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.
The SeedNet System is a cryosurgical unit with argon-cooled probes. The modified SeedNet System includes cryoneedles and cryoprobes of different sizes, shapes, or made of different materials, a remote MRI Compatible Mobile Distribution Panel (MDP) for the MRI compatible system, functional features added to the software to indicate the user when no signal is detected from specific temperature sensors or thermocouples, a New General Use Template for use with the IceRod Cryoneedles, and IceRod Prostate and Renal Kits. The trade names CryoThera, Cryo-Hit, and SeedNet/SeedNetGold are associated with the system.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the Galil Medical LTD. SeedNet System.
Important Note: The provided document is a 510(k) summary for a medical device. 510(k) summaries primarily focus on demonstrating substantial equivalence to a previously cleared predicate device, rather than presenting de novo clinical trial data with acceptance criteria for novel performance. Therefore, the information typically found in a clinical study report regarding specific acceptance criteria and detailed performance metrics might be limited or absent, as is the case here.
This submission argues for substantial equivalence primarily based on technological characteristics, mode of operation, performance characteristics, and intended use being similar to existing cleared devices. The "performance data" mentioned refers to design verification testing, not a clinical study to prove efficacy against specific, pre-defined acceptance criteria.
Acceptance Criteria and Device Performance
Based on the provided text, there are no explicitly stated quantitative acceptance criteria for a study designed to prove the device's performance against specific metrics of diagnostic accuracy (like sensitivity, specificity, accuracy) that are commonly seen in AI/diagnostic device submissions.
The document's "Performance Data & Substantial Equivalence" section emphasizes the modified SeedNet System's equivalence to predicate devices and outlines a "comprehensive testing process as part of the design verification process," including electrical, mechanical, and biocompatibility testing. This type of testing ensures the device functions as intended and safely, but it does not evaluate its diagnostic or therapeutic efficacy against a defined clinical "ground truth" with statistical measures.
The core argument for clearance is substantial equivalence. The "performance" being evaluated implicitly is that the modified device performs comparably to the predicate devices in its intended use, which is cryogenic tissue destruction.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence to Predicate Devices: - Ability to perform cryogenic destruction of tissue. - Safety (electrical, mechanical, biocompatibility). | - "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 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." |
| Specific Indications for Use: - Effective ablation for prostate tissue, cancerous/malignant tissue, skin lesions, etc. (as per predicate device's established efficacy). | - The modified device retains the same indications for use as the predicate SeedNet System, implying that its ability to perform these functions is considered equivalent. |
Study Information
Given the nature of a 510(k) summary for a cryosurgical unit, the "study" referred to is a series of engineering verification and validation tests, not a clinical trial in the sense of evaluating diagnostic or therapeutic efficacy with patient data. Therefore, many of the requested points below (e.g., sample size for test sets, ground truth, experts for ground truth, MRMC studies) are not applicable or not detailed in this document.
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Sample size used for the test set and the data provenance:
- Sample Size: Not applicable in the context of a clinical test set from patient data. The "test set" would refer to the device units and components undergoing design verification. No specific numerical sample size for components or systems is provided, nor is patient data involved.
- Data Provenance: Not applicable for clinical data. The testing is internal design verification and validation.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as there is no mention of "ground truth" being established by experts for clinical performance in this submission. The "ground truth" for electrical, mechanical, and biocompatibility testing would be adherence to engineering specifications and relevant standards, verified by qualified engineers and testers.
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Adjudication method for the test set:
- Not applicable. There's no mention of an adjudication process for clinical outcomes, as this is not a clinical efficacy study.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This device is a cryosurgical unit, not an AI-assisted diagnostic or imaging interpretation tool. There are no "human readers" or AI in the context of improving interpretation.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware cryosurgical system, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the design verification testing mentioned, the "ground truth" would be adherence to defined engineering specifications, industry standards, and regulatory requirements (e.g., for electrical safety, mechanical integrity, biocompatibility). It is not clinical "ground truth" like pathology or outcomes data.
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The sample size for the training set:
- Not applicable. This device does not involve AI or machine learning models that require a "training set."
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How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
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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 cryosurgicalunits with argon cooled cryoprobes as class IIdevices under 21 C.F.R. § 878.4350. However, FDAhas cleared Galil Medical SeedNetTM andSeedNetGoldTM, which are cryosurgical units withargon-cooled Cryoprobes, as Class II devices(K031117, K003065, K010991, K011950, andK021261). Therefore, cryosurgical units with argon-cooled probes are Class II medical devices. |
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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)
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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™).
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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.
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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,
elgmal
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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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.)
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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 |
|---|---|
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\\DC - 67930/0001 - 20868 ! 4 vi
§ 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.