The INFINITY Modular Monitors are intended for multi-parameter patient monitoring. The devices will produce visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. These devices will connect to an R50 Bedside recorder, either directly or via the INFINITY Network.

The INFINITY Modular monitors are capable of monitoring:

Heart rate
Respiration rate
Invasive pressure
Non-invasive pressure
Arrhythmia
Temperature
Cardiac output
Arterial oxygen saturation
Pulse rate
Apnea
ST Segment Analysis
12-Lead ST Segment Analysis
tcp02/tcpC02
EEG signals
FiO2

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure the content of CO2, N2O, O2 and one of the anesthetic agents, halothane, isoflurane, Enflurane, Sevoflurane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

With etCO2 the monitors can measure end tidal carbon dioxide, inspired carbon dioxide, and respiration rate in either mainstream or side-stream measurement mode; and with etCO2+Respiratory Mechanics, spirometry and carbon dioxide can be monitored. The monitors can interface with specific third party devices via an MIB protocol converter.

Device Description

The VF4 release of the INFINITY Modular monitors supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. An alarm indicator has been added to the top center of the device that illuminates in red or vellow for the purpose of displaying both life threatening and serious alarms respectively.

Additional minor software modifications have been implemented that primarily address customer requested enhancements.

AI/ML Overview

The provided text is a 510(k) summary for the INFINITY Modular Monitors with VF4 Modifications. This document describes a modification to an existing medical device and focuses on demonstrating that the modified device is as safe and effective as its predicate device. It does not contain information about the development and testing of a new AI/Machine Learning algorithm for a diagnostic or predictive task.

Therefore, many of the requested criteria related to performance metrics, sample sizes for AI model training/testing, expert consensus for ground truth, and MRMC studies are not applicable to this document as it describes a software and hardware update to a physiological monitor, not an AI-powered diagnostic device.

Here's an analysis of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, or accuracy) for any particular function. This is because it is a submission for modifications to an existing physiological monitor, not a new diagnostic algorithm. The acceptance "criteria" in this context would be that the modified device remains "as safe and effective" as the predicate device.

Acceptance Criteria	Reported Device Performance
"as safe and effective as the previous released versions of the monitors"	"Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors with VF4 modifications are as safe and effective as the previous released versions of the monitors."

Other Requested Information (Not Applicable or Not Provided in this Document)

The following points are largely not applicable to this 510(k) submission, as it focuses on demonstrating equivalence of a modified physiological monitor rather than the performance of a new AI-powered diagnostic or predictive algorithm.

Sample size used for the test set and the data provenance: Not applicable. The document refers to "testing in accordance with internal design control procedures" but does not specify sample sizes of patients or data, nor the provenance of such data, as would be expected for an AI performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no mention of expert consensus for ground truth as this is not a diagnostic AI device.
Adjudication method for the test set: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physiological monitor, not an AI assistance tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable for a standalone AI algorithm performance, however, the "Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications" implies standalone testing of the modified device's functionality.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of a diagnostic ground truth. The "ground truth" would be the expected functional performance of the monitoring parameters based on engineering specifications and validated medical standards.
The sample size for the training set: Not applicable. This document does not describe the development of an AI model, and therefore, no training set for an algorithm.
How the ground truth for the training set was established: Not applicable.

Summary

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Special 510(k) Notification INFINITY Modular Monitors with VF4 Modifications

510(k) SUMMARY

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Official Correspondent: Connie Hertel, Director Quality Assurance & Regulatory Affairs Contact person for this submission: Penelope H. Greco Date submission was prepared: November 21, 2003

Trade Name, Common Name and Classification Name:

A. Trade Name:
INFINITY Modular Monitors (Delta / DeltaXL / Kappa and SC 7000 / SC 9000XL / SC 8000)
B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
Monitor, Physiological, Patient (witharrhythmia detection or alarms)	MHX	II	21 CFR 870.1025
Arrhythmia detector & Alarm	74DSI	II	21 CFR 870.1025

Legally Marketed Device Identification:

INFINITY SC 8000 Monitor, K983632 / K990563 INFINITY SC 7000 / SC 9000XL Modular Monitors, K031340, K003243/K982730/ K980882

Description of Modification:

Additional minor software modifications have been implemented that primarily address customer requested enhancements.

Testing in accordance with internal design control procedures has verified that the INFINITY Modular Monitors with VF4 modifications are as safe and effective as the previous released versions of the monitors.

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Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

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

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Intended Use:

Assessment of non-clinical performance data for equivalence:

Verification and validation testing of VF4 software, as well as testing applicable to the hardware modifications for the new Draeger look indicate no new issues relative to safety and efficacy.

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards and Guidances:

IEEE 802.11 Reviewer Guidance for Premarket Notification 510(k) Submissions, November 1993

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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/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 2 2004

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

Re: K033694

Trade Name: INFINITY Modular Monitors (Delta / DeltaXL / Kappa and SC 7000 / SC 9000XL / SC 8000) Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: November 21, 2003 Received: November 24, 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) 594-4648. 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 yours,

Dma R. Vochner

Image /page/3/Picture/5 description: The image shows a signature on the left and the letters 'E' and 'D' on the right. The signature is illegible, but it appears to be written in cursive. The letters 'E' and 'D' are in uppercase and are next to each other. The image is simple and contains only these elements.

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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510(k) Number (if known):_ Ko33694

Device Name:___INFINITY Modular Monitors

Indications for Use:

The INFINITY Modular monitors are capable of monitoring:

. Heart rate
Respiration rate .
. Invasive pressure
Non-invasive pressure
. Arrhythmia
Temperature
. Cardiac output
Arterial oxygen saturation .
. Pulse rate
. Apnea
ST Segment Analysis .
12-Lead ST Segment Analysis .
. tcp02/tcpC02
EEG signals .
FiO2 .

Prescription Use ← (Per 21 CFR 801.109)

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. Vachner

Division Sign-Only

510(k) Number K033694

Page 1 of 2

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Indications for Use

The devices are intended to be used in the 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.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the parameter Cardiac Output, ST Segment Analysis, and arrhythmia which are intended for use in the adult and pediatric populations only; and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

MRI Compatibility Statement:

The INFINITY Modular Monitors are not compatible for use in a MRI magnetic field.

P. Vachner

(Division of Cardiovascular Devices

510(k) Number K033694

Page 2 of 2

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.