The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, non-invasive pressure, arthythmia, temperature, cardiac output, arterial oxygen saturation, pulse rate, apnea, ST Segment Analysis, and 12-Lead ST Segment Analysis.
The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.
Kappa XLT receives EEG signals when connected to an Infinity EEG pod.
The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.
The SCIO module sample breathing gases from adults and pediatrics. 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 Kappa XLT.
With etCO2 the Kappa XLT 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 device can interface with specific third party devices via an RS 232 connection.
The device is 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.

Device Description

The Infinity Kappa XLT is an addition to Draeger's INFINITY patient monitoring system that combines on one platform the patient monitoring features of the Infinity Delta/DeltaXL/Kappa and the Infinity Explorer, Draeger's software-driven critical care workstation.
The Kappa XLT System consists of three basic components:

The Kappa XLT Vital Signs Engine that acquires all signals
The Kappa XLT Display, a medical grade display unit
The Kappa XLT Power Supply.

AI/ML Overview

The provided 510(k) summary for the Draeger Medical Systems' Infinity Kappa XLT does not contain specific acceptance criteria or an explicit study proving performance against such criteria. Instead, it relies on a declaration of substantial equivalence to predicate devices.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for arrhythmia detection, ST segment analysis) are detailed in the submission. The document primarily focuses on stating the device's capabilities and its equivalence to predicate devices.

Acceptance Criteria	Reported Device Performance
Not specified	"The Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices."
Not specified	"Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer."

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

No information regarding sample size for a test set, nor data provenance (country of origin, retrospective/prospective), is provided.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

No information is provided regarding experts, their number, or qualifications for establishing ground truth.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as there is no specific test set described in the context of performance metrics.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study is mentioned. The submission focuses on device equivalence rather than demonstrating AI-assisted human performance improvement.

6. Standalone (Algorithm Only) Performance Study:

No standalone algorithm performance study is detailed. The device is a physiological monitoring system with integrated analysis capabilities, not a standalone AI algorithm being evaluated for its own performance metrics. The "clinical performance evaluation" mentioned appears to be a general assessment of the device's overall function in comparison to predicates.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used. Given the nature of the device (physiological monitor), ground truth would typically come from:

Reference Devices/Gold Standards: Comparison of measurements (e.g., heart rate, respiration rate, SpO2, invasive pressure) against calibrated reference instruments or established clinical methods.
Expert Clinical Assessment: For aspects like arrhythmia detection or ST segment analysis, comparison against interpretations by qualified clinicians (cardiologists, intensivists).
However, the submission does not elaborate on these methodologies.

8. Sample Size for the Training Set:

No sample size for a training set is mentioned, as this is a traditional medical device submission based on predicate equivalence, not a machine learning model requiring a distinct training set for algorithm development.

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

Not applicable, as no training set for a machine learning model is described.

Summary of the K042904 Submission:

This 510(k) submission for the Infinity Kappa XLT primarily relies on demonstrating substantial equivalence to previously cleared predicate devices (Infinity Explorer, Infinity Delta/DeltaXL/Kappa, Infinity SC 8000). The "Assessment of non-clinical performance data for equivalence" and "Assessment of clinical performance data for equivalence" sections state that the device was tested in accordance with applicable standards and internal design control procedures and found to be "as safe and effective" and "substantially equivalent" to its predicates. This is a common pathway for medical device clearance, where detailed performance metrics against specific acceptance criteria for novel algorithms might not be required if the device's functionality and technology are similar to existing cleared devices.

Summary

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K042904

510(k) SUMMARY FEB | 8 2005

as required per 807.92(c)

Submitters Name, Address:

Draeger Medical Systems, Inc. Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879 Contact person for this submission: Penelope H. Greco October 20, 2004 Date submission was prepared:

Trade Name, Common Name and Classification Name:

A. Trade Name: Infinity Kappa XLT

B. Common Name, Classification Name, Class and Regulation Number:

Common Name	Classification Number	Class	Regulation Number
Monitor, physiological, patient (with arrhythmia detection or alarms	MHX	2	870.1025
System, Network and Communication, Physiological Monitors	MSX	2	870.2300
Computers and Software, Medical	LNX

Predicate Device Identification:

Infinity Explorer (K040945) Infinity Delta / DeltaXL / Kappa (K033957) Infinity SC 8000 (K012016)

Device Description:

The Kappa XLT System consists of three basic components:

The Kappa XLT Vital Signs Engine that acquires all signals ●
The Kappa XLT Display, a medical grade display unit .
. The Kappa XLT Power Supply.

Page 1 of 2

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

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

Intended Use:

The Infinity Kappa XLT is capable of measuring heart rate, respiration rate, invasive pressure, I he inimity trapper HD rovingia, temperature, cardiac output, arterial oxygen saturation, pulse non invasite prossure, and 12-Lead ST Segment Analysis. The device produces rate, apped, of beginent if any of the physiological parameters monitored vary beyond preset Imits and timed or alarm recordings will be produced. The device will connect to an R50 millis and thised or thank rocereings with the evice is capable of displaying clinical data received over a hospital information system.

Assessment of non-clinical performance data for equivalence:

The Infinity Kappa XLT was tested in accordance with applicable standards and internal design control procedures and was determined to be as safe and effective for its intended use as the predicate devices.

Assessment of clinical performance data for equivalence:

Clinical performance evaluation indicates that the Infinity Kappa XLT is substantially equivalent to the Infinity Delta series monitors and the Infinity Explorer.

Biocompatability:

Not applicable

Sterilization:

Not applicable

Standards and Guidance: IEC 60601-1

Draeger Medical Systems, Inc. 16 Electronics Avenue Danvers, MA 01923 Tel: (978) 907-7500 Fax: (978) 750-6879

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

FEB 1 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

K042904 Re: Trade Name: Infinity Kappa XLT Regulation Number: 21 CFR 870.1025 Regulation Name: Arrythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: 74 MHX Dated: January 20, 2005 Received: January 21, 2005

Dear Ms. Greco:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becement on the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or 10 eonimered prior to may 2017 11:11 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 i touse oc northou that I Dr bristian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I oderated and 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 (21 CFR Part 820); and if applicable, the electronic for at many a morely by so wisions (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) rms letter will anow yours ough finding of substantial equivalence of your device to a legally prestiated 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 may be obtained 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,

Bhimma for

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 K042904

510(k) Number (if known):_

Device Name: Infinity Kappa XLT

The device produces visual and audible alarms if any of the physiological parameters monitored vary beyond preset limits and timed or alarm recordings will be produced. The device will connect to an R50 recorder via the Infinity Network and is capable of displaying clinical data received over a hospital information system.

Kappa XLT receives EEG signals when connected to an Infinity EEG pod.

The Infinity Trident NMT pod measures the muscle response to electrical stimulation of a peripheral nerve and when connected to a Kappa XLT transmits that information to the device.

The SCIO module sample breathing gases from adults and pediatrics. 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 Kappa XLT.

With etCO2 the Kappa XLT 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 device can interface with specific third party devices via an RS 232 connection.

The device is 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.

MRI Compatibility Statement:

The Infinity Kappa XLT is not compatible for use in a MRI magnetic field.

Prescription Use - -Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ OR (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)

Blumuma

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.