(222 days)
SeedNet™, CRYO-HIT™, Cryo-Mono with TUF Probe
No
The document explicitly states that the software algorithm has not been modified, and there are no mentions of AI, DNN, or ML.
Yes
The device is intended for the "cryogenic destruction of tissue during surgical procedures" and is indicated for treating various medical conditions and tissues, including cancers, benign tumors, and other lesions, which constitutes a therapeutic use.
No
Explanation: The device is intended for cryogenic destruction of tissue during surgical procedures, acting as a cryosurgical tool, not for diagnosing conditions.
No
The device description explicitly states that the system includes hardware components ("probes," "flexible probes," and "computer screens") in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "cryogenic destruction of tissue during surgical procedures." This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The description details a system with probes designed to apply extreme cold temperatures to tissue. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD device is used in vitro (outside the body) to examine specimens (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
The device is a surgical tool used for cryoablation, a therapeutic procedure.
N/A
Intended Use / Indications for Use
The modified SeedNet™ System is intended for cryogenic destruction of tissue during surgical procedures. is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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.
The modified SeedNet 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEH
Device Description
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System with STPS (K010991). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
Addition of 2 and 3 mm probes which are included in the previously cleared the Cryo-Hit™, to which the SeedNet™ is a modification.
Addition of flexible probes as an accessory to the SeedNet™
The systems computer screens, but not its software algorithm have slightly been modified.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, oral cavity, rectum, female genitalia, 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)
Not Found
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.
SeedNet™, CRYO-HIT™, Cryo-Mono with TUF Probe
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.
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
p.1/2 Galil Medical Proprietary Information
SECTION 8-510(K) SUMMARY
510(k) Summary
Galil Medical - SeedNet™ System
JAN 2 9 2002
510(k) Number
Kolly50
Company Name:
Galil Medical Ltd.
Contact Person:
Dr. Roni Zvuloni, Director of IP & Regulatory Affairs Telephone: +972-4-959 10 80 +972-4-959 10 77 Fax:
Trade Proprietary Name:
SeedNet™.
Classification Name:
CRYOSURGICAL UNIT
Classification:
GEH
1
Predicate Devices:
-
- SeedNet™
-
- CRYO-HIT™
-
- Cryo-Mono with TUF Probe
Indication for Use:
The modified SeedNet™ System is intended for cryogenic destruction of tissue during surgical procedures. is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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.
The modified SeedNet 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
2
Technological Characteristics:
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System with STPS (K010991). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
Addition of 2 and 3 mm probes which are included in the previously cleared the Cryo-Hit™, to which the SeedNet™ is a modification.
Addition of flexible probes as an accessory to the SeedNet™
The systems computer screens, but not its software algorithm have slightly been modified.
Substantial Equivalence
The modified SeedNet has the same intend use as the cleared SeedNet, Cryo-Hit, and Cryo-Mono with TUF Probe, the same general and specific indications as the Cryo-Hit, the same principles of operation as the cleared SeedNet, and very similar technological characteristics as the cleared SeedNet, Cryo-Hit and Cryo-Mono with TUF Probe. The minor difference in the diameter of the modified SeedNet's and Cryo-Mono's flexible probes and the modified SeedNet's computer screens does not raise any new questions of safety or effectiveness. Thus, the SeedNet™ System is substantially equivalent to these predicate devices.
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FEB 2 1 2008
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogin & Hartson L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K011950
Trade/Device Name: SeedNet™ System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL. GEH Dated: October 30, 2001 Received: October 31, 2001
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of January 29, 2002.
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 (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.
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.
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Page 2 - Mr. Jonathan S. Kahan
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); 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.
This letter will allow you to continue marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerelv yours,
Q.M.a
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE
JAN 2 9 2002
Koll1950 510(k) Number (if known):
Device Name:
SeedNet™ System
Indications for Use:
The SeedNet™ System is intended for cryogenic destruction of tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, neurology, 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.
The SeedNet 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas,
6
sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
510(k) Number
Prescription Use 1 (Per 21 CFR 801.109)
Over the Counter Use
Muriam C. Provost
OR
(Division Sign-Off) Division of General, Restorative and Neurological Devices
510(k) Number_Koll 950