Search Results
Found 1 results
510(k) Data Aggregation
K Number
DEN200029Device Name
Parallel
Manufacturer
Date Cleared
2020-11-25
(209 days)
Product Code
Regulation Number
876.5960Why did this record match?
Applicant Name (Manufacturer) :
Mahana Therapeutics, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
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.
Device Description
Parallel is a web-based program designed to deliver Cognitive Behavioral Therapy (CBT) to patients with IBS who continue to have symptoms despite other forms of medical therapy. It is a responsive, web-based application that is intended to be a prescription device for use in the home for patients with IBS under the management of a qualified health care professional for the treatment of their IBS. Parallel is comprised of browser-delivered digital therapy that provides the CBT content. A desktop or laptop computer with a web browser and internet connectivity is required for use.
CBT works by targeting problematic thoughts, feelings, and behaviors, building adaptive coping skills, and interrupting the cycle that is perpetuating the targeted symptoms. CBT can be delivered in-person by a mental health practitioner with adequate training in CBT. A critical component of treatment outcome is the degree to which CBT is administered competently, reliably, and as intended. Parallel treatment uses psychoeducation and teaching behavioral and cognitive skills and techniques to alter patterns of behavior and change unhelpful thoughts.
Parallel is accessed via a secure website. Initially, the patient will receive a secure email containing an access link for the Parallel web application. Upon receiving the email invitation, the user can register electronically to begin their prescription. Once registered, patients are presented with onboarding material that introduces the program. Upon completion of reading the onboarding material, the patient can start the program.
Parallel consists of eight CBT sessions, which include interactive components. The interactive components help patients remember the guidance and concepts, reflect, and engage in the therapeutic processes of CBT. In each session, patients review key points from the previous session and review their homework, thereby reinforcing previous learning. The patient must complete the sessions in sequential order. However, a patient may go back to a previously completed session. The prescription is for 90 days and patients should complete the eight sessions within that 90-day period. After the 90 days, patients can still access the sessions that they have completed.
Ask a Question
Ask a specific question about this device
Page 1 of 1