The ISOLIS cryoprobes, used with the Cryocare Systems, are 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 systems are designed to freeze/ablate tissue by the application of extreme cold temperatures including prostate and kidney tissue, tumors, skin lesions, and warts.

In addition, the systems are 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 ISOLIS cryoprobe is a single use, disposable device designed for use with CryoCare® Systems. ISOLIS cryoprobes are designed to deliver cold temperatures for cryoablation using high-pressure argon gas circulated through the cryoprobe, followed by active thawing using helium gas. The refrigerative and warming capability is limited to the distal end of the probe shaft that is comprised of stainless steel and is designed with a pointed tip to facilitate cryoprobe insertion and placement.

AI/ML Overview

This document is a 510(k) Premarket Notification for the ISOLIS Cryoprobe, which aims to demonstrate substantial equivalence to a predicate device (CRYOCARE TOUCH™ System and Accessories, K201588). The document primarily focuses on explaining the device, its intended use, and comparing its technical characteristics to the predicate. It does not contain a study designed to prove the device meets specific acceptance criteria in the way one might expect for an AI/ML-driven device or a device requiring clinical performance validation against metrics like sensitivity/specificity.

The information provided describes a design and performance validation process rather than a clinical study with human subjects, ground truth adjudication, or statistical metrics like AUC, sensitivity, or specificity commonly associated with AI/ML device performance. The "acceptance criteria" here are implicitly related to the device's functional and performance characteristics mirroring or improving upon the predicate device within established safety and effectiveness parameters.

Here's an attempt to structure the available information relevant to your request, with significant caveats that much of the information you've asked for (e.g., sample size for AI, number of experts for ground truth, MRMC study, effects of AI assistance) is not applicable or not present in this type of premarket notification for a physical medical device like a cryoprobe.

Device: ISOLIS Cryoprobe (K230271)

Type of Device: Cryosurgical Unit And Accessories (Product Code: GEH)

Summary of Acceptance Criteria and Device Performance (Based on Bench Testing and Comparison to Predicate):

Acceptance Criteria Category	Reported Device Performance (ISOLIS Cryoprobe)
Functional & Electrical Safety	Successfully passed functional and electrical safety tests, demonstrating compliance with established design criteria.
Performance (Non-functional): Isotherm Size	Maximum diameter at -20°C = 38mm. This is an improvement (larger isotherm) compared to the predicate device's 25mm at -20°C. Rationale: Improved isotherm performance.
Performance (Non-functional): Temperature-Time History	Temperature profile is within the established range of the predicate devices with no substantial change to the coldest temperature achieved or rate of change in temperature.
Physical (Design Changes)	- Probe Shaft Tip Angle: Trocar Tip with 15° tip angle (Predicate: 16°). Rationale: Smaller trocar tip angle provides a sharper tip, aiding in piercing hard tumors.- Handle Construction & Materials: Heat shrink (polyolefin or PVDF) covering a stainless-steel vacuum handle (Predicate: Plastic ABS injection molded handle). Rationale: Smaller, slimmer handle and provides better improved insulation.- Heat Exchanger: Copper-nickel alloy finned tubing coiled around a stainless-steel mandrel (Predicate: Copper screw-type cryostat). Rationale: Increases surface area for thermal exchange, maximizing freeze performance.- Accessories: Two Return Hose Clips added to the Return Hose. Rationale: Added as an optional feature to aid in stability of the Return Hose and probe, especially during CT imaging.
Usability	Successfully passed usability evaluations.
Packaging & Sterilization	Successfully passed packaging tests. Sterilization method (Gamma Irradiation) and Single-Use, Sterile, Disposable status are the same as the predicate.
Biocompatibility	Successfully passed biocompatibility evaluations (10993-1, Externally communicating medical device with tissue/bone/dentin contact with limited duration (≤24 hours)). Same as predicate.
Risk Profile	Verified that the differences between the subject and predicate devices did not alter the overall risk profile.

Study Details (Relevant to a physical device without AI/ML component):

Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a "sample size" in the context of patient data or clinical images. The testing described is bench testing of the physical device variants. The document lists 4 variants of the ISOLIS Cryoprobe (PC-2.1E, PC-2.1S, PC-2.1EL, PC-2.1SL). It is implied that these variants, or representative samples thereof, were subjected to the described bench tests.
- Data Provenance: Not applicable in the context of clinical data. The "data" comes from engineering bench tests conducted by Varian Medical Systems, Inc. (located in Austin, TX, USA). The testing is non-clinical.
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. "Ground truth" in the context of this device's performance refers to the objective physical measurements obtained during bench testing (e.g., isotherm size, temperature profiles) and engineering design specifications. These are established through validated measurement methods and engineering principles, not expert consensus on medical images or clinical outcomes.
Adjudication Method for the Test Set:
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert labeling of data, typically in AI/ML performance studies or clinical trials involving subjective assessments. This document describes objective bench testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This device is a physical cryoprobe, not an AI/ML-driven diagnostic tool. MRMC studies are used to evaluate human reader performance, often with and without AI assistance. This type of study is not relevant for this device.
- Effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device does not contain an "algorithm" in the sense of AI/ML. Its function is based on physical principles (Joule-Thomson Effect). The performance evaluation is based on the physical properties and functional output of the probe itself.
The type of ground truth used:
- The "ground truth" for this device's performance testing is based on objective physical measurements and engineering specifications. For example, the "size of isotherm" is a measurable physical property of the cryoprobe's freezing capability, measured directly during bench testing under controlled conditions. "Temperature-time history" is also a direct physical measurement.
The sample size for the training set:
- Not applicable. This document describes a physical medical device, not an AI/ML model for which a "training set" would be relevant.
How the ground truth for the training set was established:
- Not applicable. As there is no AI/ML model or training set, this question is not relevant.

Conclusion from the Document:

The manufacturer concluded that the ISOLIS Cryoprobe is substantially equivalent to the predicate device (Slimline probes) based on:

Successful completion of comprehensive bench testing (functional, electrical safety, performance, physical, usability, packaging, bioburden, gamma sterilization adoption, and biocompatibility).
Demonstration that the device meets established design criteria.
Confirmation that the differences in design and performance (e.g., improved isotherm size, sharper tip, better handle insulation) do not alter the overall risk profile.
The fact that the indications for use and principle of operation are identical to the predicate device.
The isotherm and temperature-time history data are similar to (or improved upon) the predicate device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in two lines, with "FDA" being larger and bolder than the rest of the text.

March 28, 2023

Varian Medical Systems, Inc. Peter Coronado Director Regulatory Affairs 3100 Hansen Way Palo Alto, California 94304-1038

Re: K230271

Trade/Device Name: ISOLIS Cryoprobe Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit And Accessories Regulatory Class: Class II Product Code: GEH Dated: January 31, 2023 Received: January 31, 2023

Dear Peter 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.

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

{1}------------------------------------------------

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 (OS) 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 mediation-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,

Jessica Carr -S

for 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) K230271

Device Name ISOLIS cryoprobe

Indications for Use (Describe)

In addition, the systems are 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)

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/1 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 background is plain white.

Varian Medical 5 Spectrum Drive

PREMARKET NOTIFICATION

510(k) Summary

ISOLIS™ Cryoprobe

The following information is provided as required by 21 CFR 807.92

l. Submitter's Information:

Name and Address: Varian Medical Systems Inc. 9825 Spectrum Drive, Building 2 Austin, TX 78717 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: 31st January 2023

II. Device Information:

Proprietary Name:	ISOLIS™ Cryoprobe
Common/ Usual Name:	Cryosurgical Unit and accessories
Classification Name:	Cryosurgical unit and accessories
Regulation Number:	21 CFR 878.4350
Product Code:	GEH

III. Predicate Device:

CRYOCARE TOUCH™ System and Accessories: (K201588)

IV. Device Description:

Model No	Description
PC-2.1E	Varian 2.1mm (14 G) ISOLIS™ Cryoprobe, 15cm Length, Ellipsoidal
PC-2.1S	Varian 2.1mm (14 G) ISOLIS™ Cryoprobe, 15cm Length, Spherical
PC-2.1EL	Varian 2.1mm (14 G) ISOLIS™ Cryoprobe, 20cm Length, Ellipsoidal
PC-2.1SL	Varian 2.1mm (14 G) ISOLIS™ Cryoprobe, 20cm Length, Spherical

ISOLIS Cryoprobe comprises 4 variants as listed below:

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image shows the word "varian" in a bold, sans-serif font. The letters are black and the background is white. The word is centered in the image and takes up most of the space.

Varian Medical
Systems, Inc.
9825 Spectrum Drive
Building 2,
Austin, TX 78717

Intended Use/ Indications of Use Statement: V.

The ISOLIS cryoprobes, used with the CryoCare Systems, are 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 systems are 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 systems are 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}------------------------------------------------

Image /page/6/Picture/1 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 background is plain white.

Comparison of Technological Characteristics with the Predicate Device: VI.

Technological differences between the subject and predicate devices are summarized below:

. Probe Shaft Tip Angle

The trocar tip angle in the subject device has been reduced for a slightly sharper tip which will aid in piercing hard tumors.

● Handle Construction

The subject device has a vacuum sleeve handle in comparison to the molded plastic handle in the predicate device to reduce overall size of the handle to provide stability and additional insulation.

. Handle Materials

The subject device handle is made of heat shrink while the predicate device handle is made of plastic ABS injection molded handle covering a stainless-steel tube for a smaller, slimmer probe handle and provides better improved insulation.

