(28 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, 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 stop 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 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 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. There is a proposed change to the active venting disposable spray kit. The proposed change reduces the Outside Diameter (OD) of the CDT from 20 French to 16 French without changing performance specifications, adds additional Marker Bands to the 16 French version of the CDT and makes the 16 Fr CDT and 20 Fr CDT available as a 5-pack box in addition to as a part of the active venting kit.
The provided text describes a 510(k) premarket notification for the truFreeze System, focusing on minor modifications to an already cleared device. Therefore, a full-scale clinical study with extensive acceptance criteria, ground truth establishment, and multi-reader comparative effectiveness studies as typically seen for novel diagnostic AI devices, is not applicable here.
Instead, the submission details a verification and validation process for specific physical changes to a component of the device (the Cryoablation Drug Delivery Tube, CDT). The "acceptance criteria" are essentially the performance specifications for these modified components.
Here's an analysis based on the provided text, structured to address your points where applicable, and noting when information is not present due to the nature of this submission:
Acceptance Criteria and Device Performance
The acceptance criteria are the "Test Specifications" and the "Reported Device Performance" is the "Result" column.
| Proposed Change | Acceptance Criteria (Test Specification) | Reported Device Performance (Result) |
|---|---|---|
| Reduce CDT OD | The CDT shall be less than or equal to 16.5 Fr | Pass |
| The CDT shall not crack, break or experience lumen separation after exposure to temperatures with the boundary range of - 196°C and 40°C. | Pass | |
| Shall have sufficient column strength to allow it to be advanced over a 0.072” Savary Wire | Pass | |
| Shall maintain structural integrity and not kink while looped in a minimum internal bend radius. | Pass | |
| A complete flex of the CDT shall meet current kinking specification. | Pass | |
| The bonded CDT connector will withstand a minimum of 10lbf pull force without failing. | Pass | |
| Flow Rate shall meet current specification. | Pass | |
| The CDT OD shall not deform per specification. | Pass | |
| The bonded CDT connector will shall meet current. pull force specification without failing. | Pass | |
| Enhance Visualization | Circumferential banding must be sufficient to identify the banding through an endoscope. | Pass |
| Shall be labeled with four side-by-side 0.100"±0.030" wide identifying bands 7.7" ±0.1" from the distal end. | Pass | |
| All 0.100" wide bands shall be 360 degrees. | Pass | |
| Reduce CDT OD (DV) | CDT diameter will be as small as possible while enabling gas egress and allowing it to pass through the majority of anatomies with and without dilation. | Pass |
| Enhance Visualization (DV) | CDT will have Mark Bands to assist user for performing the initial, approximate placement of the CDT. | Pass |
Note: (DV) indicates Design Validation Testing.
Study Details Addressing Your Points:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify the sample sizes (e.g., number of CDTs tested) for the individual mechanical and material tests. These are typically internal verification tests.
- For the Design Validation tests:
- User Survey / Simulated Use (PRO-R-17-00193): The sample size for the user survey/simulated use is not explicitly stated. It would likely involve a small number of users.
- Animal Study (PRO-R-17-00198): The sample size (number of animals) for the animal study is not explicitly stated.
- Data provenance (country of origin, retrospective/prospective) is not mentioned, as these are internal design control activities for a physical device modification.
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)
- For the physical and functional tests, "ground truth" is established through engineering and material science standards and measurements. There are no "experts" in the sense of medical professionals establishing ground truth for diagnostic accuracy here.
- For the "User Survey / Simulated Use" and "Animal Study," the "experts" would be the participants in the survey/study and the veterinarians/surgeons conducting the animal procedures. Their number and specific qualifications are not detailed in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic accuracy studies where there's subjectivity (e.g., interpreting medical images). This is not applicable here as the tests are for physical and functional properties of a medical device component. The "pass" results imply that the device met the predefined specifications, which is a form of objective assessment.
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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, typically in diagnostic imaging. The truFreeze System is a cryosurgical tool, and this submission concerns a minor physical modification to an existing component, not an AI diagnostic algorithm.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical cryosurgical system and does not involve a standalone algorithm for diagnostic or prognostic purposes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the physical and functional tests is based on engineering specifications, material science properties, and direct objective measurements.
- For the "User Survey / Simulated Use," the ground truth would be the subjective feedback and observed performance from the users.
- For the "Animal Study," the ground truth would be the physiological outcomes and observations documented during and after the animal procedures.
- None of these involve pathology or long-term outcomes data related to disease diagnosis, as the device is a therapeutic (surgical) tool.
