(50 days)
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, and general surgery, to ablate benign and malignant lesions.
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 kit: There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use.
This document describes a 510(k) premarket notification for the truFreeze® System (K161557), which is a cryosurgical unit. The submission focuses on modifications to the predicate device (K160273) and assesses if these changes introduce new questions of safety or effectiveness. The core of the evaluation is demonstrating that the modified device remains substantially equivalent to its predicate.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't explicitly state "acceptance criteria" in a quantitative manner for specific performance metrics like accuracy, sensitivity, or specificity. Instead, the acceptance criteria are implicitly defined as successful completion of various verification and validation tests, ensuring that the software and hardware modifications do not negatively impact the code, system performance, or functionality, and do not raise new questions of safety or effectiveness.
The "Verification Testing Summary Table" provides a good overview of the tests performed and their outcomes:
| Test Type | Proposed truFreeze System Performance | Predicate truFreeze System (K150920) Performance | Comments |
|---|---|---|---|
| Software Regression Tests | |||
| - 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 |
| Software Integration Tests | |||
| - Fill Code | Pass | NA | The integration tests were specific to the proposed modifications and therefore it was not part of K150920 |
| - Procedure Code | Pass | NA | The integration tests were specific to the proposed modifications and therefore it was not part of K150920 |
| System Functional Tests | |||
| - truFreeze Field Verification | Pass | Pass | Equivalent |
| Hardware Stress Tests | |||
| - Simulated Shock and Rotation | Pass | NA | The simulated shock and rotation methods were not part of K150920 testing. |
Reported Device Performance Summary: All tests, including software regression, software integration, system functional, and hardware stress tests, were successfully completed with a "Pass" result for the proposed truFreeze System, demonstrating that the modifications did not negatively affect the device's safety or functionality.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Software Testing:
- Regression Tests: The document states that "Regression testing was successfully completed and all tests passed," implying 100% pass rate for the tested code components (BIT, Fill, Procedure, Data, Service, Admin, Home Codes). The exact number of individual test cases within these categories is not specified.
- Integration Tests: "All integration tests were completed and were considered acceptable." Again, the specific number of test cases or scenarios is not provided.
- Unit Tests: "Unittests were used to verify the BIT and code revision updates... only one run on one console is required for this testing." This indicates a single run for these specific unit tests.
- Hardware and System Functional Testing:
- Hardware Stress Testing: "Three production equivalent systems underwent stress testing."
- System Functional Tests: "System functional testing was performed on three production consoles."
- Data Provenance: The testing appears to be internal to CSA Medical, Inc. or its contractors. No information is provided about the country of origin of data, or whether it was retrospective or prospective in the sense of patient data. This is a simulated/laboratory testing environment, not clinical data provenance.
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 type of information is not applicable to the testing described in this document. The truFreeze® System is a cryosurgical tool, and the testing outlined is focused on verifying software and hardware functionality and safety of modifications, not diagnostic accuracy requiring expert panel review. The "ground truth" for these tests would be the expected behavior of the system as defined by its design specifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This is not applicable as the testing primarily involves automated software verification, hardware stress tests, and functional checks against predetermined specifications, not subjective interpretation of results by multiple human adjudicators. The evaluation outcome (Pass/Fail) is based on objective criteria related to system performance and behavior.
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 is not applicable. The truFreeze® System is a physical medical device (cryosurgical unit) and its modifications are for internal system functionality, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists interpreting images). Therefore, an MRMC study or assessment of AI assistance effect size is irrelevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable in the context of an "algorithm only" performance as it relates to AI/diagnostic algorithms. The device itself is a standalone system with specific functionalities, and the testing implicitly evaluates its standalone performance relative to its design specifications. However, this is not a device whose performance would be measured in terms of classification, detection, etc., like an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the tests described is the expected behavior and performance of the device's software and hardware as defined by its design specifications and requirements. For example:
- For software regression, the ground truth is that the updated code should produce the same correct output as the previous version for existing functionalities.
- For integration tests, the ground truth is that the software should correctly detect errors and display messages as designed.
- For hardware stress tests, the ground truth is that the hardware modifications should withstand simulated stress without failure.
