(55 days)
Not Found
No
The document describes a cryoablation system with probes and temperature monitoring. There is no mention of AI, ML, or any features that would suggest the use of such technologies for analysis, prediction, or decision-making. The performance studies focus on equivalence to a predicate device and standard engineering tests.
Yes
The device is intended to freeze/ablate tissue for various medical conditions, including cancerous and benign tumors, lesions, and other disorders affecting different anatomical sites, which are therapeutic interventions.
No
The device is described as a "Surgical System" intended for "freeze/ablate tissue" and "cryoablative tissue destruction," indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states the system consists of a "mobile console system" and "associated accessories that include cryoprobes and TempProbe devices," indicating it is a hardware-based system with software components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a surgical system designed to freeze/ablate tissue within the body for therapeutic purposes (treating various conditions like cancers, lesions, warts, etc.). This is an in vivo procedure, meaning it's performed on living tissue within the body.
- Device Description: The device description confirms it's a "mobile console system intended for cryoablative tissue destruction," using cryoprobes to deliver cold temperatures directly to the targeted tissue.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, tissue samples) outside the body (in vitro) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of specimens.
Therefore, the Cryocare CS Surgical System is a therapeutic surgical device, not an in vitro diagnostic device.
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, oncology, neurology, 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 tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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
GEH
Device Description
The Endocare Cryocare CS Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe devices to monitor temperatures in the surrounding tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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
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)
Appropriate verification and validation activities were performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate design. Testing included bench performance, software validation, electrical safety and electromagnetic compatibility testing. The results of all studies confirmed equivalency between the subject and predicate device, and that no new issues of safety or efficacy were raised.
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure, with three faces overlapping to create a sense of depth and community. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 1, 2016
Endocare, a wholly owned subsidiary of HealthTronics, Incorporated Ms. Maritza Ward Manager, Regulatory Affairs 9825 Spectrum Drive, Building 2 Austin, Texas 78717
Re: K151968
Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 14, 2015 Received: July 16, 2015
Dear Ms. Ward:
This letter corrects our substantially equivalent letter of September 9, 2015.
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 application (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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
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
1
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
David Krause -S
for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K151968
Device Name Cryocare CS Surgical System
Indications for Use (Describe)
The Cryocare CS Surgical System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, neurology, 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 tumors, dermatofibromas, small hemangiomas, mucocele cysts, multiple warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Image /page/4/Picture/0 description: The image shows the logo for HealthTronics. The logo features a stylized "H" inside a circular design with an orange swoosh. The text "HealthTronics" is written in a combination of orange and gray next to the symbol.
510(k) Summary Cryocare CS Surgical System
| COMPANY: | Endocare, a wholly owned subsidiary of
HealthTronics, Inc.
9825 Spectrum Drive, Building 2
Austin, TX 78717 | |
|---------------------------|----------------------------------------------------------------------------------------------------------------------|-------------------------------|
| CONTACT: | Maritza Ward
Manager, Regulatory Affairs
Telephone: (512) 439-8361
Fax: (512) 439-8311 | |
| PROPRIETARY
TRADE NAME | Cryocare CS Surgical System | |
| CLASSIFICATION NAME: | Cryosurgical Unit and Accessories | |
| CLASS: | II | |
| PRODUCT CODE: | GEH | |
| REGULATION NUMBER: | 21 CFR 878.4350 | |
| PREDICATE DEVICE: | | |
| | Cryocare CS Surgical System | K141110
Cleared 06/25/2015 |
PRODUCT DESCRIPTION:
The Endocare Cryocare CS Surgical System is a mobile console system intended for cryoablative tissue destruction. The system consists of a compact, easy to operate console and associated accessories that include cryoprobes to deliver cold temperatures to the targeted tissue, and TempProbe devices to monitor temperatures in the surrounding tissue.
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, neurology, 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:
5
Image /page/5/Picture/0 description: The image shows the logo for HealthTronics. The logo features the letters "HT" in orange, with a gray circle around them. The word "HealthTronics" is written in a combination of orange and gray letters to the right of the "HT" symbol. The letters "Health" are in orange, while the letters "Tronics" are in gray.
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 hemangiomas, mucocele cysts, multiple warts, plantar warts, hemorrhoids, anal fissures, perianal condylomata, pilonidal cysts, actinic and seborrheic keratoses, cavernous hemangiomas, 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
TECHNOLOGICAL CHARACTERISTICS:
The proposed Cryocare CS Surgical System console design is identical to its predicate, with the exception of a new integrated ultrasound and minor hardware and software updates to accommodate the modified configuration. The subject design has the same fundamental technological features and intended use and is compatible with the same Cryocare CS Surgical System accessories as the predicate design.
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Image /page/6/Picture/0 description: The image shows the logo for HealthTronics. The logo features a stylized "H" inside a circular design, with the word "HealthTronics" written in a combination of orange and gray. The "Health" part of the word is in orange, while the "Tronics" part is in gray. There is a trademark symbol next to the word.
NON-CLINICAL TESTING
Appropriate verification and validation activities were performed on the subject device to evaluate conformance to product specifications and equivalence to the predicate design. Testing included bench performance, software validation, electrical safety and electromagnetic compatibility testing. The results of all studies confirmed equivalency between the subject and predicate device, and that no new issues of safety or efficacy were raised.
CONCLUSION:
Based on a comparison of indications for use and technological characteristics, the proposed device has demonstrated substantial equivalence to the predicate design and is accordingly considered safe and effective for its intended use.