(14 days)
Not Found
No
The document describes a cryoablation system with integrated ultrasound and guidance software, but there is no mention of AI or ML in the device description, intended use, or performance studies. The "AutoFreeze mode" appears to be a pre-programmed parameter setting, not an AI/ML driven feature.
Yes.
The device is specifically designed to ablate/freeze tissues for the treatment of various medical conditions and diseases, including cancers, lesions, and warts, across multiple surgical specialties.
No
The primary function of the device is to freeze/ablate tissue for therapeutic purposes, not for diagnosis. While it has an integrated ultrasound system that can provide imaging, this is stated to be for guiding probe placement and monitoring treatment, not for diagnosing conditions. The 10LAP4 probe is mentioned to be for "diagnostic ultrasound imaging or fluid flow analysis", but it is a component of the system and the overall system's intended use is therapeutic.
No
The device description clearly outlines hardware components such as a console, display screen, video printer, CD-R/W drive, keypad, ultrasound system with transducers, CryoProbes, and TempProbes. It is a system that includes both hardware and software for cryoablation and ultrasound imaging.
Based on the provided text, the Cryocare CS Surgical System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The primary intended use of the Cryocare CS Surgical System is to freeze/ablate tissue during surgical procedures. This is a therapeutic action, not a diagnostic one performed on samples outside the body.
- Device Description: The system is described as delivering cold temperatures to tissue and monitoring temperatures. While it includes an ultrasound system for imaging, the imaging component is used for guidance and planning during the surgical procedure, not for analyzing samples in vitro to diagnose a condition.
- IVD Definition: In Vitro Diagnostics are defined as devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. The Cryocare CS Surgical System does not fit this definition.
The inclusion of the ultrasound probe (10LAP4) for diagnostic ultrasound imaging is a component of the system used for in vivo imaging to support the surgical procedure, not for in vitro diagnostic testing.
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 .
The intended use of the 10LAP4 probe, when used as a part of the Cryocare CS Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the human body and is a subset of the uses cleared under K043278, and is documented in Section 4.3 of this submission.
Product codes (comma separated list FDA assigned to the subject device)
OCL, GEH, IYN, ITX
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 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.
The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated 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 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows:
Frequency: 7.0 MHz
Elements: 128
Array type: Linear
Pitch (mm): 0.30
Elevation width (mm): 5.0
Geometric focus (mm): 25
Azimuth radius (mm): N/A
Azimuth length (mm): 38.4
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
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
prostate and kidney tissue, liver metastases, tumors, skin lesions, warts, oral cavity, rectum, mouth, eyelid, canthus area, anus, ear, nose, throat, lung, thoracic, female genitalia, nerve tissue, heart
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
Èndocare, Inc. Traditional 510(k): Cryocare CS Surgical System FEB 2 5 2005
| Image: logo | endocare
extending life everyday |
| ------------- | -------------------------------------------- |
|---|
510(K) SUMMARY
Page ① of ②
Prepared -- December 12, 2004
| 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 | K032333 - Endocare Cryocare CS Surgical System | |
| Decision date: 8/18/2003 | ||
| K043278 - Teratech Model 8IOC4, 8IOL4, 10LAP4 Probe | ||
| Decision date: 12/13/2004 | ||
| 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 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.
The Cryocare CS Surgical System has an ultrasound system with available a trans-rectal transducer for prostate imaging or a laparoscopic transducer. The transducers operate in B, Power Doppler, Color Doppler (including directional and non-directional Power Doppler), and Harmonic Imaging. The Trans-rectal transducer is capable of transverse and sagittal views.
Ultrasound images may be obtained either from an external ultrasound (via video connection) or the integrated 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 10LAP4 Probe is intended for use with Cryocare CS Surgical System's ultrasound imaging system. Technical specifications for the probes is as follows: | |
1
Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System
| ರ | S | い
ﺎ | ् |
|---|---------|--------|---|
| | く
ﮐﺮ | | |
| Frequency | 7.0 MHz | |
|---|---|---|
| # Elements | 128 | |
| Array type | Linear | |
| Pitch (mm) | 0.30 | |
| Elevation width (mm) | 5.0 | |
| Geometric focus (mm) | 25 | |
| Azimuth radius (mm) | N/A | |
| Azimuth length (mm) | 38.4 | |
| 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 - K032333. | ||
| 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, live | ||
| metastases, tumors, skin lesions, and warts. | ||
| The intended use of the 10LAP4 probe, when used as a part of the Cryocare CS | ||
| Surgical System, is for diagnostic ultrasound imaging or fluid flow analysis of the | ||
| human body and is a subset of the uses cleared under K043278, and is 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; The 10LAP4 ultrasound probe is the same as Teratech's cleared under | ||
| K043278 and is intended for the same clinical application; 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. |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol. The logo is simple and recognizable, and it is often used to represent the U.S. Department of Health and Human Services.
FEB 2 1 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Endocare, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, MN 55313
Re: K050347
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, IYN, ITX Dated: February 7, 2005 Received: February 11, 2005
Dear Mr. Job:
This letter corrects our substantially equivalent letter of February 25, 2005.
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 - Mr. Mark Job
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 vours.
elmall
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
Page ① of 2
Indications for Use Statement
510(k) Number:
Device Name:
Cryocare CS Surgical System
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 _ X __ (Per 21 CFR 801.109)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050347
5
050347
Endocare, Inc. Traditional 510(k): Cryocare CS Surgical System
Page ② of 2
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 X X (PER 21 CFR 801.109)