FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

Respiration rate
. Inspired and expired Carbon Dioxide (CO2)
Inspired and expired Oxygen (MultiGas+TM only) .
. Average inspired Oxygen (MultiGasTM only)
Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, . and Nitrous Oxide.

The SC 8000 Bedside Monitor can interface with third party devices.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. Physicians, Nurses, and Technicians, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The device is intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output and ST Segment Analysis which are intended for use in the adult and pediatric populations only; Arrhythmia which is intended for use in the adult population only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

Device Description

Siemens SC 8000 Bedside Monitor with Advanced Communication Option

AI/ML Overview

This document is a 510(k) premarket notification letter from the FDA to Siemens Medical Systems for their SC 8000 Bedside Monitor with Advanced Communication Option. It informs Siemens that their device has been found substantially equivalent to legally marketed predicate devices.

The document does not contain information about specific acceptance criteria, a study proving the device meets these criteria, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or details about training sets. These types of details are typically found in the clinical study reports or technical documentation submitted as part of the 510(k) application, not in the FDA's clearance letter itself.

The provided text only includes:

Device Name: Siemens SC 8000 Bedside Monitor with Advanced Communication Option
Intended Use/Indications for Use: A list of parameters the device is capable of monitoring (Heart rate, Respiration rate, Invasive pressure, Non-invasive pressure, Arrhythmia, Temperature, Cardiac output, Arterial oxygen saturation, Pulse rate, (central) apnea, ST Segment Analysis, 12-Lead ST Segment Analysis, Inspired and expired Carbon Dioxide (CO2), Inspired and expired Oxygen, Average inspired Oxygen, Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Sevoflurane, and Nitrous Oxide). It also specifies the intended user (Healthcare Professionals) and patient populations (Adult, Pediatric, Neonatal with specific exceptions).
MRI Compatibility: Not compatible for use in an MRI magnetic field.
Regulatory Class: III
Product Code: MXH
Date of Clearance: March 25, 1999 (correcting an earlier letter from March 19, 1999)

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, and other performance-related information based on the provided text.

Summary

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.