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.

Device Description

The INFINITY Gamma, like the INFINITY GammaXL, supports the "look and feel" of the Draeger Medical product line, including the Draeger logo, colors, menu structure, and physical form. The Infinity Gamma also has an alarm at the top center that illuminates in red or yellow for the purpose of displaying both life threatening and serious alarms respectively. The primary difference between the INFINITY GammaXL and the new INFINITY Gamma is the smaller size.

AI/ML Overview

The provided document is a 510(k) summary for the INFINITY Gamma, a patient physiological monitor. It primarily focuses on demonstrating substantial equivalence to a predicate device (INFINITY GammaXL) and does not contain detailed acceptance criteria or a study that specifically proves the device meets such criteria in the way typically expected for a new, novel AI/ML medical device.

Instead, the document states performance has been verified through "internal design control procedures" and refers to the predicate device's established safety and effectiveness.

Therefore, for almost all the requested information, the answer will be "Not Applicable" or "Not Provided in this document" because the submission is for a device modification of an existing device, not a new device requiring extensive clinical or standalone performance studies against defined acceptance criteria.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Not provided in this document. The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL as submitted in 510(k) K033600." Specific performance metrics and acceptance criteria for these metrics are not detailed.

2. Sample size used for the test set and the data provenance:

Sample Size: Not provided.
Data Provenance: Not provided. The document mentions "internal design control procedures," implying testing was likely conducted internally, but no specifics on data origin (e.g., country, retrospective/prospective) are given for any test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable / Not provided. This type of information is typically relevant for studies involving subjective interpretation (e.g., image analysis) where expert consensus is needed. For a physiological monitor, ground truth would likely be established through calibrated instruments or established clinical values, not expert consensus on interpretations. No details are given.

4. Adjudication method for the test set:

Not applicable / Not provided.

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:

Not applicable. This device is a physiological monitor, not an AI-assisted diagnostic tool involving human readers.

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

Not applicable. The "device" itself performs the monitoring; there isn't a separate "algorithm" being tested in a standalone fashion distinct from the hardware and embedded software. The document states "Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL". This implies comprehensive device testing, not an isolated algorithm evaluation.

7. The type of ground truth used:

Not provided. For physiological monitors, ground truth would typically come from reference devices or established physiological standards for accuracy validation, but no specifics are mentioned in this document.

8. The sample size for the training set:

Not applicable / Not provided. This document describes a traditional medical device, not a machine learning model, so there isn't a "training set" in the sense of AI/ML development.

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

Not applicable / Not provided.

Summary

{0}------------------------------------------------

MAY 1 2 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 Regulatory Submissions Manager Date submission was prepared: April 23, 2004

Trade Name, Common Name and Classification Name:

Trade Name: INFINITY Gamma

Common Name, Classification Name, Class and Regulation Number:

Common Name	Product Code	Class	RegulationNumber
Monitor, Physiological, Patient (withArrhythmia Detection 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:

K033600 INFINITY GAMMAXL

Description of Device Modifications:

Page 1 of 2

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

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

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

Special 510(k): Device Modification INFINITY Gamma

Intended Use:

Assessment of non-clinical performance data for equivalence:

Testing in accordance with internal design control procedures has verified that the INFINITY Gamma is as safe and effective as the INFINITY GammaXL as submitted in 510(k) K033600.

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards: IEC 60601-1

Draeger Medical Systems, Inc.

द

16 Electronics Avenue Danvers, MA 01923

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

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

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 2004

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

Re: K041087

Trade Name: INFINITY Gamma Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: II (two) Product Code: MHX Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. Greco :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your became i re(i) fee 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 citilosure) to regars and in the Medical Device Amendments, or to commerce phor to May 20, 1977, are accordance with the provisions of the Federal Food, DNIg, de necs that have been require approval of a premarket approval application (PMA). alla Cosmetic Act (71ct) that do not required to the general controls provisions of the Act. The r ou may, therefore, mainer the we let include requirements for annual registration, listing of general controls provision practice, labeling, and prohibitions against misbranding and adultcration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is clussinod (itso at controls. Existing major regulations affecting your device can inay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may ou lound in the Overning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination docs not mean r lease of a rised that i ermination that your device complies with other requirements of the Act

{3}------------------------------------------------

Page 2 – Ms. Penelope Greco

or any Federal statutes and regulations administered by other Federal agencies. You must of ally it catal statutes and regaranents, including, but not limited to: registration and listing (21 Compry with an the Her STequirements, n.i., good manufacturing practice requirements as set CFR in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by techno (Sections 531-542 of the Act); 21 CFR 1000-1050. product laulation control provisions (Seeting your device as described in your Section 510(k) This letter with anow you to begin mailiers of substantial equivalence of your device to a legally premits that in the 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 If you desire specific advice for your act (301) 594-4648. Also, please note the regulation entitled, Contiact the Ories of Company of Company (21CFR Part 807.97). You may obtain Misoranums by reference to premainonsibilities under the Act from the Division of Small other general mionmation on your response 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,

Dara R. Vachner

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):_K041087

Device Name: INFINITY Gamma

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 Gamma 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.

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 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 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 neonatal population.

MRI Compatibility Statement:

The INFINITY Gamma is not compatible for use in a MRI magnetic field.

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)

Page 1 of 1

D. Vochner

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number K041087

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.