truFreeze System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three heads, representing the department's commitment to health, human services, and science. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 24, 2017 CSA Medical, Inc. Ms. Sherrie Coval-Goldsmith. M.S. VP of Regulatory & Quality 91 Hartwell Avenue Lexington, Massachusetts 02421 Re: K163244 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: April 25, 2017 Received: April 27, 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 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/Resourcesfor You/Industry/default.htm. Sincerely, # Jennifer R. Stevenson -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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K163244 Device Name truFreeze® System Indications for Use (Describe) The truFreeze System is indicated for use as a cryosurgical tool in the fields of dermatology, gynecology, and general surgery, to ablate benign (e.g. Barrett's Esophagus with high grade dysplasia) and malignant lesions. Type of Use (Select one or both, as applicable) > 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}------------------------------------------------ #### K163244 #### 510(k) SUMMARY Applicant Establishment Registration Number Contact Person Summary Date Proprietary Name Classification Classification Name Regulation Number Classification Predicate Device Reference Devices 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 May 19, 2017 truFreeze® System Class II Cryosurgical Unit, Cryogenic Surgical Device 21 CFR 878.4350 Product Code GEH K162695 (truFreeze® System) K152329 (Coldplay CryoBalloon™ Focal Ablation System), K083737 (Barrx System), and K 161202 ((Coldplay CryoBalloon™ Focal Ablation 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 technical malfunction. The console is the same as previously cleared for the predicate truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised. #### 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 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 {4}------------------------------------------------ truFreeze System (K162695). Therefore, there are no new issues of safety or effectiveness raised. ## Labeling (Intended Use/Indications for Use and Instructions for Use Document) The Intended Use/Indications for Use statement is identical in its Intended Use as the predicate device with the exception of adding a specific indication for use as an example of benign tissue that can be ablated with truFreeze. Clinical data has been generated to substantiate a change in label claim. The proposed modification adds Barrett's Esophagus with high grade dysplasia into the Intended Use/Indications for Use statement as an example of benign tissue to be ablated. ## 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 (eg. Barrett's Esophagus with high grade dysplasia) and malignant lesions. ## Technical and Operational Characteristics The truFreeze System is identical 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. Data was previously submitted to support that the use of liquid nitrogen is cold enough to ablate benign or malignant lesions (K133258) and reference is being made to that data. Clinical data are summarized below. ## Rationale For Substantial Equivalence: The Intended Use/Indications for Use statement and technological characteristics of the truFreeze System and the predicate device were compared. The Intended Use/Indications for Use statement of the two devices had equivalent general claims but a specific example of a benign lesion that can be ablated was added to the indications for use statement. Clinical data are presented to support the safety and efficacy of adding Barrett's Esophagus with high grade dysplasia as an example of specific benign that can be ablated. A clinical summary of data collected from a post market registry study (ClinicalTrials.gov Identifier: NCT01802203) supports this submission. This post-marketing registry prospectively collected data on patients treated with the FDA-cleared cryotherapy device (truFreeze® System). The instructions for use document guided the dosimetry used for ablation procedures. Similar to any clinical trial, physicians offered "all comers" with BE to participate in the registry if they met all inclusion criteria and none of the exclusion criteria. Patients were sequentially and consecutively {5}------------------------------------------------ enrolled into the registry at participating trial. The registry had pre-defined inclusion / exclusion criteria, which are consistent with the instructions for use of the cleared device. CSA Medical applied 3 additional exclusion criteria that were sequentially applied to the population of BE patients. These exclusion criteria included items 3-5 in table 1 below. This yielded patients for the efficacy population. Two medical societies cite endoscopic radiofrequency ablation (RFA) as a recognized ablation method for BE HGD. 1-2 A rate of 81% CE-D is cited in the literature with a lower rate of 62% also being cited.1- The clinical data for the patients with Barrett's Esophagus high grade dysplasia are provided in Tables 1-5 below. | Inclusion Criteria | 1. Able to read, comprehend, and complete the informed consent form.<br>2. Aged 18 or older.<br>3. Receiving spray cryotherapy procedure with the truFreeze device for<br>the first time for removal of unwanted tissues including malignant or pre-<br>malignant conditions of the aerodigestive system. | |---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Exclusion Criteria | 1. Contraindication to spray cryotherapy.<br>2. Prior treatment with spray cryotherapy. Previous or concurrent<br>treatment using other mucosal therapies such as endoscopic mucosal<br>resection or radiofrequency ablation is acceptable.