(24 days)
Not Found
No
The description focuses on the mechanical and control aspects of a cryosurgical system, with no mention of AI or ML capabilities for analysis, decision-making, or image processing.
Yes
The device is applied to the human body to treat or diagnose a disease or condition ("to ablate benign and malignant lesions." and "for cryogenic destruction of tissue") and therefore meets the definition of a therapeutic device.
No
Explanation: The device is described as a cryosurgical tool used for the destruction (ablation) of tissue, which is a therapeutic function, not a diagnostic one.
No
The device description clearly outlines hardware components including a console, touch panel computer, cryogen, suction and electronics modules, mobile cart, dual foot pedal, wireless remote control, fill kit, safety features, and disposable spray kits with catheters and tubes. While software is mentioned as managing functions, it is integral to the operation of the physical hardware.
Based on the provided information, the truFreeze® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for the "cryogenic destruction of tissue" and "to ablate benign and malignant lesions" during surgical procedures. This is a direct treatment of tissue within the body.
- Device Description: The device description details a system that applies liquid nitrogen directly to the treatment area via a catheter. This is a physical intervention on tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue samples) outside of the body to provide information for diagnosis, monitoring, or screening. The truFreeze system does not perform any such analysis of specimens.
The truFreeze System is clearly described as a surgical tool used for cryosurgery, which is a therapeutic procedure performed directly on the patient's tissue.
N/A
Intended Use / Indications for Use
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 lesions.
Product codes
GEH
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 (1) a console and (2) 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:
The truFreeze disposable spray kit consists of 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 on-board suction system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
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. Since the change does not involve any changes to the hardware or software of the truFreeze system, no additional testing was conducted to support demonstration of substantial equivalence in performance of the truFreeze system to its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be flowing or merging together.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 15, 2015
CSA Medical Incorporated Ms. Sherrie Coval-Goldsmith Vice President Regulatory Affairs/Quality Assurance 91 Hartwell Avenue Lexington, Massachusetts 02142
Re: K143625
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: December 22, 2014 Received: December 24, 2014
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
1
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.
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/Resourcesfor You/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.
for
Sincerely yours,
David Krause -S
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
2
Attachment C - Indications for Use Statement
510(k) Number (if known): K143625
Device Name: truFreeze® System
Indications For Use:
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 lesions.
Prescription Use x____________________________________________________________________________________________________________________________________________________ (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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
csamedical.com
CSA Medical Inc. 91 Hartwell Avenue Lexington, MA 02421 781.538.4720 tel 781.538.4730 fax
510K Summary TruFreeze® System
Applicant Establishment Registration Number Contact Person
Summary Date Proprietary Name Classification Classification Name Regulation Number Classification Predicate Device
CSA Medical 3004534508 Sherrie Coval-Goldsmith VP RA/QA CSA Medical 91 Hartwell Ave Lexington, Ma 02142 Phone: 781-538-7447 Fax: 781-538-4730 sgoldsmith@csamedical.com June 9, 2014 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K133258 (truFreeze System)
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 (1) a console and (2) 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.
4
Disposable spray kit:
The truFreeze disposable spray kit consists of 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 on-board 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 (K133258 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. The proposed modification adds the word "System" after the truFreeze name to add clarity to the name of the device.
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 lesions.
The Instructions for Use document did not contain the same information regarding RFID tag use as the Operator's manual and did not contain the same information regarding the physician having complete control of the procedure through activation of the foot pedal as contained in the Operator's manual. These modifications ensure consistency in content between the Instructions for Use document and Operator's manual.
The Instructions for Use document provide additional notes to the physician to assign a health care professional, in the procedure room, to audibly notify the physician of the timer display. This provides a redundant safe guard to the system's built in audible beep associated with the timer display. The intent of this addition is to enhance safe use of the device.
Therefore, the revised intended use/indications for use statement and revised Instructions for Use document raise no new issues of safety or effectiveness
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Technical and Operational Characteristics
The truFreeze System is identical in design, hardware and software, as well as operational and technological characteristics as the predicate device and supports that no new safety concerns are being raised by changes to the Instructions for use document and thus raises no new issues of safety or effectiveness.
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. Since the change does not involve any changes to the hardware or software of the truFreeze system, no additional testing was conducted to support demonstration of substantial equivalence in performance of the truFreeze system to its predicate device.
Rationale For Substantial Equivalence
The labeling (inclusive of Intended Use/Indications for Use statement and Instructions for Use document) as well as the technological characteristics of the truFreeze System and the predicate device (K133258 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 Instructions for Use (IFU) document ensure consistency between the IFU and the system Operator Manual and enhance the safe use of the device by assigning a health care professional in the procedure room to audibly notify the physician of the timer display. This provides a redundant safe guard to the system's built in audible beep associated with the timer display.
Conclusion
Based on the comparison of label, technology and testing comparisons, the truFreeze device is substantially equivalent to the predicate device listed above.