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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CRYOCARE TOUCH™ System and Accessories. This document mainly addresses the substantial equivalence of the new device to a predicate device (Cryocare CS™ Surgical System), detailing changes in user interface and accessories, and providing general statements about performance testing.

However, the document does not contain the detailed information required to answer all parts of your request, especially regarding acceptance criteria for an AI/algorithm's performance and the specific studies that prove it meets these criteria at a statistical level. This is because the CRYOCARE TOUCH™ System is a cryosurgical unit, a hardware medical device with associated software to manage its operation, rather than an AI/algorithm for diagnostic or prognostic purposes.

The "software" mentioned in the document relates to controlling the cryosurgical unit, managing displays, and responding to alarms, rather than an AI performing an analytical task that would require a test set, ground truth experts, MRMC studies, or training/validation data in the context of machine learning.

Therefore, many of the requested details, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth for training sets, are not applicable or not present in this document for an AI/algorithm-based device.

Here's a breakdown of what can be extracted or inferred based on the provided text, and what cannot:

1. Table of acceptance criteria and reported device performance:

The document lists performance specifications and mentions that testing demonstrated conformance. However, it does not provide a quantitative table of acceptance criteria alongside the specific measured performance values for each criterion. The criteria are described qualitatively.

Criterion	Reported Performance
Individual port displays probe type.	"Each individual port displays the type of the probe connected adjacent to the port controls." (Implied: Met)
Monitor/Screen displays temperature values for each probe (Cryoprobe and TempProbe).	"Monitor/ Screen must display temperature values of each probe (Cryoprobe and TempProbe) used for the cryoablation treatment." (Implied: Met and within accuracy range)
Temperature values within +/- 3 °C of displayed value from -150°C to 40°C.	"Temperature values shall be within +/- 3 °C of the displayed value from -150°C to 40°C." (Implied: Met)
Monitor/Screen displays freeze, stick, and thaw duration time with +/- 1 second accuracy.	"Monitor/ Screen must display the freeze, stick and thaw duration time; the time shall have an accuracy of +/- 1 second." (Implied: Met)
System displays warning and alarm if unexpected behavior is observed.	"System must display a warning and alarm if unexpected behavior is observed." (Implied: Met)
Electrical Safety	"Electrical Safety Testing in accordance with IEC 60601-1." (Reported: Conformance)
Electromagnetic Compatibility	"Electromagnetic Compatibility Testing in accordance with IEC 60601-1-2." (Reported: Conformance)
Human Factors and Usability	"Human Factors and Usability Testing in accordance with IEC 60601-1-6 and IEC 62366." (Reported: Conformance)
Alarm System	"Alarm system testing in accordance with IEC 60601-1-8." (Reported: Conformance)
Software Development	"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.'" (Reported: Conformance – "major" level of concern implies rigorous testing, but specific metrics are not provided.)
Biocompatibility (for PCS-17RS Cryoprobe)	"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." (Reported: Demonstrated biological safety)
Sterilization Validation (for PCS-17RS Cryoprobe)	"PCS-17RS Cryoprobe Sterilization Validation in accordance with ISO 11137-1, ISO 11137-2, 11137-3, ISO 11737-1, and ISO 11737-2." (Reported: Demonstrated gamma radiation sterilization method achieves cryoprobe sterility)
Overall Performance	"Test results showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." "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." (General statement of successful verification and validation)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The testing described is bench testing and verification/validation activities for a hardware device and its control software. It's not a "test set" in the context of an AI model evaluated on a dataset of patient data.
Data Provenance: Not applicable in the context of patient data samples for AI. The "data" refers to measurements and observations from engineering tests, not clinical patient data. The document explicitly states "No animal studies or clinical tests have been included in this pre-market submission."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable. Ground truth experts are typically used for assessing the performance of diagnostic or prognostic AI models against clinical data (e.g., radiologist reads vs. AI reads). This document describes a cryosurgical device, not an AI for image analysis or diagnosis. The "ground truth" for this device would be established by physical measurements and engineering specifications, not by human experts interpreting clinical cases.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods are used to resolve disagreements among human experts when establishing ground truth for AI model evaluation.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable. MRMC studies are performed to demonstrate the clinical utility of AI tools by comparing human performance with and without AI assistance. The CRYOCARE TOUCH™ System is a surgical device, not an AI assistant for diagnostic reading or interpretation. The document explicitly states, "No animal studies or clinical tests have been included in this pre-market submission."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. This question pertains to the performance of an AI algorithm independently of human interaction. The software in the CRYOCARE TOUCH™ System controls the hardware and provides user interface functions; it is not a standalone "algorithm" in the AI sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for this device's performance is based on engineering specifications, physical measurements, and adherence to recognized standards (e.g., IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility). For example, the accuracy of temperature readings would be verified against calibrated measurement devices, not expert consensus on pathology slides.