. Heat Exchanger

In comparison to the predicate device, the subject device's heat exchanger increases the surface area for thermal exchange and maximizes the freeze performance of the probes.

● Accessories - Addition of Return Hose Clips

The subject devices have two Return Hose Clips added to the Return Hose to aid in the stability of the Return Hose and Probe and to maintain the position of the probe in the treatment location particularly during CT imaging that requires the patient to move in and out of a gantry.

{7}------------------------------------------------

Image /page/7/Picture/1 description: The image shows the logo for Varian Medical Systems, Inc. The logo consists of the word "varian" in a bold, sans-serif font on the left, and the company name and address on the right. The address is 9825 Spectrum Drive, Building 2, Austin, TX 78717.

Summary of the technological characteristics between subject and predicate devices VII.

Feature and/orSpecification	PREDICATE DEVICE(S)CRYOCARE TOUCH™ System and Accessories (K201588)	SUBJECT DEVICE(S)ISOLIST™ Cryoprobe	Comparison betweenpredicate and subjectdevices and Rationale
Product Name	Slimline Cryoprobes	ISOLIST™ Cryoprobe	The subject devices are aline extension to thecryoprobes compatible withVarian Cryoablation Systems
Prescription/ Rx	Yes	Yes	Same
Compatible VarianCryoablation Systems	CRYOCARE TOUCH System (K201588)CRYO-CS-3 Basic (K153489)Cryocare CS-3 V5 (K151968)Cryocare CS-3 V4 (K141110)Cryocare CS-3 (K101333)Cryocare SL (K011074)Cryocare-CS (K060279)	CRYOCARE TOUCH System (K201588)CRYO-CS-3 Basic (K153489)Cryocare CS-3 V5 (K151968)Cryocare CS-3 V4 (K141110)Cryocare CS-3 (K101333)Cryocare SL (K011074)Cryocare-CS (K060279)	Same
Intended Use /Indications of Use of thecompatible VarianCryoablation Systems	Intended for use in open, minimally invasive or endoscopicsurgical procedures in the areas in general surgery, urology,gynecology, oncology, neurology, dermatology, ENT,proctology, pulmonary surgery, and thoracic surgery. Thesystem is designed to freeze/ablate tissue by the applicationof extreme cold temperatures including prostate and kidneytissue, liver metastases, tumors, skin lesions, and warts.In addition, the CRYOCARE TOUCH 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, sebaceoushyperplasia, basal cell tumors of the eyelid or canthus area.	Intended for use in open, minimally invasive or endoscopicsurgical procedures in the areas in general surgery, urology,gynecology, oncology, neurology, dermatology, ENT,proctology, pulmonary surgery, and thoracic surgery. Thesystem is designed to freeze/ablate tissue by the applicationof extreme cold temperaturesincluding prostate and kidney tissue, liver metastases, tumors,skin lesions, and warts.In addition, the systems are intended for use in the followingindications: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, sebaceoushyperplasia, basal cell tumors of the eyelid or canthus area.	Same

	ulcerated basal cell tumors, dermatofibromas, smallhemangiomas, mucocele cysts, multiple warts, plantar warts,hemorrhoids, anal fissures, perianal condylomata, pilonidalcysts, actinic and seborrheic keratoses, cavernoushemangiomas, recurrent cancerous lesions
	Urology	Urology
	· Ablation of prostate tissue in cases of prostate cancer andbenign prostatic hyperplasia	· Ablation of prostate tissue in cases of prostate cancer andbenign prostatic hyperplasia
	Gynecology	Gynecology
	· Ablation of malignant neoplasia or benign dysplasia of thefemale genitalia	· Ablation of malignant neoplasia or benign dysplasia of thefemale genitalia
	Oncology	Oncology
	· Ablation of cancerous or malignant tissue	· Ablation of cancerous or malignant tissue
	· Ablation of benign tumors	· Ablation of benign tumors
	· Palliative intervention	· Palliative intervention
	Neurology	Neurology
	· Freezing of nerve tissue in pain management/ cryoanalgesia	· Freezing of nerve tissue in pain management/ cryoanalgesia
	Dermatology	Dermatology
	· Ablation or freezing of skin cancers and other cutaneousdisorders	· Ablation or freezing of skin cancers and other cutaneousdisorders
	Proctology	Proctology
	· Ablation of benign or malignant growths of the anus orrectum	· Ablation of benign or malignant growths of the anus orrectum
	· Ablation of hemorrhoids	· Ablation of hemorrhoids
	Thoracic Surgery	Thoracic Surgery
	· Ablation of cancerous lesions	· Ablation of cancerous lesions
Software	Not Applicable; Probes do not have software.	Not Applicable; Probes do not have software.	Not Applicable
Fundamental Technology	Joule-Thomson Effect	Joule-Thomson Effect	Same
Mechanism of Action(Freezing/ThawingTechnology)	Operate on the Joule-Thomson Effect.	Operate on the Joule-Thomson Effect.	Same
Stick Function forablation	Yes, via compatible Cryocare system	Yes, via compatible Cryocare system	Same
Activation Method	Software (Freeze, thaw, stop) via compatible Cryocare system	Software (Freeze, thaw, stop) via compatible Cryocare system	Same
Size of Isotherm	Size of isotherm is model specific as indicated in IFUMaximum diameter at -20°C = 25mm	Size of isotherm is model specific as indicated in IFUMaximum diameter at -20°C = 38mm	Improved isothermperformance

