(88 days)
No
The document describes a cryosurgical system with minor technological modifications, primarily related to accessories, probe options, and software for display. There is no mention of AI or ML in the intended use, device description, or any other section.
Yes.
The device is intended for the destruction or ablation of various tissues, including cancerous and benign tumors and lesions, to treat a wide range of medical conditions across multiple surgical fields. This direct intervention to treat or alleviate disease qualifies it as a therapeutic device.
No
The device is intended for the destruction of tissue during surgical procedures by applying extreme cold temperatures, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly mentions hardware components such as probes, a multiprobe distribution panel, and a flexible hose, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the CRYO-HIT™ 200 System is for "cryogenic destruction of tissue during surgical procedures." This is a therapeutic intervention performed directly on the patient's body.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This device does not perform such tests.
- Device Description: The device description details a system with probes and hoses used for applying extreme cold temperatures to tissue. This aligns with a surgical tool, not a diagnostic test.
Therefore, the CRYO-HIT™ 200 System is a surgical device used for tissue ablation, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CRYO-HITTM 200 System, like the already cleared CRYO-HITTM 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, 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, tumor, lesions and warts.
In addition the CRYO-HIT™ 200 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, 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 hemangilomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, 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
GEH
Device Description
The CRYO-HIT™ 200 System is the exact same device as Galil Medical LTD's cleared CRYO-HIT™ System (K980913) except for the following tochnological modifications: (1) Additional accessories are made available (1.5 mm probe, multiprobe distribution panel). (2) disposable probes are added as an option; (3) an additional method of controlling the freeze process is offered; and (4) minor changes to the software that are necessary for the display of the screen information have been made: and (5) the probes are available in chrome-coated brass and the flexible hose is available in two additional materials.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and kidney tissue, liver metastases, tumor, lesions, warts, male genitalia (prostate), female genitalia, oral cavity, rectum, skin, eye (eyelid or canthus area), heart (cardiac tissue), anus.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical procedures
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)
Not Found
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
Galil Medical Proprietary Information
JUL 27 1999
1-411 P.03/08 JOB-555
K991517
Section 9
510(K) Summary Galil Medical - CRYO-HITTM 200 System 510(k) Number K991517
Galil Medical Ltd. Company Name: Shaike Schatzberger, President and CEO Contact Person: Telephone: 972-4-959 10 80 972-4-959 10 77 Fax: CRYO-HITTM 200 Trade Proprietary Name:
GEH
Classification:
Predicate Devices:
ENDOcare CRYO-HITTM System
Indication for Use:
The CRYO-HITTM 200 System, like the already cleared CRYO-HITTM 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, 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, tumor, lesions and warts.
In addition the CRYO-HIT™ 200 System has the following specific indications:
1
Galil Medical Proprietary Information
Section 9
Urology (ablation of prostate tissue in cases of prostate cancer and Benign Prostate Hyperplasia ("BPH"))
Oncology (ablation of cancerous or malignant tissue, 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 hemangilomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, 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)
Device Description:
The CRYO-HIT™ 200 System is the exact same device as Galil Medical LTD's cleared CRYO-HIT™ System (K980913) except for the following tochnological modifications: (1) Additional accessories are made available (1.5 mm probe, multiprobe distribution panel). (2) disposable probes are added as an option; (3) an additional method of controlling the freeze process is offered; and (4) minor changes to the software that are necessary for the display of the screen information have been made: and (5) the probes are available in chrome-coated brass and the flexible hose is available in two additional materials.
Substantial equivalence: The CRYO-HITTM 200 System has the same intended use, and very similar principle of operation and technological characteristic as the cleared ENDOcare and cleared CRYO-HITTM System, thus the CRYO-HITTM 200 System is substantially equivalent to these legally marketed predicate devices.
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 image of an eagle or bird with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 27 1999
Galil Medical, Ltd. c/o Mr. Jonathan S. Kahan Hogan & Hartson L.L.P. Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004
K991517 Re: Trade Name: Cryo-Hit™ 200 Regulatory Class: II Product Code: GEH Dated: April 17, 1999 Received: April 30, 1999
Dear Mr. Kahan:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
3
Page 2 – Mr. Jonathan S. Kahan
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Numed. Sager
Celia M. Witten, Ph.D., M.D. for Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): K991517
Device Name: Cryo-Hit™ 200
Indications for Use: The Cryo-Hit™ 200 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, 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.
In addition the Cryo-Hit 200 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, 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 tumore of the oral cavity, rectum and skin, and ablation of leukoplakia of the mouth, angiomas, sebacous hyperplaaia, basal coll tumors of the eyelid or canthus area, ulcerated basal cell tumors, dermatofibromas, small hemangilomas, mucocele cyste, multiple warts, plantar warts, hemorrhoids, and 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)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use I (Per 21 C.F.R. 801.109)
OR
Over-The-Counter Use_
Henrik V. Hagen, Dr. Ing.