The Varian Urethral Warming Catheter Kit, a set of disposable components used in conjunction with a warmer system, sterile water or saline, and peristaltic pump, is intended to transfer heat to urethra during urological cryosurgery with Varian CRYOCARE Systems.

Device Description

The Urethral Warming Catheter Kit (CRYO-77) warms a patient's urethra during the cryoablation procedure by transferring heat through a catheter inserted within the urethra. The catheter contains fluid that is warmed using dry heat from an electrical heating unit (Warming unit) and circulated in a closed circuit using a peristaltic pump (circulating pump).

The Urethral Warming Catheter Kit contains the following:

22 french urethral balloon catheter
Tubing
Flow indicator
Tubing clamp ●
IV bag decanter
Two luer connections
Tube placement markers for pump ●
Tube retainer ●

and is used in conjunction with a compatible fluid warming system and peristaltic pump. The fluid warming system supplies a steady flow of warm, sterile water or saline to the urethral catheter which transfers heat to the urethra during urological cryosurgery. The water or saline is circulated by a peristaltic pump from the catheter to the I.V. bag in a closed circuit.

AI/ML Overview

The provided text describes a medical device called the "Urethral Warming Catheter Kit" (K211149) and its substantial equivalence to a predicate device, the "Urethral Warming System" (K963970). However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of diagnostic accuracy, which would typically involve metrics like sensitivity, specificity, or AUC, as seen in AI/ML medical devices.

Instead, the document focuses on the performance data (non-clinical testing) to demonstrate that the device performs as intended and meets its essential performance specifications. This type of device (a catheter kit for warming) is unlikely to have performance metrics like those for diagnostic AI, but rather functional and safety performance.

Here's a breakdown of the requested information based on the provided text, recognizing that some points are not applicable to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of quantitative acceptance criteria for diagnostic performance (e.g., sensitivity, specificity, accuracy) or a corresponding reported device performance, because this is a physical medical device, not a diagnostic AI/ML system.

However, the "Performance Data (Non-Clinical Testing)" section (VII) lists functional and safety performance aspects that were tested:

Acceptance Criteria (Inferred from testing)	Reported Device Performance (Summary)
Catheter to include flow indicator to ensure fluid is not impeded and flowing correctly through closed circuit system.	Design Verification and Design Validation test results showed the catheter performs as intended.
Catheter is closed-circuit, free of fluid leaking or component separation.	Design Verification and Design Validation test results showed the catheter performs as intended.
Catheter is designed to dissipate cold thermal energy from the urethral mucosa.	Design Verification and Design Validation test results showed the catheter performs as intended.
Biocompatibility	Testing in accordance with ISO 10993 series of standards.
Sterilization Validation	Testing in accordance with EN 556-1, ANSI/AAMI ST67, ISO 11137-1, ISO 11137-2, ISO 11737-1 and ISO 11737-2.
Usability	Testing in accordance with IEC 62366-1 Annex C.
Equivalent heat transfer to urethra during cryoablation procedure.	Test results showed the subject device and its compatible on-market components (warmer and pump) perform equivalent to the predicate cleared device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Bench testing" and "Design Verification and Design Validation testing." It does not specify the sample size for these tests. There is no information regarding data provenance (e.g., country of origin, retrospective or prospective) as these are bench tests on the physical device, not data from patients or clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable. The device is a physical urethral warming catheter kit, not a diagnostic system requiring expert interpretation of results or establishment of ground truth in a clinical sense. The "ground truth" for this device would be its functional performance and safety characteristics as determined by engineering and laboratory testing.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic devices where subjective interpretations need to be reconciled. The testing described for this device is physical and engineering-based.

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

No. This is not applicable as the device is a physical medical device (catheter kit) and not an AI/ML diagnostic tool involving human readers.

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

This is not applicable as the device is a physical medical device (catheter kit), not an algorithm.

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

The "ground truth" for this device's performance would be established through:

Engineering specifications and design requirements.
Physical measurements and observations during bench testing to verify functionality (e.g., fluid flow, leak integrity, heat transfer).
Compliance with recognized international standards for biocompatibility, sterility, and usability.

8. The sample size for the training set

This is not applicable. The device is a physical medical device, not an AI/ML algorithm that requires a training set.

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

This is not applicable. As stated above, the device is a physical medical device, not an AI/ML algorithm that requires a training set and corresponding ground truth.

