(90 days)
The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ System is intended for cryogene as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, general surgery, oncology, and urology, and urology, The system is designed to gynecology, oncology, proctorogy, and aronegy of temperatures including prostate and kidney tissue, liver metastascs, turnors, skin lesions, and warts.
In addition the modified CRYO-HIT™ System has the following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hynernlasia "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 fomale 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 recturn, and ablation of hemorrhoids)
The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe got a available in each model (1-probe, 2-probe, 3-probe, 4-probe, 5-probe, 5-probe, 7-probe and 8-probe configurations) and the number of temperature sensor ports, to meet the needs of different customers.
The probes that can be used in the different configurations are exactly the same. The modified CRYO-HIT™ System is the exact same device as Galil Medical I.TD's cleared CRYO-HIT™ System (K980913) except for the following technological modifications: (1) Additional probes are made available; (2) single use probes are added as an option; (3) a foot pedal is added as an operating option; (4) the number of probes and external thermocouples is more varied; (5) the modified CRYO-HIT™ System allows an additional method of controlling the freeze process; and (6) minor changes to the software that are necessary for the display of the screen informations
The provided document is a 510(k) summary for the Galil Medical CRYO-HIT™ System, which is a cryosurgical unit. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement that would be required to answer the specific questions posed.
Therefore, I cannot provide the requested information from the given text.
The information includes:
- Company Name: Galil Medical Ltd.
- Trade/Proprietary Name: CRYO-HIT™ System
- Classification Name: CRYOSURGICAL UNIT
- Predicate Devices: ENDOcare CRYO-HIT™ System
- Indications for Use: Cryogenic destruction of tissue during surgical procedures in various fields (general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology). Specifically for ablating prostate and kidney tissue, liver metastases, tumors, skin lesions, warts, and other specified conditions.
- Device Description: Multiple models with varying numbers of probe ports (1-8), but same performance, technology, and intended use. Modified version includes additional probes, single-use probes option, foot pedal, more varied probe/thermocouple numbers, an additional freeze process control method, and minor software changes.
- Claim of Substantial Equivalence to previously cleared CRYO-HIT™ System (K980913) and ENDOcare system.
- FDA 510(k) clearance letter (K991272) dated February 21, 2008 (correcting a previous letter from July 12, 1999).
To answer the questions, information on clinical or non-clinical performance testing would be necessary, which is not present in this 510(k) summary. Usually, a 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed study results as an IDE or PMA submission would.
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Galil Medical Proprietary Information
JUL 1 2 1999
ﺗﻤ
510(k) Summary
Galil Medical - CRYO-HIT™ System
Company Name:
Galil Medical Ltd.
Contact Person:
Shaike Schatzberger, President and CEO Telephone: +972-4-959 10 80 +972-4-959 10 77 Fax:
Trade Proprietary Name:
CRYO-HIT™.
CRYOSURGICAL UNIT
Classification Name:
Classification:
GEH
Predicate Devices:
ENDOcare CRYO-HITTM System
Indication for Use:
The modified CRYO-HIT™ System, like the already cleared CRYO-HIT™ The modilled CKYO-HIT™ System, inst agtion of tissue during surgical System is intended for cryogene as a cryosurgical tool in the fields of general surgery, dermatology, neurology, thoracic surgery, ENT, general surgery, oncology, and urology, and urology, The system is designed to gynecology, oncology, proctorogy, and aronegy of temperatures including prostate and kidney tissue, liver metastascs, turnors, skin lesions, and warts.
In addition the modified CRYO-HIT™ System has the following specific indications:
{1}------------------------------------------------
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hynernlasia "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 fomale 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 recturn, and ablation of hemorrhoids)
Device Description:
The different CRYO-HIT™ models have the same performance, technology and intended use. The only difference between them are the number of probe got a available in each model (1-probe, 2-probe, 3-probe, 4-probe, 5-probe, 5-probe, 7-probe and 8-probe configurations) and the number of temperature sensor ports, to meet the needs of different customers.
