(145 days)
The device is a sphygmomanometer intended to be used with a stethoscope or Doppler for indirect measurement of arterial blood pressure. This device includes an aneroid gauge. Koven Technology, Inc. intends to provide the device for use by healthcare providers. Our product is for both hospital and clinical use and are intended for pediatric through adults, excluding neonates.
The FAST Sphyg by Koven is an aneroid sphygmomanometer that uses the auscultatory blood pressure technique in combination with a stethoscope or Doppler and occluding cuff to determine systolic and diastolic blood pressure measurement. The FAST Sphyg includes an aneroid qauge, as well as a battery powered air pump so the user can control the inflation. When the activation button is pushed on the device, the air pump inflates the cuff. When the activation button is released, inflation stops, but the system remains pressurized. The aneroid gauge on the device reflects this increase in pressure, which is displayed in mmHg. A release valve is activated through a trigger switch to manually deflate the cuff and notate the blood pressure measurement.
The provided text describes the FAST Sphyg by Koven, an aneroid sphygmomanometer intended for indirect measurement of arterial blood pressure. The document focuses on establishing substantial equivalence to a predicate device and adherence to relevant performance standards.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance:
The document does not present a single, consolidated table explicitly labeled "acceptance criteria" and "reported device performance" in the context of clinical accuracy for blood pressure measurement. Instead, it refers to compliance with performance standards, primarily ISO 81060-1:2007 Non-invasive sphygmomanometers - Part 1: Requirements and test methods for non-automated measurement type.
However, the document lists other technical standards that the device meets, which can be considered acceptance criteria for electrical safety and electromagnetic compatibility:
Standard / Test Acceptance Criteria / Test Level Reported Device Performance / Compliance Level ISO 81060-1:2007 Requirements and test methods for non-automated measurement type Designed and tested to meet this standard. (Specific accuracy metrics not detailed in this excerpt) IEC 60601-1 (2007) - Electrical Safety Class II device (Protection class against electric shock) Class II device, Internally powered equipment Type B applied part (Protection grade against electric shock) Type B applied part IEC 60601-1-2 (2007) - Electromagnetic Emissions RF Emissions CISPR 11 Group 1 Group 1 RF Emissions CISPR 11 Class B Class B Harmonic Emissions IEC 61000-3-2 Class A Class A Flicker Emissions IEC 61000-3-3 Not Applicable Not Applicable IEC 60601-1-2 (2007) - Electromagnetic Immunity Electrostatic Discharge (ESD) IEC 61000-4-2 ±6kV Contact, ±8kV Air ±6kV Contact, ±8kV Air Electrical Fast Transient/burst IEC 61000-4-4 ±2kV for power supply lines, ±1kV for input/output lines ±2kV for power supply lines, ±1kV for input/output lines Surge IEC 61000-4-5 ±1kV differential mode, ±2kV common mode ±1kV differential mode, ±2kV common mode Voltage dips, short interruptions, and variations
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).