(26 days)
Not Found
No
The device description focuses on hardware components, temperature control, and pre-programmed parameters (AutoFreeze mode), with no mention of AI or ML capabilities for analysis, prediction, or adaptation.
Yes
The device is intended to freeze/ablate tissue for various medical conditions, which is a therapeutic action.
No
The device is a surgical system intended to freeze/ablate tissue for therapeutic purposes, not for diagnosis.
No
The device description clearly outlines hardware components such as a console, display screen, video printer, CD-R/W drive, keypad, CryoProbes, TempProbes, and a warming system, all of which are integral to the device's function. While it utilizes a microprocessor and software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Cryocare CS Surgical System is a surgical device designed to freeze/ablate tissue directly within the body using extreme cold temperatures. It is used in various surgical procedures to destroy or remove targeted tissue.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It directly interacts with and modifies tissue within the body.
The intended use and device description clearly indicate that this is a therapeutic surgical device, not a diagnostic one that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
In addition, the system is intended for use in the following indications:
- · General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
- · Urology
- · Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
- · Gynecology
- · Ablation of malignant neoplasia or benign dysplasia of the female genitalia
- · Oncology
- · Ablation of cancerous or malignant tissue
- · Ablation of benign tumors
- · Palliative intervention
- · Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
- · Dermatology
- · Ablation or freezing of skin cancers and other cutaneous disorders
- · Proctology
- Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
- · Thoracic Surgery
- · Ablation of arrhythmic cardiac tissue
- · Ablation of cancerous lesions
Product codes (comma separated list FDA assigned to the subject device)
GEH, OCL
Device Description
The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).
The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.
The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.
Associated accessories include the following:
I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.
Helium gas is used after the freezing process to thaw tissue. As the gas passes through the J-T port, there is a significant pressure drop, which conversely results in an increase in the gas temperature.
The patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System.
- 2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
- 3.) A warming system for use in urological applications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate and kidney tissue, liver, skin, oral cavity, rectum, eyelid or canthus area, anus, female genitalia, nerve tissue, cardiac tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician or licensed healthcare professional
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)
The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use.
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.
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
Cryocare Surgical System
510(k) SPECIAL PREMARKET NOTIFICATION SUMMARY
• Device Trade or Proprietary Name: Cryocare CS Surgical System · Common / Classification Name: Impedance Cryosurgical unit and accessories · Class: Class II Regulation Number: . 878.4350
- Product Code: GEH
- · Labeling:
Federal (United States) Law restricts this device to sale by or on the order of a physician or licensed healthcare professional.
· Predicate Device for Substantial Equivalence Comparison:
The Cryocare CS Surgical System CryoProbe accessory is claimed to be substantially equivalent to the following currently marketed Predicate Device and currently being marketed by Endocare:
| Manufacturer | Device Name | 510-K Number | Decision Date |
|---|---|---|---|
| Endocare, Inc. | Cryocare CSTM | K050347 | February 05, 2005 |
· Device Description:
The Cryocare CS Surgical System consists of a compact, easy-to-operate console that delivers cold temperatures to targeted tissue (via connected CryoProbes) and monitors temperatures in the surrounding tissue (via connected TempProbes).
The Cryocare CS Surgical System has a fold-down 19" LCD high-resolution display screen, a video printer for hard copy prints of the captured images and patient information, a CD-R/W drive for data storage and retrieval, an alphanumeric keypad and a remote keypad.
The Cryocare CS Surgical System can control up to eight, single-use, disposable CryoProbes and monitor up to eight independent TempProbes. The console operates off standard 120/230 VAC (60/50 Hz) wall power and utilizes inert argon and helium gas. An IBM compatible microprocessor serves as the host computer operating in a Windows environment. CryoProbe control can also be achieved via the remote control keypad. The CryoProbes can be operated manually or using the AutoFreeze mode, which allows users to pre-program specific prostate treatment parameters.
Associated accessories include the following:
I.) CryoProbes that deliver cold temperatures to targeted tissue. The CryoProbes operate
KO60279
1
on the Joule-Thompson Principle and the refrigerative capacity is limited to the distal end of the probes. Each CryoProbe incorporates a thermocouple to measure internal CryoProbe temperatures.
Helium gas is used after the freezing process to thaw tissue. As the gas passes through the J-T port, there is a significant pressure drop, which conversely results in an increase in the gas temperature.