8. The sample size for the training set:

This is not applicable. The device's software is a control system for a medical device, not a machine learning model that requires a "training set" of data in the AI sense.

9. How the ground truth for the training set was established:

This is not applicable. See the explanation for point 8.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K201588

Device Name CRYOCARE TOUCHTM System and Accessories

Indications for Use (Describe)

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.

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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.

. 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

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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

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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/orSpecification	Subject DeviceCRYOCARE TOUCH System andAccessories	Predicate DeviceCryocare CS Surgical System andAccessories	Comparisonbetween Subjectand Predicate
510(k)	K201588	K153489	N/A
Indications foruse	The Cryocare CS Surgical System isintended for use in open, minimallyinvasive or endoscopic surgicalprocedures in the areas in generalsurgery, urology, gynecology, oncology,neurology, dermatology, ENT, proctology,pulmonary surgery and thoracic surgery.The system is designed to freeze/ablatetissue by the application of extreme coldtemperatures including prostate andkidney tissue, liver metastases, tumors,skin lesions, and warts.In addition, the system is intended for usein 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 orcanthus area, ulcerated basal celltumors, dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,hemorrhoids, anal fissures, perianalcondylomata, pilonidal cysts, actinicand seborrheic keratoses, cavernoushemangiomas, recurrent cancerouslesionsUrology• Ablation of prostate tissue in cases ofprostate cancer and benign prostatichyperplasiaGynecology• Ablation of malignant neoplasia orbenign dysplasia of the femalegenitalia	The CRYOCARE TOUCH™ System isintended for use in open, minimallyinvasive or endoscopic surgicalprocedures in the areas in generalsurgery, urology, gynecology, oncology,neurology, dermatology, ENT, proctology,pulmonary surgery and thoracic surgery.The system is designed to freeze/ablatetissue by the application of extreme coldtemperatures including prostate andkidney tissue, liver metastases, tumors,skin lesions, and warts.In addition, the system is intended for usein 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 orcanthus area, ulcerated basal celltumors, dermatofibromas, smallhemangiomas, mucocele cysts,multiple warts, plantar warts,hemorrhoids, anal fissures, perianalcondylomata, pilonidal cysts, actinicand seborrheic keratoses, cavernoushemangiomas, recurrent cancerouslesionsUrology• Ablation of prostate tissue in cases ofprostate cancer and benign prostatichyperplasiaGynecology• Ablation of malignant neoplasia orbenign dysplasia of the femalegenitalia	Subject Deviceremoves theindication for"Ablation ofarrhythmic cardiactissue"
Feature and/orSpecification	Subject DeviceCRYOCARE TOUCH System andAccessories	Predicate DeviceCryocare CS Surgical System andAccessories	Comparisonbetween Subjectand 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 ofAction	Joule-Thomson Effect	Joule-Thomson Effect	Same
Freeze Gas	Argon	Argon	Same
Thaw Gas	Helium	Helium	Same
Human InterfaceDevice/Connections	1x Touchscreen1 X Remote Keypad	1x Integrated Main Keyboard1 X Remote Keypad	Subject devicesincorporatetouchscreencapability

Table 1. – Predicate and Subject Device Comparison – CRYOCARE TOUCH System and Accessories

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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/ orSpecification	Subject Device: PCS-17RS Endocare™1.7mm Round Ice PerCryo™Cryoprobe, Short	Predicate Device: PCS-17R Endocare™1.7mm Round Ice PerCryo™ Cryoprobe	Comparisonbetween Subjectand Predicate
510(k)	K201588	K153489	N/A
Model	PCS-17RS	PCS-17R	New Model Number
Indications for use	Shares the CRYOCARE TOUCH Systemindications for use.	Shares the CRYOCARE CS Surgical Systemindications for use.	Same
Shaft Diameter	1.7 mm	1.7 mm	Same
Shaft Length	7 cm	15 cm	Subject device hasshorter 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.

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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.

Regulation Number and Section

§ 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.