Summary

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January 5, 2022

Varian Medical Systems, Inc. Peter Coronado Senior Director Regulatory Affairs 9825 Spectrum Drive, Building 2, Suite 250 Austin, Texas 78717

Re: K211149

Trade/Device Name: Urethral Warming Catheter Kit Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical Unit and Accessories Regulatory Class: Class II Product Code: GEH Dated: December 7, 2021 Received: December 8, 2021

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/cdrl/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) K211149

Device Name Varian Urethral Warming Catheter Kit

Indications for Use (Describe)

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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Varian Medical

PREMARKET NOTIFICATION

510(k) Summary

Urethral Warming Catheter Kit

The following information is provided as required by 21 CFR 807.92

l. Submitter's Information:

Name and Address:	Varian Medical Systems9825 Spectrum Drive Building 2, Suite 250Austin, 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:	December 7, 2021

Device Information: II.

Proprietary Name:	Urethral Warming Catheter Kit
Common/ Usual Name:	Cryosurgical Unit and accessories
Classification Name:	Cryosurgical unit and accessories
Regulation Number:	21 CFR 878.4350
Product Code:	GEH

Predicate Device: III.

Urethral Warming System (K963970)

IV. Device Description:

The Urethral Warming Catheter Kit contains the following:

22 french urethral balloon catheter
Tubing
Flow indicator
Tubing clamp ●
IV bag decanter
Two luer connections
Tube placement markers for pump ●
Tube retainer ●

The Urethral Warming Catheter Kit is recommended to use with 3M™ Ranger™ Model 245 Fluid

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Varian Medical ctrum Drive ing 2 Suite 250

Warmer System and 3M™ Ranger™ Fluid Warming Set, and a peristaltic pump meeting the following technical specifications:

Pump mechanism- Roller-type peristaltic pump ●
Compatible Pump head- Masterflex L/S® Easy-Load for use with 13, 14, 16, 25, 17, 18 tubing (07518-60, 77200-60, 77201-60 or similar)
Operational nominal flow rate- 500 mL/min
Minimum Pump RPM range 0-300RPM
. Maximum Continuous Pressure- 40PSIG
. Rated voltages 100V-240V; 50/60Hz
. IEC 61010 certified

The compatible fluid warming system and peristaltic pump are not owned or distributed by Varian. The system integration of Urethral Warming Catheter Kit with compatible accessories is the responsibility of end user.

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Varian Medical Systems. Inc. 9825 Spectrum Drive Building 2. Suite 250 Austin, TX 78717

V. Indications for Use Statement:

Comparison of Technological Characteristics with the Predicate Device: VI.

At a high level, the subject device is similar to the predicate based on the following characteristics:

Both the subject and predicate device have same indication for use to transfer heat to urethra during cryosurgery and have same . urological clinical application
The mechanism of action of urethral warming catheter is same in both subject and predicate device, the catheter in both devices . uses heat transference to maintain the temperature of urethral tissue.

At a high level, the subject device differs from the predicate as a result of the following characteristics:

The predicate device is a complete system consisting of a fluid warming system, peristaltic pump, IV stand, urethral warming ● catheter and tubing set. The subject device is a stand-alone device consisting of urethral warming catheter and tubing.
. Modification in indication for use of the subject device to include on-market available compatible accessories fluid warming system and peristaltic pump which deliver substantially equivalent tissue warming to that achieved by predicate device. The compatible accessories are not owned or distributed by Varian.
. Modification in sterilization method of urethral warming catheter
Modification in packaging of urethral warming catheter
Removal of heat exchanger cartridge from Urethral Catheter Kit
Change in temperature range of fluid warming system ●
Change in flow range of peristaltic pump

The table below includes a high-level comparison of the predicate and subject devices.

