MODIFICATION TO INFINITY EXPLORER

K040945 · Draeger Medical Systems, Inc. · MSX · May 12, 2004 · Cardiovascular

Device Facts

• Record ID: K040945
• Device Name: MODIFICATION TO INFINITY EXPLORER
• Applicant: Draeger Medical Systems, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: May 12, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system. The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use with the adult, pediatric and neonatal populations.

Device Story

INFINITY Explorer is a software-driven critical care workstation; functions as a central display for physiological parameters and alarm data received from Infinity Modular Monitors; integrates DICOM images from hospital information systems. Operated by trained healthcare professionals (physicians, nurses, technicians) in clinical environments. Provides real-time data visualization and remote control capabilities for bedside monitors. Enhances clinical decision-making by consolidating patient data on a single interface; facilitates efficient monitoring of patient status across diverse populations (adult, pediatric, neonatal).

Clinical Evidence

No clinical data. Bench testing performed in accordance with internal design control procedures to verify safety and efficacy of software version VF4 and MDS II hardware.

Technological Characteristics

Software-driven workstation; integrates with Infinity Modular Monitors and hospital information systems. Connectivity via network for physiological data and DICOM image retrieval. Complies with IEC 60601-1-1. Not MRI compatible.

Indications for Use

Indicated for adult, pediatric, and neonatal patients requiring physiological parameter monitoring and alarm data visualization in clinical settings. Not MRI compatible.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• Infinity Explorer with MDSII (K030615)
• Infinity Explorer (K013515)

Submission Summary (Full Text)

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K040945

## 510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: [phone] Fax: [phone] Official Correspondent: Connie Hertel, Director, QA/RA Contact person for this submission: Penelope H. Greco Date submission was prepared: April 5, 2004

Trade Name, Common Name and Classification Name:

- A. Trade Name:
INFINITY Explorer

Common Name, Classification Name, Class and Regulation Number:

| Common Name | Product Code | Class | Regulation Number |
|--------------------------------------------------------------|--------------|-------|-------------------|
| System, Network and Communication,<br>Physiological Monitors | MSX | II | 870.2300 |

Legally Marketed Device Identification:

Infinity Explorer with MDSII, 510(k) K030615 Infinity Explorer, 510(k) K013515

## Description of Modification:

- . The INFINITY EXPLORER is a software-driven application that allows the user to extend the viewing capability of the Infinity modular monitors and integrate additional patient information on a single display. INFINITY EXPLORER is capable of displaying real-time patient data, providing control back to the bedside and integrating other applications with patient data on the PC. The VF4 modifications include:
- u New MDSII Hardware
- D New user interface with enhanced monitor applications

Intended Use:

The INFINITY EXPLORER is a critical care workstation intended to display physiological parameters received from INFINITY Modular Monitors and to visually display alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

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COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 USA Tel: [phone] Fax: [phone]

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## Special 510(k): Device Modification INFINITY Explorer VF4

Assessment of non-clinical performance data for equivalence: Testing in accordance with internal design control procedures indicates no new issues relative to safety and efficacy for INFINITY EXPLORER with software version VF4 and the new MDS II.

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances: IEC 60601-1-1 FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices FDA Guidance for Off-the-Shelf Software use in Medical Devices

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COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 USA Tel: [phone] Fax: [phone]

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AY 1 2 2004

Draeger Medical Systems, Inc. c/o Ms. Penelope Greco Regulatory Submissions Manager 16 Electronics Avenue Danvers, MA 01923

Re: K040945

Trade Name: INFINITY Explorer with VF4 and MDS II Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MSX Dated: April 5, 2004 Received: April 12, 2004

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.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean that FDA has made a determination that your device complies with other requirements of the Act

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Page 2 - Ms. Penelope Greco

or any Federal statutes and regulations administered by other Federal agencies. You must or any I ecolul studies and registered to the registration and limited to: registration and listing (21 Comply with an the Fee 8 requirements)01); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in alle quality of sell provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product ladiation control pro horoms (eveting your device as described in your Section 510(k) This letter with anow you to begin mains of substantial equivalence of your device to a legally prematicated 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 If you desire specific acrioliance at [phone]. 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 other general informational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours.

Dana R. Vochner

( Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known): Ko40945

Device Name: INFINITY Explorer

Indications for Use:

This device is capable of displaying physiological parameters received from INFINITY Modular monitors and visually displaying alarm data for those parameters. The device is capable of displaying DICOM images received over a hospital information system.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, 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 for use with the adult, pediatric and neonatal populations.

MRI Compatibility Statement:

______________________________________________________________________________________________________________________________________________________________________________

The INFINITY EXPLORER is not compatible for use in a MRI magnetic field.

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> Prescription Use_ (Per 21 CFR 801.109)

OR

Over-The-Counter Use_

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Duna R. Lochner

(Division Sign-Off) Division of Cardiovascular Devices

510(K) Number_K040945

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