The truFreeze® System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Device Description

The truFreeze® System is a cryosurgical tool that applies medical-grade liquid nitrogen to the ablation area via a small, low pressure, open tipped catheter. The truFreeze System consists of (1) a console and (2) a disposable spray kit. 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 the touch panel. A 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 procedure 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 shut-off button. The truFreeze spray kit consists of sterile single-use catheters and cryogen decompression tubes (CDTs). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.

AI/ML Overview

The provided text is a 510(k) summary for the truFreeze® System. This type of document is for regulatory clearance of medical devices and focuses on demonstrating substantial equivalence to existing devices, rather than detailed performance studies and acceptance criteria in the way a clinical trial report would.

Therefore, the input does not contain the specific information required to complete the detailed table and answer all questions regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.

However, I can extract what is available and highlight what is missing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria (from document)	Reported Device Performance (from document)
Conformance to Product Specifications	The truFreeze System must conform to product specifications.	"Test results demonstrated that the truFreeze System meets its specifications."
Safety Issues	The truFreeze System should not raise any new safety issues compared to predicate devices.	"Test results demonstrated that the truFreeze System... does not raise any new safety and/or effectiveness issues."
Effectiveness Issues	The truFreeze System should not raise any new effectiveness issues compared to predicate devices.	"Test results demonstrated that the truFreeze System... does not raise any new safety and/or effectiveness issues."
Ease of Use	Improvements in ease of use compared to predicate devices.	"The minor differences and additional features improve the overall ease of use..."
Robustness	Improvements in robustness compared to predicate devices.	"...robustness and serviceability..."
Serviceability	Improvements in serviceability compared to predicate devices.	"...robustness and serviceability..."
Electrical Safety	Compliance with applicable electrical safety standards.	"Electrical safety and electromagnetic compatibility testing... were conducted in accordance with applicable standards."
Electromagnetic Compatibility (EMC)	Compliance with applicable EMC standards.	"Electrical safety and electromagnetic compatibility testing... were conducted in accordance with applicable standards."
Software Testing	Adherence to software requirements.	"software testing... were conducted in accordance with applicable standards."
Biocompatibility	Compliance with applicable biocompatibility standards.	"biocompatibility and sterilization testing... were conducted in accordance with applicable standards."
Sterilization	Compliance with applicable sterilization standards.	"sterilization testing... were conducted in accordance with applicable standards."

Missing Information for Table: The document states that the device "meets its specifications" but does not explicitly list the quantitative or qualitative acceptance criteria themselves (e.g., "Cryogen flow rate must be X L/min +/- Y%"). It also doesn't provide specific numerical performance results for most categories.

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not specified. The document mentions "a comprehensive test program" and "user validations using animal models." It does not provide the number of animal models or specifics of other testing samples.
Data Provenance: Not specified. "User validations using animal models" suggests prospective testing, but the country of origin or specific study sites are not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided. The study focuses on device performance against specifications and predicate devices, not on diagnostic accuracy requiring expert panel ground truth.

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

This information is not applicable and not provided for the type of testing described (device function and safety, not diagnostic accuracy).

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a cryosurgical tool, not an AI-assisted diagnostic or interpretative system.

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

Yes, the "Summary of Testing" section implies standalone testing: "The truFreeze System was subjected to a comprehensive test program to evaluate conformance to product specifications... Electrical safety and electromagnetic compatibility testing, software testing, biocompatibility and sterilization testing were conducted in accordance with applicable standards." These tests evaluate the device's inherent functional performance.

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

The "ground truth" for the testing appears to be engineering specifications, recognized industry standards, and pre-defined functional performance criteria for a medical device (e.g., electrical safety, EMC, software functionality, biocompatibility, sterilization efficacy). For the animal model user validations, the "ground truth" would likely relate to the observed physiological effects of cryoablation in the animal tissue, as expected for the intended use.

8. The sample size for the training set

This concept is not applicable as the truFreeze System is a physical medical device, not a machine learning algorithm that requires a "training set."

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

Not applicable (see point 8).

Summary

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510(k) Summary

truFreeze® System

Image /page/0/Picture/2 description: The image shows a logo for CSA medical. The logo consists of the letters "CSA" in a bold, sans-serif font, with the word "medical" in a smaller font below. Above the letters is a semi-circle with a series of dots above it, arranged in a radiating pattern. The dots appear to be emanating from a central point.

K113021

Applicant Establishment Registration Number Contact Person

Summary Date Proprietary Name Classification Classification Name Regulation Number Classification Product Code Predicate Devices

CSA Medical 3004534508 Colleen A. Kistler, RAC tel. 443-524-9688 fax. 866-300-5183 ckistler@csamedical.com

FEB - 7 2012

January 23, 2012 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 GEH CryMed Cryo-Ablator (K040809) CryoSpray Ablation System (K060555, K0702651) Mobile Care Monitor (K090138) Smart Wand-DTX System (K093557)

Device Description

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 the touch panel. A 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 procedure 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 shut-off button.

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510(k) Summary

truFreeze® System

Image /page/1/Picture/2 description: The image shows a logo for CSA medical. The logo consists of the letters "CSA" in a bold, sans-serif font, with the word "medical" in a smaller font below. Above the letters is a semi-circular shape with a series of dots arranged in a conical pattern, suggesting a beam or spray. The overall design is simple and professional, likely representing a company in the healthcare or medical field.

The truFreeze spray kit consists of sterile single-use catheters and cryogen decompression tubes (CDTs). The catheter is flexible and capable of retroflex in a scope. The CDT and accessory tubes are included for use with the on-board suction system.

Intended Use/Indications for Use

The truFreeze System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology and general surgery.

Technical and Operational Characteristics

The truFreeze System is similar in design and has the same operational and technological characteristics as the predicate devices. The minor differences and additional features improve the overall ease of use, robustness and serviceability and do not raise any new issues of safety and effectiveness.

Summary of Testing

The truFreeze System was subjected to a comprehensive test program to evaluate conformance to product specifications and demonstrate substantial equivalence to the predicate device(s). Electrical safety and electromagnetic compatibility testing, software testing, biocompatibility and sterilization testing were conducted in accordance with applicable standards. In addition to the design verification and validation testing, user validations using animal models were also conducted. Test results demonstrated that the truFreeze System meets its specifications and does not raise any new safety and/or effectiveness issues.

Substantial Equivalence

The truFreeze System has the same technological characteristics and principles of operation as the predicate device(s). The minor differences between the truFreeze System and its predicate device do not raise any new issues of safety and effectiveness and therefore is substantially equivalent.

The truFreeze System has the same intended use and indication for use as other legally marketed predicate liquid nitrogen cryosurgical devices and therefore is substantially equivalent.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the circumference of the circle.

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

CSA Medical, Incorporated % Ms. Colleen A. Kistler, RAC Director, Regulatory & Quality 1101 East 33td Street, Suite E305 Baltimore, Maryland 21218

Re: K113021

FEB - 7 2012

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: January 5, 2012 Received: January 6, 2012

Dear Ms. Kistler:

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 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.

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Page 2 - Ms. Colleen A. Kistler, RAC

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please rr you aw.l/www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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,

for Pete Dimemat
Mark N. Melkerson
Asp LLin Dr.

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATION FOR USE

510(k) Number (if known): K113021

Device Name: truFreeze® System

Indications for Use:

The truFreeze® System is intended for use as a cryosurgical tool for the destruction of unwanted tissue in the fields of dermatology, gynecology, and general surgery.

Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K113021

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.