Freespira Breathing System

{0} **FDA** **U.S. FOOD & DRUG** ADMINISTRATION April 25, 2025 Freespira, Inc Simon Thomas President 12020 113th Ave NE, Suite 215 Kirkland, Washington 98034 Re: K233337 Trade/Device Name: Freespira Breathing System Regulation Number: 21 CFR 882.5050 Regulation Name: Biofeedback Device Regulatory Class: Class II Product Code: SEN, CCK Dated: December 26, 2024 Received: December 27, 2024 Dear Simon Thomas: 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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K233337 - Simon Thomas Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K233337 - Simon Thomas Page 3 Sincerely, **Heather L. Dean -S** for Vivek Pinto, PhD, MBA Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K233337 Device Name Freespira Indications for Use (Describe) Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions. In patients 13 to 17 years old, Freespira is indicated for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of patient-reported symptoms associated with stress and anxiety. The device is prescription only, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions. 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." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} K233337 # 510(k) Summary # **DATE PREPARED** April 24, 2025 # **MANUFACTURER AND 510(k) OWNER** Freespira, Inc. 12020 113$^{th}$ Ave NE, Building C, Suite 215 Kirkland, WA 98034, U.S.A. Telephone: (925) 594-8404 Fax: (844) 394-2533 Official Contact: Simon Thomas, President # **REPRESENTATIVE/CONSULTANT** Allison Komiyama, Ph.D., RAC Erin Gontang, Ph.D. RQM+ Telephone: (412) 816-8253 Email: akomiyama@rqmplus.com; egontang@rqmplus.com # **PROPRIETARY NAME OF SUBJECT DEVICE** Freespira® # **COMMON NAME / DEVICE CLASSIFICATION** Device, Biofeedback (21 CFR 882.5050, SEN, Class II) Analyzer, Gas, Carbon---Dioxide, Gaseous---Phase (21 CFR 868.1400, CCK, Class II) # **PREMARKET REVIEW** OPEQ/OHT5/DHT5B – Neuromodulation and Psychiatry Devices Team # **INDICATIONS FOR USE** Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD), to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions. In patients 13 to 17 years old, Freespira is indicated for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of patient-reported symptoms associated with stress and anxiety. The device is prescription only, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions. {5} K233337 ## DEVICE DESCRIPTION Freespira® is intended for use as a relaxation treatment for the reduction of stress by leading the user through guided and monitored breathing exercises. The device is indicated as an adjunctive treatment of symptoms associated with panic disorder (PD) and/or posttraumatic stress disorder (PTSD) for adults 18 years of age or older. For those 13-17 years of age, the device is indicated as an adjunctive treatment of symptoms associated with stress and anxiety. The device is prescription use only, to be used under the direction of a healthcare professional, together with other pharmacological and/or non-pharmacological interventions. Patients are trained to use the Freespira Sensor and the Freespira Mobile App to measure and display their exhaled carbon dioxide (EtCO₂) level and respiration rate (RR) and how different breathing techniques affect EtCO₂ levels. ## PREDICATE DEVICE IDENTIFICATION Freespira is substantially equivalent to the following predicates: | 510(k) Number | Predicate Device Name / Manufacturer | Predicate Type | | --- | --- | --- | | K180173 | Freespira Breathing System / Freespira, Inc | Primary | | K131586 | Canary Breathing System/ Freespira, Inc | Secondary | ## SUMMARY OF NON-CLINICAL TESTING No FDA performance standards have been established for Freespira. Reports on the following tests were provided to demonstrate safety based on current industry standards: Biocompatibility: Patient contacting material was evaluated for biocompatibility in compliance to ISO 10993-1:2009(R)2013 *Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.* Software Verification: The software development and testing was executed according to FDA’s Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Electromagnetic Compatibility and Electrical Safety: The subject device was tested in compliance to methods outlined in IEC 60601-1:1988 +A1:1991 +A2:1995 – *Medical Electrical Equipment Part 1: General Requirements for Safety*; ANSI/AAMI ES60601-1:2005 *Medical Electrical Equipment – Part 1: General Requirements For Basic Safety And Essential Performance*; IEC/EN 60601-1-2:2007 – *Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic compatibility – Requirements and tests*; IEC 60601-1-4:1996 + A1:1999 – *Medical electrical equipment – Part 1-4: General requirements for safety – Collateral standard: Programmable electrical medical systems*; and IEC 60601-1-11:2010 – *Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.