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.

Device Description

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. This Special submission includes minor modifications to the hardware and software.

AI/ML Overview

The provided text describes a 510(k) summary for the Draeger Medical Systems, Inc. Infinity Explorer, a critical care workstation. However, it does not include detailed information regarding specific acceptance criteria, a standalone study proving device performance against those criteria, or an MRMC comparative effectiveness study with AI.

Here's the information that can be extracted and a clear statement of what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document.	"Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III."
Not explicitly stated in the document.	"Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."

Missing Information: The document does not provide a table with specific, quantifiable acceptance criteria (e.g., accuracy, reliability, latency) and corresponding reported performance metrics for the device. The statements are general and qualitative about overall performance and equivalence to previous versions.

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

Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

Not applicable as the document does not mention a "test set" in the context of expert review for ground truth establishment. The testing described is for "overall performance" and "verification and validation" of the device's functionality and safety, not for diagnostic accuracy evaluated against expert-established ground truth.

4. Adjudication Method for the Test Set

Not applicable for the same reason as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study is mentioned. This device is a critical care workstation for displaying physiological parameters and DICOM images, not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC study with AI assistance is not relevant to the described device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

The document states: "Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III." and "Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."
This suggests standalone testing of the device's functionality and performance as an integrated system, but it's not a "standalone (algorithm only)" study in the context of AI diagnostic algorithms. It's a system performance validation.

7. The Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy for this device. The "ground truth" for the verification and validation testing would be the expected functional behavior and safety requirements of the device's components and system as designed.

8. The Sample Size for the Training Set

Not applicable. This device is a critical care workstation, not a machine learning model that requires a training set.

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

Not applicable for the same reason as above.

Summary of Missing Information:

The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device and verifying that modifications do not alter the fundamental technology or safety. It lacks specific details regarding quantitative acceptance criteria, explicit performance metrics against those criteria, or any studies involving expert review for diagnostic accuracy or AI performance. The nature of the device (a critical care workstation) explains why many of these specific AI-centric questions are not applicable to the content provided.

Summary

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K060254
P 1/2

4 2006 APR

510(k) SUMMARY

as required per 807.92(c)

Draeger Medical Systems, Inc. Submitter's Name and Address: 16 Electionics Avenue Danvers, MA 01923 Karen Iorio Contact Person: Director QA/RA Ph: (978) 564-8364 Fax: (978) 750-6879 January 25, 2006 Date submission was prepared: Device Name: System, Network and Communication, Common Name: Physiological Monitors Classification Name: MSX Regulation Number: 21 CFR 870.2300 Class: 2 Legally Marketed Device Identification: Infinity Explorer

Device Description:

Testing has been performed to verify the overall performance of the INFINITY Explorer with VF6 modifications and the new MDS III.

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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.

Substantial Equivalence:

Assessment of non-clinical performance data for equivalence:

Verification and validation testing performed indicate that the modifications implemented are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidance: IEC 60601-1-1

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

4 2006 APR

Draeger Medical Systems, Inc. c/o Mr. Thomas M. McIntosh Regulatory Affairs Manager 16 Electronics Avenue Danvers, MA 01923

Re: K060254

Trade Name: Infinity Explorer Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MSX Dated: March 17, 2006 Received: March 20, 2006

Dear Mr. McIntosh:

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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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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours.

Bhimman for

Bran D. Zuckerman, M.D. 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):_

Device Name: Infinity Explorer

Indications for Use

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:

Infinity Explorer is not compatible for use in a MRI magnetic field.

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)

Blummen

510/k) Numbe

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).