FDA Device Approvals, Classifications: POWERLOOK Software, ASTRON Pulsar Stent, OCULEVE Tear Stimulator – Drug and Device Digest

FDA BRIEF: Week of May 8, 2017

FDA approved

Image result for iCAD PowerLook® Tomo Detection Software

PowerLook® Tomo Detection Software

iCAD Inc. Nashua, NH, USA

INDICATION FOR USE: Software device intended to be used concurrently by radiologists while reading GE Senoclaire breast tomosynthesis exams. The system detects up to five soft tissue densities (masses, architectural distortions and asymmetries) in the 3D tomosynthesis images. The detections are blended with the standard 2D synthetic image and the computer assisted detection (CAD)-enhanced 2D synthetic image is viewed on a mammography review workstation.

The CAD-enhanced 2D synthetic image assists radiologists in identifying densities (masses, architectural distortions and asymmetries) that may be confirmed or dismissed by the radiologist in the digital breast tomosynthesis (DBT) images.


  • Class III, Product Code: MYN


  • Software in conjunction with the GE Senoclaire and mammography review workstation create a CAD-enhanced 2D synthetic image
  • Allow radiologists to review tomosynthesis images more quickly without a statistically significant decrease in performance
  • Detects soft tissue densities (masses, architectural distortions and asymmetries)
  • Blending algorithm processes CAD detections from  3D planes and merges into GE’s existing 2D volume preview
  • Software uses pattern recognition technology to identify potential regions of interest
  • Enhancement step to project 3D structure onto the V-Preview image


  • Pivotal Reader Study was a retrospective, multi-reader, multi-case study
  • Average radiologist performance with CAD noninferior to performance using GE DBT images without CAD enhanced 2D V-Preview images
  • Average AUC increased by 0.009 (95% CI: -0.012, 0.030; non-inferiority p < 0.01), from 0.841 without CAD to 0.850 with CAD
  •  Average radiologist reading time was improved with CAD


  • Aid in the interpretation of existing DBT images
  • Does not modify the existing DBT image acquisition process nor alter native DBT images
  • Use of the software does not directly involve the patient
  • Risk is increased false positives or false negatives


Pulsar-18 Image

ASTRON Pulsar Stent System

Biotronik, Inc, Oswego, OR, USA

INDICATION FOR USE: The Astron Pulsar and Pulsar-18 stent systems are indicated for use to improve luminal diameter in patients with symptomatic de novo, restenotic or occlusive lesions located in the superficial femoral or proximal popliteal arteries, with reference vessel diameters from 3.0 to 6.0 mm and total lesion lengths up to 190 mm.


  • Class III, Product Code : NIP


  • Self-expanding stent loaded on an over-the-wire (OTW) delivery system
  • Delivery system consists of inner shaft and outer shaft
  • Safety tab prevents accidental stent release
  • Black release marker that indicates completion of stent deployment, ends with a Luer port
  • Stent mounted between inner shaft and outer shaft between two radiopaque markers to facilitate fluoroscopic visualization and positioning across lesion
  • Guide wire to facilitate advancement of the delivery system toward and through lesion


  • Prospective, non-randomized, multi-center study with two treatment cohorts, iliac lesion treatment and superficial femoral artery (SFA) or proximal popliteal artery (PPA) lesion treatment
  • Primary effectiveness endpoint: Stent patency at 12 months as evidenced by peak systolic velocity ratio (PSVR)<2.4 from duplex ultrasound (DUS)
  •  Pre-specified endpoint not met : Primary patency rate numerically above performance goal; however the 95% lower confidence bound not met
  • Kaplan Meier analysis and imputed analysis for missing data supported primary patency rates similar to the observed rate; secondary endpoints met


  • Primary safety endpoint: Freedom from composite rate of procedure- or stent-related Major Adverse Events at 30 days post-index procedure : 99.7%, 95%
  • Higher than performance goal of 88% (p<0.001)




Image result for Oculeve Intranasal Tear Neurostimulator

OCULEVE Intranasal Tear Stimulator 

Oculeve Inc (Allergan), Dublin, IRELAND

INDICATION FOR USE: Provides temporary increase in tear production during neurostimulation in adult patients.

REG PATHWAY: De Novo request

  • Regulation Number: 21 CFR 886.5300
  • Regulation Name: Tear Electrostimulation Device
  • Regulatory Classification: Class II
  • Product Code: PQJ

GENERIC DEVICE TYPE: Tear electrostimulation device is a non-implantable, electrostimulation device intended to increase tear production


  • Tissue damage due to over-stimulation/understimulation or mechanical injury, device breakage:  Non-clinical performance testing, Software verification, validation and hazard analysis, Electrical, thermal, and mechanical safety testing, Labeling
  • Pain, headache, or discomfort: Non-clinical performance testing, Electrical, thermal, and mechanical safety testing, Labeling
  • Adverse tissue reaction: Biocompatibility, Labeling
  • Infection : Labeling
  • Electrical shock or burn: Electrical, thermal, and mechanical safety testing, Software verification, validation and hazard analysis, Labeling
  • Interference with other devices: Electromagnetic compatibility testing, Software verification, validation and hazard analysis, Labeling

Classification Order

Image sources: iCAD, Biotronik, Google


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