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ECG App

Apple

INDICATION FOR USE: 

The ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel electrocardiogram (ECG) similar to a Lead I ECG.

The ECG app determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The ECG app is not recommended for users with other known arrhythmias.

The ECG app is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG app is intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and not intended to replace traditional methods of diagnosis or treatment.

The ECG app is not intended for use by people under 22 years old.

GENERIC TYPE OF DEVICE: Electrocardiograph software for over-the-counter use

Creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis

IDENTIFIED RISKS/MITGATION MEASURES:

  • Poor quality ECG signal resulting in failure to detect arrhythmia: Clinical performance testing, Human factors testing, Labeling
  • Misinterpretation and/or over-reliance on device output, leading to:  Failure to seek treatment despite acute symptoms, Discontinuing or modifying treatment for chronic heart condition: Human factors testing, Labeling 
  • False negative resulting in failure to identify arrhythmia and delay of further evaluation or treatment: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling
  • False positive resulting in additional unnecessary medical procedures: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling

REGULATORY PATHWAY: De Novo request

  • Trade/Device Name: ECG App
  • Regulation Number: 21 CFR 870.2345
  • Regulation Name: Electrocardiograph software for over-the-counter use
  • Regulatory Class: Class II
  • Product Code: QDA

CLASSIFICATION ORDER


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Irregular Rhythm Notification Feature

Apple

INDICATION FOR USE:  software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user.

The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.

The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib.

GENERIC TYPE OF DEVICE: Photoplethysmograph analysis software for over-the-counter use.

Analyzes photoplethysmograph data and provides information for identifying irregular heart rhythms. This device is not intended to provide a diagnosis.

IDENTIFIED RISKS/MITGATION MEASURES:

  • Poor quality incoming PPG signal resulting in failure to detect irregular heart rhythms: Clinical performance testing, Human factors testing, Labeling
  • Misinterpretation and/or over-reliance on device output, leading to: Failure to seek treatment despite acute symptoms (e.g., fluttering sensation in the chest,  lightheadedness, and irregular pulse), Discontinuing or modifying treatment for
    chronic heart condition: Human factors testing, Labeling
  • False negative resulting in failure to detect irregular heart rhythms and delay of further evaluation or treatment: Clinical performance testing, Software verification, validation, and hazard analysis, Non-clinical performance testing, Labeling
  • False positive resulting in additional unnecessary medical procedures: Clinical performance testing, Software verification, validation, and hazard analysis
    Non-clinical performance testing, Labeling

REGULATORY PATHWAY: De Novo request

  • Trade/Device Name: Irregular Rhythm Notification Feature
  • Regulation Number: 21 CFR 870.2790
  • Regulation Name: Photoplethysmograph analysis software for over-the-counter use
  • Regulatory Class: Class II
  • Product Code: QDB

CLASSIFICATION ORDER


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LUMOXITI (moxetumomab pasudotox-tdfk) for injection

AstraZeneca

INDICATION: Treatment of adult patients with relapsed or refractory hairy cell leukemia (HCL) who received at least two prior systemic therapies, including treatment with a purine nucleoside analog (PNA).

ADDRESSING UNMET NEED:

  • HCL is a rare, slow-growing cancer of the blood
  • Approval fills an unmet need for patients with hairy cell leukemia whose disease has progressed after trying other FDA-approved therapies
  • Result of important research conducted by the National Cancer Institute

MECHANISM OF ACTION: CD22-directed cytotoxin, results in ADP-ribosylation of elongation factor 2, inhibition of protein synthesis, and apoptotic cell death

EFFICACY:

  • Single-arm, open-label clinical trial, n=80 patients who had received prior treatment for HCL with at least two systemic therapies
  • Endpoints: Blinded independent review committee (IRC)-assessed Durable complete response (CR), defined as maintenance of hematologic remission for more than 180 days after achievement of CR
  • Durable CR: 30%,
  • Overall response rate: 75%

SAFETY:

  • Most common non-laboratory adverse reactions: Infusion related reactions, edema, nausea, fatigue, headache, pyrexia, constipation, anemia, and diarrhea
  • Most common grade 3 or 4 adverse reactions: Hypertension, febrile neutropenia, and hemolytic uremic syndrome (HUS)

REGULATORY PATHWAY: BLA

  • Orphan, fast track and priority review designations
  • Postmarketing requirements: Safety  in patient who are 65 years of age and older and  in patients who have moderate renal impairment

LABEL


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PK Papyrus System 

Biotronik

INDICATION FOR USE: Treat acute coronary artery perforations, or tears in the blood vessels of the heart

ADDRESSING UNMET NEED: 

  • Acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures
  • First device approved by the FDA for this indication in 17 years

DEVICE DESCRIPTION:

  • Balloon-expandable covered coronary stent and delivery system
  • Advanced into the perforated coronary artery vessel using a balloon catheter
  • Once  implanted, it provides a physical barrier to seal the tear in the artery wall while still allowing blood to flow through the device to the heart muscle
  • Successful sealing can be a life-saving procedure without the need for open-heart surgery

EFFECTIVENESS & SAFETY:

  • Real-world survey data, n=80 patients who received PK Papyrus Stents to treat coronary artery perforations
  • Successfully delivered to the perforation site: 95%
  • Successfully sealed the perforation: 73%
  • Deaths: Two, occurred during the PCI procedure, post-procedure, in-hospital death occurred in five patients with perforations successfully sealed by PK Papyrus Stents and one patient in which the PK Papyrus Stent did not successfully seal the perforation

REGULATORY PATHWAY: Humanitarian Device Exemption

  •  Intended to benefit patients by treating or diagnosing a disease or condition that affects not more than 8,000 individuals in the U.S. per year
  • Classification Name: Coronary covered stent
  • Product Code: NIV

BROCHURE


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AJOVY (fremanezumab-vfrm) injection

Teva

INDICATION: Preventive treatment of migraine in adults

ADDRESSING UNMET NEED: Second FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide (CGRP), a molecule that is involved in migraine attacks

EFFICACY:

  • Two multicenter, randomized, 3-month, double-blind, placebo-controlled studies, n=875, 1130
  • Primary efficacy endpoint was the mean change from baseline in the monthly average number of migraine days during the 3-month treatment period
  • Statistically significant improvement vs placebo

SAFETY:

  • The most common adverse reactions (≥5% and greater than placebo) were
    injection site reactions

REGULATORY PATHWAY: BLA

LABEL


Image credit: Apple, AstraZeneca, Biotronik, Teva

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