CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice

Q: Who is the manufacturer of CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

Varian Medical Systems, Inc. filed the 510(k) submission for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice (K201588).

Q: What is the FDA product code for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

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

Q: What is the regulatory pathway for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

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

Q: What are the predicate devices for CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

Cryocare CS™ Surgical System (K153489).

Q: Who can help prepare an FDA 510(k) submission like CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice?

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.

K201588 · Varian Medical Systems, Inc. · GEH · Aug 11, 2020 · General, Plastic Surgery

Device Facts

Record ID	K201588
Device Name	CRYOCARE TOUCH System and Accessories, Endocare 1.7mm Round Ice PerCryo Cryoprobe, Short, Round Ice
Applicant	Varian Medical Systems, Inc.
Product Code	GEH · General, Plastic Surgery
Decision Date	Aug 11, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4350
Device Class	Class 2
Attributes	Therapeutic

Intended Use

The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, 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, 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 cancerous lesions

Device Story

Standalone cryotherapy system; utilizes Joule-Thomson effect with argon (freeze) and helium (thaw) gases. Console features 15-inch LCD touchscreen, remote keypad, and ports for up to eight cryoprobes and eight temperature probes. Operated by surgeons in OR/clinic settings. System software manages gas flow to distal end of probes; monitors tissue temperature via TempProbe devices. Provides real-time feedback on freeze/thaw duration and temperature. Enables precise tissue ablation; aids in tumor palliation and lesion destruction. Enhancements over predicate include touchscreen interface and integrated pressure transducers for improved control.

Clinical Evidence

Bench testing only. No clinical data or animal studies included. Testing included electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), human factors/usability (IEC 60601-1-6, IEC 62366), alarm system testing (IEC 60601-1-8), software verification, biocompatibility (ISO 10993), and sterilization validation (ISO 11137).

Technological Characteristics

Cryosurgical unit using Joule-Thomson effect; argon/helium gas source. Console with 15-inch LCD touchscreen. Accessories include Endocare cryoprobes and TempProbe devices. Sterile, single-use probes. Gamma radiation sterilization. Software-controlled gas delivery. Electrical safety per IEC 60601-1; EMC per IEC 60601-1-2.

Indications for Use

Indicated for patients requiring tissue ablation or freezing in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Specific conditions include prostate cancer, BPH, malignant/benign tumors, skin lesions, warts, breast fibroadenomas, and nerve tissue freezing for pain management.

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

Cryocare CS™ Surgical System (K153489)