Freeze Gas	Argon	Argon	Same
Thaw Gas	Helium	Helium	Same
Packaged Single-Use,Sterile and Disposable	Yes	Yes	Same
Sterilization	Gamma Irradiation	Gamma Irradiation	Same
BiocompatibilityClassification	10993-1Externally communicating medical device with tissue/bone/dentin contact with limited duration (≤24 hours).	10993-1Externally communicating medical device with tissue/bone/dentin contact with limited duration (≤24 hours).	Same
Probe Construction
Probe Shaft	304 Stainless Steel, 304L Stainless Steel (Tip)	304 Stainless Steel, 304L Stainless Steel (Tip)	Same
Probe Shaft Tip	Trocar Tip with 16° tip angle	Trocar Tip with 15° tip angle	Smaller trocar tip angleprovides a sharper tip
Probe Shaft Insulation	Stainless steel 316LVM vacuum sleeve	Stainless steel 316LVM vacuum sleeve	Same
Probe HandleConstruction andMaterials	Plastic ABS injection molded handle covering a stainless-steeltube	Heat shrink (polyolefin or PVDF) covering a stainless-steelvacuum handle	Smaller and slimmer probehandle and provides betterinsulation
Heat Exchanger	Uses a copper screw-type cryostat for allowing thermal heatexchange of return gas to incoming gas.	Uses a copper-nickel alloy finned tubing coiled around astainless-steel mandrel allowing thermal heat exchange ofreturn gas to incoming gas.	The heat exchanger of thesubject device increases thesurface area for thermalexchange and maximizes thefreeze performance of theprobes.
Optional Feature	None	Two Return Hose Clips added to the Return Hose	Return Hose Clips added tothe subject devices as anoptional feature to aid in thestability of the Return Hoseand the probes

{8}------------------------------------------------

varian

Varian Medical Systems, Inc. 9825 Spectrum Drive Building 2, Austin, TX 78717

{9}------------------------------------------------

Varian Medical Systems, Inc. varian 9825 Spectrum Drive Building 2, Austin, TX 78717

{10}------------------------------------------------

Varian Medical
Systems, Inc.
9825 Spectrum Drive
Building 2,
Austin, TX 78717

VIII. Performance Data (Non-Clinical Testing)

ISOLIS™ Cryoprobe underwent bench testing of the design and performance to demonstrate that the ISOLIS Cryoprobe meets the established design criteria and support the substantial equivalence with the predicate devices. The subject devices successfully completed functional, electrical safety, performance (non-functional), physical, usability, packaging, bioburden, gamma sterilization adoption, and biocompatibility evaluation and verified that the differences between the subject and predicate devices did not alter the overall risk profile.

Performance Data (Clinical Testing and Animal) IX.

No animal studies or clinical tests have been included in this pre-market submission.

X. Software

ISOLIS™ Cryoprobe does not have software and hence, no software update was required. Additionally, the use of ISOLIS™ Cryoprobe with Varian CryoCare Systems did not require any updates to system design (hardware and software).

XI. Substantial Equivalence Data

A comparison of the isotherm performance data between the subject and predicate devices at 0°C, -20°C, and -40°C shows that the isotherm sizes of the subject devices are within the established range of the isotherm sizes of the predicate devices.

In addition, the temperature-time history data of the subject and predicate devices at 0°C, -20°C and -40°C also show that the temperature profile of the subject devices is within the established range of the predicate devices with no substantial change to the coldest temperature achieved or rate of change in temperature.

In conclusion, the isotherm data demonstrates the isotherm performance and temperaturetime history of the subject and predicate devices are similar and therefore, the isotherm performance of the subject devices and predicate devices is substantially equivalent.

Conclusion XII.

ISOLIS Cryoprobe is a new family of probes and introduces few design changes to the features when compared to the predicate device. These changes were made to provide improved performance and user experience while maintaining the overall risk profile.

The outcomes observed in the performance testing, Verification and Validation demonstrate that the device is as safe and effective as the predicate. Further, the indications for use and principle of operation are identical to the predicate device. Varian, therefore, believes the data demonstrates that the subject device ISOLIS Cryoprobe is substantially equivalent to the predicate device, Slimline probes.

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.