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 (MultiGas™ only) .
Inspired and expired gas concentrations of Enflurane, Halothane, Isoflurane, Desflurane, Sevoflurane, . and Nitrous Oxide.

The SC 7000 and SC 9000XL can interface with third party devices.

The devices are 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 devices are 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 Transcutaneous Oxygen which is intended for use in the neonatal population when the patient is not under gas anesthesia.

Device Description

The SC 7000 and SC 9000XL modular bedside monitors are enhanced versions of the SC 9000 (predicate device - original submission K946306) and use the same front panel display and user interface as the SC 9000. In addition, the SC 9000 docking station is compatible with the SC 7000 and SC 9000XL for power and communication capabilities.

The SC 7000 (mid-level monitor) and the SC 9000XL (high-end monitor) are additions to the Siemens INFINITY Modular Portable Bedside Monitoring Series. Both the SC7000 and SC 9000 XL utilize the same electronics and software, but with different base configurations and available options.

AI/ML Overview

The provided text describes the Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors and their intended use, but it does not contain information about specific acceptance criteria or a study that proves the device meets those criteria.

The document is a 510(k) summary, which is typically a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. While it lists various monitoring capabilities and specifications, it does not detail performance metrics, study designs, or results that would demonstrate the device meets specific acceptance criteria.

Therefore, many of the requested sections about acceptance criteria and study details cannot be answered from the provided text.

Here's what can be extracted based on the information given, with explicit notes where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not provided in the document. The document lists the types of parameters the monitors are capable of measuring (e.g., heart rate, respiration rate, invasive pressure, etc.), but it does not specify performance metrics (e.g., accuracy, precision, response time, false alarm rates) or compare them against predefined acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Not provided. The document does not describe any specific test set or clinical study data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not provided. The document does not describe any test set or ground truth establishment process.

4. Adjudication Method for the Test Set

Not provided. The document does not describe any test set or adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The document describes a medical device (patient monitor), not an AI algorithm for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study or AI assistance is not relevant to the information provided.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a patient monitor, which by its nature is an "algorithm only" type of device in terms of measuring and displaying parameters. However, the document does not contain details of standalone performance studies for its various algorithms (e.g., arrhythmia detection, ST segment analysis). It relies on substantial equivalence to a predicate device.

7. The Type of Ground Truth Used

Not provided. As no specific performance studies are detailed, the type of ground truth is not mentioned.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device is a hardware and software system for patient monitoring, not a machine learning model that undergoes "training" in the conventional sense for AI. If there were internal algorithm development or validation, the sample sizes for such activities are not mentioned.

9. How the Ground Truth for the Training Set was Established

Not applicable/Not provided (see #8).

Summary of Device and Regulatory Status:

Device Name: Siemens SC7000 and SC9000XL INFINITY Modular Bedside Monitors
Predicate Device: Siemens SC9000/SC9015 Patient Monitoring System (K946306)
Regulatory Pathway: 510(k) premarket notification to establish substantial equivalence.
Date of Submission: August 13, 1998
FDA Clearance Date: August 24, 1998
Intended Use: To monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, cardiac output, central apnea, end-tidal carbon dioxide, ST segment analysis, 12-Lead ST Segment Analysis, and transcutaneous oxygen & transcutaneous carbon dioxide. Also includes measurement of various gas concentrations with add-on modules. The device provides visual and audible alarms.
Intended Population: Adult, Pediatric, and Neonatal (with specific parameter restrictions for different populations).
Intended Environment: Healthcare environment where patient care is provided by healthcare professionals.
Evidence for Equivalence: The document indicates an "Assessment of non-clinical performance data for equivalence: See Section U" and "Assessment of clinical performance data for equivalence: See Section V". However, these sections are not provided in the given text, so the specific details of the data reviewed by the FDA for substantial equivalence are missing. The primary argument in the provided text for equivalence is the similarity in manufacturer, intended use, population, environment, display, waveforms, arrhythmia detection, modularity, networking, NBP, MIB, MultiGas, ST, and IBP features to the predicate device.

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.