(174 days)
The Spot Vital Signs Ultra automatically measures systolic and diastolic pressure, Mean Arterial Pressure (MAP), pulse rate, temperature (oral, adult axillary, pediatric axillary, rectal, and ear), and pulse oximetry (SpO2) of adult and pediatric patients. Furthermore, Spot Vital Signs Ultra allows the manual entry of height, weight, respiration, and pain level. Spot Ultra also calculates Body Mass Index (BMI) following height and weight entry. The device is intended to be used by clinicians and medically qualified personnel. It is available for sale only upon the order of a physician or licensed health care provider.
The Welch Allyn Spot Ultra Vital Signs Device utilizes an Oscillometric BP Algorithm and temperature technology, similar to Spot Vital Signs and utilizes the same SpO2 OEM as the Welch Allyn Spot Vital Signs. The new Spot Ultra Vital Signs will incorporate a new temperature module (Braun 4000) and a new SpO2 OEM module the Masimo SET as options.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information for the Welch Allyn Spot Ultra Vital Signs device:
Welch Allyn Spot Ultra Vital Signs Device: Acceptance Criteria and Study Information
This 510(k) summary describes the Welch Allyn Spot Ultra Vital Signs device, which measures blood pressure, pulse rate, temperature, and pulse oximetry. The summary establishes substantial equivalence to existing predicate devices (Welch Allyn Spot Vital Signs) by comparing technological characteristics and adherence to relevant standards.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Standard / Predicate) | Reported Device Performance |
|---|---|---|
| Blood Pressure Measurement Accuracy | AAMI SP10-1992 (Predicate Device) | AAMI SP10-2002 (Spot Ultra Vital Signs Device) |
| Cuff Pressure: +/- 3 mmHg | ||
| Systolic: 60-250 mmHg | ||
| Diastolic: 30-160 mmHg | ||
| Heart Rate (Oscillometric): +/- 5% (35-199 bpm) | ||
| Nellcor® OEM SpO2 Measurement Accuracy | SpO2: 70-100% +/- 3% ( |
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).