FDA BRIEF: Week of Aug 22, 2016

iPro2 Continuous Glucose Monitoring System 

Medtronic MiniMed, Northridge, CA, USA

 

INDICATION FOR USE: The iPro2 Recorder is to be used with either Enlite sensor or Sof-Sensor and is intended to continuously record interstitial glucose levels in pesons with diabetes mellitus.

This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring device.

The information collected by the iPro2 Recorder may be uploaded to a computer (with Internet access) and reviewed by healthcare professionals.

This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.

REG PATHWAY:

PMA. The iPro2 CGM system previously approved for use with the Sof-sensor . This approval is for use with  Enlite sensor.

Device Procode: MDS

Classification: Sensor, Glucose, Invasive

DEVICE DESCRIPTION:

(1) iPro2 Digital Recorder

• Portable electrical current meter, data storage, and wired data communication system
• Continuous glucose recorder (measure, process, store, and upload glucose data ) for use under a physician’s direction
• Intended only for retrospective review and analysis by a healthcare professional

(2) Enlite Sensor

• Single-use, disposable component, to continuously monitor glucose levels
• Inserted into subcutaneous tissue  with sensor insertion device
• Connects to the iPro2 Digital Recorder to permit continuous glucose recording

EFFECTIVENESS:

Based on : (1) Pre-clinical bench testing results and (2) Re-analysis of clinical data

• Tests performed: Environmental exposure, functional testing, electro-magnetic compatibility (EMC), biocompatibility, cleaning/disinfection, packaging/shelf-life, software verification and validation, and human factors/usability
• Bench testing data confirmed system capability of sensing, storing, and uploading data

SAFETY:

Based on post-market data (MDR analysis) and non-clinical data

• CGM values masked – User cannot make treatment decisions
• Device-related, non-serious: Local infection, Skin inflammation, Pain or discomfort, Bleeding, Bruising, Itching, Scarring or skin discoloration, Allergic reactions to adhesive, Sensor or needle fracture during insertion, wear or removal

FDA REVIEW

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ImPACT computerized cognitive test & ImPACT Pediatric

ImPACT Applications, Pittsburgh, PA, USA

INTENDED USE: Assess cognitive function following a possible concussion. They are intended as part of the medical evaluation that doctors perform to assess signs and symptoms of a head injury.

UNMET NEED:

• > 2 million emergency room visits  due to traumatic brain injuries;  50,000 deaths
• Significant number of  injuries are mild – ‘concussion’
• Need for tool to aid in the evaluation of patients experiencing possible signs of a concussion
• But clinicians should not rely on these tests alone to rule out a concussion or determine whether an injured player should return to a game

REG PATHWAY: De Novo, Class II

DEVICE DESCRIPTION:

• ImPACT software runs on desktop or laptop for ages 12 to 59
• ImPACT Pediatric runs on an iPad for ages 5 to 11
• Licensed health care professionals perform test and interpret the results.
• Test cognitive skills such as word memory, reaction time and word recognition, all of which could be affected by a head injury
• Results compared to an age-matched control database or to a patient’s pre-injury baseline scores, if available.

EFFECTIVENESS & SAFETY:

• 250 peer-reviewed articles, half were independently conducted clinical research studies
• Analyzed devices’ validity, reliability and ability to detect evidence of cognitive dysfunction that might be associated with a concussive head injury
  

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Image credit: Medtronic, ImPACT