Related Devices

K123865 — VISUAL-ICE CRYOABLATION SYSTEM · Galil Medical, Inc. · Feb 6, 2013
K060279 — CRYOCARE CS SURGICAL SYSTEM · Endocare, Inc. · Feb 28, 2006
K143564 — Visual-ICE Cryoablation System, Software Revision 1.3.1 · Galil Medical, Inc. · Mar 5, 2015
K023757 — CRYOCARE SURGICAL SYSTEM, MODEL CRYO 20 · Endocare, Inc. · Dec 5, 2002
K113860 — VISUAL-ICE CRYOABLATION SYSTEM · Galil Medical, Inc. · Mar 12, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. August 11, 2020 Varian Medical Systems, Inc. Mr. Peter Coronado Senior Director Regulatory Affairs 3100 Hansen Way, m/s E110 Palo Alto, California 94304 Re: K201588 Trade/Device Name: CRYOCARE TOUCH System and Accessories Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: June 11, 2020 Received: June 12, 2020 Dear Mr. Coronado: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. {1}------------------------------------------------ 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- 542 of the Act); 21 CFR 1000-1050. 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely. Long Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201588 Device Name CRYOCARE TOUCHTM System and Accessories ### Indications for Use (Describe) The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, oncology, oncology, 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, 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 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 word "varian" in a bold, sans-serif font. The letters are all lowercase and evenly spaced. The word is centered and takes up most of the frame. The color of the text is black, and the background is white. Endocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 Austin, TX 78717 www.varian.com ### PREMARKET NOTIFICATION K201588 510(k) Summary CRYOCARE TOUCH™ System and Accessories The following information is provided as required by 21 CFR 807.92 #### l. Submitter's Name: Varian Medical Systems 3100 Hansen Way, m/s E110 Palo Alto, CA 94304 Contact Name: Mr. Peter J. Coronado, Senior Director Regulatory Affairs Phone: 650-424-6320 | Fax: 650-646-9200 E-mail: submissions.support@varian.com Date Prepared: 11 June 2020 #### ll. Device Information: | Proprietary Name: | CRYOCARE TOUCH™ System and Accessories | |----------------------|----------------------------------------| | Common/ Usual Name: | Cryosurgical Unit and accessories | | Classification Name: | Cryosurgical unit and accessories | | Regulation Number: | 21 CFR 878.4350 | | Product Code: | GEH | #### lll. Predicate Device: Cryocare CS™ Surgical System (K153489) #### IV. Device Description: The CRYOCARE TOUCH™ System and accessories are a cryotherapy delivery system that is used to freeze/ablate tissue by the application of extreme cold temperatures. The CRYOCARE TOUCH System is a standalone surgical system consists of a compact, easyto-operate console and associated accessories that include Endocare™ Cryoprobe devices to deliver cold temperatures to the therapeutic tissue and Endocare TempProbe™ Devices to monitor temperatures in the surrounding tissue. The system utilizes the Joule-Thomson effect and inert argon and helium gases to provide cryotherapy and is comprised of the following: - . CRYOCARE TOUCH Control Console - 15-inch LCD Touchscreen Monitor with folding Monitor Arm - Side Handles to facilitate mobility ● - Wheels with wheel locks - . Power Supply - . Argon Port, Regulator, and Supply Line - . Helium Port, Regulator, and Supply Line - . Cryoprobe Interface with eight (8) cryoprobe connections - . TempProbe Interface with eight (8) TempProbe connections - Alarm Audio Output on Back Panel - . Remote Keypad The CRYOCARE TOUCH system software manages the therapy delivered to the patient by the Endocare cryoprobes. The cryoprobes are designed to deliver cold temperatures for cryotherapy using highpressure argon gas circulated through the cryoprobe. Active tissue thawing is achieved by circulating helium gas through the cryoprobe. The refrigerative and warming capacity is limited to the distal end of the probe shaft. {5}------------------------------------------------ Endocare. Inc. 9825 Spectrum Drive Building 2. Suite 250 www.varian.com Endocare Cryoprobes consists of the following cryoprobe families: - Variable Ice ("V-Probe™") Cryoprobes in straight and right-angle configurations with model ● numbers CVA2400, CVA2400RA. - . Endocare™ Right Angle Cryoprobes with model numbers R3.8 and R3.8L. - Endocare™ Cryoprobes in straight configuration with model number CRYO-48-F. - Slimline™ Cryoprobes in right-angle configuration with model numbers PCS-17. PCS-17R, PCS-. 17RS, RS-17, RS-17L, PCS-24, PCS-24L, RS-24, RS-24L. The TempProbe™ device is designed for use with the Endocare Cryocare Systems to monitor tissue temperatures in or around the targeted freeze zone. The TempProbe devices has model number CRYO-54-F and CRYO-55-F. The Endocare Cryoprobes and TempProbe devices are previously cleared within K153489, except for the PCS-17RS cryoprobe model number which is included as a line extension within K201588. Additionally, K201588 proposes a standalone indicate for use the Endocare Cryoprobes (excluding the TempProbe devices). The proposed indication is included in the following section. #### V. Indications for Use: The CRYOCARE TOUCH™ System is intended for use in open, minimally invasive or endoscopic surgical procedures in the areas in general surgery, urology, gynecology, 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 cancerous lesions {6}------------------------------------------------ Endocare, Inc. 9825 Spectrum Drive Building 2, Suite 250 Austin, TX 78717 www.varian.com ### VI. Comparison of Technological Characteristics with the Predicate Device: At a high level, the subject device differs from the predicate as a result of the following characteristics: - Removal of indication for ablation of arrhythmic cardiac tissue ● - Touchscreen user interface - Addition of pressure transducers - . Corresponding software updates to incorporate