(11 days)
Not Found
No
The document describes software modifications for a central monitoring workstation, focusing on features like waveform export, calipers, and parameter support. There is no mention of AI, ML, or related concepts.
No.
The device is described as a "central monitoring device, communications network, and remote display" for patient monitoring systems, which are tools for observing patient data rather than directly treating a condition.
No
The device is described as a "central monitoring device, communications network, and remote display" for patient monitoring systems. Its upgrades include features for displaying and manipulating waveform data, but it does not state that it analyzes or interprets medical data to provide a diagnosis. Its function is to display and manage data from other monitoring systems.
No
The device description explicitly states "INFINITY MultiView WorkStation (MVWS) software version VF3 modifications include...". While it mentions software modifications, the overall device is described as a "central monitoring device, communications network, and remote display" for "Siemens Patient Monitoring Systems and recorders." This implies the device is a system that includes hardware components (workstation, network, display) in addition to the software. The 510(k) is for modifications to the software component of this larger system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders." This describes a system for displaying and managing patient physiological data, not for performing tests on biological samples in vitro (outside the body).
- Device Description: The description focuses on software features related to displaying and analyzing waveforms and parameters from patient monitoring systems. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The focus is entirely on data from patient monitoring devices.
Therefore, the Siemens INFINITY MultiView WorkStation, INFINITY Network, and Remote Display fall under the category of patient monitoring and data management systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The intended use of Siemens MultiView WorkStation & INFINITY Network is to act as a communications network, central monitoring device, and remote display for Siemens Patient Monitoring Systems and recorders.
Siemens INFINITY MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.
Product codes
DSI, MSX, MHX
Device Description
The INFINITY MultiView WorkStation (MVWS) software version VF3 modifications include:
Waveform Export: Waveform Export allows the user to export 25 hours of the four full disclosure waveforms to any client device. The export protocol uses Native File System (NFS), a standard file transfer protocol.
Calipers: The release of software version VF3 includes the caliper application, which is an extension of the Full Disclosure database application. The caliper application allows the user to select an 18-second ECG waveform segment from the Full Disclosure database and perform simple caliper measurements.
Selected Strip Report: The Selected Strip Report allows the user to select an area of the topmost channel within Full Disclosure by defining the beginning and ending cursor times.
Second SpO2 and Pulse Parameter Support: Minor software modifications have been implemented to support a second SpO2 and Pulse parameter received from the bedside.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Assessment of non-clinical performance data for equivalence: Section J
Assessment of clinical performance data for equivalence: Not applicable
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
1. 510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
Siemens Medical Solutions, Inc. Electromedical Systems Group, PCS Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Establishment Registration Number: 1220063 Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: October 21, 2002
Trade Name, Common Name and Classification Name:
- A. Trade Name: INFINITY MultiView WorkStation
- B. Common Name, Classification Name, Class and Regulation Number:
| Common Name | Product
Code | Class | Regulation
Number |
|--------------------------------------------------------------|-----------------|-------|----------------------|
| Detector and Alarm, Arrhythmia | DSI | III | 870.1025 |
| System, Network and Communication,
Physiological Monitors | MSX | II | 870.2300 |
Legally Marketed Device Identification:
Olympus Communications Network, SC 3000 WorkStation and Remote Display K955029 (now referred to as the Infinity Network, MultiView WorkStation and Remote Display)
K003246 Infinity VentViewer (now known as VentCentral)
Device Description:
Introduction
Some features included in the INFINITY MultiView WorkStation VF3 software release are locked options that will be submitted separately.
Page 1 of 2
Siemens Medical Solutions, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
K023569
page 2 of 2
The INFINITY MultiView WorkStation (MVWS) software version VF3 modifications include:
Waveform Export
Waveform Export allows the user to export 25 hours of the four full disclosure waveforms to any client device. The export protocol uses Native File System (NFS), a standard file transfer protocol.
Calipers
The release of software version VF3 includes the caliper application, which is an extension of the Full Disclosure database application. The caliper application allows the user to select an 18-second ECG waveform segment from the Full Disclosure database and perform simple caliper measurements.
Selected Strip Report
The Selected Strip Report allows the user to select an area of the topmost channel within Full Disclosure by defining the beginning and ending cursor times.
Second SpO2 and Pulse Parameter Support
Minor software modifications have been implemented to support a second SpO2 and Pulse parameter received from the bedside.
The Indications for Use have not changed with the implementation of Waveform Export, Calipers, or support for a second SpO2 and Pulse parameter received from the bedside. Testing has been performed according to internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation.
Intended Use:
The intended use of Siemens MultiView WorkStation & INFINITY Network is to act as a communications network, central monitoring device, and remote display for Siemens Patient Monitoring Systems and recorders.
Assessment of non-clinical performance data for equivalence: Section J
Assessment of clinical performance data for equivalence: Not applicable
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: Section E
Page 2 of 2
Siemens Medical Solutions, Inc.
Electromedical Systems Group, PCS
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville .MD 20850
NOV 4 2002
Siemens Medical Solutions, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager Electromedical Systems Group, PCS 16 Electronics Avenue Danvers, MA 01923
Re: K023569
Trade Name: INFINITY MultiView WorkStation Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: MHX Dated: October 21, 2002 Received: October 24, 2002
Dear Ms. Greco:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Penelope H. Greco
Please be advised that F.DA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Oktaten
B. Zeller, M.P.
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page 1 of 1 .
510(k) Number (if known):
Device Name: INFINITY MultiView WorkStation
Indications for Use:
Siemens INFINITY MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Siemens Patient Monitoring Systems and recorders.
and the country of the country of the county of
MRI Compatibility Statement:
The MultiView WorkStation and Infinity Network are not compatible for use in a MRI magnetic field.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Athin
Division of Cardiovascular & Respiratory Devices
510(k) Number K023564