Feature and/ orSpecification	Predicate DeviceUrethral Warming System (K963970)	Subject DeviceUrethral Warming Catheter Kit	Comparison betweenSubject and Predicate
Model Number	CRYO-60	CRYO- 77	NA
Indications for use	The Endocare Urethral Warming System isintended to transfer heat to urethral tissueduring urological cryosurgery.	The Varian Urethral Warming Catheter Kit, a set ofdisposable components used in conjunction witha warmer system, sterile water or saline, andperistaltic pump, is intended to transfer heat to	The indication and clinicalapplication remain the same.The differences in wording aredue to the subject device's
Feature and/ orSpecification	Predicate DeviceUrethral Warming System (K963970)	Subject DeviceUrethral Warming Catheter Kit	Comparison betweenSubject and Predicate
		urethra during urological cryosurgery with VarianCRYOCARE Systems.	compatibility with on-marketavailable fluid warming systemsand peristaltic pumps ratherthan exclusive use withEndocare Urethral WarmingSystem components - AltonDean FW-537 warming systemand adjustable RPM RotaryPeristaltic pump.
Product Configuration	Fluid Warming System Peristaltic Pump IV Stand Urethral Catheter Kit containingUrethral Warming Catheter, Tubing andHeat Exchanger Cassette	Urethral Warming Catheter Tubing	Predicate device is a completesystem whereas the subjectdevice is a stand-alone device.
Compatibility withVarian CRYOCARESystems	CRYO-CS System (K153489) CRYO-204-V and CRYO-2017-V(K153489)	CRYO-CS System (K153489) CRYO-38T (K201588) CRYO-204-V and CRYO-207-V (K153489,K201588)	Subject device will beadditionally compatible withCRYO-38T
Fluid Warming System	Alton Dean FW-537	3M™ Ranger™ Model 245 Fluid WarmerSystem 3M™ Ranger™ Fluid Warming Set	Subject device is compatiblewith fluid warming system andfluid warming set available on-market. The compatibleaccessories are notmanufactured and distributedby Varian.
Temperature Range ofFluid Warmer	35-39°C	41-43°C	Difference in the temperaturerange of fluid warming systemdue to on-market availablecompatible accessories.
Pump	Adjustable RPM Rotary Peristaltic pumphave the following technical specifications,	Peristaltic Pump available on-market meeting thefollowing technical specifications,	Subject device is compatiblewith peristaltic pump availableon-market. Peristaltic pump
Feature and/ or	Predicate Device	Subject Device	Comparison between
Specification	Urethral Warming System (K963970)	Urethral Warming Catheter Kit	Subject and Predicate
	Pump mechanism- Roller-type peristaltic pump Compatible Pump head- Masterflex L/S® Easy-Load for use with 13, 14, 16, 25, 17, 18 tubing (77200-60)	Pump mechanism- Roller-type peristaltic pump Compatible Pump head- Masterflex L/S® Easy-Load for use with 13, 14, 16, 25, 17, 18 tubing (07518-60, 77200-60, 77201-60 or similar)	should meet the mentioned technical specifications to be compatible with subject device and 3M™ Ranger™ Fluid Warmer System. The compatible accessories are not manufactured and distributed by Varian
Flow Range ofPeristaltic Pump	140-1700 mL/min	0-1140 mL/min	Difference in the flow range of peristaltic pump is mitigated by providing nominal operational flow rate
Operational Flow rate	Not specified in K963970 submission	Nominal 500 mL/min, recommended by 3M™ Ranger™ Fluid Warmer System	Operational flow rate of predicate device is not specified in K963970 submission; however, the subject device is tested to perform at operational flow rate of nominal 500 mL/min, the specified fixed flow rate prevents over/under fluid circulation. The test result showed the subject device and its on-market available components (warmer and pump) installed together as a system perform equivalent to predicate cleared device and transfer the heat to the urethra equally during cryoablation procedure.
Mechanism of Action	Heat transfer	Heat transfer	Same
Urethral Warming	Double lumen closed circuit catheter	Double lumen closed circuit catheter	Same
Feature and/ orSpecification	Predicate DeviceUrethral Warming System (K963970)	Subject DeviceUrethral Warming Catheter Kit	Comparison betweenSubject and Predicate
Catheter Description
Catheter Material	Polyurethane shaft with polyester balloon	Polyurethane shaft with polyester balloon	Same
Catheter Size	16-22 French	16-22 French	Same
Catheter SterilizationMethod	Ethylene Oxide	Gamma	Subject device uses Gammairradiation process
Packaging	Plastic film side and coated paper	Tray, Tyvek top, chipboard box	Subject uses Tray, Tyvek top,chipboard box

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K211149

Varian Medical Systems, Inc. varian 9825 Spectrum Drive Building 2, Suite 250 Austin, TX 78717

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K211149

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Varian Medical
Systems, Inc.
9825 Spectrum Drive
Building 2, Suite 250
Austin, TX 78717

VII. Performance Data (Non-Clinical Testing)

Design Verification and Design Validation testing were completed to demonstrate that the Urethral Warming Catheter Kit performs as intended and meets its essential performance specifications.

Catheter to include flow indicator to ensure fluid is not impeded and flowing correctly through closed circuit system.
· Catheter is closed-circuit, free of fluid leaking or component separation
Catheter is designed to dissipate cold thermal energy from the urethral mucosa

Bench testing included testing of the system, including:

· Biocompatibility Testing in accordance with ISO 10993 series of standards, including ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-12
Sterilization Validation in accordance with EN 556-1, ANSI/AAMI ST67, ISO 11137-1, ISO 11137-2, ISO 11737-1 and ISO 11737-2
Usability Testing in accordance with IEC 62366-1 Annex C

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 configure urethral warming catheter as a stand-alone device compatible with onmarket available accessories.

The 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 Varian Urethral Warming Catheter Kit is substantially equivalent to the predicate device, Endocare Urethral Warming System.

IX. Conclusion

The assessment following the outcomes observed in the performance testing determines that the Urethral Warming Catheter Kit conforms to the defined user needs and intended uses. Varian therefore considers the Urethral Warming Catheter Kit 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.