The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant

Device Description

The truFreeze system is a cryosurgical tool that applies medical-grade liquid nitrogen to the treatment area via a small, low pressure, open tipped catheter. The truFreeze System consists of a console and a disposable spray kit.

Console:
The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart, Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit:
There are no proposed changes to the disposable spray kit. The truFreeze disposable spray kit continues to consist of five (5) individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the onboard suction system.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a medical device called the truFreeze® System (K150920). This submission is for a software modification to an existing device (K143625). The document focuses on demonstrating that the updated device is substantially equivalent to its predicate.

Here's an analysis based on your request, extracting the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative manner (e.g., minimum sensitivity or specificity). Instead, it describes various tests performed to ensure the software modification did not negatively impact the device and added new safety features. The "acceptance criteria" can be inferred as successful completion of these tests without introducing new safety or performance concerns.

Test Type	Acceptance Criteria (Inferred from study description)	Reported Device Performance
Software Regression Tests	No negative impact on existing code functionality. All previous functionalities maintained.	All tests passed, verifying that updates did not negatively impact the code. No additional safety or functionality concerns were observed.
Software Integration Tests	Ability of the software to correctly detect and respond to cDAQ related hardware and communication errors.	All integration tests completed and considered acceptable. Demonstrated ability to correctly detect (or not) cDAQ related hardware and communication errors and respond accordingly.
System Functional Tests	No negative impact on system performance and functionality. System functions as intended per software specifications.	All tests successfully performed and passed. Confirmed software updates did not negatively impact system performance and functionality.
Specific Software Functions	Software functions as intended per software performance specifications. All input and output software values are as specified. System functions as intended. Software functions as intended when a cDAQ hardware error is present or not present.	All items successfully verified and validated.

2. Sample Size Used for the Test Set and Data Provenance

The document states:

"Two sets of testing were performed for each of the load packages available to customers."
"Three consoles were successfully loaded with the respective load packages."

This implies a very small sample size for the "test set" (e.g., 3 consoles). The data provenance is prospective in the sense that the testing was conducted specifically for this 510(k) submission on the modified device. The country of origin of the data is not explicitly stated, but the company is based in Lexington, Massachusetts, USA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. The testing described is primarily focused on software and system functionality, not on diagnostic accuracy requiring expert interpretation of clinical data.

4. Adjudication Method for the Test Set

This information is not provided and is not relevant for the type of software/system functional testing described. The "ground truth" for these tests would be the expected software behavior and system response to various inputs and error conditions.

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, an MRMC comparative effectiveness study was not done. The device is a cryosurgical tool, and the submission concerns a software update to improve safety by detecting communication errors, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This is a standalone assessment of the software's functionality and its impact on the system. The "algorithm" (software control) was tested for its ability to detect and respond to communication interruptions. The performance is assessed without a human-in-the-loop in the context of the software's detection capability. However, the overall device (truFreeze® System) is a tool used by a clinician, so there is always a human-in-the-loop for its clinical application.

7. The Type of Ground Truth Used

The ground truth used for the software and system testing was based on:

Software performance specifications: The expected design and functionality of the software.
Intended system behavior: How the system is designed to operate, especially its response to error conditions (e.g., closing valves upon error detection).
Predicate device's established performance: Ensuring the modified device maintained equivalence to the predicate for unchanged aspects.

It is not expert consensus, pathology, or outcomes data, as these are not relevant to the described software modification.

8. The Sample Size for the Training Set

The document describes software updates and validation, not a machine learning model that requires a "training set." Therefore, a training set sample size is not applicable.

9. How the Ground Truth for the Training Set Was Established

As there is no training set for a machine learning model, this question is not applicable. The "ground truth" for the software development and testing was established through engineering specifications and design requirements.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 17, 2015

CSA Medical Incorporated Ms. Sherrie Coval-Goldsmith Vice President of Regulatory Affairs/ Quality Assurance 91 Hartwell Avenue Lexington, Massachusetts 02421

Re: K150920

Trade/Device Name: truFreeze® System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: April 6, 2015 Received: April 6, 2015

Dear Ms. Coval-Goldsmith:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Jennifer R. Stevenson -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Attachment C

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K150920

Device Name truFreeze® System

Indications for Use (Describe)

The truFreeze® System is intended for cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.

The truFreeze® System is Indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant

Type of Use (Select one or both, as applicable)2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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. Send comments regarding this burden estimate or any other aspet 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."

