Predicate Devices

Reference Devices

K153489, K151968, K141110, K101333, K011074, K060279

AI/ML (Artificial Intelligence / Machine Learning)

No
The document describes a cryoablation system and its intended uses. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Therapeutic

Yes
The device is intended to freeze/ablate tissue for therapeutic purposes, such as destroying warts or lesions, ablating tumors, and managing pain.

Diagnostic

No.
The device is described as a cryoprobe intended for therapeutic purposes, specifically to "freeze/ablate tissue by the application of extreme cold temperatures." It is used in surgical procedures for tissue destruction, ablation, and pain management, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a single-use, disposable hardware device (cryoprobe) designed to deliver cold temperatures for cryoablation using high-pressure argon gas and helium gas. It is a physical instrument used in surgical procedures.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
Device Function: The ISOLIS cryoprobes and Cryocare Systems are used within the body (in vivo) during surgical procedures to freeze and ablate tissue. They are a therapeutic device, not a diagnostic one.
Intended Use: The intended use clearly describes surgical procedures for tissue ablation and destruction, not diagnostic testing of samples.
Device Description: The description details a device designed to deliver cold temperatures for tissue freezing, not to analyze biological samples.

Therefore, the ISOLIS cryoprobes and Cryocare Systems fall under the category of surgical or therapeutic devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

GEH

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.

ISOLIS Cryoprobe comprises 4 variants as listed below:

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

CRYOCARE TOUCH™ System and Accessories: (K201588)

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

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)

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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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)

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

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

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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:

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.

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:

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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

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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.

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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/or
Specification | PREDICATE DEVICE(S)
CRYOCARE TOUCH™ System and Accessories (K201588) | SUBJECT DEVICE(S)
ISOLIST™ Cryoprobe | Comparison between
predicate and subject
devices and Rationale |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Slimline Cryoprobes | ISOLIST™ Cryoprobe | The subject devices are a
line extension to the
cryoprobes compatible with
Varian Cryoablation Systems |
| Prescription/ Rx | Yes | Yes | Same |
| Compatible Varian
Cryoablation 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 the
compatible Varian
Cryoablation Systems | 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 CRYOCARE TOUCH 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. | 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 systems are intended for use in the following
indications:

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.

Intended Use / Indications for Use

Product codes (comma separated list FDA assigned to the subject device)

Device Description

Mentions image processing

Mentions AI, DNN, or ML

Input Imaging Modality

Anatomical Site

Indicated Patient Age Range

Intended User / Care Setting

Description of the training set, sample size, data source, and annotation protocol

Description of the test set, sample size, data source, and annotation protocol

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

§ 878.4350 Cryosurgical unit and accessories.

Indications for Use

Indications for Use (Describe)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

PREMARKET NOTIFICATION

l. Submitter's Information:

II. Device Information:

III. Predicate Device:

IV. Device Description:

Intended Use/ Indications of Use Statement: V.

General Surgery

Urology

Gynecology

Oncology

Neurology

Dermatology

Proctology

Thoracic Surgery

Comparison of Technological Characteristics with the Predicate Device: VI.

. Probe Shaft Tip Angle

● Handle Construction

. Handle Materials

. Heat Exchanger

● Accessories - Addition of Return Hose Clips

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

varian

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

VIII. Performance Data (Non-Clinical Testing)

Performance Data (Clinical Testing and Animal) IX.

X. Software

XI. Substantial Equivalence Data

Conclusion XII.