Intended Use: The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC, requiring either active or passive venting during surgical procedures.

Indications for Use: 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 lesions.

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 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 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 Kits: Currently, there are 2 types of spray kits available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting CryoDecompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

This 510(k) introduces a third Spray Kit to the truFreeze System, referred to as the Rapid AV Spray Kit. These catheters provided with the proposed truFreeze System are only to be used for active venting procedures and have been modified to shorten the time it takes to pre-cool the catheter so it can achieve frost quicker.

The proposed Rapid AV Spray Kit consists of a carton with five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the Rapid AV Spray Kit includes a carton of five (5) sterile, single-use, dual-lumen Cryo- Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

AI/ML Overview

This document describes the regulatory submission for the truFreeze® System with a new Rapid AV Spray Kit. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K162695). The changes primarily relate to the catheter design of the Rapid AV Spray Kit, which aims to shorten the pre-cooling time for faster frost formation.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative manner as typically seen for AI/ML performance metrics (e.g., target specificity, sensitivity, or AUC). Instead, the acceptance criteria are implicitly defined by a series of engineering and performance tests, all of which had a "Passed" result. The overall acceptance criterion for the submission is demonstrating substantial equivalence to the predicate device.

Test Description	Acceptance Criteria (Implicit)	Reported Device Performance
Incoming Inspection	Conform to specifications	Passed
Measure Working Length	Conform to specifications	Passed
Measure Insulation Length	Conform to specifications	Passed
Distal Shaft Profile Dimensions	Conform to specifications	Passed
Visual Marker Band	Conform to specifications	Passed
Strain Relief	Conform to specifications	Passed
Handle Insertion and Removal	Conform to specifications	Passed
Catheter Insertion into Gastroscope	Conform to specifications	Passed
Marker Band Durability	Conform to specifications	Passed
Catheter Handle and Insulation Temperature Testing	Conform to specifications	Passed
Leak Testing	Conform to specifications	Passed
Static Burst Testing	Conform to specifications	Passed
Catheter Removal Force	Conform to specifications	Passed
Catheter Insertion Force	Conform to specifications	Passed
Bayonet Tensile Test	Conform to specifications	Passed
Time to Frost	Reduced pre-cooling time for faster frost	Passed
Temperature Exposure	Conform to specifications	Passed
Temperature Cycling	Conform to specifications	Passed
Bend Angle and Radius	Conform to specifications	Passed
Retroflex Power	Conform to specifications	Passed
Cooling Power	Conform to specifications	Passed
Biocompatibility	Meet biocompatibility standards	Passed
Sterilization Adoption	Accepted sterilization method	Accepted
Accelerated Aging	Support 6 months shelf life	Supports 6 months
Ship Test	Withstand shipping conditions	Passed

2. Sample sizes used for the test set and the data provenance:

Test Set Sample Size: "Sample size required for each test was guided by the risk index as determined by the DFMEA. Sample size considered both attribute data and variable data." However, specific numerical sample sizes for each test are not provided in the document.
Data Provenance: The tests are described as "bench data collected" for the truFreeze System. This indicates that the data was generated in a controlled laboratory or testing environment, likely in the US (where the company is based). It is prospective data derived from product testing, not retrospective patient data.

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 information is not applicable as the document describes a medical device (cryosurgical unit) performance validation, not an AI/ML diagnostic or prognostic system requiring expert-established ground truth from images or clinical data. The "ground truth" for these engineering tests would be the established engineering specifications and performance standards.

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

This information is not applicable for the same reasons as point 3.

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:

This information is not applicable as the document is about a hardware medical device (cryosurgical unit), not an AI/ML algorithm or system that assists human readers/clinicians.

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

This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm.

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

The "ground truth" for the tests described is the engineering specifications, design requirements, and regulatory standards for a medical device. For example, for "Measure Working Length," the ground truth is the specified design length. For "Biocompatibility," the ground truth is meeting established biocompatibility standards.

