ISOLIS Cryoprobe

K230271 · Varian Medical Systems, Inc. · GEH · Mar 28, 2023 · General, Plastic Surgery

Device Facts

• Record ID: K230271
• Device Name: ISOLIS Cryoprobe
• Applicant: Varian Medical Systems, Inc.
• Product Code: GEH · General, Plastic Surgery
• Decision Date: Mar 28, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4350
• Device Class: Class 2
• Attributes: Therapeutic

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, 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, 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 Story

ISOLIS cryoprobe is a single-use, disposable surgical instrument used with Varian CryoCare Systems; facilitates cryoablation via high-pressure argon gas (Joule-Thomson effect) and active thawing via helium gas. Distal tip (stainless steel) delivers extreme cold to target tissue; features include trocar tip for insertion, vacuum sleeve handle for insulation, and return hose clips for stability during imaging. Operated by physicians in OR/clinic settings; provides localized tissue destruction/ablation. Output is physical tissue freezing/thawing; healthcare providers monitor via system interface to guide clinical decision-making for tumor/lesion management. Benefits include precise tissue ablation and improved handling/stability compared to previous probe designs.

Clinical Evidence

No clinical data or animal studies included. Substantial equivalence supported by bench testing, including functional, electrical safety, performance, physical, usability, packaging, bioburden, sterilization, and biocompatibility evaluations.

Technological Characteristics

Single-use cryoprobe; 304/304L stainless steel shaft; 316LVM stainless steel vacuum sleeve; heat shrink (polyolefin/PVDF) handle; copper-nickel alloy finned tubing heat exchanger. Joule-Thomson effect cooling (Argon) and warming (Helium). Gamma sterilization. No software.

Indications for Use

Indicated for patients requiring tissue ablation or freezing in general surgery, urology, gynecology, oncology, neurology, dermatology, ENT, proctology, pulmonary, and thoracic surgery. Includes treatment of prostate/kidney tissue, tumors, skin lesions, warts, breast fibroadenomas, hemorrhoids, and nerve tissue for pain management.

Regulatory Classification

Identification

(1) Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. (2) Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold. (3) Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.

Predicate Devices

• CRYOCARE TOUCH System and Accessories (K201588)

Reference Devices

• 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)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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## 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)

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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: [phone] | Fax: [phone] E-mail: [e-mail] 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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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.

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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<br>Specification | PREDICATE DEVICE(S)<br>CRYOCARE TOUCH™ System and Accessories (K201588) | SUBJECT DEVICE(S)<br>ISOLIST™ Cryoprobe | Comparison between<br>predicate and subject<br>devices and Rationale |
|------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Name | Slimline Cryoprobes | ISOLIST™ Cryoprobe | The subject devices are a<br>line extension to the<br>cryoprobes compatible with<br>Varian Cryoablation Systems |
| Prescription/ Rx | Yes | Yes | Same |
| Compatible Varian<br>Cryoablation Systems | CRYOCARE TOUCH System (K201588)<br>CRYO-CS-3 Basic (K153489)<br>Cryocare CS-3 V5 (K151968)<br>Cryocare CS-3 V4 (K141110)<br>Cryocare CS-3 (K101333)<br>Cryocare SL (K011074)<br>Cryocare-CS (K060279) | CRYOCARE TOUCH System (K201588)<br>CRYO-CS-3 Basic (K153489)<br>Cryocare CS-3 V5 (K151968)<br>Cryocare CS-3 V4 (K141110)<br>Cryocare CS-3 (K101333)<br>Cryocare SL (K011074)<br>Cryocare-CS (K060279) | Same |
| Intended Use /<br>Indications of Use of the<br>compatible Varian<br>Cryoablation Systems | Intended for use in open, minimally invasive or endoscopic<br>surgical procedures in the areas in general surgery, urology,<br>gynecology, oncology, neurology, dermatology, ENT,<br>proctology, pulmonary surgery, and thoracic surgery. The<br>system is designed to freeze/ablate tissue by the application<br>of extreme cold temperatures including prostate and kidney<br>tissue, liver metastases, tumors, skin lesions, and warts.<br><br>In addition, the CRYOCARE TOUCH System is intended for use<br>in the following indications:<br><br><b>General Surgery</b><br>· Destruction of warts or lesions<br>· Palliation of tumors of the oral cavity, rectum and skin<br>· Ablation of breast fibroadenomas<br>· Ablation of leukoplakia of the mouth, angiomas, sebaceous<br>hyperplasia, basal cell tumors of the eyelid or canthus area. | Intended for use in open, minimally invasive or endoscopic<br>surgical procedures in the areas in general surgery, urology,<br>gynecology, oncology, neurology, dermatology, ENT,<br>proctology, pulmonary surgery, and thoracic surgery. The<br>system is designed to freeze/ablate tissue by the application<br>of extreme cold temperatures<br>including prostate and kidney tissue, liver metastases, tumors,<br>skin lesions, and warts.<br><br>In addition, the systems are intended for use in the following<br>indications:<br><br><b>General Surgery</b><br>· Destruction of warts or lesions<br>· Palliation of tumors of the oral cavity, rectum and skin<br>· Ablation of breast fibroadenomas<br>· Ablation of leukoplakia of the mouth, angiomas, sebaceous<br>hyperplasia, basal cell tumors of the eyelid or canthus area. | Same |
| | | | |
| | ulcerated basal cell tumors, dermatofibromas, small<br>hemangiomas, mucocele cysts, multiple warts, plantar warts,<br>hemorrhoids, anal fissures, perianal condylomata, pilonidal<br>cysts, actinic and seborrheic keratoses, cavernous<br>hemangiomas, recurrent cancerous lesions | | |
| | Urology | Urology | |
| | · Ablation of prostate tissue in cases of prostate cancer and<br>benign prostatic hyperplasia | · Ablation of prostate tissue in cases of prostate cancer and<br>benign prostatic hyperplasia | |
| | Gynecology | Gynecology | |
| | · Ablation of malignant neoplasia or benign dysplasia of the<br>female genitalia | · Ablation of malignant neoplasia or benign dysplasia of the<br>female 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 cutaneous<br>disorders | · Ablation or freezing of skin cancers and other cutaneous<br>disorders | |
| | Proctology | Proctology | |
| | · Ablation of benign or malignant growths of the anus or<br>rectum | · Ablation of benign or malignant growths of the anus or<br>rectum | |
| | · 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<br>(Freezing/Thawing<br>Technology) | Operate on the Joule-Thomson Effect. | Operate on the Joule-Thomson Effect. | Same |
| Stick Function for<br>ablation | 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 IFU<br>Maximum diameter at -20°C = 25mm | Size of isotherm is model specific as indicated in IFU<br>Maximum diameter at -20°C = 38mm | Improved isotherm<br>performance |
| | | | |
| Freeze Gas | Argon | Argon | Same |
| Thaw Gas | Helium | Helium | Same |
| Packaged Single-Use,<br>Sterile and Disposable | Yes | Yes…