(11 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware and basic software features.
Yes
The device is intended for the destruction of tissue during surgical procedures for various medical conditions, indicating a therapeutic purpose.
No
Explanation: The device is intended for cryogenic destruction/ablation of tissue during surgical procedures, which is a therapeutic function, not a diagnostic one. While it can be used with MRI or ultrasound for visualization, these are for guiding the procedure, not for diagnosing conditions.
No
The device description explicitly states it is a "cryosurgical unit with argon-cooled probes" and includes physical components like "cryoneedles and cryoprobes," indicating it is a hardware device with associated software, not a software-only device.
Based on the provided information, the SeedNet System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the SeedNet System is for the "cryogenic destruction of tissue during surgical procedures." This is a therapeutic intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a cryosurgical unit with probes and accessories used for applying extreme cold to tissue. This aligns with a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVD devices, such as reagents, sample handling, or analysis of biological fluids or tissues in vitro (outside the living organism).
The use of imaging modalities like MRI and ultrasound is for guiding the surgical procedure and visualizing the tissue in vivo, not for analyzing samples in vitro.
N/A
Intended Use / 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 (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 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 may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.
Product codes (comma separated list FDA assigned to the subject device)
GEH, OCL
Device Description
The SeedNet System is a cryosurgical unit that utilizes argon-cooled probes. It is intended for cryogenic destruction of tissue during surgical procedures across various medical fields. The described device is a modified version of the SeedNet System, with principal changes including: the addition of new cryoneedles and cryoprobes of different sizes, shapes, or materials; inclusion of a remote MRI Compatible Mobile Distribution Panel (MDP) for MRI compatibility; addition of functional software features to aid system operation and alert users about absent temperature sensor signals; inclusion of a New General Use Template for IceRod™ Cryoneedles; and provision of IceRod™ Prostate and Renal Kits. The device is also associated with the trade names CryoThera and Cryo-Hit.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
magnetic resonance imaging (MRI) device, ultrasound device
Anatomical Site
prostate, kidney, liver, skin, rectum, anus, female genitalia, oral cavity, cardiac (arrhythmic 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The modified SeedNet System and its modified accessories were subjected to a comprehensive testing process as part of the design verification process. This included electrical, mechanical and biocompatibility testing. The modified SeedNet System does not raise any new safety and/or effectiveness issues.
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.
K031117, K003065, K010991, K011950, K021261
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
MAY - 6 2005
K05/052
Page 1 of 3
510(K) SUMMARY Galil Medical LTD. SeedNet System
Applicant's Name:
Galil Medical Ltd. Tavor 1 Building Shaar Yokneam Yokneam Industrial Park 20692 ISRAEL Tel: 972-4-9591080 ﻟﺴﻨﺔ 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:
Classification:
SeedNet/SeedNetGold System, CryoThera System, Cryo-Hit System
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 SeedNetTM and | |
| SeedNetGoldTM, which are cryosurgical units with | |
| argon-cooled Cryoprobes, as Class II devices | |
| (K031117, K003065, K010991, K011950, and | |
| K021261). Therefore, cryosurgical units with argon- | |
| cooled probes are Class II medical devices. |
1
Page 2 of 3
Predicate Devices:
Galil's SeedNet™ System and SeedNetGold™ System and Galil's Cryo-Hit™ System.
Intended Use:
The SeedNet System is intended for cryogenic destruction of tissue during surgical procedures. The SeedNet System is indicated for use as a cryosurgical tool in the fields of general surgery, dermatology, (including cryoanalgesia), thoracic surgery, ENT. neurology 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 피 and Benign Prostate Hyperplasia "BPH")
- Oncology (ablation of cancerous or malignant tissue and benign 미 tumors, and palliative intervention)
- Dermatology (ablation or freezing of skin cancers and other I cutaneous disorders. Destruction of warts or lesions, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, basal cell tumors, dermatofibromas small ulcerated 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 제 of the female genitalia)
- (palliation of tumors of the rectum, . General surgery hemorrhoids, anal fissures, pilonidal cysts, and recurrent cancerous lesions.)
- ENT (Palliation of tumors of the oral cavity and ablation of 트 leukoplakia of the mouth).
- (ablation of arrhythmic cardiac tissue · Thoracic surgery cancerous lesions)
2
K05/052
Page 3 of 3
- Proctology (ablation of benign or malignant growths of the anus 트 or rectum, and hemorrhoids)
The 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.
Performance Data & Substantial Equivalence:
The modified SeedNet System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available SeedNet System. The principle changes between the devices include:
-
- Addition of the cryoneedles and cryoprobes that are different sizes, shapes, or made of different materials
-
- The MRI compatible SeedNet System was modified to include a remote MRI Compatible Mobile Distribution Panel (MDP)
- က် Addition of functional features to the software that the operation of the system and indicate the user when no signal is detected from specific temperature sensors or thermocouples.
- Inclusion of New General Use Template for use with the IceRod™ 4. Cryoneedles
-
- Provision of IceRod™ Prostate and Renal Kits.
- Addition of the trade name CryoThera in addition to Cryo-Hit and 6. SeedNet/SeedNetGold.
The modified SeedNet System and its modified accessories were subjected to a comprehensive testing process as part of the design verification process. This included electrical, mechanical and biocompatibility testing. The modified SeedNet System does not raise any new safety and/or effectiveness issues. Thus, the modified SeedNet System is substantially equivalent to the cleared SeedNet System (the SeedNet™; the SeedNetGold™ and the Cryo-Hit™).
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is simple and monochromatic.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Galil Medical Ltd. c/o Mr. Jonathan S. Kahan Hogan and Hartson 555 13th Street, N.W. Washington, DC 20009
Re: K051052
Trade/Device Name: SeedNet System (SeedNet/SeedNetGold System, CyroThera System, Cyro-Hit System) Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: April 19, 2005 Received: April 25, 2005
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of May 6, 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 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,
elgmal
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K05/052
Page 1 of 2
INDICATIONS FOR USE
510(k) Number (if known):
Device Name:
SeedNet System (SeedNet/SeedNetGoId System, CryoThera System, Cryo- Hit 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 (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 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.)
6
K05/052
Page 2 of 2
- 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 may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to provide realtime visualization of the cryosurgical procedure.
AND/OR Use Prescription X (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (PART 21 C.F.R. 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| -------------------------------------------------------- | -- |
| Restorative | |
|---|---|
| Neurological |
| K051052 | 9-8 |
|---|---|
| --------- | ----- |
\\DC - 67930/0001 - 20868 ! 4 vi