FDA Approvals, Evaluations: LIGHTMIX ZIKA test, ERELZI biosimilar, TREVO clot retrieval, De Novo Summaries
FDA BRIEF: Week of August 29, 2016
LIGHTMIX Zika rRT-PCR Test
Roche Molecular Systems, Pleasonton, CA, USA
INTENDED USE: Real-time RT-PCR test intended for the qualitative detection of RNA from the Zika virus in serum or EDTA plasma from individuals meeting CDC Zika virus clinical criteria (e.g., clinical signs and symptoms associated with Zika virus infection) and/or CDC Zika virus epidemiological criteria (e.g., history of residence in or travel to a geographic region with active Zika transmission at the time of travel, or other epidemiologic criteria for which Zika virus testing may be indicated). Testing is limited to CLIA certified laboratories to perform high complexity tests, or by similarly qualified non-U.S. laboratories
REG PATHWAY: Emergency Use Authorization
TEST PRINCIPLE: Zika virus primers and probe set detects RNA from the Zika virus in serum or EDTA plasma from patients presenting signs and symptoms of the Zika virus infection in conjunction with epidemiological risk factors.
- LightMix® Zika rRT-PCR Test PSR: Pathogen-specific reagent (PSR) to specifically detect Zika viral RNA
- LightMix® Zika rRT-PCR Test ivRNA Positive Control: Lyophilized synthetic RNA, designed to react with the LightMix® Zika rRT-PCR Test PSR to indicate whether the LightMix® Zika rRT-PCR Test has worked properly.
- Negative Process Control, :Negative rRT-PCR Control, Positive Control, Extraction Control
ERELZI (etanercept-szzs) injection
Sandoz Inc., Princeton, NJ, USA
INDICATION: Multiple inflammatory diseases
- moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
- moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
- active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
- active ankylosing spondylitis (an arthritis that affects the spine); and
- chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.
PRODUCT DESCRIPTION: Biosimilar to ENBREL (etanercept), which was originally licensed in 1998
REG PATHWAY: Biosimilar pathway – not an interchangeable product.
DATA to demonstrate biosimilarity to Enbrel:
- Structural and Functional characterization
- Animal study
- Human pharmacokinetic and pharmacodynamics
- Clinical immunogenicity
- Clinical Safety and Effectiveness data
TREVO clot retrieval devices
Concentric Medical Inc. (Stryker) Mountain View, CA, USA
INDICATION FOR USE: Clot retrieval devices as an initial therapy for strokes due to blood clots (ischemic) to reduce paralysis, speech difficulties and other stroke disabilities. These devices should be used within six hours of symptom onset and only following treatment with a clot-dissolving drug (tissue plasminogen activator or t-PA), which needs to be given within three hours of symptom onset.
- ~ 130,000 Americans killed by stroke each year; 85% ischemic strokes
- Only first-line treatment for acute ischemic stroke was iv t-PA
- Need for devices alongside t-PA
- Potential to help further reduce the devastating disabilities associated with strokes compared to t-PA alone
- Another tool for treating stroke and potentially preventing long-term disability
REG PATHWAY: De Novo. Prior 510(k) clearance in 2012 for patient ineligible for t-PA or failed t-PA therapy.
- Clot removal device inserted through catheter into blood vessel to blood clot site
- Shaped section at end fully expanded (3-6 mm diameter), grips clot
- Clot retrieved by physician
EFFECTIVENESS & SAFETY:
- Clinical trial, Trevo device (n=96) along with t-PA vs t-PA only (n=-249)
- Functional independence (no symptoms- slight disability) 3 m0. post-treatment: 29% vs. 19%
- Risks: Failure to retrieve the blood clot, device malfunctions including breakage and navigation difficulties.
IMPACT, IMPACT PEDIATRIC
ImPACT Applications, Inc, Pittsburgh, PA, USA
INDICATION FOR USE:
ImPACT is intended for use as a computer-based neurocognitive test battery to aid in the
assessment and management of concussion.
ImPACT is a neurocognitive test battery that provides healthcare professionals with
objective measure of neurocognitive functioning as an assessment aid and in the
management of concussion in individuals ages 12-59.
ImPACT Pediatric is intended for use as a computer-based neurocognitive test battery to
aid in the assessment and management of concussion.
ImPACT Pediatric is a neurocognitive test battery that provides healthcare professionals
with objective measure of neurocognitive functioning as an assessment aid and in the
management of concussion in individuals ages 5-11.
- De Novo, Class II
- Regulation Number: 21 CFR 882.1471
- Regulation Name: Computerized Cognitive Assessment Aid for Concussion
- Product Code: POM
PRODUCT DESCRIPTION: Prescription device that uses an individual’s score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.
IDENTIFIED RISKS – MITIGATION MEASURES:
- User discomfort (e.g., visual or mental fatigue) – Labeling
- False positive, False negative – Clinical performance testing, Software verification, validation, hazard analysis, Labeling
- Software, including proprietary algorithm(s): Software requirements specification (SRS) and software design specification (SDS), software verification, validation, and hazard analysis
- Clinical performance: Device functioning, clinical interpretation, test-retest reliability, inclusion and exclusion criteria, statistical methods and model assumptions
- Labeling: Clinical testing summary, device functioning, testing summary, warnings, instructions for use
PERMASEAL Apical Closure Device
Micro Interventional Devices, Inc., Newtown, PA, USA
INDICATION FOR USE: Soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.
- De Novo, Class II
- Regulation Number: 21 CFR 870.4510
- Regulation Name: Apical Closure Device
- Product Code: PNQ
PRODUCT DESCRIPTION: Prescription device consisting of a delivery system and implant component that is used for soft tissue approximation of cardiac apical tissue during transcatheter valve replacement procedures.
IDENTIFIED RISKS – MITIGATION MEASURES:
- Infection – Sterilization Validation, Shelf Life Testing, Labeling
- Adverse Tissue Reaction – Biocompatibility Evaluation, In vivo Performance Testing
- Bleeding – Non-clinical Performance Testing, In vivo Performance Testing Labeling
- Tissue Damage – Non-clinical Performance Testing, In vivo Performance Testing, Labeling, Training
- New Hypokinesia or Akinesis of Apex – In vivo Performance Testing, Labeling
- Thromboemboli and Full Thickness Injury – In vivo Performance Testing, Labeling, Training
- Pericardial TamponadeL In vivo Performance Testing, Labeling
- Biocompatibility of patient contacting materials
- Sterility of the patient-contacting components
- Shelf life by continued sterility, package integrity, and device functionality
- Non-clinical performance testing of performance
- In vivo evaluation of performance