INFINITY GAMMAXL by Draeger Medical Systems, Inc.

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

AI/ML Overview

The provided documents describe a 510(k) submission for modifications to the INFINITY GammaXL physiological patient monitor. The submission asserts that the modified device is as safe and effective as its predicate device (SC 6802XL, K030313 / K993974). However, the documents available do not contain detailed acceptance criteria, reported device performance data in a tabular format, or information about specific studies that prove the device meets such criteria.

The submission states: "Testing in accordance with internal design control procedures has verified that the INFINITY GammaXL with VF4 modifications is as safe and effective as the SC 6802XL as submitted in 510(k) K030313." It also mentions "Assessment of non-clinical performance data for equivalence: Section J" and "Assessment of clinical performance data for equivalence: Not applicable." This suggests that the modifications were primarily related to user interface ("look and feel"), mechanical design, and the addition of an alarm indicator, and that extensive new clinical performance data (beyond what was established for the predicate device) was not deemed necessary for this particular 510(k) submission.

Since the provided text does not contain the information requested, I cannot complete the table or answer most of the questions.

Here's a breakdown of what is not available in the provided text:

A table of acceptance criteria and the reported device performance: Not provided. The submission states that testing was done to verify equivalence but doesn't detail performance metrics or acceptance criteria for those tests.
Sample size used for the test set and the data provenance: Not provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided.
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 for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI-driven algorithm, as this is a physiological monitor. The device's performance would be assessed on its ability to accurately measure and alarm on physiological parameters.
The type of ground truth used: Not specified, beyond the general statement of "testing in accordance with internal design control procedures." For physiological monitors, ground truth typically involves calibrated reference devices.
The sample size for the training set: Not applicable and not provided, as this is not an AI/ML device requiring a training set in that sense.
How the ground truth for the training set was established: Not applicable and not provided.

Summary

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

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: November 12, 2003

Trade Name, Common Name and Classification Name:

INFINITY GammaXL Trade Name:

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 SC 6802XL K030313 / K993974

Description of Device Modifications:

The VF4 release of the INFINITY GammaXL (SC 6802XL) 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 yellow for the purpose of displaying both life threatening and serious alarms respectively. Testing in accordance with internal design control procedures has verified that the INFINITY GammaXL with VF4 modifications is as safe and effective as the SC 6802XL as submitted in 510(k) K030313.

Intended Use:

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, noninvasive pressure, arrhythmia, temperature, arterial oxygen saturation and pulse rate, central apnea, 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: Section J Assessment of clinical performance data for equivalence: Not applicable Biocompatability: Not applicable Sterilization: Not applicable Standards: Section J

Draeger Medical Systems, Inc.

16 Electronics Avenue Danvers, MA 01923

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

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

Food and Drug Administration

Public Health Service

DEC 1.1 2003

9200 Corporate Boulevard Rockville MD 20850

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

Re: K033600

Trade Name: INFINITY GammaXL Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm Regulatory Class: Class II (two) Product Code: MHX Dated: November 12, 2003 Received: November 14, 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 ecommerce provided 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). the Coometer Fee (110) inn the device, subject to the general controls provisions of the Act. The I ou may, aterest, mains 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 If your de rio is enation (controls. Existing major regulations affecting your device can may or defect to 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.

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

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 Of R ratt 60779 to one (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) rms leter with as a minding of substantial equivalence of your device 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 If you acono eposition 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 vours.

Elsa D'Arz hr

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: INFINITY GammaXL

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 .
(central) apnea .
end-tidal CO2 .
ST Segment Analysis .

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 GammaXL is not compatible for use in a MRI magnetic field.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

(Optional Format 1-2-96)

Prescription Use (Per 21 CFR 801.109)	X
	QDA FRBPZ 12/11/93
510(k) Number:	K033600
	Division of Cardiovascular & Respiratory Devices

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.