(17 days)
No
The document describes standard patient monitoring and ECG analysis functionalities, including arrhythmia and ST segment analysis, which are typically based on established algorithms and signal processing techniques, not AI/ML. There is no mention of AI, ML, or related terms.
No
The device is described as a central monitoring device, communications network, and remote display for patient monitoring systems. Its functions include measuring and displaying patient parameters and providing interpretive diagnostic statements and reports when connected to an ECG monitor, which are diagnostic rather than therapeutic actions.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor." It also mentions "ECG Arrhythmia Analysis" and "ST segment analysis," which are diagnostic functions.
No
The device description explicitly mentions receiving ECG data from a "Reynolds CardioCollect" via an "RS232 connection," indicating interaction with external hardware components beyond just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes the device as a central monitoring device, communications network, and remote display for patient monitoring systems. It focuses on measuring and displaying physiological parameters like heart rate, ECG, oxygen saturation, and pulse rate.
- Device Description: The device description reinforces its role in receiving and processing ECG data from another device (CardioCollect) and calculating baseline coefficients for patient monitoring.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not mention the analysis of such specimens.
The device is clearly focused on in vivo patient monitoring, not in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The INFINITY MultiView WorkStation, INFINTY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor.
Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate
- . ECG Arrhythmia Analysis
- . Arterial oxygen saturation
- . Pulse rate
- ST segment analysis .
The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.
Product codes (comma separated list FDA assigned to the subject device)
MHX, MSX, DSI
Device Description
With the release of software version VF4, the Infinity MultiView WorkStation can receive ECG data sent from a Reynolds CardioCollect and process Rest ECG reports (K980625) when a CardioCollect is interfaced to a MultiView WorkStation via an RS232 connection. Additionally, when a 12-lead Rest ECG for a TruST monitored patient is successfully acquired and uploaded, the MultiView WorkStation calculates a set of baseline coefficients specific to each patient.
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
adult and pediatric patient populations
Intended User / Care Setting
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing has been performed in accordance with internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation.
Assessment of non-clinical performance data for equivalence: Section J
Assessment of clinical performance data for equivalence: Section J
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
OCT 3 1 700 Special 510(k): Device Modifica INFINITY MultiView WorkStation TruST
1. 510(k) SUMMARY
as required per 807.92(c)
Submitters Name, Address:
-
Draeger Medical Systems, Inc. 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 13, 2003
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 | MHX | III | 870.1025 |
| System, Network and Communication, | |||
| Physiological Monitors | MSX | II | 870.2300 |
Legally Marketed Device Identification:
K030738 Infinity MultiView WorkStation Telemetry with TruST
K023569 Infinity MultiView WorkStation VF3 Modifications
K980625 Infinity MultiView WorkStation Enhanced with Rest ECG
Device Description:
With the release of software version VF4, the Infinity MultiView WorkStation can receive ECG data sent from a Reynolds CardioCollect and process Rest ECG reports (K980625) when a CardioCollect is interfaced to a MultiView WorkStation via an RS232 connection. Additionally, when a 12-lead Rest ECG for a TruST monitored patient is successfully acquired and uploaded, the MultiView WorkStation calculates a set of baseline coefficients specific to each patient.
Page 1 of 2
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
1
The Indications for Use and Intended Use of the INFINITY MultiView WorkStation and Telemetry System have not changed with VF4 software. Testing has been performed in accordance with internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation.
Intended Use:
The INFINITY MultiView WorkStation, INFINITY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
The INFINTY MultiView WorkStation (MVWS) Telemetry System is intended to measure and produce visual and audible alarms for one or more physiological parameters
The INFINITY MultiView WorkStation with Rest ECG can provide interpretive diagnostic statements and reports when connected to a monitor with ECG monitoring capability.
The INFINTY MVWS telemetry System with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.
This device is intended for use in an 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.
Assessment of non-clinical performance data for equivalence: Section J
Assessment of clinical performance data for equivalence: Section J
Biocompatability: Not applicable
Sterilization: Not applicable
Standards and Guidances: Section J
Page 2 of 2
Draeger Medical Systems, Inc.
16 Electronics Avenue Danvers, MA 01923
Tel: (978) 907-7500 Fax: (978) 750-6879
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 3 1 2003
Draeger Medical Systems, Inc. c/o Ms. Penelope H. Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers. MA 01923
Re: K033305
Trade Name: INFINITY MultiView WorkStation & Telemetry System with VF4 Modifications Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class III (three) Product Code: DSI Dated: October 13, 2003 Received: October 14, 2003
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 FDA'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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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 vours,
Dina Husakuefor
B.S., R.Z. de Leon, M.D.
Bram D. Zuckerman. N Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Infinity MultiView WorkStation & Telemetry System with VF4 Device Name: Modifications
Indications for Use:
The INFINITY MultiView WorkStation, INFINTY Network and Remote Display are indicated for use as a central monitoring device, communications network, and remote display for Draeger Patient Monitoring Systems and recorders.
The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor.
Use of the INFINITY MultiView WorkStation Telemetry System is indicated for adult and pediatric patient populations in an environment where patient care is provided by Healthcare Professionals (Physicians, Nurses, Technicians) when the professional determines that a device is required to measure and produce visual and audible alarms for any one or more of the following parameters:
- Heart rate
- . ECG Arrhythmia Analysis
- . Arterial oxygen saturation
- . Pulse rate
- ST segment analysis .
The INFINITY MultiView WorkStation (MVWS) Telemetry System with TruST is indicated for use when 12-Lead ECG monitoring with a reduced set of electrodes is desired. Reconstructed leads are intended for real-time assessment of ST segment changes.
MRI Compatibility Statement:
The Infinity MultiView WorkStation & Telemery Systems 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 | Over-The-Counter Use | |
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) | |
| (Division Sign-Off) | ||
| Division of Cardiovascular Device | ||
| 510(k) Number | 2033305 |