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Attachment E - 510(k) Summary (truFreeze® System)

K150920 (page 1/3)

Applicant Establishment Registration Number Contact Person

CSA Medical 3004534508 Sherrie Coval-Goldsmith Vice President RA/OA CSA Medical 91 Hartwell Ave Lexington, Ma 02421 Phone: 781-538-7447 Fax: 781-538-4730 sgoldsmith@csamedical.com April 3, 2015 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K143625 (truFreeze System)

Device Description

Summary Date

Classification

Predicate Device

Proprietary Name

Classification Name

Regulation Number

Console:

The console is the central interface of the system and is comprised of a touch panel computer (TPC) and cryogen, suction, and electronics modules packaged in a mobile cart, Users interact with the console through a dual foot pedal and a touch panel. An off-the-shelf controller and associated software manage the cryogen level sensing, filling, pressure, cooling, defrost, suction, timing and data management functions. A wireless remote control provides alternative timer control from a distance in the treatment room. A fill kit, stored on the rear of the console, allows for liquid nitrogen transfer from the source tank to the console. Safety features include indicators, tank pressure relief valves, an isolated low voltage power system, and an emergency button to be used in the event of user or technical malfunction.

Disposable spray kit:

There are no proposed changes to the disposable spray kit. The truFreeze disposable spray kit continues to consist of five (5) individually packaged sterile single-use catheters (7 Fr Straight Tip Catheter and one Catheter Introducer) and 5 individually packaged cryogen decompression tubes (CDTs) (each containing one Dual Lumen 20 Fr CryoDecompression Tube (CDT), Connector, and Suction Tubing). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the onboard suction system.

Labeling (Intended Use/Indications for Use and Instructions for Use Document)

The truFreeze System is identical in its Intended Use as the predicate device (K143625 truFreeze system), Both devices describe the ablation of benign and malignant tissue in general terms and the requirement to use either active or passive venting during surgical procedures. Both devices are indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions. This is the same indication for use as previously cleared for the previous version of the truFreeze System (K143625).

Page E- 1

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K150920 (page 2/3)

Technical and Operational Characteristics

This 510(k) implements a software modification to incorporate a control that will detect and respond to communication interruptions or failures with the internal cDAQ chassis and associated modules. Detecting and responding to communication interruptions or failures during the RUN cycle prevents the system from delivering an excessive rate of cryogen flow to the target area. Specifically, the two commercially available load packages were updated with additional error detection capabilities to:

1. Identify cDAQ related hardware and communication errors
1. Lockout and notify the user from the SW interface if these failures occur
1. Send a signal to close applicable valves.

Other than this additional software control, the technical and operational characteristics of the truFreeze System are unchanged.

Testing

The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, software testing, animal testing, biocompatibility and sterilization testing. Two sets of testing were performed for each of the load packages available to customers. Three consoles were successfully loaded with the respective load packages. The software modification was validated via software regression testing, software integration testing and system functional testing.

CSA Software Load Package Regression Tests:

Regression testing was successfully completed and all tests passed, verifying that the updates did not negatively impact the code. No additional safety or functionality concerns were observed during testing.

CSA Software Load Package Integration Tests:

All integration tests were completed and were considered acceptable. The successful completion of these tests demonstrate the ability of the software to correctly detect (or not) cDAQ related hardware and communication errors and respond accordingly.

truFreeze System Functional Tests

Functional testing was successfully performed and passed confirming that the software updates implemented did not negatively impact system performance and functionality,

After successfully completing the regression testing, and console field verification, the following items have been successfully verified and validated:

The software functions as intended per software performance specifications
All input and output software values are as specified .
The system functions as intended
The software functions as intended when a cDAQ hardware error is present or not present.

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K150920 (page 3/3)

Verification Testing Summary Table
Test Type	ProposedtruFreezeSystem(K150920)	PredicatetruFreeze System(K143625)	Comments
SoftwareRegressionTests	BIT Code	Pass	Pass	Equivalent
	Fill Code	Pass	Pass	Equivalent
	Procedure Code	Pass	Pass	Equivalent
	Data Code	Pass	Pass	Equivalent
	Service Code	Pass	Pass	Equivalent
	Admin Code	Pass	Pass	Equivalent
	Home Code	Pass	Pass	Equivalent
IntegrationTests	Fill Code	Pass	NA	The integration tests were specific tothe K150920 and therefore it wasnot part of K143625 testing.
	Procedure Code	Pass	NA	The integration tests were specific tothe K150920 and therefore it wasnot part of K143625 testing.
SystemFunctionalTests	truFreeze FieldVerification	Pass	Pass	Equivalent

Rationale For Substantial Equivalence

The labeling as well as the technological characteristics of the truFreeze System K150920 and the predicate device (K143625 truFreeze system) were compared. The Intended Use/Indications for Use statement of the two devices had identical general claims and do not raise new questions of safety and performance. The proposed changes to the software enhance the safe use of the device by providing additional controls. This provides a

control that will detect and respond to communication interruptions or failures with the internal cDAQ chassis and associated modules. Verification and validation testing demonstrate that the software modification does not raise new questions of safety and performance.

Conclusion

Based on the comparison of labeling, technology and verification/validation testing comparisons, the truFreeze device is substantially equivalent to the predicate device listed above.

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.