(29 days)
Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
Parallel is a Prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). PDTs are a new class of treatment using software to treat medical diseases. The Parallel CBT program has been tailored for patients with IBS. The rationale for applying CBT to treat IBS is grounded in the biopsychosocial model. This model states that one's biology, thoughts, and behaviors influence IBS symptom expression in a bidirectional way. The biological substrate of these interactions that affect IBS outcomes is the "brain-gut axis". The brain-gut axis underlies the pathways (e.g., psychological, behavioral functioning, and physiological interactions) that contribute to IBS symptom manifestation. CBT allows patients to influence brain-gut communication in order to reduce the severity of IBS. Parallel is available by prescription only and is intended to provide 3 months of cognitive behavioral therapy for adult patients, aged 22 years and older, with IBS. Parallel is intended to provide CBT, as an adjunct to any other IBS treatments. The Parallel mobile application uses the patient's mobile phone or tablet to deliver therapy on demand as a complement to the provider's care. Typical length of the therapy period is 3 months and is composed of ten (10) sessions. The first session explains IBS symptoms, the key features of the brain-gut axis, and the personalization of the rationale for CBT. The next nine (9) sessions provide personalized treatment for IBS by asking patients and getting them to complete interactive tasks. Each session contains several pages of content which may be text, audio files, video files, or interactive components. During the program, patients are provided short tasks to complete during the week. Patients are also asked to complete questionnaires from time to rate the severity of their IBS symptoms and the impact symptoms are having on their life and mood.
This document is a 510(k) premarket notification decision letter from the FDA to Mahana Therapeutics, Inc. for their Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS). It primarily outlines the FDA's determination of substantial equivalence to a predicate device and the regulatory controls that apply.
Crucially, this document states that "no additional clinical studies are necessary to establish substantial equivalence between the web and mobile versions of Parallel, and to provide reasonable assurance of safety and effectiveness." This means that this 510(k) submission does not contain new clinical study data proving the device meets specific acceptance criteria based on performance. Instead, it relies on the predicate device's existing evidence and demonstrates that the mobile version's changes do not impact safety or effectiveness.
Therefore, I cannot provide the detailed information requested in the prompt's points 1 through 9 regarding acceptance criteria and a new study demonstrating the device meets those criteria. The document explicitly states that such studies were not deemed necessary for this particular submission due to the nature of the changes from the predicate device.
To answer your request, I will explain what would be provided if the document did contain the information, and then explicitly state what is missing based on this document.
What is present in the document (and why other information is absent for this 510(k) submission):
- Device Name: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
- Regulation Number: 21 CFR § 876.5960
- Regulation Name: Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions
- Regulatory Class: II
- Product Code: OMY
- Indications for Use: Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
- Predicate Device: Parallel - DEN200029 (web version)
- Reason for no new clinical studies: "The core CBT skills that constitute the clinical basis of the predicate Parallel (web version) are unchanged and remain identical in the subject Parallel (mobile version). There is no impact to clinical functionality, and no new introduced or modified existing risks."
Based on the provided document, the following requested information cannot be extracted because the submission relies on the predicate device's data and asserts that no new clinical studies were necessary due to the nature of the changes from web to mobile:
- A table of acceptance criteria and the reported device performance: This document does not present any new performance data against acceptance criteria. It states that the device is substantially equivalent to the predicate, implying it meets the predicate's established safety and effectiveness.
- Sample sized used for the test set and the data provenance: No new clinical test set data is presented.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new clinical test set data is presented.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no new clinical test set data is presented.
- 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. This is a digital therapeutic for IBS, not an imaging AI diagnostic aid.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a prescribed therapeutic, used by patients to deliver CBT. Its performance is directly tied to user engagement and clinical outcomes, not an "algorithm-only" performance in the diagnostic sense. No new study of its direct performance is presented.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new clinical test set data is presented. Performance relies on the predicate's established efficacy.
- The sample size for the training set: Not applicable as no new clinical test set data from the mobile version's development is presented.
- How the ground truth for the training set was established: Not applicable as no new clinical test set data from the mobile version's development is presented.
