(87 days)
Not Found
No
The summary describes a cryosurgical system that controls probes and monitors temperature. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The device appears to be a hardware-based system for applying cold temperatures.
Yes
The device is clearly indicated for destroying tissue and treating various medical conditions, which aligns with the definition of a therapeutic device.
No
The device is described as a cryosurgical system intended to destroy tissue by applying extreme cold temperatures. It is used for therapeutic purposes (tissue destruction), not for diagnosing conditions.
No
The device description explicitly states the system consists of a console, disposable CRYOprobes, and inputs for thermocouples, all of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "destroy tissue by the application of extreme cold temperatures." This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is a cryosurgical system that controls probes and monitors temperature during a surgical procedure.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, tissue, etc.) in vitro (outside the body) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device performs a therapeutic action directly on the patient.
N/A
Intended Use / Indications for Use
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.
Product codes
GEH
Device Description
The ENDOcare CRYOcare™ Cryosurgical System consists of a console which can control one to eight single-use, disposable CRYOprobes™ and one to eight independent inouts to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
Several models will be provided depending on the needs of the customer. Currently, the system is available in a 1, 4 and 8-CRYOprobe™ configuration. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (e.g., 1-8) and the size of the outer case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, and breast tissue, liver, skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology
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
DEC ≤ 1997
Section II - SMDA 1990 Requirements
K.973686
Safety and Effectiveness Summary
Device Description
The ENDOcare CRYOcare™ Cryosurgical System consists of a console which can control one to eight single-use, disposable CRYOprobes™ and one to eight independent inouts to monitor temperatures from standard T-type needle thermocouples. The system is compact and operates off of standard 110 VAC wall power.
Several models will be provided depending on the needs of the customer. Currently, the system is available in a 1, 4 and 8-CRYOprobe™ configuration. The performance characteristics and internal design of each model are equivalent. The only differences are the number of valves to control the CRYOprobes™ (e.g., 1-8), number of thermocouple inputs (e.g., 1-8) and the size of the outer case.
Indications for Use
The ENDOcare CRYOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology. The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.
Substantial Equivalence
The ENDOcare CRYOcare™ CRYOsurgical System is substantially equivalent to the ENDOcare 8-probe system which was cleared on January 19, 1995 (reference K942299) and the 2 and 5-probe system which was cleared on December 18, 1996 (reference K963826). The ENDOcare system is also substantially equivalent to the Urosprobe System Model 1000 which was cleared on April 1, 1996 (reference K960387).
Sterilization Methodology
The following sterilization information is applicable to the CRYOprobes™ only. Sterilization validation was based on the recommendations in the current AAMI (American Association for the Advancement of Medical Instrumentation) Guideline for Industrial Ethylene Oxide Sterilization of Medical Devices. A minimum Sterility Assurance Level (SAL) of 10 was achieved. Sterile barrier packaging consists of standard disposable medical device packaging containing a plastic film and a coated paper side. Maximum levels of EtO residuals did not exceed:
1
25 ppm for ethylene oxide
25 ppm for ethylene chlorohydrin
250 ppm for ethylene glycol
Shelf Life Determination
Ten (10) simulated products and one (1) control were packaged, sealed and processed through a full sterilization cycle to replicate sterilization parameter effects on package seal integrity. Following sterilization, the packaged CRYOprobes™ were submitted to an outside testing laboratory for accelerated aging equivalent to one year using the following parameters:
2.5 weeks at 55℃ and 75 + 5% relative humidity 24 hours at -15°C + 5°C 2.5 weeks at 55℃ and Trade Name: ENDOcare CRYOcare™ Cryosurgical System Regulatory Class: II Product Code: GEH Dated: September 25, 1997 Received: September 26, 1997
Dear Mr. Cutarelli:
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 requirements , 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
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Page 2 - Mr. Cutarelli
devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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,
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use Statement
510(k) Number: K973686
Device Name: ENDOcare CRYOcare™ Cryosurgical System
The ENDOcare CR YOcare™ Cryosurgical System is intended for use in general surgery, urology, gynecology, oncology, neurology, thoracic surgery, dermatology, ENT, and proctology, The system is designed to destroy tissue by the application of extreme cold temperatures including prostate, kidney, and breast tissue, liver metastases, tumors, skin lesions, and warts.
Concurrence of CDRH, Office of Device Evaluation (ODE):
tecouto
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _
Prescription Use: X (Per 21 CFR 801.109)