FDA BRIEF: Week of January 9, 2016


Hem-Avert Perianal Stabilizer, Stetrix, Inc., Oakland, TN, USA

Image result for Hem-Avert Perianal Stabilizer

INDICATION FOR USE:  Providing counter-pressure to the anus during vaginal childbirth, applied at 8-10 cm of dilation, to help reduce the likelihood of cesarean delivery

REG PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 884.5210
  • Regulation Name: Pressure wedge for the reduction of cesarean delivery
  • Regulatory Classification: Class II
  • Product Code: PNU

GENERIC DEVICE TYPE: Pressure wedge for the reduction of cesarean delivery

  • Prescription device that provides external mechanical support to the perianal region during the labor and vaginal delivery process. External mechanical support of the perianal region is intended to help reduce the occurrence of cesarean delivery

IDENTIFIED RISKS AND MITIGATIONS:

  • Skin/tissue trauma: Nonclinical performance data, Clinical performance data, Labeling
  • Device failure (breakage, slippage): Nonclinical performance data, Labeling
  • Infection: Sterilization validation, Shelf life testing, Labeling
  • Adverse tissue reaction: Biocompatibility evaluation
  • Pain: Labeling
  • Use error: Labeling

CLASSIFICATION ORDER


APAS Compact, Clever Culture Systems, Bäch, Switzerland

INDICATION FOR USE: The APAS Compact is an in vitro diagnostic system comprised of an instrument for automated imaging of agar culture plates and a software analysis module for the following use:

The APAS Compact, when using its urine analysis module, automates urine culture plate imaging and interpretation to detect the presence or absence of microbial growth on sheep blood and MacConkey agar culture plates that are inoculated with a 1µL sample volume. The APAS Compact, when using its urine analysis module, provides a semi-quantitative assessment of colony counts that are used as an aid in the diagnosis of urinary tract infection. All urine culture plates that are identified as positive for growth by the APAS Compact, when using its urine analysis module, must be reviewed by a trained microbiologist.

REG. PATHWAY: De Novo Request

  • Regulation Number: 21 CFR 866.2190
  • Regulation Name: Automated image assessment system for microbial colonies on solid culture media
  • Regulatory Classification: Class II
  • Product Code: PPU

GENERIC DEVICE TYPE: Automated image assessment system for microbial colonies on solid culture media

System that is intended to assess the presence or absence of microbial colonies on solid microbiological culture medium, and to interpret their number, phenotypic and morphologic characteristics through analysis of two dimensional digital images as an aid in diagnosis of infectious disease.

IDENTIFIED RISKS & MITIGATIONS:

  • False positive results (i.e., incorrect designation of plates for “Review” or as “Positive”):  General controls and special controls
  • False negative results (i.e., failure to detect growth and incorrect designation of plates as “Negative”): General controls and special controls

CLASSIFICATION ORDER


CipherOx CRI Tablet, Flashback Technologies, Boulder, CO, USA

INDICATION FOR USE: For continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (measured by an SpO2 sensor), and the Compensatory Reserve Index (CRI), which trends changes in intravascular volume relative to the individual patient’s response to hypovolemia.

For patients with a finger thickness of 0.3” to 1” in hospital and pre-hospital settings

CRI trends with changes in intravascular volume relative to the individual patient’s response to hypovolemia, and should only be used by qualified medical providers as an adjunct to rather than as a replacement for traditional hemodynamic measures.

CRI is indicated for adults (19-36 years old) in the supine position under non-motion conditions and without cardiovascular disease. CRI has not been studied in trauma patients.

REG PATHWAY:De Novo Request

  • Regulation Number: 21 CFR 870.2200
  • Regulation Name: Adjunctive cardiovascular status indicator
  • Regulatory Classification: Class II Product Code: PPW

GENERIC DEVICE TYPE: Adjunctive cardiovascular status indicator

  • Prescription device based on sensor technology for the measurement of a physical parameter(s). This device is intended for adjunctive use with other physical vital sign parameters and patient information and is not intended to independently direct therapy.

IDENTIFIED RISKS & MITIGATIONS:

  • Delayed or incorrect treatment due to erroneous output as a result of software malfunction or algorithm error: Software verification, validation, and hazard analysis Non-clinical performance testing, Clinical performance testing, Labeling
  • Delayed or incorrect treatment due to user misinterpretation: Usability assessment, Labeling

CLASSIFICATION ORDER


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