(50 days)
K160273 (truFreeze® System)
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No
The document describes a cryosurgical system with standard electronic and software controls for managing cryogen flow, pressure, and timing. There is no mention of AI, ML, or any capabilities that would suggest learning or adaptive algorithms based on data. The software testing described focuses on regression, integration, and functional testing of standard control logic.
Yes
The device is described as a "cryosurgical tool" intended "to ablate benign and malignant lesions," which directly indicates its use for therapeutic intervention.
No
Explanation: The device is described as a "cryosurgical tool" intended for "cryogenic destruction of tissue" and to "ablate benign and malignant lesions." These functions are therapeutic, not diagnostic.
No
The device is a cryosurgical system that includes a console with hardware components (touch panel computer, cryogen, suction, and electronics modules, mobile cart, foot pedal, fill kit, safety features) and disposable spray kits (catheters, CDTs, tubing). While it utilizes software for control and management, it is fundamentally a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The device is intended for the cryogenic destruction of tissue and is indicated for use as a cryosurgical tool to ablate benign and malignant lesions. This describes a direct surgical intervention on the patient's body.
- Device Description: The description details a system that applies liquid nitrogen directly to tissue via a catheter. This is a physical treatment method.
- Lack of IVD Characteristics: An IVD device is used to examine specimens (like blood, urine, or tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The provided information does not mention any analysis of specimens or diagnostic purposes.
The truFreeze System is clearly a therapeutic device used for surgical procedures, not a diagnostic device used for analyzing samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GEH
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 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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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 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: Unit tests were used to verify the BIT and 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 or functionality 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). In addition, 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 console to console variability. All testing was successful and no safety or functionality concerns were observed.
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. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K160273 (truFreeze® System)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
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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
1
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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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