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.

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.

AI/ML Overview

This 510(k) submission (K033305) is for modifications to the INFINITY MultiView WorkStation, specifically with the release of software version VF4 and its integration with the TruST system. This submission primarily focuses on the device's ability to process Rest ECG reports and reconstruct 12-lead ECGs from a reduced electrode set for ST segment analysis.

The document states that a clinical performance study was performed to demonstrate substantial equivalence, but the details of the study, including acceptance criteria and reported device performance metrics, are not provided in the extracted text. The text explicitly says: "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Section J", indicating that these details are elaborated in Section J of the full 510(k) submission, which is not included here.

Therefore,Based on the provided text, it's not possible to describe the acceptance criteria and the study that proves the device meets those criteria comprehensively. The document states that testing was performed in accordance with internal design control procedures and indicates no affect on the safety or efficacy of the MultiView WorkStation, but no specific performance data or acceptance criteria are detailed.

Here's what can be inferred and what cannot be from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in the extract. The document mentions "Assessment of clinical performance data for equivalence: Section J," implying this information is elsewhere in the submission. Without Section J, specific acceptance criteria (e.g., sensitivity, specificity, accuracy for ST segment changes, or interpretive diagnostic statements) and the reported performance metrics are unknown.

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

Not provided in the extract. The document does not specify the number of patients or ECGs used in any test set, nor the country of origin of the data, or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not provided in the extract. The document does not mention the involvement of experts for establishing ground truth, their number, or their qualifications.

4. Adjudication Method:

Not provided in the extract. There is no information regarding any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not provided in the extract. The document does not mention any MRMC study or the effect size of human readers improving with or without AI assistance. The device is described as providing "interpretive diagnostic statements" and "reconstructed leads intended for real-time assessment of ST segment changes," suggesting an algorithmic function rather than direct human assistance for interpretation.

6. Standalone Performance Study:

Implied but not detailed. The device is stated to "calculate a set of baseline coefficients specific to each patient" and "provide interpretive diagnostic statements and reports." This suggests standalone algorithmic performance for these functions. However, no specific standalone performance study results (e.g., sensitivity, specificity, or accuracy compared to a gold standard) are provided in the extract.

7. Type of Ground Truth Used:

Not explicitly stated for performance evaluation. For the interpretive diagnostic statements and ST segment analysis, the ground truth would typically be established by expert cardiologists reviewing full 12-lead ECGs or potentially correlated with clinical outcomes or pathology, but the document does not specify which was used.

8. Sample Size for the Training Set:

Not provided in the extract. The document does not mention any training set or its size.

9. How the Ground Truth for the Training Set Was Established:

Not provided in the extract. As no training set is mentioned, the method for establishing its ground truth is also not specified.

In summary, the provided text from the 510(k) summary (K033305) indicates that a clinical performance assessment was conducted (referenced in Section J), but it does not contain the specific details required to answer the questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement. The focus of this specific summary is on the modifications to the software for existing functionalities related to ECG processing and ST segment analysis.

Summary

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K033305

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:

Page 1 of 2

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

Tel: (978) 907-7500 Fax: (978) 750-6879

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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

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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.

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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

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Infinity MultiView WorkStation & Telemetry System with VF4 Device Name: Modifications

Indications for Use:

The INFINITY MultiView WorkStation with Rest ECG is intended to provide interpretive diagnostic statements and reports when connected to an ECG monitor.

Heart rate
. ECG Arrhythmia Analysis
. Arterial oxygen saturation
. Pulse rate
ST segment analysis .

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

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.