<br>3. Patients not having Barrett's Esophagus with high grade dysplasia.<br>4. Patients without a pre-therapy and post-therapy histology.<br>5. Patients who received other therapies (such as endoscopic mucosal<br>resection) during the ablation therapy period. | | Safety Population | 111 Patients | | Efficacy population | 46 patients | | Device Used | truFreeze System | Table 1 Summary of Populations analyzed ## Table 2 Demographics | | BE Patients<br>(Safety Population)<br>(N=111) | BE HGD Patients<br>(Efficacy Population)<br>(N=46) | |----------------------------|-----------------------------------------------|----------------------------------------------------| | Age Mean (yrs) | 67.8 (10.8) | 67.4 (9.1) | | Range (yrs) | 24 - 89 | 50 - 86 | | Female | 29 (26.1%) | 15 (32.6%) | | Male | 82 (73.9%) | 31 (67.4%) | | Segment length (cm) <= 3 | 65 (59%) | 30 (65%) | | Segment length (cm) 3-6 | 17 (15%) | 8 (17%) | | Segment length (cm) >=6 | 21 (19%) | 5 (11%) | | Segment length (cm)Unknown | 8 (7%) | 3 (7%) | {6}------------------------------------------------ | | BE Patients<br>(Safety Population)<br>(N=111) | BE HGD Patients<br>(Efficacy Population)<br>(N=46) | |-----------------------------------------|-----------------------------------------------|----------------------------------------------------| | Previous EMR, no. (%) | 30 (28%) | 17 (37%) | | Mean time since EMR (months), mean (SD) | 6.9 (11.8)<br>N=28<br>(2 missing data) | 7.0 (12.7)<br>N=17 | Table 3 . Procedure Information to Achieve Best Response | | 46 BE-HGD Patients in Efficacy<br>Population | |--------------------------------------------------------------|----------------------------------------------| | Patients receiving 1 procedure session to best<br>response | 19 (41%) | | Patients receiving 2 procedure sessions to best<br>response | 17 (37%) | | Patients receiving 3 procedure sessions to best<br>response | 6 (13%) | | Patients receiving >3 procedure sessions to best<br>response | 4 (9%) | | Mean Procedure Sessions (SD) | 1.89 (0.95) | | Mean Cycles per procedure (SD) | 2.23 (0.52) | | Mean Time (sec) per cycle (SD) (seconds) | 21.17 (2.94) | Table 4 Procedure or Device Related Adverse Event Rate per Procedure Session | | BE Patients<br>Safety Population Procedures<br>(258 procedures) | BE HGD Patients<br>Efficacy Population Procedures<br>(113 procedures) | |---------------|-----------------------------------------------------------------|-----------------------------------------------------------------------| | Stricture | 3 (1.2%) | 1 (0.9%) | | Pancreatitis* | 1 (0.4%) | 1 (0.9%) | * This is the only serious adverse event reported. The physician stated the relationship of truFreeze treatment and development of pancreatitis was highly unlikely. However, a possible causal relation with the device could not be ruled out because of the temporal association. {7}------------------------------------------------ # Table 5 Barrett's segment length for CE-D Results | | Response<br>CE-D | |------------------------------------|------------------| | Efficacy Population | 46 | | N Responders | 40 (87.0%) | | Response rate by BE segment length | | | Unknown | 2 (4.3%) | | <= 3cm | 27 (58.7%) | | 3-6cm | 7 (15.2%) | | >=6cm | 4 (8.7%) | # Table 6 Safety Data | | truFreeze Per Patient Rate | |---------------------|----------------------------| | | Safety Population (N=111) | | Stricture | 3 (2.7%) | | Abdominal Pain | 0 (0%) | | Pancreatitis | 1 (0.9%) | | Chest Pain | 0 (0%) | | GI Hemorrhage | 0 (0%) | | Mucosal Lacerations | 0 (0%) | # Table 7 Efficacy Data (N=46) | | CE-D Patients (%) | |-----------|-------------------------------| | truFreeze | 40 (87% BE-HGD patients only) | {8}------------------------------------------------ ## Discussion The data show that the majority of BE-HGD patients were successfully treated with the truFreeze device. Among the 46 BE-HGD patients in the efficacy population, 40 achieved a response of CE-D of 87.0 %. This success rate is comparable to the success rate for the Barrx System and the Coldplay CryoBalloon™ Focal Ablation System among all phenotypes of BE patients, ranging from no dysplasia to early adenocarcinoma and across 3 different ablation doses. The safety rate of the trufreeze device is also substantially equivalent to these 2 reference devices. ## Conclusion In summary, endoscopic ablation of Barrett's Esophagus with high grade dysplasia with the truFreeze device does not raise new questions of safety or efficacy as compared to the reference devices or the predicate device and warrant adding Barrett's Esophagus with high grade dysplasia as an example of benign tissues that can be ablated, to the truFreeze label. This indication was supported by clinical data obtained from the post market registry study (ClinicalTrials.gov Identifier: NCT01802203). #### References - ASGE Standards of Practice Committee. The role of endoscopy in Barrett's esophagus and other 1. premalignant conditions of the esophagus. Gastrointestinal Endoscopy 2012; 76 (6): 1087 (available at https://www.asge.org/docs/default-source/education/practice_guidelines/doc-therole-of-endoscopy-in-barretts- esophagus-and-other-premalignant-conditions-of-theesophagus.pdf?sfvrsn=8). - Nicholas J. Shaheen , MD, MPH, FACG , Gary W. Falk , MD, MS, FACG, Prasad G. lyer , MD, MSc, 2. FACG andLauren Gerson , MD, MSc, FACG. ACG Clinical Guideline: Diagnosis and Management of Barrett's Esophagus. Am J Gastroenterol advance online publication, 3 November 2015; doi: 10.1038/ajg.2015.322 (available at https://gi.org/guideline/diagnosis-and-management-of-barretts-esophagus/).