(285 days)
The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use.
The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure.
K5 is intended to use with adults and children over the age of 14 years.
It is to be used by physicians or by trained personnel on a physician responsibility.
The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases
The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts:
- Main portable unit
- Optional Bluetooth receiver
- PC software
- Face mask with head cap
- Turbine flowmeter with optoelectronic reader and wind cover
- Harness
- Heart rate monitor belt
- 02 sensor
- Battery charger + batteries
- AC/DC adapter
- USB cable
- Carrying case
- Optional pressure regulator for calibration
The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.
Here's an analysis of the acceptance criteria and study information for the COSMED K5 Wearable Metabolic Technology, based on the provided FDA 510(k) summary:
Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report. Therefore, some of the requested information, particularly regarding specific study details like training set provenance, expert qualifications, and detailed statistical methodologies for clinical trials, is not fully elaborated in this type of document.
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Accuracy validation (Vt, RF, VO2, VCO2)" as a non-clinical test. The table on page 7 provides specific measurement accuracies for ventilation, VO2, and VCO2, which serve as the acceptance criteria and reported performance.
| Parameter | Acceptance Criteria (Subject Device) | Reported Device Performance (Subject Device) | Predicate Device Accuracy |
|---|---|---|---|
| Ventilation |
§ 868.1880 Pulmonary-function data calculator.
(a)
Identification. A pulmonary-function data calculator is a device used to calculate pulmonary-function values based on actual physical data obtained during pulmonary-function testing.(b)
Classification. Class II (performance standards).