This device is capable of monitoring: Heart Rate, Respiration Rate, Invasive Pressure, Non-Invasive Pressure, Arrhythmia, Temperature, Arterial oxygen saturation, Pulse rate, central apnea accomplished through impedance plethysmography, apnea accomplished through capnograpy, end-tidal CO2, ST Segment Analysis. This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network. When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures 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.

Device Description

The INFINITY GammaXL and SC 6802XL with software version VF3 and above are capable of displaying gas-monitoring data received from a Scio gas module (K031340). Anesthetic gas monitoring is available when a GammaXL or SC 6802XL is attacted via a specific cable to a Scio gas module. This is a password protected locked optical. The GammaXL and SC 6802XL with Scio are similar to the Infinity Modular Monitors with Scio (K031340) in that they display gas-monitoring parameters received from the Scio gas module.

AI/ML Overview

The provided text is a 510(k) summary for the INFINITY GammaXL and SC 6802XL with Scio, which is a device for physiological monitoring with integrated gas monitoring capabilities. The document details the device's modifications from previous versions and its intended use. Here's a breakdown based on your request, highlighting that this document outlines regulatory approval rather than a detailed study report:

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

The document does not provide a table with specific, quantifiable acceptance criteria and corresponding reported device performance metrics in the way one would expect from a clinical performance study for a diagnostic AI device.

Instead, the submission states:

Acceptance Criteria (Implied): Equivalence to legally marketed predicate devices, with "no new issues of safety and efficacy" and operating "as intended with no adverse affects." The General Controls provisions of the Act (annual registration, listing, GMP, labeling, prohibitions against misbranding and adulteration) also serve as broad acceptance criteria for regulatory compliance.
Reported Device Performance:
- "Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy."
- "The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects."

The focus here is on demonstrating that the modified device maintains the safety and efficacy profile of its predicate devices, particularly regarding the display of gas-monitoring data from the Scio module, rather than presenting a performance study against novel acceptance targets.

2. Sample sized 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 a "test set" with a particular sample size in the context of a performance study. The evaluation appears to be a systems-level verification and validation process for a device modification, focusing on functional performance and safety. Therefore, information about data provenance (country of origin, retrospective/prospective) is not 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 information is not provided. The nature of the device (physiological monitor displaying gas data) means that "ground truth" would likely be established through calibrated sensing equipment and established physiological principles, rather than expert human interpretation of complex data for diagnostic purposes.

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

This information is not applicable and not provided. The evaluation described is for a physiological monitoring device's functional and safety performance, not for a diagnostic device requiring adjudication of expert interpretations.

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

An MRMC comparative effectiveness study was not done. This type of study is typically performed for AI-assisted diagnostic tools where human readers interpret medical images or complex data. The INFINITY GammaXL and SC 6802XL with Scio is a physiological monitoring device that displays data directly, not an AI diagnostic assistant for human interpretation.

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

This document describes a medical device that includes software for displaying physiological parameters and gas-monitoring data. While the device's internal algorithms process data from sensors (e.g., for arrhythmia detection or calculating end-tidal CO2), the "standalone performance" in the context of diagnostic AI algorithms is not applicable here. The device itself operates autonomously to monitor and display, but it's not an "algorithm only" product for diagnostic interpretation. Its performance is evaluated as an integrated system.

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

The document does not explicitly state the type of ground truth used. However, given the device's function, it is highly probable that the "ground truth" for verification and validation would involve:

Reference gas analyzers/simulators: For accurate measurement of CO2, N2O, O2, and anesthetic agents, against which the Scio module's measurements would be compared.
Calibrated physiological simulators: For heart rate, respiration rate, pressure, temperature, SpO2, etc., to ensure the device accurately measures and displays these parameters.
Physical testing and engineering verification: To confirm signal integrity, alarm functionality, and system integration.

8. The sample size for the training set

This information is not applicable and not provided. The INFINITY GammaXL and SC 6802XL with Scio is a physiological monitoring device that processes sensor data using established algorithms, not a machine learning or AI-based system that requires a "training set" in the context of modern AI development.

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

This information is not applicable and not provided, as there is no mention of a "training set" in the context of this device.

Summary

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INFINITY GAMMAXL / SC 6802XL WITH SCIO

510(k) SUMMARY

as required per 807.92(c)

Submitters Name. Address:

(k) Notification

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 Regulatory Submissions Manager Date submission was prepared: January 23, 2004

Trade Name, Common Name and Classification Name: Trade Name: INFINITY GammaXL and SC 6802XL with Scio

Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	Regulation Number
Monitor, Physiological, Patient (with ArrhythmiaDetection or Alarms)	MHX	II	870.1025
Arrhythmia Detector & Alarm	74DSI	II	870.1025
System, Network and Communication,Physiological Monitors	MSX	II	870.2300

Legally Marketed Device:

INFINITY GammaXL / SC 6802XL INFINITY Modular Monitors with Scio

K033600 / K030313 / K993974 K031340

Description of Device Modifications:

Page 1 of 2

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA . 01923

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

{1}------------------------------------------------

Intended Use:

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, non-invasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea is accomplished through impedance plethysmography and apnea through capnography, end-tidal carbon dioxide, and ST Segment Analysis. This device will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.

Assessment of non-clinical performance data for equivalence: Verification and validation testing of the Infinity GammaXL and SC 6802XL with SCIO, indicates no new issues relative to safety and efficacy.

Assessment of clinical performance data for equivalence: The review of clinical data indicates that the GammaXL/SC 6802XL with Scio operates as intended with no adverse affects.

Biocompatability: Not applicable

Sterilization: Not applicable

Draft Reviewer Guidance for Premarket Notification 510(k) Standards: Submissions, November 1993 IEC 601-1, Medical Electrical Equipment, Part 1: General Requirements for Safety
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 seal of the Department of Health & Human Services - USA. The seal features an eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are written in a circle around the eagle. The eagle is black, and the text is also black. The background of the seal is white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Penelope H. Greco Regulatory Submissions Manager Draeger Medical Systems, Incorporated 16 Electronics Avenue Danvers, Massachusetts 01923

Re: K040188

Trade/Device Name: Infinity Gammaxl and SC 6802XL with the Scio Gas Module Regulation Number: 868.1500 Regulation Name: Enflurane gas analyzer Regulatory Class: II Product Code: NHP. MHX Dated: April 8, 2004 Received: April 9, 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.

APR 1 4 2004

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Page 2 - Ms. 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 (OS) 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 yours.

Qur

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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510(k) Number (if known):_ KO40 188

Device Name: INFINITY GammaXL / SC 6802XL with Scio

Indications for Use:

This device is capable of monitoring:

. Heart Rate
Respiration Rate ●
Invasive Pressure .
. Non-Invasive Pressure
Arrhythmia .
. Temperature
Arterial oxygen saturation .
. Pulse rate

SAwhlm

logy. General Hospital

510(k) Number: KO 40188

central apnea accomplished through impedance plethysmography ●
apnea accomplished through capnograpy .
� end-tidal CO2
ST Segment Analysis ◆

This Infinity GammaXL and SC 6802XL will produce visual and audible alarms if any of these parameters vary beyond preset limits and produce timed or alarm recordings. This device will connect to R50 recorders, either directly or via the INFINITY network.

When connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures 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.

The device is intended to be used in the environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the device, 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 for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonalal population.

MRI Compatibility Statement:

The INFINITY GammaXL and SC 6802XL are not compatible for use in a MRI magnetic field.

Prescription Use _ ) OR Over-The-Counter Use_ (Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 868.1500 Enflurane gas analyzer.

(a)
Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.(b)
Classification. Class II (performance standards).