The probes that can be used in the different configurations are exactly the same. The modified CRYO-HIT™ System is the exact same device as Galil Medical I.TD's cleared CRYO-HIT™ System (K980913) except for the following technological modifications: (1) Additional probes are made available; (2) single use probes are added as an option; (3) a foot pedal is added as an operating option; (4) the number of probes and external thermocouples is more varied; (5) the modified CRYO-HIT™ System allows an additional method of controlling the freeze process; and (6) minor changes to the software that are necessary for the display of the screen informations
Substantial Equivalence: The modified CRYO-HIT™ System has the same intended use, and very similar principle of operation and technological characteristic as the cleared ENDOcare and cleared CRYO-HIT™ System, thus the modified CRYO-HIT™ System is substantial equivalent to these legally marketed predicate devices.
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Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 1 2008
Galil Medical Ltd. c/o Mr. Howard M. Holstein Hogan & Hartson, L.L.P. 555 Thirteenth Street, NW Washington, DC 20004
Re: K991272 Trade Name: Cryo-Hit™ System Regulatory Class: II (two) Product Code: OCL, GEH Dated: February 17, 1999 Received: April 13, 1999
Dear Mr. Holstein:
This letter corrects our substantially equivalent letter of July 12, 1999.
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. Howard M. Holstein
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,
elma
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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Section 9
Galil Medical Proprietary Information
INDICATIONS FOR USE
CRYO-HIT'" System
510(k) Number (if known):
Device Name:
Indications for Use:
The modified CRYO-HIT™ System. like the already cicared CRYO-HIT™ System is imended for exposence desouction of
CRYO-HIT™ System is incendures It is indicated for use as a tissue during surgical procedures. It is indicated for use as a cryosurgical tool in the fictios of general surgery, demandology, neurology, thoracie surgery, ENT, gystem is designed to designed to destroy proctology. and urology. The system is designed to designed to destroy tissue by the application of extreme of extreme cold temperatures, including prostate and kidney tissue, liver metastases, tumors,
including prostation and kidney tissue, liver metastases, tumors,
including prostationers
skin lesions, and warts. skin lesions, and wards.
In addition the modified CRYO-HIT™ System has the
following specific indications: following specific indications:
Urology (ablation of prostate tissue in cases of prostate cancer
Urology (ablack and themalesia "BPH") Urology (ablation of prosuate Hyperplassia "BPH")
and Benign Prosuate Hyperplassia "BPH")
Oncalogy (ablation of cancerous or malignant ticsuo, and Oncalors (ablation of benign lumors, and palliative intervention) Dermatology (ablation or freezing of skin cancers and other
curaneous disorders) Gynecology (ablation of malignant neoplasia or benign
Grandogy (ablation of malignant neoplasia or benign
dysplasia of the famale genitalia) dysplasia of the female genitalia)
General surgery (destruction of wars or lesions, palliation of
General surgery (destruction of wars or lesions, and ablation of General surgery (desiration of warts of restum and skins, and ablation of
tumors of the other mayer, enchomas, sebaceous nyperplast leukoplakia of the mouth, anglomas, sebacaus nyperplastis, basal cell tumors of the eyelid or canthus area, ulcerated basal
basal cell tumors of the cyclid or canthus area, ulcerated basal cell tumors, dermatofibromes small hemanglomas, muchocole cysis, multiple warts, plantar wars, hemorroids, and fissures,
cysis, multiple warts, plantar wars, hemorroids, and fissures, perianal conylomata, pilonidal cysts, actinic and seborthere perianal conylomata, pilonidal cysts, actinto and 100%.
Keratoses, cavernous hemangiomas, and recurrent cancerous
lesions)
Thoracic surgery (ablation of arrhythmic cardiac tissuc, and lesions) ablation of cancerous lesions) ablation of cancerous iesions)
Proctology (ablation of benign of malignant growths of the
Proctology (ablation of occition of hemorrhoids)
(PLEASE DO NOT WRITE BELOW THIS LINE -CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Collier. Sign-off)
Division of Reproff)
Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices
510(k) Number K 971137
Prescription Use
(Per 21 CFR 801.109)
OR
Over the Counter Use_
Ronald Lyons Jr.
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§ 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.