(33 days)
No
The document describes a cryosurgical system and its accessories, focusing on the mechanism of action (freezing tissue using Argon gas) and its various clinical applications. There is no mention of AI, ML, image processing, or any data-driven analytical capabilities within the device description or intended use.
Yes
Explanation: The device is intended for the ablation and treatment of various tissues, lesions, and tumors, including cancerous and benign growths, which falls under the definition of a therapeutic device.
No
Explanation: The device is described as a surgical system intended for "freezing/ablation tissue" and "destruction/ablation of tumors, lesions, and other tissues." These actions are therapeutic interventions, not diagnostic ones. The text does not mention any function for identifying or characterizing disease.
No
The device description explicitly mentions a "CRYOcare V-probe" which is a physical accessory that delivers cold temperatures via Argon gas. This indicates the device includes hardware components beyond just software.
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 and tumors). This is an in vivo procedure, meaning it's performed on a living organism.
- Device Description: The device description reinforces this by describing a probe that delivers cold temperatures to targeted tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
The CRYOcare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K060279 Decision Date February 28, 2006.
The Cryocare CS Surgical system has the same intended use as previously cleared. The CRYOsurgical CS Surgical System and accessories 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 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, perianal condylomata, pilonidal cvsts, 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
Product codes (comma separated list FDA assigned to the subject device)
GEH
Device Description
The CRYOcare V-probe is a CRYOprobe accessory to be used in conjunction with the CRYOcare CS Surgical System. The indications for use have not changed. The V-Probe delivers cold temperatures via Argon gas utilizing the Joules Thompson principle to targeted tissue. The patient contact V- Probe (an accessory item to the CRYOcare CRYOsurgical CS System) is supplied as a single use Sterile Disposable item.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
prostate, kidney, liver, skin, oral cavity, rectum, eyelid or canthus area, anus, female genitalia, cardiac tissue, nerve tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
open, minimally invasive or endoscopic 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): 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.
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
K1013333
Image /page/0/Picture/1 description: The image shows the logo for Endocare. The logo features a stylized graphic to the left of the word "endocare" in a sans-serif font. Below the word "endocare" is the tagline "extending life everyday" in a smaller font. The logo is black and white.
510(k) Summary
Prepared – December 12, 2004
JUN 1 4 2010
"
| TRADE NAME | Cryocare CS Surgical System |
|---|---|
| COMMON NAME | Cryosurgical unit and accessories |
| CLASSIFICATION | Class II (21 CFR 878.4350) |
| SUBMITTED BY | Endocare, Inc. as wholly own subsidiary of Healthtronics, Inc. |
| 9825 Spectrum Drive | |
| Building 2 | |
| Austin, TX 78717 |
Contact: Cheryl Blake
949-285-3517
e-mail: cheryl.blake@cox.net |
| PREDICATE
DEVICE | K060279 - Endocare Cryocare CS Surgical System
Decision date: February 26, 2006 |
| DEVICE
DESCRIPTION | The CRYOcare V-probe is a CRYOprobe accessory to be
used in conjunction with the CRYOcare CS Surgical System.
The indications for use have not changed. The V-Probe
delivers cold temperatures via Argon gas utilizing the Joules
Thompson principle to targeted tissue. The patient contact V-
Probe (an accessory item to the CRYOcare CRYOsurgical CS
System) is supplied as a single use Sterile Disposable item. |
1
INDICATIONS FOR USE
The CRYOcare CS Surgical System has the same intended use as previously cleared for the Cryocare CS Surgical System - K060279 Decision Date February 28, 2006.
The Cryocare CS Surgical system has the same intended use as previously cleared. The CRYOsurgical CS Surgical System and accessories 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 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, perianal condylomata, pilonidal cvsts, 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
2
| | 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 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUMMARY OF
SUBSTANTIAL
EQUIVALENCE | The Cryocare CS Surgical System has the following
similarities to that of the previously cleared predicate devices:
Has the same intended use; The 10LAP4 ultrasound probe is the same as
Teratech's cleared under K043278and is intended for
the same clinical application; Uses the same operating principle and has not altered
the fundamental technology; Incorporates the same system design; Incorporates the same patient contacting materials; Same manufacturing materials; and Packaged and sterilized using the same materials and
processes. In summary, the modified Cryocare CS Surgical System
described in this submission is substantially equivalent to the
predicate devices. |
.
·
:
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing segments, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 1 4 2010
Endocare. Inc. % Underwriters Laboratories, Inc. Mr. Ned Devine Senior Staff Engineer 333 Pfingsten Road Northbrook, Illinois 60062
Re: K101333
Trade/Device Name: Cryocare CS Surgical System Regulation Number: 21 CFR 878.4350 Regulation Name: Cyrosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: May 29, 2010 Received: June 02, 2010
Dear Mr. Devine:
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
4
Page 2 - Mr. Ned Devine
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 device-related 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A Milkersan
Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number:
Cryocare CS Surgical System Device Name:
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 t
- Palliation of tumors of the oral cavity, rectum and skin 0
- 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, perianal 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) ×
Michael P. Allen for mam
(Division Sign Off)
Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K101333
6
Indications for Use Statement (Continued)
Urology
- . Ablation of prostate tissue in cases of prostate cancer and benign prostatic hyperplasia
Gynecology
- o Ablation of malignant neoplasia or benign dysplasia of the female genitalia
Oncology
- t Ablation of cancerous or malignant tissue
- t Ablation of benign tumors
- Palliative intervention t
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 .
- t Ablation of hemorrhoids
Thoracic Surgery
- Ablation of arrhythmic cardiac tissue t
- Ablation of cancerous lesions a
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
Prescription Use 510(k) Number ...
PREMARKET NOTIFICATION TRUTHFUL AND ACCURATE STATEMENT (as required by 21 CFR 807.87(k))