the touchscreen and pressure transducers - . Line extension to include model number PCS-17RS as a compatible accessory The tables below include a high-level comparison of the predicate and subject devices. | Feature and/or Specification | Subject Device CRYOCARE TOUCH System and Accessories | Predicate Device Cryocare CS Surgical System and Accessories | Comparison between Subject and Predicate | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | 510(k) | K201588 | K153489 | N/A | | 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 | The CRYOCARE TOUCH™ 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 | Subject Device removes the indication for "Ablation of arrhythmic cardiac tissue" | | Feature and/or Specification | Subject Device CRYOCARE TOUCH System and Accessories | Predicate Device Cryocare CS Surgical System and Accessories | Comparison between Subject and Predicate | | | 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 | 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 cancerous lesions | | | Mechanism of Action | Joule-Thomson Effect | Joule-Thomson Effect | Same | | Freeze Gas | Argon | Argon | Same | | Thaw Gas | Helium | Helium | Same | | Human Interface Device/ Connections | 1x Touchscreen 1 X Remote Keypad | 1x Integrated Main Keyboard 1 X Remote Keypad | Subject devices incorporate touchscreen capability | ### Table 1. – Predicate and Subject Device Comparison – CRYOCARE TOUCH System and Accessories {7}------------------------------------------------ Endocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 Austin, TX 78717 www.varian.com ### Table 1. – Predicate and Subject Device Comparison – CRYOCARE TOUCH System and Accessories ### Table 2. Predicate and Subject Device Comparison - PCS-17RS Cryoprobe | Feature and/ or Specification | Subject Device: PCS-17RS Endocare™ 1.7mm Round Ice PerCryo™ Cryoprobe, Short | Predicate Device: PCS-17R Endocare™ 1.7mm Round Ice PerCryo™ Cryoprobe | Comparison between Subject and Predicate | |----------------------------------|------------------------------------------------------------------------------------|---------------------------------------------------------------------------|------------------------------------------------| | 510(k) | K201588 | K153489 | N/A | | Model | PCS-17RS | PCS-17R | New Model Number | | Indications for use | Shares the CRYOCARE TOUCH System indications for use. | Shares the CRYOCARE CS Surgical System indications for use. | Same | | Shaft Diameter | 1.7 mm | 1.7 mm | Same | | Shaft Length | 7 cm | 15 cm | Subject device has shorter shaft length | | Shape of Probe Tip | Trocar | Trocar | Same | | Usage | Sterile, Single-Use | Sterile, Single-Use | Same | ### VII. Performance Data (Non-Clinical Testing) Design Verification and Design Validation testing were completed to demonstrate that the CRYOCARE TOUCH System and Accessories performs as intended and meets its essential performance specifications: - Each individual port displays the type of the probe connected adjacent to the port controls. - . Monitor/ Screen must display temperature values of each probe (Cryoprobe and TempProbe) used for the cryoablation treatment. Temperature values shall be within +/- 3 °C of the displayed value from -150°C to 40°C. - Monitor/ Screen must display the freeze, stick and thaw duration time; the time shall have an accuracy of +/- 1 second. - System must display a warning and alarm if unexpected behavior is observed. {8}------------------------------------------------ Fndocare, Inc. 9825 Spectrum Drive Building 2. Suite 250 www.varian.com The system software for the subject device is considered to have a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. The biocompatibility testing of the Endocare cryoprobes was intended to demonstrate the biological safety of the subject cryoprobe model number PCS-17RS. The sterilization validation testing of the Endocare cryoprobes was intended to demonstrate that the gamma radiation sterilization method achieves cryoprobe sterility. Bench testing included testing of the system, software, and cryoprobes, including: - Electrical Safety Testing in accordance with IEC 60601-1. ● - . Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2. - . Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366. - . Alarm system testing in accordance with IEC 60601-1-8. - . Software development in accordance with IEC 62304 and the FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." - PCS-17RS Cryoprobe Biocompatibility Testing in accordance with ISO 10993 series of standards, including ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12. - . PCS-17RS Cryoprobe Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2. Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly. No animal studies or clinical tests have been included in this pre-market submission. #### VIII. Determination of Substantial Equivalence to the Predicate Device A subset of technological characteristics and features of the subject device differs from the predicate device. These differences are all considered to be enhancements of the predicate, intended to modernize the user interface. The Intended Use and indications for use are substantially the same as the predicate device. Further, there are no changes in the principle of operation of the devices. The Verification and Validation demonstrates that the device is as safe and effective as the predicate. Varian therefore believes the data demonstrates that the CRYOCARE TOUCH System and Accessories is substantially equivalent to the predicate device, CRYOCARE CS Surgical System and Accessories. #### IX. Conclusion The assessment following the outcomes observed in the performance testing and software design verification and design validation determines that the CRYOCARE TOUCH System and Accessories conforms to the defined user needs and intended uses. Varian therefore considers the CRYOCARE TOUCH System and Accessories to be safe and effective and to perform at least as well as the predicate device.