ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522

• K Number: K982216
• Device Name: ULTIMA RESPIRATORY EFFORT SENSOR MODELS 0520 AND 0522
• Manufacturer: BRAEBON MEDICAL CORP.
• Date Cleared: 1998-09-11 ( 80 days)
• Product Code: BZQ
• Regulation Number: 868.2375
• Type: Traditional
• Panel: AN
• Reference & Predicate Devices: N/A

Intended Use

An indicator of respiratory effort for recording onto a data acquisition system.

Device Description

Ultima Respiratory Effort Sensor, 0520 and 0522

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for the Ultima Respiratory Effort Sensor Models 0520 and 0522. It primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

While it mentions the device's intended use and target population, it lacks the detailed information required to answer your specific questions regarding acceptance criteria, study methodologies, and performance metrics.

Specifically, the document does not contain:

1. A table of acceptance criteria or reported device performance.
2. Details about sample sizes, data provenance, or ground truth establishment for any test sets.
3. Information on expert qualifications, adjudication methods, or MRMC studies.
4. Data on standalone algorithm performance or training set details.

Therefore, I cannot provide the requested information based on the provided text.

Regulation Number and Section

§ 868.2375 Breathing frequency monitor.

(a)
Identification. A breathing (ventilatory) frequency monitor is a device intended to measure or monitor a patient's respiratory rate. The device may provide an audible or visible alarm when the respiratory rate, averaged over time, is outside operator settable alarm limits. This device does not include the apnea monitor classified in § 868.2377.(b)
Classification. Class II (performance standards).