(87 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on hardware modifications and imaging modalities for visualization, not algorithmic processing.
Yes
The device is intended for the cryogenic destruction of tissue during surgical procedures to treat various conditions, which directly indicates a therapeutic purpose.
No
The device is a cryosurgical tool used for the destruction of tissue by applying extreme cold temperatures. While it can be used with MRI or ultrasound for guidance, its primary function is therapeutic (tissue destruction), not diagnostic.
No
The device description explicitly states it is a "system" and mentions "probes" and an "MRI kit," which are hardware components. The system is used for "cryogenic destruction of tissue," which involves physical interaction with the body, not just software processing.
Based on the provided text, the CRYO-HIT™ System for MRI is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- CRYO-HIT™ System Function: The CRYO-HIT™ System is a surgical tool used for the destruction of tissue within the body through cryoablation. It directly interacts with the patient's tissue during a surgical procedure.
- Intended Use: The intended use clearly states "cryogenic destruction of tissue during surgical procedures" and lists various anatomical sites and conditions where this destruction is applied. It does not involve the analysis of specimens taken from the body.
Therefore, the CRYO-HIT™ System for MRI falls under the category of a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CRYO-HIT™ System for MRI 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, 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 CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, pailiation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
Product codes
OCL, GEH
Device Description
The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).
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, prostate, female genitalia, oral cavity, rectum, anus, cardiac
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)
Reference Device(s)
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
FEB 1 8 2000
510(k) Summary Galil Medical - CRYO-HIT™ System 510(k) Number
Company Name:
Galil Medical Ltd.
Contact Person:
Dr. Roni Zvuloni, IP, QA & Regulatory Manager Telephone: +972-4-959 10 80 +972-4-959 10 77 Fax:
Trade Proprietary Name:
CRYO-HIT™.
Classification Name:
CRYOSURGICAL UNIT
Classification:
GEH
Predicate Devices:
CRYO-HIT™200 System
Indication for Use:
The CRYO-HIT™ System for MRI 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, 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 CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ System has the following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia "BPH")
1
Oncology (ablation of cancerous or malignant tissue, and ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, palliation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides real-time visualization of the cryosurgical procedure.
Device Description:
The CRYO-HIT™ system for MRI is the exact same device as Galil Medical LTD's cleared System (K991517) except for the following technological modification: (1)- the additional MRI kit and (2) the availability of more probe types: 2 mm probe, surface probe, and disk shaped probe (The probes cleared for use with the modified CRYO-HIT™ System under K991272 include the same 2 mm probes, surface and disk shape probes, proposed for use with the CRYO-HIT™ for MRI).
Substantial Equivalence: The CRYO-HIT™ System for MRI has the same intended use, and very similar principle of operation and technological characteristic as the cleared CRYO-HIT™ 200 System (K991517). Therefore, the CRYO-HITTM System for MRI is substantially equivalent to the CRYO-HITTM 200 System (K991517).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The logo is presented in black and white.
FEB 2 1 2008
Public Health Service
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: K993965 Trade Name: CRYO-HITTM Regulatory Class: II (two) Product Code: OCL, GEH Dated: November 23, 1999 Received: November 23, 1999
Dear Mr. Kahan:
This letter corrects our substantially equivalent letter of February 18, 2000.
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.
3
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,
ll.
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
510(k) Number (if known):
Device Name:
Indications for Use:
Nero Segura
Prescription Use X
(Per 21 CFR 801.109)
(Per 21 CFR 801.109)
CRYO-HIT™ System
The CRYO-HIT™ System for MRI 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, 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 CRYO-HIT™ System for MRI, like the already cleared CRYO-HIT™ 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 ablation of benign tumors, and palliative intervention)
Dermatology (ablation or freezing of skin cancers and other cutaneous disorders)
Gynecology (ablation of malignant neoplasia or benign dysplasia of the female genitalia)
General surgery (destruction of warts or lesions, pailiation of tumors of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, 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, hemorroids, anal fissures, perianal conylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, and recurrent cancerous lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissue, and ablation of cancerous lesions)
Proctology (ablation of benign or malignant growths of the anus or rectum, and ablation of hemorrhoids)
5
The CRYO-HIT™ System for MRI may be used with a magnetic resonance imaging (MRI) device or an ultrasound device to locate the target tissue, ensure correct placement of the probes and monitor the size of the iceball. The MRI or ultrasound device provides 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
510(k) Number
Prescription Use (Per 21 CFR 801.109)
OR
5
Over the Counter Use_
Rienzi Jayson
(Division Sign-Off) Division of General Restorative Devices 510(k) Number