8. The sample size for the training set:

This information is not applicable as the document is about a hardware medical device, not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reasons as point 8.

In summary:

This document is a 510(k) summary for a hardware medical device (cryosurgical unit), not an AI/ML-driven device. Therefore, many of the requested categories pertaining to AI/MRMC studies, expert adjudication, or training/test sets for algorithms are not relevant to the information provided. The acceptance criteria are based on successful completion of a comprehensive set of engineering, mechanical, and safety tests, demonstrating that the modified device (Rapid AV Spray Kit) maintains the safety and effectiveness of its predicate, leading to a determination of substantial equivalence.

Summary

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an image of three faces in profile, stacked on top of each other, with a stylized representation of a human form below them.

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

July 14, 2017

CSA Medical, Inc. Ms. Sherrie Coval-Goldsmith VP of Regulatory & Quality 91 Hartwell Avenue Lexington, Massachusetts 02421

Re: K171522

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: May 12, 2017 Received: May 25, 2017

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 Actinclude 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

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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.

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" (21 CFR 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.

Sincerelv.

Image /page/1/Picture/9 description: The image shows the name "Jennifer R. Stevenson -S3" in a large, bold font. The name is arranged in two lines, with "Jennifer R." on the first line and "Stevenson -S3" on the second line. The text is black, and the background is a light blue color. The letters "FDA" are faintly visible in the background.

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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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 on last page

510(k) Number (if known) K171522

Device Name

truFreeze ® System

Indications for Use (Describe)

Intended Use

The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of -196ºC, requiring either active or passive venting during surgical procedures.

Indications for Use

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 lesions.

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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

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K171522 Page 1/4 510(k) SUMMARY

Applicant Establishment Registration Number Contact Person

CSA Medical, Inc. 3010140265 Sherrie Coval-Goldsmith, M.S. Vice President RA/QA CSA Medical 91 Hartwell Ave Lexington, MA 02421 Phone: 781-538-7447 Fax: 781-538-4730 sgoldsmith@csamedical.com

Summary Date Proprietary Name Classification Classification Name Regulation Number Classification Predicate Device

May 12, 2017 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K162695 (truFreeze® System)

Device Description

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 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 technicalmalfunction.

Disposable Spray Kits:

Currently, there are 2 types of spray kits available for active venting procedures and one kit is available for passive venting procedures. Both active and passive venting kits are provided in a carton of five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit includes a carton of five (5) sterile, single-use, dual-lumen Active Venting CryoDecompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit contains Instructions for Use.

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K171522 Page 2/4

The proposed Rapid AV Spray Kit consists of a carton with five (5) sterile, single-use catheters with introducers in individual pouches. Additionally, the Rapid AV Sprav Kit includes a carton of five (5) sterile, single-use, duallumen Cryo- Decompression Tubes (CDTs) with associated tubing in individual pouches. Each carton within a spray kit

contains Instructions for Use. The Same as previously cleared for the predicate truFreeze System (K162695).

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

The Intended Use/Indications for Use statements are identical to the predicate device. The truFreeze System is intended for cryogenic destruction of tissue using Liquid Nitrogen spray that has a boiling point of-196°C 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 lesions. This is the same indication for use as previously cleared for the previous version of the truFreeze System (K162695).

Since the proposed Spray Kit will be used for active venting only, the instructions for use document will not contain information required for passive venting procedures. Additionally, a precaution statement was added to remind the user that the catheter should not be used for passive venting or low flow procedures and a reminder to ensure that the correct catheter was being used. Additionally, the colors on the product label have been changed to help distinguish the Rapid AV catheter from the predicate spray kits.

The outside diameter (OD) measurement unit of the catheter label has changed from a unit of French (Fr) to a unit of mm to support current measurement conventions. This is also reflected in the Operator's Manual.

Technical and Operational Characteristics

The truFreeze System, with the exception of the Liquid Nitrogen delivery catheter, is identical in design, operational and technological characteristics as the predicate device.