* ## SUMMARY OF CLINICAL TESTING Clinical Investigators performed an unblinded feasibility investigation and a pilot waitlist randomized clinical trial (RCT) of Freespira. Additionally, patients aged 13-17 years old who presented with symptoms associated with stress and anxiety disorders were treated with Freespira during the COVID-19 public health emergency under FDA’s “Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency.” {6} K233337 1. The feasibility study investigated the feasibility and acceptability of Freespira in adolescents 13-17 years old. Twelve subjects with a broad spectrum of anxiety disorders were enrolled after being screened with the Screen for Child Anxiety Related Disorders (SCARED) survey. The investigators reported good acceptability and safety profiles for those using Freespira, with no adverse events reported. Outcomes were measured using the SCARED survey which reported a significant reduction in symptoms overall and in the Social Anxiety and Significant School Avoidance subscales following treatment. Protocol adherence was 47% and average exhaled CO2 increased from 36.6 to 38.0 mmHg, which represents values moving into the physiological normal range. 2. The pilot study enrolled 60 children and adolescents (aged 9-17), and used the SCARED survey, CASI (Child and Adolescent Symptom Inventory) and the Panic Disorder Severity Scale – Adolescent (PDSSA) to assess symptom changes post-treatment and extending out to 12-months. This study was a randomized waitlist design in which the treatment group received Freespira, and the control group waited 2-months before starting treatment with Freespira. The treated and waitlist groups were compared to assess the effectiveness of Freespira. The study hypothesized that from baseline to the 2-month post-treatment, at least 65% of study participants in the Freespira (test) group experience a clinically meaningful change in their total SCARED score (41-item) version vs. 20% in the active waitlist control group. A clinically meaningful change was defined as at least a 25% reduction in SCARED score from baseline to 2 months post-treatment. At study completion, 52% test and 25% control met success threshold for clinical significance (25% reduction in SCARED score). This difference in proportions did not reach statistical significance (p=0.057, Fisher's exact test). The study showed a decrease in overall SCARED symptom scores at 4-weeks, 8-weeks, and 6-months with a smaller decrease at 12-months. The waitlist group did not show a significant reduction in scores through 8 weeks. The SCARED PN subscale (panic disorder or significant somatic symptoms) showed a similar response as the overall scale results. A reduction in CASI scores (Changes in Child and Adolescent Symptom Inventory) was reported in the treated adolescents, with no significant changes in the control group. The study also measured the effect of Freespira on panic attack symptoms using the PDSSA (Panic Disorder Severity Scale-Adolescents). In adolescent patients with significant panic attack symptoms (i.e., a PDSSA score >=10), treatment reduced the scores post-treatment, at 8-weeks, 6-months, and 1-year. Adverse events were similar to those reported in previous adult studies. The adverse events were short in duration, concentrated in early sessions, and only experienced during the sessions. Shortness of breath while performing the breathing exercises in early sessions was the most common. 3. Based on the results from the RCT in adolescents with panic attack symptoms, Freespira was made available to adolescents (aged 13-17) during the COVID-19 pandemic under FDA's "Enforcement Policy for Digital Health Devices for Treating Psychiatric Disorders During the COVID-19 Public Health Emergency." Outcomes were determined for 106 treated adolescents {7} K233337 aged 13-17 and compared to two cohorts of patients (aged 18-21 and 21+) treated in the same period. Analyses were conducted post-hoc and were not prespecified in the study. Patients were evaluated for panic disorder symptom severity, panic attacks and PTSD symptom severity at baseline and post treatment using PDSS, PDSS-A and PCL surveys as appropriate. However, since DSM-5 diagnostic scales were not used as formal inclusion