(78 days)
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No
The document describes a cryoablation needle and system that uses extreme cold temperatures to destroy tissue. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The technology described is based on physical principles of cryoablation.
Yes
The device is described as a "cryoablative destruction of tissue during surgical procedures" for various medical conditions, indicating its use in treating diseases or injuries, which aligns with the definition of a therapeutic device.
No
Explanation: The device is a cryoablation system intended for the destruction of tissue using extreme cold temperatures during surgical procedures. Its purpose is therapeutic, not diagnostic.
No
The device description explicitly details physical components like needles, shafts, handles, and gas tubes, indicating it is a hardware device used in conjunction with a cryoablation system.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device 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 description details a "Cryoablation System" and "Cryoablation Needles" which are tools used for physically destroying tissue with extreme cold.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) in vitro (outside 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 tool used for treatment.
N/A
Intended Use / 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, 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, 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 turnors, 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)
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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, skin, female genitalia, rectum, hemorrhoids, anal fissures, pilonidal cysts, breast, oral cavity, cardiac tissue, anus
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted on the IceRod Plus 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 and included dimensional testing, functional testing, freezing performance and stability. Additionally, the needles meet the biocompatibility requirements outlined in ISO 10993. Test results demonstrated that the IceRod Plus needles meet defined specifications and do not raise any new safety or effectiveness issues.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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.
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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).
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§ 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 circle at the end of one of its arms, followed by the text "GALIL MEDICAL" in bold, sans-serif font. Below the company name is the tagline "A New Vision of Precision" in a smaller, regular font.
Section 5. 510(k) Summary JUN 2 1 2011
510(k) SUMMARY TEMPLATE
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 Davies
Sr. Regulatory Affairs Advisor
Galil Medical Inc.
Phone: 651-287-5098 |
|--------------------------------|-------------------------------------------------------------------------------------------------|
| Fax:
Email: | 651-287-5099
lynne.davies@galilmedical.com |
| Device Name: | IceRod Plus 17G Cryoablation Needles |
| Device Classification
Name: | Cryosurgical unit and accessories (GEH)
21 CFR 878.4350 |
| Predicate Device: | IceRod 17G Cryoablation Needle (K051052)
IceRod 17G 90° Cryoablation Needle (K060144) |
Device Description:
The IceRod Plus 17G Cryoablation Needles are sterile, single use, disposable components used in conjunction with a Galil Medical Cryoablation System when performing cryoablative destruction of tissue. They are intended to convert high-pressure gas to either a very cold freezing application or to a warm thawing application. The IceRod Plus needles are available in two configurations, straight and angled 90°. Each 17-gauge (17G) disposable cryoablation needle has a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Additionally, each needle exhibits markings every 5 mm to aid in positioning the needle in tissue. The IceRod Plus needles differ from the predicate device in that they contain an inner vacuum insulated tube to provide additional shaft insulation during a cryoablation procedure.
Intended 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, oncology, proctology, and urology. The system is
Special 510(k) - IceRod™ Plus Cryoablation Needles
1
Image /page/1/Picture/1 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 "A New Vision of Precision" in a smaller font size.
designed to destroy tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
I Cruschlation Systems have the following oppositions:
| • | 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 IceRod Plus Cryoablation Needles have the same intended use and method of operation as compared to the predicate devices. The IceRod Plus needles differ in design in that they contain an inner vacuum insulated tube to enhance shaft insulation during the cryoablation procedure. Both the new and predicate devices consist of a sharp cutting tip, a shaft, a color-coded handle, a gas tube, and a connector. Both the new and predicate devices are comprised of similar materials and serve as conduits for high pressure gas during a cryoablation procedure.
Performance testing was conducted on the IceRod Plus 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 and included dimensional testing, functional testing, freezing performance
Special 510(k) - IceRod™ Plus Cryoablation Needles
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, uppercase letters. Below the company name is the tagline "A New Vision of Precision" in a smaller font size.
and stability. Additionally, the needles meet the biocompatibility requirements outlined in ISO 10993. Test results demonstrated that the IceRod Plus needles meet defined specifications and do not raise any new safety or effectiveness issues.
Conclusion:
The information and data provided in this 510(k) Notification establish that the IceRod Plus 17G Cryoablation Needles are substantially equivalent to the legally marketed predicate devices.
Special 510(k) - IceRod™ Plus Cryoablation Needles
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three wing-like strokes. The bird is positioned above the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the bird.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Galil Medical Ltd. % Ms. Lynne Davies Sr. Regulatory Affairs Advisor Tavor 1 Building, Shaar Yokneam Yokneam Industrial Park 20692 Israel
JUN 2 1 2011
Re: K110946
Trade/Device Name: IceRod™ Plus Cryoablation Needles Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 21, 2011 Received: May 25, 2011
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.
4
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 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.
Eric Keith
C / Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known):
Device Name: IceRodTM Plus Cryoablation Needles
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, 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, 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 turnors, 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 8 (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)
Nailre Ogle for nkn
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number