing/Thawing Technology | Same |
| Function | Iceball more uniform shape |
| Freezing Parameters | Same |
| Thaw Parameters | Same |
Table 1 Comparison to Predicate
Therefore as outlined in Table 1 the proposed IceSphere needles, incorporating the component exchange, have the same:
- . device design (with the exception of the internal component);
- materials;
- principle of operation; and
- . mechanism of action.
The component exchange does not change the functionality, intended use or the indications for use of the needles from that of the predicate non-insulated IceSphere needles.
Intended Use:
The intended use for Galil's proposed insulated IceSphere cryoablation needles has not changed as a result of the modification described in this Special 510(k). The intended use and indications for use are the same as the predicate indications for use of Galil Medical Cryoablation Systems and associated needles.
Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems are 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.
Galil Medical Cryoablation Systems 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)
2
Image /page/2/Picture/0 description: The image shows the logo for Galil Medical. The logo features 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 "Leading Through Innovation" in a smaller, lighter font.
- Dermatology (ablation or freezing of skin cancers and other cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the evelid 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 (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:
Performance testing was conducted on Galil's non-insulated predicate and the proposed insulated lceSphere Cryoablation Needles 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. The insulated IceSphere successfully passed all the design properties testing in accordance with the established acceptance criteria compared to the non-insulated leeSphere predicate. Test results demonstrated that the proposed insulated IceSphere needles meet defined specifications and do not raise any new safety or effectiveness issues as compared to the predicate. .
Conclusion:
Galil Medical believes the information and data provided in this Special 510(k) Notification establishes that the IceSphere needles incorporating the vacuum sleeve component do not affect safety or effectiveness, or raise different questions of safety and effectiveness from that of the predicate IceSphere and is therefore, substantially equivalent to the legally marketed predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 2, 2014
Galil Medical Ltd. Ms. Lynne A. Davies Senior Regulatory Affairs and Quality Advisor 4364 Round Lake Road Arden Hills, Minnesota 55112
Re: K141485
Trade/Device Name: IceSphere Cryoablation Needle Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: June 4, 2014 Received: June 5, 2014
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. 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 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
4
Page 2 - Ms. Lynne A. Davies
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/ResourcesforYou/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.
Sincerely yours.
David Krause -S
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
5
Indications for Use Statement
510(k) Number (if known): K141485
Device Name: IceSphere Cryoablation Needle
Indications For Use:
Galil Medical Cryoablation Systems are intended for cryoablative destruction of tissue during surgical procedures. The cryoablation systems 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.
Galil Medical Cryoablation Systems 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 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 |
AND/OR Over-The-Counter Use Prescription Use X (Part 21 CFR 801 Subpart D) (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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