Not Found
No
The summary describes a cryosurgical unit and its intended uses, with no mention of AI or ML capabilities in the device description, intended use, or performance studies sections.
Yes
The device is used for the destruction of tissue, including cancerous and benign tissues, and the palliation of symptoms, which are therapeutic interventions.
No
The device is described as a cryosurgical tool intended for the destruction or ablation of tissue, not for diagnosing conditions.
No
The device description explicitly states it is a "Cryosurgical unit with argon-cooled probes," indicating it includes hardware components (the unit and probes) in addition to any potential software control.
No, the Isis System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens taken from the human body. This includes things like blood, urine, tissue samples, etc., to provide information about a person's health.
- The Isis System is used directly on the human body during surgical procedures. Its purpose is to destroy tissue in situ using cryosurgery.
The description clearly states its intended use is for "cryogenic destruction of tissue during surgical procedures" and lists various anatomical sites where it is applied directly. This is the definition of a surgical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Isis System is intended for cryogenic destruction of tissue during surgical procedures. The Isis System 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 Isis 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, ablation of breast fibroadenoma)
- 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)
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
Not Found
Anatomical Site
Prostate, kidney, liver, skin, male genitalia, female genitalia, rectum, breast, oral cavity, heart, anus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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.
K980913, K991272, K991517, K993965, K003065, K010991, K012497, KO11950, K021261, K031117, K042667, K051052, K052530, K060144, K060390
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.
Isis™ System
MAR 2 0 2007
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
Email: sarit@galil-medical.co.il
Trade Name: IsisTM
Classification: Cryosurgical Unit
1
Common/Usual Name: Cryosurgical unit with argon-cooled probes
Product Code: GEH
Regulation No.: 878.4350
II; FDA has not specifically classified cryosurgical Class: units with argon-cooled cryoprobes as class II devices under 21 C.F.R. § 878.4350. However, FDA has cleared Galil Medical's Presice™, Cryo-Hit®, SeedNet® SeedNetGold®, CryoThera® which are cryosurgical units with argon-cooled cryoprobes, as Class II devices (K980913, K991272, K991517, K993965, K003065, K010991, K012497, KO11950, K021261, K031117, K042667, K051052, K052530, K060144, K060390). Therefore, cryosurgical units with argon-cooled probes are Class II medical devices.
Predicate Devices: Galil's SeedNet Family of systems, specifically Galil's Presice™ system and Galil's Cryo-Hit® System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Galil Medical Ltd. c/o Mr. Jonathan S. Kahan c/o Hagan & Hartson, L.L.P. 555 Thirteenth Street, NW
Washington, DC 20004
Re: K070482 Trade/Device Name: Isis™ Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: February 8, 2007 Received: February 20, 2007
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of March 20, 2007.
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.
FEB 2 1 2008
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.
3
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.
29mde
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Isis
The Isis System is intended for cryogenic destruction of tissue during surgical procedures. The Isis System 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 Isis System has the following specific indications:
- Urology (ablation of prostate tissue in cases of prostate cancer 배 and Benign Prostate Hyperplasia "BPH")
- r Oncology (ablation of cancerous or malignant tissue and benign tumors, and palliative intervention)
88
5
- 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.)
- I Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
- General surgery (palliation of tumors of the rectum, hemorrhoids, l anal fissures, pilonidal cysts, and recurrent cancerous lesions, ablation of breast fibroadenoma)
- ENT (Palliation of tumors of the oral cavity and ablation of 트 leukoplakia of the mouth)
- ı Thoracic surgery (ablation of arrhythmic cardiac tissue cancerous lesions)
- Proctology (ablation of benign or malignant growths of the anus or rectum, and hemorrhoids)
89
6
Prescription Use _XX
AND/OR
Over-The-Counter Use__
(Per 21 C.F.R. 801.109)
(Per 21 C.F.R. 807 Subpart C)
(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 General, Restorative, and Neurological Devices
510(k) Number_ C O 10 4 F2