(75 days)
K011950, CRYO-HIT™
No
The summary describes a cryosurgical system for tissue ablation and mentions its use with imaging modalities for visualization, but there is no mention of AI or ML in the intended use, device description, or any other section.
Yes.
The device is intended for the cryogenic destruction of tissue for various medical conditions across multiple surgical fields, directly addressing and treating these conditions, which aligns with the definition of a therapeutic device.
No
The SeedNet™ System is described as being "intended for cryogenic destruction of tissue during surgical procedures" and "designed to destroy tissue by the application of extreme cold temperatures". Its function is therapeutic (tissue destruction), not diagnostic (identifying or characterizing disease). While it can be used with MRI or ultrasound for visualization, these are for guiding the destructive procedure, not for diagnosis by the SeedNet system itself.
No
The device description explicitly states it is a "System" and mentions the addition of a "4.5 mm surface probe," which is a hardware component. The intended use also describes a cryosurgical tool for tissue destruction, which inherently involves hardware for delivering the cryotherapy.
Based on the provided information, the SeedNet™ System (SeedNet Gold™ System) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that 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 used for cryosurgery, involving probes and the application of extreme cold temperatures to destroy tissue. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening. The SeedNet™ System does not perform any such analysis of biological specimens. It is a surgical tool used for direct tissue ablation.
Therefore, the SeedNet™ System is a surgical device used for therapeutic purposes, not an IVD device.
N/A
Intended Use / Indications for Use
The SeedNet™ System (SeedNet Gold™ 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 (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.
The SeedNet™ System (SeedNet Gold™ 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 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.)
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).
Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,)
Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)
The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Product codes
OLC, GEH
Device Description
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System (K011950). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
-
- The inclusion of cryoanalgesia as an example of the device's cleared neurology general indication.
-
- The addition of a 4.5 mm surface probe.
-
- Addition of trade name: SeedNetGold™ System.
-
- Provision of the use of the modified SeedNet system together with magnetic resonance imaging (MRI) device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI) device or an ultrasound device
Anatomical Site
prostate, kidney, liver, skin, female genitalia, rectum, anus, oral cavity, cardiac tissue
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K011950, CRYO-HIT™
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
SECTION 8-510(K) SUMMARY
Image /page/0/Picture/3 description: The image contains a sequence of characters that appear to be handwritten. The characters are 'K', 'O', '2', '1', 'a', and 'b', followed by the number '1'. The characters are written in a casual, slightly slanted style, and they are all connected to each other. The image has a simple, unadorned look, with the focus solely on the handwritten characters.
510(k) Summary
Galil Medical - SeedNet™ System
510(k) Number
Company Name:
Galil Medical Ltd.
Contact Person:
Dr. Roni Zvuloni, Director of IP & Regulatory Affairs Telephone: +972-4-959 10 80 Fax: +972-4-959 10 77
Trade Proprietary Name:
SeedNet™ System , SeedNetGold™ System
Classification Name:
CRYOSURGICAL UNIT
Classification:
GEH
Predicate Devices:
-
- SeedNet™
-
- CRYO-HIT™
\\DC - 67930/1 - #1514804 v1
1
Indication for Use:
The modified SeedNet 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.
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 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 tumors of the rectum, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)
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)
The Modified SeedNet System may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
2
Technological Characteristics:
The Galil Medical's SeedNet™ System is a modification of Galil Medical LTD's cleared SeedNet™ System (K011950). The SeedNet™ System is the exact same device as the SeedNet™ except for the following modifications to its technological characteristics:
-
- The inclusion of cryoanalgesia as an example of the device's cleared neurology general indication.
-
- The addition of a 4.5 mm surface probe.
-
- Addition of trade name: SeedNetGold™ System.
-
- Provision of the use of the modified SeedNet system together with magnetic resonance imaging (MRI) device.
Substantial Equivalence
The modified SeedNet has the same intended use as the cleared SeedNet™ and the Cryo-Hit™, the same general and specific indications as the Cryo-Hit™, the same general and specific indications as the cleared SeedNet, except for the provision of the cryoanalgesia example of a neurology indication, the same principles of operation as the cleared SeedNet™ and the Cryo-Hit™, and the same technological characteristics as a combination of the cleared Cryo-Hit and the cleared SeedNet™ The inclusion of the cryoanalgesia as an example of the device's cleared neurology general indication, the addition of the Cryo-Hit's cleared 4.5 mm surface probe, and the MRI option do not raise any question of safety and effectiveness. The use of the alternative SeedNet Gold™ System trade name does not affect the safety or effectiveness of the device. Thus, the modified SeedNet System is substantially equivalent to the predicate devices.
3
Image /page/3/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of what appears to be an abstract human figure.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004-1109
Re: K021261
Trade Name: SeedNet™ System (SeedNet Gold™ System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit Regulatory Class: Class II (two) Product Code: OLC, GEH Dated: April 17, 2002 Received: April 19, 2002
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of July 03, 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
Sincerely yours.
elmee
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
510(k) Number (if known):
12021261
Device Name:
SeedNet™ System (SeedNet Gold™ System)
Indications for Use:
The SeedNet™ System (SeedNet Gold™ 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 (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.
The SeedNet™ System (SeedNet Gold™ 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
6
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.)
ENT (Palliation of tumors of the oral cavity and ablation of leukoplakia of the mouth).
Thoracic surgery (ablation of arrhythmic cardiac tissue and cancerous lesions,)
Proctology (ablation of benign or malignant growths of the anus or rectum and hemorrhoids)
The SeedNet™ System (SeedNet Gold™ System) may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
(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
Stye Rhodes
510(k) Number
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
510(k) Number_________________________________________________________________________________________________________________________________________________________________
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X Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR ·
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Over the Counter
Use__________________________________________________________________________________________________________________________________________________________
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