(65 days)
SeedNet Family, CryoCare CS system, Visica system
Not Found
No
The summary describes a cryosurgical unit with argon-cooled probes for tissue destruction. There is no mention of AI or ML in the intended use, device description, or any of the provided sections. The use of imaging modalities (MRI, ultrasound) is for visualization, not for AI/ML processing.
Yes
The device is used to destroy tissue during surgical procedures for various medical conditions, indicating a therapeutic purpose.
No
The device is described as a "cryosurgical tool" intended for the "cryogenic destruction of tissue during surgical procedures." It is used for ablation of various tissues and lesions, not for diagnosing them. While it "may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure," these imaging devices are external and used for guidance, not for the SeedNet Family itself to perform a diagnosis.
No
The device description explicitly states it is a "Cryosurgical unit with argon-cooled probes," indicating it includes hardware components (the unit and probes) for performing the cryosurgical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the SeedNet Family is for the "cryogenic destruction of tissue during surgical procedures." This is a therapeutic procedure performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The description is of a "Cryosurgical unit with argon-cooled probes," which is a surgical tool, not a diagnostic test kit or instrument.
- Anatomical Site: The device is used on various anatomical sites within the body, not on samples taken from the body.
The use of imaging modalities like MRI or ultrasound is for guiding the surgical procedure, not for performing an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet Family 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 Family has the following specific indications:
- I Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
- 트 Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention).
- 트 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, l hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.)
- ENT (Palliation of tumors of the oral cavity and ablation of u leukoplakia of the mouth).
- . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
- 트 Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The SeedNet Family 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 (comma separated list FDA assigned to the subject device)
GEH, OCL
Device Description
Not Found
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 tissue, liver, skin, breast, oral cavity, heart, anus, rectum, female genitalia, eyelid or canthus area
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 Family, CryoCare CS system, Visica system
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.
Not Found
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
510(K) SUMMARY Galil Medical LTD.
SeedNet Family
Applicant's Name:
Galil Medical Ltd. Tavor 1 Building Shaar Yokneam Yokneam Industrial Park 20692 ISRAEL Tel: 972-4-9591080 Fax: 972-4-9591077
Contact Person:
Sarit Gelbart VP Regulatory Affairs Galil Medical Ltd. Tel: +972-4-9591080, Ext. 240 Fax: +972-4-9591077 sarit@galil-medical.co.il
Trade Name:
SeedNet/SeedNetGold System, CryoThera System, Cryo-Hit System (for ease of reference, the CryoThera, Cryo-Hit, SeedNet, and SeedNetGold are collectively being called the "SeedNet Family" in this 510(k) notice except when there is a need to distinguish between the devices).
| Classification: | Cryosurgical Unit |
|---|---|
| Common/Usual Name: | Cryosurgical unit with argon-cooled probes |
| Product Code: | GEH |
| Regulation No.: | 878.4350 |
| Class: | II; FDA has not specifically classified |
| cryosurgical units with argon cooled cryoprobes | |
| as class II devices under 21 C.F.R. § 878.4350. | |
| However, FDA has cleared Galil Medical | |
| SeedNet™ and SeedNetGold™, which are | |
| cryosurgical units with argon-cooled Cryoprobes, | |
| as Class II devices. Therefore, cryosurgical units | |
| with argon-cooled probes are Class II medical | |
| devices. |
1
Predicate Devices:
Galil Medical Ltd. believes that the current SeedNet Family with the expanded Indications for Use is substantially equivalent to the combination of the following predicate devices, all classified under product code GEH:
- SeedNet Family, Galil Medical.
- 『 CryoCare CS system.
- E Visica system.
Intended Use:
The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet Family 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 Family has the following specific indications:
- I Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
- 트 Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention).
- 트 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)
2
- General surgery (palliation of tumors of the rectum, l hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.)
- ENT (Palliation of tumors of the oral cavity and ablation of u leukoplakia of the mouth).
- . Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
- 트 Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
The SeedNet Family may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide real-time visualization of the cryosurgical procedure.
Performance Data & Substantial Equivalence:
The Indications for Use of the current SeedNet Family is expanded to include the specific indication of ablation of breast fibroadenomas. The only change between the current and the cleared indications of the SeedNet Family is the addition of this indication to the cleared General Surgery specific indications. This indication of breast fibroadenomas is claimed by both the 510(k)-cleared CryoCare CS system and Visica system. All systems are cryo-surgery systems, which employ similar performance characteristics. In all other aspects including technological characteristics, software, user interface and principles of operation, the SeedNet Family described in this submission is substantially equivalent to the cleared SeedNet Family.
Therefore, Galil Medical Ltd. believes that the SeedNet Family described in this submission is substantially equivalent to the combination of its predicate devices; the cleared SeedNet Family (the SeedNet™; the SeedNetGold™ , the CryoThera™ and the Cryo-Hit™), the CryoCare CS and the Visica systems, and does not raise any new questions of safety and/or effectiveness.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with outstretched wings. The bird is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird.
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
Re: K052530
Trade/Device Name: SeedNet Family (SeedNet/SeedNetGold System, CryoThera System, Cryo- Hit System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: September 6, 2005 Received: September 14, 2005
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of November 18, 2005.
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.
4
Page 2 - Mr. Jonathan 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 (OS) 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 vours.
elgmee
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
KOS2520
510(k) Number (if known):
Device Name:
SeedNet Family (SeedNet/SeedNetGold System, CryoThera System, Cryo- Hit System)
Indications for Use:
The SeedNet Family is intended for cryogenic destruction of tissue during surgical procedures.
It is indicated for use as a cryosurgical tool in the fields of surgery, dermatology, neurology (including general 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 Family 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 recturn, hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenomas.)
Mark
Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number
KOS-2530
6
- ENT (Palliation of tumors of the oral cavity and t 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 Family may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.
Prescription Use x (Part 21 C.F.R. 801 Subpart D)
AND/OR
Over-The-Counter Use (PART 21 C.F.R. 801 Subpart C)
Mark H. Milliken
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
K05253
510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)