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OSIRIX CDE SOFTWARE MODULE (Medical Device Development Tool)

TBI Endpoints Initiative, Unv. of California, San Francisco

CONTEXT OF USE: Contusions, as assessed by an expert rater from MRI using OsiriX CDE Software Module MDDT, may be used for enrichment of clinical trials for therapeutic medical devices intended to improve outcomes at 3 months for patients aged between 18-65 years with acute non-penetrating head trauma and Glasgow Coma Scale (GCS) 13-15 who have undergone acute head CT (e.g., as part of standard clinical care) at a U.S. Level 1 trauma center

ADDRESSING UNMET NEED:

  • First biomarker test tool type
  • Tool for more efficient development of devices in traumatic brain injury (TBI) treatment

TOOL DESCRIPTION AND OPERATION:

  • Software module that provides standardized way to mark boundaries and classify brain contusions (bruises) using Common Data Element (CDE) criteria
  • Information can be used to label abnormalities on MR images for enriching enrollment in clinical trials for therapeutic medical devices intended to improve outcomes of mild Traumatic Brain Injury (TBI) patients
  • Detection of a medical device effect (if present) is more likely than it would be in an unselected population
  • Can be used by medical device developers to identify and enroll patients into TBI studies.

EVIDENCE TO SUPPORT QUALIFICATION:

  • Clinical study evaluate the association between contusions and diffuse axonal injury with 3-month Glasgow Outcome Scale  and Interrater reliability
  • Previous investigations and pilot studies on level of risk associated with MDDT use,  possible advantages/disadvantages

REGULATORY PATHWAY: Qualification through MDDT pathway

  • Program to qualify tools that medical device sponsors can use in the development and evaluation of medical devices
  • ‘Qualification’ means FDA has evaluated the tool and concurs with available supporting evidence that the tool produces scientifically and clinically meaningful measurements within the authorized context of use
  • Qualified tools serve as a resource that can be referenced by any medical device sponsor
  • When used consistent with the qualified Context of Use: Results support regulatory decision-making, eliminates sponsor burden to demonstrate validation, reduces workload of FDA staff e

QUALIFICATION SUMMARY


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EARLY BIRD Bleed Monitoring System

Saranas, Inc

INDICATION FOR USE: For the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures.
The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.

GENERIC TYPE OF DEVICE: Intravascular bleed monitor.

Probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.

RISKS & MITIGATIONS: 

  • Adverse tissue reaction: Biocompatibility evaluation
  • Infection: Sterilization validation, Pyrogenicity testing, Shelf-life testing, Labeling
  • Blood loss, bleeding, hematoma: Human factors testing, Labeling, Animal performance testing, Non-clinical performance testing
  • Embolization (micro or macro) with ischemia: Human factors testing, Labeling
    Animal performance testing, Non-clinical performance testing
  • Vascular trauma: Human factors testing, Labeling, Animal performance testing, Non-clinical performance testing
  • Electrical shock: Electrical safety testing
  • Device failure due to interference with other devices: Electromagnetic compatibility (EMC) testing, Electrical safety testing
  • Device failure due to software malfunction: Software verification, validation, hazard analysis

REGULATORY PATHWAY: De Novo classification

  • Regulation Number: 21 CFR 870.1345
  • Regulation Name: Intravascular bleed monitor
  • Regulatory Class: Class II
  • Product Code: QFJ

CLASSIFICATION ORDER


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CLEARMATE ventilation device

Thornhill Research, Inc.

INDICATION FOR USE: To be used by emergency department medical professionals as an adjunctive treatment for patients suffering from carbon monoxide poisoning. The use of ClearMate enables accelerated elimination of carbon monoxide from the body by allowing isocapnic hyperventilation through simulated partial rebreathing

ADDRESSING UNMET NEED: 

  • Carbon monoxide poisoning affects thousands of people each year
  • Hyperbaric treatment, necessary for severe poisoning, has low accessibility; only 60 US medical centers with hyperbaric units
  • New device provides access to lifesaving device

DEVICE DESCRIPTION:

  • Gas mixer, valves, meters, breathing circuits, oxygen reservoir, mask and hoses
  • Speeds up elimination of carbon monoxide from body
  • Delivers both 100 % oxygen to patient, as well as a mixture of oxygen and carbon dioxide, to breathe faster
  • Increased breathing accelerates rate of elimination of carbon monoxide in body

GENERIC DEVICE TYPE: Isocapnic ventilation device

Prescription device used to administer a blend of carbon dioxide and oxygen gases to a patient to induce hyperventilation. This device may be labeled for use with breathing circuits made of reservoir bags (21 CFR 868.5320), oxygen cannulas (21 CFR 868.5340), masks (21 CFR 868.5550), valves (21 CFR 868.5870), resuscitation bags (21 CFR 868.5915), and/or tubing (21 CFR 868.5925).

EFFECTIVENESS AND SAFETY:

  • Data from multiple clinical studies for efficacy and safety, n=100
  • Effective at eliminating carbon monoxide; combination of oxygen and carbon dioxide resulted in faster elimination of carbon monoxide but not faster than hyperbaric oxygen therapy
  • Patients did not experience any device-related complications

RISKS & MITIGATIONS:

  • Hypocapnia (lacking CO2): Non-clinical performance testing, Labeling
  • Hypercapnia (excess CO2): Non-clinical performance testing, Labeling
  • Hypoxemia (lacking O2): Non-clinical performance testing, Labeling
  • High airway pressure (e.g., barotrauma): Non-clinical performance testing
    Labeling
  • Adverse tissue reaction: Biocompatibility evaluation

REGULATORY PATHWAY: De Novo classification

  • Regulation Number: 21 CFR 868.5480
  • Regulation Name: Isocapnic ventilation device
  • Regulatory Class: Class II
  • Product Code: QFB

CLASSIFICATION ORDER


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 MITRACLIP NT Clip Delivery System and MITRACLIP NTR/XTR Clip Delivery System

Abbott Vascular

EXPANDED INDICATION:  To include secondary (or functional) mitral regurgitation (MR), when MR is caused by a dysfunctional left ventricle, not by degeneration of the mitral valve itself

ORIGINAL INDICATION (2013): For the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.

ADDRESSING UNMET NEED: 

  • 6.5 million American adults live with chronic heart failure
  • Small percentage also have moderate-to-severe or severe secondary mitral regurgitation, increasing risks and complicating heart failure treatment
  • This small percentage of patients could be candidates for the new indication

DESCRIPTION:

  • MitraClip device repairs MR without open-heart surgery and is delivered to the heart through a small incision in the leg
  • Clips portions of the leaflets, or flaps, of the mitral valve together to reduce the backflow of blood, restoring the heart’s ability to pump oxygenated blood more efficiently

EFFECTIVENESS & SAFETY:

  • Patients with heart failure and moderate-to-severe or severe secondary mitral regurgitation, n=614,  transcatheter mitral-valve repair plus medical therapy (device group)  vs. medical therapy alone (control group)
  • Primary effectiveness end point: All hospitalizations for heart failure within 24 months of follow-up
    • 35.8% per patient-year in device group vs. 67.9% per patient-year in control group, P<0.001
  • Primary safety end point: Freedom from device-related complications at 12 months vs. performance goal of 88.0%
    • 96.6%  vs. 88% performance goal, P<0.001
    • Death from any cause: 29.1% in device group vs. 46.1% in control, P<0.001
  • Potential adverse events: Death, stroke, major bleeding, and atrial fibrillation

CONSUMER INFORMATION


Image Credit: UCSF, Saranas, Thornhill, Abbott 

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