The patient contact CryoProbe (an accessory item to the Cryocare System) is supplied as a Single use Sterile Disposable item. This probe attaches to a reusable Cryo-Hose, which in turn attaches to the Cryocare System.
- 2.) TempProbes to monitor temperatures in the surrounding tissue. The TempProbes are standard T-type thermocouples.
- 3.) A warming system for use in urological applications.
• Indications for Use Statement:
The Cryocare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K050347
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, oncology, dermatology, ENT, proctology, pulmonary surgery and thoracic surgery. The system is designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
In addition, the system is intended for use in the following indications:
- · General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- · Ablation of leukoplakia of the mouth, angiomas, sebaceous hyperplasia, basal cell tumors of the eyelid or canthus area, ulcerated basal cell turnors, dermatofibromas, small hemanglomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
- · Urology
- · Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
- · Gynecology
- · Ablation of malignant neoplasia or benign dysplasia of the female genitalia
- · Oncology
- · Ablation of cancerous or malignant tissue
- · Ablation of benign tumors
- · Palliative intervention
- · Neurology
- · Freezing of nerve tissue in pain management/cryoanalgesia
- · Dermatology
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4060279
- · Ablation or freezing of skin cancers and other cutaneous disorders
- · Proctology
- Ablation of benign or malignant growths of the anus or rectum
- · Ablation of hemorrhoids
- · Thoracic Surgery
- · Ablation of arrhythmic cardiac tissue
- · Ablation of cancerous lesions
- Contraindications for Use ●
- There are no specific contraindications for the use of this device. .
- · Rationale for Substantial Equivalence
-
- The Cryocare CS Surgical System patient interface accessory CryoProbe and Cryo-Hose design is very similar to the predicate device [Cryocare CS Surgical System accessory item already approved by the FDA and currently being marketed by Endocare, Inc.].
-
- The INTENDED USES and the OPERATING PRINCIPLES (i.e. Effectiveness) of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME as the predicate device.
-
- The OPERATIONAL FEATURES of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME to those offered by the predicate device
-
- The SAFETY FEATURES of the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are the SAME to those offered by the predicate device.
-
Therefore, in summary, the Cryocare CS Surgical System CryoProbe and Cryo-Hose accessory items are substantially equivalent to the identified predicate device accessory items that have previously been allowed for commercial distribution in the United States.
3
• Safety and Effectiveness
The Cryocare CS Surgical System complies with the ASTM "Standard Performance and Safety Specification for Cryosurgical Medical Instruments" [Designation: F 882-82 (reapproved 2002)] which reasonably assures the device is safe when used as directed for its prescribed intended use.
The Cryocare CS Surgical System does not raise any new issues of safety, effectiveness or performance of the device when compared to the existing predicate device,
· Conclusions
The data submitted in this 510(k) Premarket Notification, for the Cryocare CS Surgical System demonstrates that this CryoProbe and Cryo-Hose accessory item is substantially equivalent with respect to the indications for use, operating principles, operational features, and safety features to the identified legally marketed predicate device. With the information provided, the safety and effectiveness of the product can be reasonably assured, and we believe that this device clearly meets the requirement for a "Substantial Equivalence" decision in accordance with the 510(k) guidelines.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. The logo is presented in black and white.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocare, Inc. c/o Mr. Alden Kay Senior Director, Quality and Regulatory 201 Technology Drive Irvine, CA 92618
Re: K060279
Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II (two) Product Code: OCL, GEH Dated: January 27, 2006 Received: February 2, 2006
Dear Mr. Kay:
This letter corrects our substantially equivalent letter of February 28, 2006.
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. Alden Kay
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
elgmall
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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Indications for use
Indications for Use Statement
Device Name: Cryocare CS Surgical System
Indications for Use:
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic The Cryoure Do builgion in the areas in general surgery, urology, oncology, neurology, surgiour procedures proctology, pulmonary surgery and thoracic surgery. The system is designed definatology; ENT', provices }) Firstion of extreme cold temperatures including prostate and kidney tissue, liver metastases, tumors, skin lesions, and warts.
In addition, the system is intended for use in the following indications:
- · General Surgery
- · Destruction of warts or lesions
- Palliation of tumors of the oral cavity, rectum and skin
- 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, hemorrhoids, anal fissures, nerianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemanglomas, recurrent cancerous lesions
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use ______ (Per 21 CFR 801.109)
510(k) Number: K0 60279
el.gm@l
Division of General, Restorative, and Neurological Devices
KO60279 510(k) Number_