8. The sample size for the training set:
This is not applicable. The document describes verification and validation of modifications to a physical medical device and its embedded software, not the development or training of a machine learning or AI model. Therefore, there is no "training set" in this context.
9. How the ground truth for the training set was established:
This is not applicable as there is no training set for an AI model. The ground truth for the testing was established through design specifications and requirements for the device's intended functionality and safety.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on health and well-being.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2016
CSA Medical, Inc. Ms. Sherrie Coval-Goldsmith VP of Regulatory & Quality 91 Hartwell Avenue Lexington, Massachusetts 02421
Re: K161557
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: Mav 27, 2016 Received: June 6, 2016
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
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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.
Sincerely yours.
Christopher J. Ronk -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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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) K161557
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, 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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510(k) SUMMARY
Applicant Establishment Registration Number Contact Person
CSA Medical, Inc 3010140265 Sherrie Coval-Goldsmith, MS Vice President RA/QA CSA Medical 91 Hartwell Ave Lexington, Ma 02421 Phone: 781-538-7447 Fax: 781-538-4730 sgoldsmith@csamedical.com
May 27, 2016 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K160273 (truFreeze® System)
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 kit:
There are 2 types of spray kits available. One kit is available for active venting procedures and one is available for passive venting procedures. Both active and passive venting kits include are provided in a carton of five (5) individually packaged sterile, single-use catheters with introducers in individual pouches. Additionally, the active venting kit is provided with includes a carton of five (5) individually packaged sterile, single-use CDTs with associated tubing in individual pouches. Each carton within a spray kit contains the instructions for use. The disposable kit is the same as previously cleared for the predicate truFreeze System (K160273). Therefore, there are no new issues of safety or effectiveness raised.
Labeling (Intended Use/Indications for Use and Instructions for Use Document)
There are no proposed changes to the Intended Use/Indications for Use statement. 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. 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 (K160273).
K161557 Page 1/5
Proprietary Name Classification Classification Name Regulation Number Classification Predicate Device
Summary Date
Device Description
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Technical and Operational Characteristics
This 510k implements software and hardware modifications to: 1) minimize procedural disruptions and user annoyance; 2) implement hardware manufacturability improvements and 3) correct a discrepancy in the operator's manual.
The software is designed to send a Terminal Error message to alert the user to stop a procedure if a potential safety issue (stemming from a communication error) occurs while in the Procedure code, of an issue in Fill code occurs and to take additional actions.
However, within the Procedure code are non-spraying states which carry no risk to the patient. In these situations, following the actions prompted by the current message results in unwarranted procedural disruption. A modification to the software will provide state specific instructions on the GUI to allow the user to take appropriate actions with minimal disruption during a procedure. A state specific Terminal Error message will also be modified in the Fill Code, which like the non-spray states has no effect on patient safety. Additionally, by reducing the sampling rate for communication errors during non-spray Procedural states, the number of Terminal Error messages should be reduced.
Additionally, Terminal Errors may occur as a result of loose hardware connections. Hardware modifications will be implemented to make connections more rugged and resistant against loosening.
Other software modifications include: 1) elimination of a beep sound associated with an unsuccessful scan of the catheter's RFID tag or a scan of an expired tag (the beep sound associated with a successful scan remains) and 2) permit more time during the BIT pressure sensor test to mitigate situations where tank pressure may be low for an extended period of time (e.g. fill), allowing more time to build the tank pressure required to pass the BIT test. These two modifications are intended to provide more clarity to the use of the system and to reduce user annoyance.
Hardware that is not available for use by the user was removed to improve manufacturability. The current UFD is no longer available for purchase by the manufacturer and is being replaced with another UFD with the same storage capacity.
There is a reference within the Operator's manual to filling the truFreeze System from a 22PSI source tank and from a <50PSI source tank within the manual. To eliminate confusion, the <50PSI reference will be modified to <30 PSI, 22PSI recommended. This clarification meets the current specification and reflects currently available medical grade LN2 source tanks.
Other than these modifications, the technical and operational characteristics of the truFreeze System are unchanged.
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Summary of Testing
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 and is not being repeated. Verification testing to support the proposed hardware and software modifications in this submission was performed.
