(52 days)
Intended Use: 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.
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.
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 provided text is a 510(k) summary for the truFreeze System, a cryosurgical tool. It describes the device, its intended use and indications for use, and a comparison to a predicate device (K152668).
However, the document explicitly states: "Since the change in the truFreeze System is limited to the Indications for Use and adds to it information currently present in truFreeze System labeling, no additional testing was performed."
This indicates that no new study was conducted specifically for this 510(k) submission (K160273) to establish new acceptance criteria or prove device performance for new claims. The submission relies on the substantial equivalence to a previously cleared device (K152668) and its existing testing.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from this document, because this document states no new studies were performed.
If information from the previous 510(k) submission (K152668) were available, it might contain the details of studies that established performance for the original truFreeze System. Without that context, I can only report what is stated in this document.
Based on the provided text, the following points can be made:
- 1. A table of acceptance criteria and the reported device performance: Not available in this document as no new testing was performed. The device is deemed substantially equivalent based on label and technology comparison to a predicate device.
- 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not available as no new testing was performed.
- 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): Not available as no new testing was performed.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not available as no new testing was performed.
- 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: Not applicable. The truFreeze System is a cryosurgical tool, not an AI-assisted diagnostic or imaging device used by human readers. No MRMC study was mentioned.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The truFreeze System is a physical surgical device, not an algorithm.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available as no new testing was performed.
- 8. The sample size for the training set: Not applicable as a training set for an algorithm is not relevant to this type of device and no new testing was performed.
- 9. How the ground truth for the training set was established: Not applicable.
{0}------------------------------------------------
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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, composed of three overlapping profiles facing to the right. The profiles are rendered in a dark color, creating a sense of depth and layering.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 25, 2016
CSA Medial, Inc. Ms. Sherrie Coval-Goldsmith Vice President of Regulatory & Quality 91 Hartwell Avenue Lexington, Massachusetts 02421
Re: K160273
Trade/Device Name: truFreeze System Regulation Number: 21CFR 878.4350. Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: February 2, 2016 Received: February 2, 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 of medical devicerelated 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.
{1}------------------------------------------------
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 vours. Jennifer R. Stevenson -
A
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
{2}------------------------------------------------
510(k) Number (if known)
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 -196 C 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.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) SUMMARY- K160273
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 Requlation Number Classification Predicate Device
February 2,2016 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21CFR 878.4350 Product Code GEH K152668 (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:
There are no proposed changes to 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 no proposed changes to the 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.
Intended Use: 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.
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.
The truFreeze System adds information to the Intended Use/Indications for Use statement regarding the use of liquid Nitrogen spray. This information is currently located within the predicate device Instructions for Use document and Operator's manual. Other than this modification, the Intended Use/Indications for Use statement is identical in its Intended Use as the predicate device (K152668 truFreeze system). Both
{4}------------------------------------------------
K160273
devices describe the ablation of benign and malignant tissue in general terms and the requirement to use either active or passive venting during surgicalprocedures. 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. This is the same indication for use as previously cleared for the previous version of the truFreeze System (K152668).
Adding the name of the cryogen being delivered:its boiling point temperature: the delivery of the cryogen in the form of a spray; highlights important information currently found within the current Instructions for Use and Operator's Manual documents into a prominent location of the label. The intent of this modification is to enhance safe use of the device by making the information readily available to the user. Therefore, the revised intended use/indications for use statement raise no new issues of safety or effectiveness.
Technical and Operational Characteristics
The truFreeze System is similar in design, operational and technological characteristics as the predicate device and supports that no new safety concerns are being raised by change in intended use/indications for use statement and thus raises no new issues of safety or effectiveness.
Summary of 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 in the truFreeze System is limited to the Indications for Use and adds to it information currently present in truFreeze System labeling, no additional testing was performed.
Rationale For Substantial Equivalence
The Intended Use/Indications for Use statement and technological characteristics of the truFreeze System and the predicate device (K152668) were compared. The Intended Use/Indications for Use statement of the two devices had equivalent general claims and do not raise new questions of safety and performance. A comparison of the instructions for use document, operator's manual and performance documents demonstrated that both devices use liguid nitrogen spray that has a boiling point property of -196°C. The proposed changes to the Intended Use statement is well supported by a review of the peer reviewed clinical literature and are similar to those of the predicate device with the same general intended use of cryogenic destruction of tissue requiring either active or passive venting during surgical procedures.
The addition of this information to the Intended Use/Indications for Use statement enhances the safe use of the device by making information readily available to the user relating to the cryogen being delivered.
Conclusion
Based on the label and technology comparison as well as the performance testing. the 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.