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
tcn02/tcp(02 .
EEG signals .
FiQ2 .

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas modules continuously measure and produce real time and derived gas information of CO2, NO, 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 with etCO2 and instream 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.

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 population only, and tcpO2 which is to be used in the neonatal population only when the patient is not under gas anesthesia.

Device Description

The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.

AI/ML Overview

The provided document describes a Special 510(k) Notification for modifications to the INFINITY Modular MonitorsVF4 software release, specifically in support of the Scio gas module for dual-anesthetic agent display. This is a modification to an existing, legally marketed device, and the submission primarily focuses on demonstrating that the modified device is as safe and effective as the previous versions.

Therefore, the document does not contain information about the development and testing of a new AI/ML device that would typically involve acceptance criteria, performance metrics, ground truth establishment, or clinical studies involving human readers. Instead, it describes a verification and validation study to ensure that the modifications to the existing software and hardware do not introduce new safety or efficacy issues.

Here's an analysis based on the information provided, recognizing that the scope is for device modification rather than a new AI/ML product:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table. Instead, it refers to:

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

The implicit acceptance criterion is that the modified device performs similarly to or better than the predicate device without introducing any new safety or efficacy concerns. The "reported device performance" is a qualitative statement of conformity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size for any test set or the data provenance. It generally states that "verification and validation testing of VF4 software" was performed. Given this is a software modification for an existing monitor, the testing would likely involve simulation, bench testing, and potentially some form of in-house functional testing using synthetic or recorded physiological data, but no details are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable to the type of submission described. "Ground truth" in the context of device performance, especially for AI/ML, refers to a definitive correct answer for a given input. For this type of physiological monitoring device modification, the "ground truth" would be the known physiological parameters (e.g., gas concentrations) used during testing, established by calibrated reference equipment, not by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data, and there's a need to resolve discrepancies. This submission pertains to software and hardware modifications to a physiological monitor, not diagnostic image interpretation.

5. 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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids where human interpretation is involved. The INFINITY Modular Monitors are physiological monitors that directly display parameters. The modifications relate to displaying dual-anesthetic agents.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document implies that the device's performance (i.e., its ability to monitor and display physiological parameters) was assessed independently through "verification and validation testing." However, it does not explicitly use the term "standalone performance" in the context of an algorithm. The device itself, as a monitor, operates in a "standalone" fashion by measuring and displaying data, and the software modifications were tested to ensure this function remains effective.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The type of "ground truth" for a physiological monitor would typically be measurements from calibrated reference instruments or known physiological states (e.g., a gas mixture with a known concentration of anesthetic agents). The document does not explicitly state how ground truth was established, but it would be part of standard verification and validation procedures for such devices. For example, to test the accuracy of gas measurements, the Scio module would be exposed to precisely mixed gas samples with known concentrations, and the device's readings would be compared to these known values.

8. The sample size for the training set

Not applicable. This is a modification to an existing physiological monitor, not an AI/ML product that undergoes a training phase with a dataset.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set mentioned or implied for this type of device modification.

Summary

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K033957

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

MAY 1 4 2004

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: May 13, 2004

Trade Name, Common Name and Classification Name:

A. Trade Name:
INFINITY Modular Monitors
B. Common Name, Classification Name, Class and Regulation Number:

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

Legally Marketed Device Identification:

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

Description of Modification:

The INFINITY Modular monitor VF4 software release includes a modification in support of the Scio gas module for dual-anesthetic agent display.

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

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

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

IEEE 802.11 Standards and Guidances: Reviewer Guidance for Premarket Notification 510(k) Submissions, November 1993

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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three stylized human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 4 2004

Ms. Penelope H. Greco Regulatory Submissions Manager Siemens Medical Solutions USA, Incorporated 16 Electronics Avenue Danvers, MA 01923

Re: K033957

Trade Name: INFINITY Modular Monitors VF4 Modifications with Scio Regulation Number: 21 CFR 870.1025 Regulation Name: Physiological Patient Monitor, (W/ Arrhythmia Detection or Alarms) Regulatory Class: II Product Code: MHX Dated: April 14, 2004 Received: April 15, 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 adultcration.

If your device is classified (sec 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 Please be advised that I DT 5 issualled on that your device complies with other requirements mean that ITDA has made a deceminations administered by other Federal agencies. of the Act of ally rederal statues and regirements, including, but not limited to: registration You must comply with an the Fee o required (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labeling (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality ison 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) This letter will anow you to begal mading of substantial equivalence of your device to a premarket notification. - The PD Printers 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), If you desire specific advice for your as 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 Inay obtain of Small Manufacturers, International and Consumer Assistance at its toll-free Driston 01 01 01638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): 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 �
tcn02/tcp(02 .
EEG signals .
FiQ2 .

The SCIO and MultiGas/MultiGas+ modules sample breathing gases from adults and pediatrics. The gas I he octo and ivalitious mancedo internet of CO2, NO, O2 and one of the anesthetic agents, halothane, inoduces continuously mousal rane and Desflurane in any mixture and communicates real time and derived gas information to the INFINITY monitors.

The monitors can interface with specific third party devices via an MIB protocol converter.

The devices are intended to be used on Adult, Pediatric and Neonatal populations, with the exception of the The devices are intended to ot Segment Analysis, and arrhythmia which are intended for use in the adult purameter Cardial Galph, 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.

Prescription Use_Y (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

(
(SDL)

Division Sign-Off)

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.