criteria for the real-world study, it is unclear whether all subjects in the pivotal and real-world studies would have met the DSM-5 criteria for a PD and/or PTSD diagnosis. Results from 88 adolescents (aged 13-17) treated for panic symptoms and included in the analyses based on PDSS score, showed no significant differences in PDSS response rates and in the proportion achieving remission (Fisher's exact test). Mean reduction in PDSS were also comparable with similar effect sizes for all. | | Adolescents(13-17 years) | Adolescents(18-21 years) | Adults(22+ years) | | --- | --- | --- | --- | | Number of Subjects | 88 | 63 | 1,465 | | Average Adherence | 70% | 65% | 82% | | Mean Baseline PDSS(A) Score (SD) | 15.8 (5.5) | 16.0 (4.7) | 14.7 (5.1) | | Mean Post-Treatment PDSS(A) Score (SD) | 7.3 (5.9) | 7.3 (5.5) | 6.6 (5.6) | | Mean PDSS(A) Reduction – Points (%) | 8.6 (54%) | 8.7 (54%) | 8.2 (56%) | | PDSS(A) Reduction Effect Size | 0.53 | 0.60 | 0.54 | | % patients achieving Response (40% decrease in PDSS(A) from baseline) post-tx | 68% | 79% | 71% | | % patients achieving Remission (PDSS(A) score ≤5) post-tx | 45% | 38% | 48% | Note: PDSS(A): Panic Disorder Severity Scale (Adolescents); SD: Standard Deviation Results from 18 adolescents (aged 13-17) being treated for PTSD symptoms and included in the analyses based on PCL score showed no significant differences in PCL response rates versus patients (aged 18-21 and 21+) and rates of achieving PCL scores below the diagnostic threshold of 32 points (Fisher's exact test). Mean reductions in PCL were also comparable with similar effect sizes for all. | | Adolescents(13-17 years) | Adolescents(18-21 years) | Adults(22+ years) | | --- | --- | --- | --- | | Number of Subjects | 18 | 24 | 961 | | Average Adherence | 75% | 87% | 78% | | Mean Baseline PCL Score (SD) | 49.5 (16.1) | 56.1 (12.9) | 49.6 (14.6) | | Mean Post-Treatment PCL Score (SD) | 27.6 (18.2) | 35.7 (21.7) | 28.6 (19.5) | | Mean PCL Reduction - Points (%) | 21.9 (44%) | 20.3 (36%) | 21.1 (42%) | | PCL Reduction Effect Size | 0.46 | 0.40 | 0.43 | | % patients achieving Response (10-point decrease PCL from baseline) | 75% | 67% | 71% | | % patients below threshold for diagnosis (PCL score <32) | 75% | 50% | 62% | Note: PCL: PTSD Checklist; SD: Standard Deviation {8} K233337 These clinical data demonstrate that Freespira provides substantially equivalent safety and effectiveness as the predicate device, as adjunct at-home treatment of symptoms associated with stress and anxiety disorders for adolescents aged 13-17 who have been screened, but are not necessarily diagnosed, and that Freespira can be easily and widely disseminated. Freespira treatment is completed in 4-weeks at home without serious side-effects; this may have contributed to the average protocol adherence of 71% for adolescents (aged 13-17), which is similar to the 71% and 80% average protocol adherence of older adolescents (aged 18-21) and adults (aged 22+), respectively. Furthermore, no new adverse events (AEs) were reported by adolescents (aged 13-17) compared to the 18+ year old age group, and the single rare AE (facial numbness) resolved immediately upon termination of the breathing exercise. ### **EQUIVALENCE TO PREDICATE DEVICE** Freespira is substantially equivalent to the predicate device based on the information summarized here: The subject device has the same design and dimensions and uses identical materials as the device cleared in K180173. The subject device has the same technological characteristics as the device cleared in K180173. The fundamental difference between the two devices is that the subject device has expanded indications for use that include its use as an adjunct treatment of symptoms associated with stress and anxiety disorders in adolescents aged 13-17. The subject device has undergone bench and clinical testing to ensure the device is as safe and effective as the predicate. ### **CONCLUSION** Based on the testing performed, including the prospective clinical studies and real-world evidence collected under the COVID-19 Enforcement Discretion Policy, it can be concluded that the subject device does not raise different questions of safety or effectiveness compared to the predicate device. The technological characteristics and performance characteristics for Freespira are similar and the device is substantially equivalent to the predicate device after appropriate modifications to labeling. The device is considered substantially equivalent to the predicate in terms of safety and effectiveness for its intended use.