Who is the manufacturer of MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

Endocare, Inc. filed the 510(k) submission for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM (K050347).

What is the FDA product code for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

GEH. It is classified under 21 CFR 878.4350 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

Endocare Cryocare CS Surgical System (K032333); Teratech Model 8IOC4, 8IOL4, 10LAP4 Probe (K043278).

Who can help prepare an FDA 510(k) submission like MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM

K050347 · Endocare, Inc. · GEH · Feb 25, 2005 · General, Plastic Surgery

Device Facts

Record ID	K050347
Device Name	MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM
Applicant	Endocare, Inc.
Product Code	GEH · General, Plastic Surgery
Decision Date	Feb 25, 2005
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic, 3rd-Party Reviewed

Intended 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 .

Device Story

Cryocare CS Surgical System is a console-based cryosurgical unit for tissue ablation. Inputs include ultrasound imaging (trans-rectal or laparoscopic transducers) and temperature data from TempProbes. System uses inert argon and helium gas to deliver extreme cold to tissue via disposable CryoProbes. Console features 19" LCD display, video printer, and CD-R/W drive. Optional 'CryoGuide' software provides intraoperative real-time guidance and planning for prostate procedures. System integrates ultrasound imaging (B-mode, Power/Color Doppler, Harmonic) with treatment screens displaying anatomical probe placement and temperature readings. Operated by clinicians in surgical settings. 'AutoFreeze' mode allows pre-programming of treatment parameters. Output includes real-time visual guidance and hard-copy documentation. Benefits include precise, image-guided tissue ablation for various surgical specialties.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Console-based cryosurgical unit; utilizes inert argon and helium gas. 10LAP4 ultrasound probe: 7.0 MHz, 128 elements, linear array, 0.30 mm pitch, 5.0 mm elevation width, 25 mm geometric focus. IBM-compatible microprocessor, Windows environment. Connectivity: video connection for external ultrasound, CD-R/W for data storage. 120/230 VAC power. Disposable CryoProbes and TempProbes.

Indications for Use

Indicated for patients requiring tissue ablation via extreme cold in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, tumors, skin lesions, warts, and nerve tissue freezing for pain management. Prescription use only.

Regulatory Classification

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.

Predicate Devices

Endocare Cryocare CS Surgical System (K032333)
Teratech Model 8IOC4, 8IOL4, 10LAP4 Probe (K043278)

Related Devices

K032333 — CRYOCARE CS SURGICAL SYSTEM · Endocare, Inc. · Aug 12, 2003
K060279 — CRYOCARE CS SURGICAL SYSTEM · Endocare, Inc. · Feb 28, 2006
K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 · Endocare, Inc. · Dec 5, 2002
K060390 — SEEDNET, SEEDNET GOLD, CRYOHIT, CRYO THERA · Galil Medical , Ltd. · Apr 27, 2006
K991272 — CRYO-HIT,MODELS ED1TO, EPITI, EP2TI, EP2T2, EP3T3, EP4T2, EPT3, EP4T4,EP5T2, EP5T3, EP5T5, EP6T5,EP7T3,EP7T5,EP8T3,AND E · Galil Medical , Ltd. · Jul 12, 1999

Submission Summary (Full Text)

{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 K050347 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: K050347 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)