(63 days)
Not Found
No
The document does not mention AI, ML, or any related concepts in the device description, intended use, or performance studies.
Yes.
The device is intended to freeze/ablate diseased tissue, such as tumors and lesions, for therapeutic purposes across various medical specialties.
No
Explanation: The device is intended for cryoablative tissue destruction, which is a therapeutic procedure involving the freezing of tissue. It is not designed to diagnose conditions.
No
The device description explicitly states it is a "mobile console system" and includes "associated accessories that include cryoprobes" and "TempProbe® devices," indicating it is a hardware system with physical components for delivering cold temperatures and monitoring temperature.
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 device is for surgical procedures to freeze/ablate tissue within the body. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a "mobile console system intended for cryoablative tissue destruction" with cryoprobes and temperature monitoring devices. This aligns with a surgical tool, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) or providing diagnostic information based on such analysis. The device's function is to physically alter tissue through freezing.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's purpose is to directly treat tissue within the body.
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 breast fibroadenomas
- · 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, 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
Product codes (comma separated list FDA assigned to the subject device)
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
Not Found
Anatomical Site
prostate, kidney, liver, breast, oral cavity, rectum, skin, eyelid, anal, female genitalia, nerve tissue, anus, 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)
Non-Clinical Testing:
- Performance Testing
- Isotherm Testing
- Packaging Integrity Testing
- Electrical Safety Testing
- Electromagnetic Compatibility Testing
- Software Verification and Validation
Conclusion: Based on a comparison of indications for use, technological characteristics and isotherm data, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their 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.
K003811, K141110, K151968, K143564, K111859, K140584
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
Image /page/0/Picture/0 description: The image shows the text "ARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, sans-serif font. The text is black and the background is white. The text is centered horizontally.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 5, 2016
Health Tronics, Inc. Maritza Ward Manager, Regulatory Affairs 9825 Spectrum Dr., Bldg. 2 Austin, Texas 78717
Re: K153489
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: December 2, 2015 Received: December 4, 2015
Dear Ms. Ward:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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" (21 CFR 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,
Jennifer R. Stevenson -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) K153489
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 breast fibroadenomas
- · 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, 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
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.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/0 description: The image shows the logo for HealthTronics. The logo features a stylized "H" with an orange swoosh around it, enclosed in a gray circle. The text "HealthTronics" is written in a combination of orange and gray, with "Health" in orange and "Tronics" in gray. There is a trademark symbol to the right of the word "Tronics".
Cryocare CS® Surgical System 510(k) Summary-K153489
| COMPANY: | Endocare, a wholly owned subsidiary of
HealthTronics, Inc.
9825 Spectrum Drive, Building 2
Austin, TX 78717 |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|
| CONTACT: | Maritza Ward, B.S.
Manager, Regulatory Affairs
Email: maritza.ward@healthtronics.com
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 Surgical System | K003811 | Cleared 10/11/2001 |
|---|---|---|
| Cryocare CS Surgical System | K141110 | Cleared 06/25/2015 |
| Cryocare CS Surgical System | K151968 | Cleared 09/09/2015 |
| Galil Medical Visual ICE | K143564 | Cleared 03/05/2015 |
| Galil Medical IceEDGE | K111859 | Cleared 10/07/2011 |
| Galil Medical IceRod | K140584 | Cleared 03/31/2014 |
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.
5
Image /page/5/Picture/0 description: The image shows the logo for HealthTronics. The logo consists of a stylized "HT" symbol enclosed within a circular design on the left, followed by the word "HealthTronics" in a combination of orange and gray lettering. The "TM" symbol is present to the right of the word.
Cryocare CS® Surgical System 510(k) Summary-K153489
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:
General Surgery
- · Destruction of warts or lesions
- · Palliation of tumors of the oral cavity, rectum and skin
- Ablation of breast fibroadenomas
- · 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
6
Image /page/6/Picture/0 description: The image shows the logo for HealthTronics. The logo features a stylized "H" inside a circular design on the left, followed by the word "HealthTronics" in a combination of orange and gray colors. The "TM" symbol is placed to the right of the word "HealthTronics".
Cryocare CS® Surgical System 510(k) Summary-K153489
TECHNOLOGICAL CHARACTERISTICS:
The proposed Cryocare CS Surgical System console and cryoprobe designs are identical to their predicates with the exception of
- Addition of previously cleared indication for use: "Ablation of breast ● fibroadenoma"
- Addition of the Cryocare CS Basic Console (CRYO-CS Basic)
- Addition of the 2.4 mm Right-Angle Variable Probe (CVA2400RA) ●
- . Addition of new part numbers associated with packaging configuration changes
The subject designs have the same fundamental technological features and intended use and are compatible with the same Cryocare CS Surgical System consoles and accessories as their predicate designs.
NON-CLINICAL TESTING
Appropriate product testing was performed on all subject devices to evaluate conformance to product specifications and equivalence to the predicate designs. Verification and validation for the proposed modifications were conducted in accordance with internal protocols conforming to international standards and FDA guidance documents.
Verification /Validation Activities
- . Performance Testing
- O Isotherm Testing
- Packaging Integrity Testing
- Electrical Safety Testing ●
- . Electromagnetic Compatibility Testing
- Software Verification and Validation ●
CONCLUSION:
Based on a comparison of indications for use, technological characteristics and isotherm data, the proposed devices have demonstrated substantial equivalence to their predicates and are shown to be safe and effective for their intended use.