(14 days)
Not Found
No
The description focuses on the hardware components, software for guidance and planning (CryoGuide), and integration with ultrasound imaging. There is no mention of AI or ML algorithms for image analysis, treatment planning, or any other function. The "AutoFreeze mode" appears to be a pre-programmed parameter setting, not an AI-driven feature.
Yes
The device is used to freeze/ablate tissue for various medical conditions, including tumors, lesions, and other medical issues, which falls under the definition of therapeutic use.
No
The device is described as a surgical system designed to freeze/ablate tissue. While it includes an ultrasound module for imaging and guidance during procedures, its primary intended use is therapeutic (tissue ablation), not diagnostic (identifying or characterizing disease). The ultrasound is used to guide the placement of cryoprobes, not to diagnose a condition.
No
The device description clearly outlines a physical console, CryoProbes, TempProbes, a display screen, a video printer, a CD-R/W drive, keypads, and an integrated ultrasound module. While it includes software (CryoGuide), it is part of a larger hardware system designed for cryoablation.
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 for therapeutic purposes in various surgical procedures. This is a direct treatment method, not a diagnostic test performed on samples outside the body.
- Device Description: The device description details a console that delivers cold temperatures via probes, monitors tissue temperature, and integrates with ultrasound for guidance during surgical procedures. These are all components and functions related to a surgical intervention, not an in vitro diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.) outside the body to diagnose a condition or provide information about a patient's health status.
In summary, the Cryocare CS Surgical System is a therapeutic device used for tissue ablation during surgery, which falls outside the definition of 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, 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 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)
OCL, GEH, IYN, IYO, ITX
Device Description
The Cryocare CS (Combo System) 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 unit integrates the functions of the existing Cryocare surgical system and the CryoGuide system into one console. The CryoGuide software is an optional brachy-like intraoperative real-time guidance and planning system, which identifies and guides CryoProbe placement for prostate procedures.
An added feature to the Cryocare CS Surgical System is integration of the Terason 2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound module utilizes the Terason Model 2000 Handheld Ultrasound System using Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital views, and operates in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. This use includes ultrasound guidance for placement of needles, cryosurgery, and brachytherapy.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or from the integrated Terason 2000 ultrasound module. The user screen simultaneously displays the real-time ultrasound image along with the treatment screen. For prostate procedures, the treatment screen displays the prostagraph showing the anatomical CryoProbe and TempProbe placements and associated temperature readings.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Prostate, kidney, liver, skin, oral cavity, rectum, eyelid, cannus 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)
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.
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
Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System
K 032333
Image /page/0/Picture/3 description: The image shows the logo for Endocare. The logo consists of a stylized graphic to the left of the word "endocare" in a bold, slightly italicized font. Below "endocare" is the tagline "extending life everyday" in a smaller, less bold font. The overall design is simple and professional.
510(K) SUMMARY
Prepared May 7, 2003
| TRADE NAME | Cryocare CS Surgical System | ||
|---|---|---|---|
| COMMON NAME | Cryosurgical unit and accessories | ||
| CLASSIFICATION | Class II (21 CFR 878.4350) | ||
| SUBMITTED BY | Endocare, Inc. | ||
| 201 Technology | |||
| Irvine, CA 92618 | CONTACT | Eben Gordon | |
| Regulatory Affairs | |||
| 949.450.5424 | |||
| 949.450.5300 | |||
| PREDICATE DEVICE | K023757 - Endocare Cryocare Surgical System | ||
| Decision date: 12/5/2002 | |||
| K002615 - Endocare Cryocare Surgical System with CryoGuide | |||
| Decision date: 11/13/2000 | |||
| K030191 - Terason Model 2000/BAS Portable Ultrasound System | |||
| Decision date: 1/29/2003 | |||
| DEVICE | |||
| DESCRIPTION | The Cryocare CS (Combo System) 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 unit integrates the functions of the existing Cryocare surgical | |||
| system and the CryoGuide system into one console. The CryoGuide software is an | |||
| optional brachy-like intraoperative real-time guidance and planning system, which | |||
| identifies and guides CryoProbe placement for prostate procedures. | |||
| An added feature to the Cryocare CS Surgical System is integration of the Terason | |||
| 2000 ultrasound trans-rectal probe for dedicated prostate imaging. The ultrasound | |||
| module utilizes the Terason Model 2000 Handheld Ultrasound System using | |||
| Model 8EC4 Endocavity Smart Probe. It is capable of transverse and sagital | |||
| views, and operates in B, Power Doppler, Color Doppler (including directional and | |||
| non-directional Power Doppler), and Harmonic Imaging. This use includes | |||
| ultrasound guidance for placement of needles, cryosurgery, and brachytherapy. | |||
| Ultrasound images may be obtained either from an external ultrasound (via video | |||
| connection) or from the integrated Terason 2000 ultrasound module. The user | |||
| screen simultaneously displays the real-time ultrasound image along with the | |||
| treatment screen. For prostate procedures, the treatment screen displays the | |||
| prostagraph showing the anatomical CryoProbe and TempProbe placements and |
1
associated temperature readings.
| | 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. |
|------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| INDICATIONS FOR
USE | The Cryocare CS Surgical System has the same intended use as previously
cleared for the Cryocare CS Surgical System - K023757. |
| | 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. |
| | The intended uses of the Terason 2000 Ultrasound System, when used as a part of
the Cryocare CS Surgical System, are a subset of the uses cleared under K030191,
and are documented in section 4.3 of this submission. |
| 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, Use the same operating principle and has not altered the fundamental technology, Incorporate the same CryoProbe, Incorporate the same system design, Incorporate 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, in our opinion, substantially equivalent to the predicate devices. |
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which is a stylized representation of a human figure embracing a globe. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the symbol. The symbol and text are all in black, set against a white background.
FEB 2 1 2008
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocare, Inc. c/o Ms. Laura Danielson 510(k) Program Manager TUV Product Service 1775 Old Highway 8 NW New Brighton, MN 55112-1891
Re: K032333
Trade 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, IYN, IYO, ITX Dated: July 28, 2003 Received: July 29, 2003
Dear Ms. Danielson:
This letter corrects our substantially equivalent letter for this application.
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.
3
Page 2 - Ms. Laura Danielson
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 (OS) 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,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System
Indications for Use Statement
510(k) Number:
K 032333
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 .
- 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 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)
lettu with
Sign-Off Division of General, Restorative and Neurological Devices
510(k) Number 032337
5
Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System
Indications for Use Statement (Continued)
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 ●
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)