In summary, this 510(k) submission for the Mahana Parallel Digital CBT Mobile Application asserts substantial equivalence to a previously cleared web-based version. It explicitly states that "no additional clinical studies are necessary" because the changes are technological (web to mobile platform) and minor content adjustments that do not impact clinical functionality or introduce new risks. Therefore, the document does not contain the details of acceptance criteria or a study proving the device meets these criteria as if it were a novel device requiring new clinical evidence.
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June 2, 2021
Mahana Therapeutics, Inc. Jean-Noel Courvoisier Senior Manager Global Regulatory Affairs One Market, Spear Tower 36th Floor San Francisco. CA 94105
Re: K211372
Trade/Device Name: Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS) Regulation Number: 21 CFR§ 876.5960 Regulation Name: Computerized Behavioral Therapy Device for Treating Symptoms of Gastrointestinal Conditions Regulatory Class: II Product Code: OMY Dated: April 30, 2021 Received: May 4, 2021
Dear Jean-Noel Courvoisier:
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. 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 located 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.
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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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known)
Device Name
Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) Mobile Application for Irritable Bowel Syndrome (IBS)
Indications for Use (Describe)
Parallel™ is a prescription-only digital therapeutic intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
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.
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510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements set forth in 21 CFR 807.92
The assigned 510(k) number is: K211372
Submitter / Company Kendal Dinsmore Senior Director, Global Quality Regulatory 415-714-1308 Kendal@mahanatherapeutics.com
Mahana Therapeutics, Inc. One Market Spear Tower, 36th Floor San Francisco, CA 94105 Establishment Registration Number: 3017935596 Owner Operator Number: 10080229
Company contact
Jean-Noel Courvoisier Senior Manager, Global Regulatory Affairs 415-335-8649 Jeannoel(@mahanatherapeutics.com
Date prepared
26 May 2021
Proposed new device
| Trade/Proprietary Name: | Mahana Parallel Digital Cognitive Behavioral Therapy (CBT) MobileApplication for Irritable Bowel Syndrome (IBS) |
|---|---|
| Common/Usual Name: | Digital Cognitive Behavioral Therapy (CBT) software for IrritableBowel Syndrome (IBS) |
| Device Class | Class II |
| Classification Name | Computerized behavioral therapy device for treating symptoms ofgastrointestinal conditions |
| Predicate Device | Parallel - DEN200029 |
| Regulation Number | 21 CFR 876.5960 |
| Product Code | QMY |
| Device Regulation Panel: | Gastrointestinal |
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Subject device description
Parallel is a Prescription Digital Therapeutic (PDT) mobile application designed to deliver Cognitive Behavioral Therapy (CBT) to patients with Irritable Bowel Syndrome (IBS). PDTs are a new class of treatment using software to treat medical diseases.
The Parallel CBT program has been tailored for patients with IBS. The rationale for applying CBT to treat IBS is grounded in the biopsychosocial model. This model states that one's biology, thoughts, and behaviors influence IBS symptom expression in a bidirectional way. The biological substrate of these interactions that affect IBS outcomes is the "brain-gut axis". The brain-gut axis underlies the pathways (e.g., psychological, behavioral functioning, and physiological interactions) that contribute to IBS symptom manifestation.2 CBT allows patients to influence brain-gut communication in order to reduce the severity of IBS.
Parallel is available by prescription only and is intended to provide 3 months of cognitive behavioral therapy for adult patients, aged 22 years and older, with IBS. Parallel is intended to provide CBT, as an adjunct to any other IBS treatments. The Parallel mobile application uses the patient's mobile phone or tablet to deliver therapy on demand as a complement to the provider's care.
Typical length of the therapy period is 3 months and is composed of ten (10) sessions. The first session explains IBS symptoms, the key features of the brain-gut axis, and the personalization of the rationale for CBT. The next nine (9) sessions provide personalized treatment for IBS by asking patients and getting them to complete interactive tasks. Each session contains several pages of content which may be text, audio files, video files, or interactive components. During the program, patients are provided short tasks to complete during the week. Patients are also asked to complete questionnaires from time to rate the severity of their IBS symptoms and the impact symptoms are having on their life and mood.
