(50 days)
K162695 (truFreeze® System)
Not Found
No
The description focuses on the mechanical and functional aspects of a cryosurgical system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies. The software mentioned manages basic system functions like pressure, timing, and data management, which are typical for medical devices and do not indicate AI/ML.
Yes
The device is described as a "cryosurgical tool" intended for the "cryogenic destruction of tissue" and to "ablate benign and malignant lesions," which directly treats a medical condition.
No
Explanation: The device is described as a "cryosurgical tool" intended for "cryogenic destruction of tissue" to "ablate benign and malignant lesions." It is used for treatment, not for diagnosing conditions.
No
The device is a cryosurgical tool that includes a console (hardware) and disposable spray kits (hardware). While it contains software for control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use and Indications for Use: The intended use and indications clearly state that the truFreeze System is for the cryogenic destruction of tissue and is used as a cryosurgical tool to ablate benign and malignant lesions. This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The description details a system that applies liquid nitrogen to tissue via a catheter. This is a direct intervention on the patient.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples. The truFreeze System is used in vivo (inside the body) for treatment.
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, 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 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 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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Verification testing (mechanical and functional performance of the catheter assembly, sterilization assessment, biocompatibility, packaging and accelerated aging testing), Electrical isolation testing.
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.
Key Results: All tests passed, including: Incoming Inspection, Measure Working Length, Measure Insulation Length, Distal Shaft Profile Dimensions, Visual Marker Band, Strain Relief, Handle Insertion and Removal, Catheter Insertion into Gastroscope, Marker Band Durability, Catheter Handle and Insulation Temperature Testing, Leak Testing, Static Burst Testing, Catheter Removal Force, Catheter Insertion Force, Bayonet Tensile Test, Time to Frost, Temperature Exposure, Temperature Cycling, Bend Angle and Radius, Retroflex Power, Cooling Power, Biocompatibility, Sterilization adoption, Accelerated Aging (supports 6 months), Ship Test. Electrical isolation testing was repeated and passed successfully.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K162695 (truFreeze® System)
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.
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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
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.
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
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 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.
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.
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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 |
|---|---|---|---|---|---|
| Incoming | |||||
| Inspection | Passed | Marker Band | |||
| Durability | Passed | Temperature | |||
| Exposure | Passed | ||||
| Measure Working | |||||
| Length | Passed | Catheter Handle | |||
| and Insulation | |||||
| Temperature | |||||
| Testing | Passed | Temperature | |||
| Cycling | Passed | ||||
| Measure | |||||
| Insulation Length | Passed | Leak Testing | Passed | Bend Angle | |
| and Radius | Passed | ||||
| Distal Shaft Profile | |||||
| Dimensions | Passed | Static Burst Testing | Passed | Retroflex Power | Passed |
| Visual Marker | |||||
| Band | Passed | Catheter Removal | |||
| Force | Passed | Cooling Power | Passed | ||
| Strain Relief | Passed | Catheter Insertion | |||
| Force | Passed | Biocompatibility | Passed | ||
| Handle Insertion | |||||
| and Removal | Passed | Bayonet Tensile | |||
| Test | Passed | Sterilization | |||
| adoption | Accepted | ||||
| Catheter Insertion | |||||
| into Gastroscope | Passed | Time to Frost | Passed | ||
| Accelerated Aging | Supports | ||||
| 6 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.