Currently there are two truFreeze software load packages in the field to support two different level sensing configurations, C-Stic level sensing and Load Cell level sensing. Since the currently released software is functioning as intended, and do not affect safety or efficacy of the system, the proposed modifications within this submission will only be available for the truFreeze console design
containing the truFreeze C-stic software load package and C-Stic level sensing.
Three consoles were tested with the proposed hardware modifications. 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 impactthe code. No 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 cDAQ related hardware and communication errors and display the applicable terminal or system error message. The removal of the Remotes test in BTT and the removal of the beep and initiation of precool after an unsuccessful scan was successfully verified. No safety or functionality concerns were observed during testing.
CSA Software Load Package Unit Testing:
Unittests were usedto verify the BITand code revision updates. Regression and Unit test results were determined solely by the code and the ini file values and were not system or run dependent. Therefore, only one run on one console is required for this testing was successfully completed and all tests passed, verifying that the updates did not negatively impact the code. No safety orfunctionality concerns were observed during testing.
CSA Hardware Stress Testing:
Three production equivalent systems underwent stress testing demonstrating that the proposed hardware modifications were robust. The shock testing was used to demonstrate the robustness of hardware modifications simulating transport to and from a fill location once per week for the total useful life of the product (5 years). Inaddition, the Panel PC was rotated back and forth and up and down repeatedly, to verify range of motion. Three consoles were used to account for typical
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console to console variability. All testing was successful and no safety or functionality concerns were observed.
trufreeze System Functional Tests
Functional testing wassuccessfully performed and passed confirming that the software updates implemented did not negatively impact system performance and functionality. System functional testing was performed on three production consoles to demonstrate that the software updates implemented did not impact system performance and functionality. The console Field Verification test was conducted on each console using the steps and methods required for field installations to confirm that the system was functioning as intended. Three consoles were used to account for any typical console to console variability. No safety or functionality concerns were observed with any functional tests.
| Verification Testing Summary Table | ||||
|---|---|---|---|---|
| Test Type | ProposedtruFreezeSystem | PredicatetruFreeze System(K150920) | Comments | |
| SoftwareRegressionTests | BIT Code | Pass | Pass | Equivalent |
| Fill Code | Pass | Pass | Equivalent | |
| ProcedureCode | Pass | Pass | Equivalent | |
| Data Code | Pass | Pass | Equivalent | |
| Service Code | Pass | Pass | Equivalent | |
| Admin Code | Pass | Pass | Equivalent | |
| Home Code | Pass | Pass | Equivalent | |
| SoftwareIntegrationTests | Fill Code | Pass | NA | The integration tests werespecific to the proposedmodifications and therefore itwas not part of K150920 |
| ProcedureCode | Pass | NA | The integration tests werespecific to the proposedmodifications and therefore itwas not part of K150920 |
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K161557 Page 5/5
| SystemFunctionalTests | truFreezeFieldVerification | Pass | Pass | Equivalent |
|---|---|---|---|---|
| HardwareStressTests | SimulatedShockandRotationTesting | Pass | NA | The simulated shock androtation methods were notpart of K150920 testing. |
Rationale For Substantial Equivalence
The labeling as well as the technological characteristics of the proposed truFreeze System and the predicate device (K160273 truFreeze system) were compared. The Intended Use/Indications for Use statement of the two devices are identical and do not raise new questions of safety and performance. The proposed changes to the hardware and software enhance the safe use of the device by: 1) providing additional levels of control against the risk of communication; 2) providing clarifying state-dependent information to the user if an error message is received to assist them in clearing the error messages; 3) clarifying a discrepancy in the source tank fill pressure found within the operator's manual and 4) eliminate a redundant beep sound relating to an unsuccessful scan of the catheter. These modifications are intended to minimize disruption to a procedure and to minimize user annoyance or confusion, while maintaining safety for the patient.
Verification and validation testing demonstrate that the software and hardware modifications do not raise new questions of safety and performance.
Conclusion
Based on the label and technology comparison as well as the performance testing, the Proposed truFreeze device is substantially equivalent to the predicate device listed above.
§ 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.