8. The sample size for the training set
- There is no training set in the context of this 510(k) submission. Training sets are used for machine learning algorithms. This submission is for a physical medical device.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of a human figure in profile, with three overlapping heads suggesting a sense of community and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 25, 2016
CSA Medical Incorporated Ms. Sherrie Coval-Goldsmith Vice President of Regulatory Affairs & Quality Assurance 91 Hartwell Avenue Lexington, Massachusetts 02421
Re: K162695
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: September 27, 2016 Received: September 29, 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 yours, 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}------------------------------------------------
Indications for Use
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 -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)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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."
FORM FDA 3881 (1/14)
EF PSC Publishing Services (301) 443-6740
{3}------------------------------------------------
510(k) 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, 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 26 September 2016 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K161557 (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 stop 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 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 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. There is a proposed change to the active venting disposable spray kit. The proposed change reduces the Outside Diameter (OD) of the CDT from 20 French to 16 French without changing performance specifications, adds additional Marker Bands to the 16 French version of the CDT and makes the 16 Fr CDT and 20 Fr CDT available as a 5-pack box in addition to as a part of the active venting kit.
Intended Use/Indications for Use and Instructions for Use
The truFreeze System is identical in its Intended Use and Indication for Use as the predicate device (K161557 truFreeze system).
Both the predicate device and the proposed device are 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.
{4}------------------------------------------------
Both the predicate device and the proposed device are indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign and malignant lesions.
These are the same Intended Use and Indication for Use as the previously cleared version of the trulFreeze System (K161557).
The Instructions for Use and the Operator's Manual require modification to reflect the availability of a 16 Fr OD CDT and the addition of two (2) Marker Bands to the 16 Fr CDT.
Technical and Operational Characteristics
The truFreeze System is similar in design, hardware and software, as well as operational and technological characteristics as the predicate device. No new safety concerns are being raised by the reduction in the CDT OD, additional Marker Bands or 5-Pack Configurations.
Testing
The truFreeze System was previously subjected to a comprehensive test program that included electrical safety and electromagnetic compatibility test, software tests, animal testing, biocompatibility and sterilization testing. The proposed modifications do not require repeating these tests.
The proposed reduction in CDT OD and addition of Marker Bands were subjected to CSA's verification and validation testing processes.
| Proposed Change | Test Specification | Result |
|---|---|---|
| Reduce CDT OD | The CDT shall be less than or equal to 16.5 Fr | Pass |
| The CDT shall not crack, break or experience lumen separation after exposure to temperatures with the boundary range of - 196°C and 40°C. | Pass | |
| Shall have sufficient column strength to allow it to be advanced over a 0.072” Savary Wire | Pass | |
| Shall maintain structural integrity and not kink while looped in a minimum internal bend radius. | Pass | |
| A complete flex of the CDT shall meet current kinking specification. | Pass | |
| The bonded CDT connector will withstand a minimum of 10lbf pull force without failing. | Pass | |
| Flow Rate shall meet current specification. | Pass | |
| The CDT OD shall not deform per specification. | Pass | |
| The bonded CDT connector will shall meet current. pull force specification without failing | Pass | |
| Enhance Visualization | Circumferential banding must be sufficient to identify the banding through an endoscope. | Pass |
| Shall be labeled with four side-by-side 0.100"±0.030" wide identifying bands 7.7" ±0.1" from the distal end. | Pass | |
| All 0.100" wide bands shall be 360 degrees | Pass |
Table 1. Summary of Test Results
{5}------------------------------------------------
| Summary of Design Validation Testing Completed | |||
|---|---|---|---|
| Proposed Change | Test Specification | Result | Protocol Report |
| Reduce CDT OD | CDT diameter will beas small as possiblewhile enabling gasegress and allowingit to pass throughthe majority ofanatomies with andwithout dilation | Pass | PRO-R-17-00193 User Survey /Simulated UsePRO-R-17-00198 Animal Study |
| EnhanceVisualization | CDT will have MarkBands to assist userfor performing theinitial, approximateplacement of theCDT | Pass | PRO-R-17-00193 User Survey /Simulated Use |
Rationale For Substantial Equivalence
The proposed changes do not affect the Indications for Use of the truFreeze System or alter the fundamental scientific technology of the device compared with the predicate device. They do not introduce any new safety or efficacy questions.
The company, through its design control activities, has determined that clinical data are not necessary to evaluate safety and effectiveness related to this change and that the results of design validation do not raise new issues of Safety or Effectiveness. Consequently, in the opinion of the company, the truFreeze System, incorporating the reduced French Size, additional Marker Bands, 5-Pack unit boxes and updated Operator's Manual, IFU and Product Labels, is substantially equivalent to the predicate device.
Conclusion
Based on the comparison of labeling, technology and verification testing comparisons, the truFreeze device is substantially equivalent to the predicate device K161557.
§ 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.