The catheter materials have changed to provide a more efficient heat transfer. This shortens the time required to pre-cool the catheter so that it can achieve frost quickly. The process of pre-cooling the catheter occurs prior to initiating the timer, which signifies the initiation of the dosimetry. There are no changes to the amount of cryogenic energy delivered or the flow rate and there are no changes to dosimetry. Other minor changes to the catheter design are required to support the stainless-steel material, address user feedback, and to distinguish the Rapid Active Venting catheter from the predicate catheter. These include: 1) use of a laminated metal to enhance heat transfer; 2) change in bayonet material to provide for patient isolation; 3) dimensional changes from material changes affecting the bayonet; 4) dimensional changes affecting the OD of catheter shaft; 5) change in adhesive required for bonding metal to a polymer; 6) reduce the number of marker bands on the catheter; and 7) change to colorant for shaft for better visualization of marker bands under endoscopicview.

Summary of Testing

The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility testing, software testing, therefore, those tests are not being repeated. However, electrical isolation testing has been repeated and passed successfully. Verification testing to support the proposed catheter modification in this submission was performed.

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K171522 Page 3/4

Once catheters were built and packaged, they were subjected to a 2x sterilization. Testing included mechanical and functional performance of the catheter assembly, sterilization assessment, biocompatibility, packaging and accelerated aging testing. Sample size required for each test was guided by the risk index as determined by the DFMEA. Sample size considered both attribute data and variable data. Results of these tests are presented below.

Test Description	Results	Test Description	Results	Test Description	Results
IncomingInspection	Passed	Marker BandDurability	Passed	TemperatureExposure	Passed
Measure WorkingLength	Passed	Catheter Handleand InsulationTemperatureTesting	Passed	TemperatureCycling	Passed
MeasureInsulation Length	Passed	Leak Testing	Passed	Bend Angleand Radius	Passed
Distal Shaft ProfileDimensions	Passed	Static Burst Testing	Passed	Retroflex Power	Passed
Visual MarkerBand	Passed	Catheter RemovalForce	Passed	Cooling Power	Passed
Strain Relief	Passed	Catheter InsertionForce	Passed	Biocompatibility	Passed
Handle Insertionand Removal	Passed	Bayonet TensileTest	Passed	Sterilizationadoption	Accepted
Catheter Insertioninto Gastroscope	Passed	Time to Frost	Passed
Accelerated Aging	Supports6 months	Ship Test	Passed

Rationale for Substantial Equivalence:

The technological characteristics of the truFreeze System were compared to the predicate device, the truFreeze System (K162695).

The proposed modifications to the catheter shortens the time required to pre-cool the catheter so that frost is achieved on the tissue faster. The process of pre-cooling the catheter occurs prior to initiating the timer, which signifies the initiation of the dosimetry. There are no changes to the amount of cryogenic energy delivered or the flow rate and there are no changes to dosimetry. These changes are intended to

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K171522 Page 4/4

address a user feedback request. The slight dimensional changes resulting from material changes have no impact on compatibility with the same size gastroscope as the predicate catheter. The colorant used to create a white shaft is biocompatible and provides a distinguishing look to improve endoscopic visualization of the marker bands.

The Intended Use/Indications for Use statements are identical to the predicate device. Since the proposed catheter will be used for active venting procedures only, the instructions for use document will not contain information required for passive venting procedures. Additionally, to enhance safety, a precaution statement was added to remind the user that the catheter should not be used for passive venting procedures as well as a reminder to ensure that the correct catheter was being used. Additionally, to enhance safety, the colors on the outer product label changed to help distinguish the Rapid AV spray kit from the predicate spray kits.

The OD measurement unit of the catheter label has changed from a unit of French (FR) to a unit of mm to support current measurement conventions. This is also reflected in the Operator's manual.

Conclusion

Based on the bench data collected for the truFreeze System, no new questions of safety or efficacy are raised. Therefore, the truFreeze System with the Rapid AV Spray Kit should be considered substantially equivalent to the legally marketed predicate, the truFreeze System.

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.