Indication for use
The indication for use of the subject Parallel (mobile version) remains identical that of the predicate Parallel (web version - DEN200029):
Parallel™ is a prescription-only digital therapeutic device intended to provide cognitive behavioral therapy for adults aged 22 years of age and older who have been diagnosed with Irritable Bowel Syndrome (IBS). Parallel is indicated as a 3 month treatment for patients with IBS. Parallel treats IBS by reducing the severity of symptoms and is intended to be used together with other IBS treatments.
Technological characteristic differences
The changes from the predicate device consist of:
- Technical optimization for mobile application environment over web-based software including: ●
- Software platform to mobile environment. -
- Web to mobile device user interface form factor. -
- Downloading homework PDF files to interactive in-app homework. -
- Minor content adjustments including: ●
- Updates to reflect current clinical best practice. -
- -Reordering of some contents within sessions.
- Changes to session breaks for length consistency. -
- Digitization of homework process. -
1 Moss-Morris, R., et al. (2010). A randomized controlled trial of a cognitive behavioural therapy-based self management intervention for irritable bowel syndrome in primary care. Psychological medicine, 40(1), 85-94.
2 van Tilburg, M. A., et al. (2013). Which psychological factors exacerbate irritable bowel syndrome? Development
of a comprehensive model. Journal of psychosomatic research, 74(6), 486-492.
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Clinical tests
The differences between the predicate (Parallel web version) and the subject (Parallel mobile version) devices consist of technological changes and minor adjustments to content.
The core CBT skills that constitute the clinical basis of the predicate Parallel (web version) are unchanged and remain identical in the subject Parallel (mobile version). There is no impact to clinical functionality, and no new introduced or modified existing risks. By following Mahana's Design Control process, it is sufficient to establish substantial equivalence between the web and mobile versions of Parallel. Therefore, no additional clinical studies are necessary to establish substantial equivalence between the web and mobile versions of Parallel, and to provide reasonable assurance of safety and effectiveness.
Non-clinical tests
Following Mahana's design control procedures, verification activities have been completed successfully for Parallel. Parallel software verification passed all tests within the passing criteria with limitations. All open bugs were triaged for risk, documented, and in accordance with ISO14971. All open bugs are either in queue for fix in the current sprint cycle or deferred for a future sprint cycle with justification. All deferred bugs have been documented and found acceptable for risk.
The subject device (Parallel mobile version) was assessed for human factors risk and there were no critical tasks discovered during risk assessment. Parallel (mobile version) passed user usability testing for usability, navigation, functionality, and ability to complete tasks.
In conclusion, the clinical and non-clinical tests demonstrate that the subject device (Parallel mobile version) is as safe, as effective, and performs as well as or better than the legally marketed device predicate (Parallel web version - DEN200029).
§ 876.5960 Computerized behavioral therapy device for treating symptoms of gastrointestinal conditions.
(a)
Identification. A computerized behavioral therapy device for treating symptoms of gastrointestinal conditions is a prescription device intended to provide a computerized version of condition-specific therapy as an adjunct to standard of care treatments to patients with gastrointestinal conditions.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical data must be provided to fulfill the following:
(i) Describe a model of therapy for the indicated gastrointestinal conditions;
(ii) Validate the model of therapy as implemented by the device using a clinically defined endpoint; and
(iii) Evaluate all adverse events.
(2) Software must be described in detail in the software requirements specification and software design specification. Software verification, validation, and hazard analysis must be performed. Software documentation must demonstrate that the device effectively implements the behavioral therapy model.
(3) Usability assessment must demonstrate that the intended user(s) can safely and correctly use the device.
(4) Labeling:
(i) Labeling must include instructions for use, including images that demonstrate how to interact with the device;
(ii) Patient and physician labeling must list the minimum operating system requirements that support the software of the device;
(iii) Patient and physician labeling must include a warning that the device is not intended for use in lieu of a standard therapeutic intervention or to represent a substitution for the patient's medication;
(iv) Patient and physician labeling must include a warning to seek medical care if a patient has feelings or thoughts of harming themselves or others; and
(v) Physician and patient labeling must include a summary of the clinical testing with the device.