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.

When a GammaXL is connected to a SCIO module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N20, 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 GammaXL.

The device is intended to be used in an 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.

not available with Infinity Vista

Device Description

Software version VF5 is the latest release of the INFINITY Gamma/GammaXL and the Infinity Vista monitor (a variant of the Infinity GammaXL with fewer options). It supports a new serial connection to the Scio gas module, as well as other minor software modifications. Testing in accordance with internal design control procedures has verified that the INFINITY Gamma/GammaXL and Vista with VF5 modifications are as safe and effective as submitted in 510(k) K040188, K041087 and K033600.

AI/ML Overview

The provided text describes a Special 510(k) for device modifications to the INFINITY Gamma/GammaXL and Vista with VF5 software. This submission focuses on verification and validation testing to demonstrate that the software modifications do not alter the fundamental technology and the device remains as safe and effective as previous versions.

Here's a breakdown based on your requested information:

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

The submission does not provide specific acceptance criteria or reported device performance metrics in a quantitative manner. It states:

Acceptance Criteria (Implied): The modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s). This is a qualitative statement of equivalence.
Reported Device Performance: "Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)." This is also a qualitative statement, indicating successful completion of internal testing without providing granular results or specific performance metrics.

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 used for the test set or the data provenance. It only mentions "Verification and validation testing performed."

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 in the document. The text does not describe an expert-driven ground truth establishment process for the testing. The testing appears to be internal verification and validation against design specifications and previous versions of the device, rather than a clinical study with expert ground truth.

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

This information is not provided. There is no mention of an adjudication process for the testing performed.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device in question is a physiological patient monitor with software modifications, not an AI-assisted diagnostic tool that would typically involve human readers.

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

The document does not explicitly describe a "standalone" performance study in the context of an algorithm's performance without human intervention. The testing performed was "Verification and validation testing" to ensure the modifications were safe and effective, implying functional and performance testing of the device itself.

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

The document does not specify the type of ground truth used. Given the nature of the device (physiological monitor) and the reported testing (verification and validation of software modifications), the "ground truth" would likely be based on:

Engineering specifications and requirements: Ensuring the device functions as designed and meets its technical parameters.
Comparison to previous versions: Confirming that the modified software performs equivalently to the predicate devices.
Internal reference standards: Using calibrated equipment or established reference values for physiological parameters.

8. The sample size for the training set

This is not applicable and therefore not provided. The submission describes modifications to existing software for a physiological monitor, not the development of a new AI/machine learning algorithm that requires a training set.

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

This is not applicable and therefore not provided, as there is no training set for an AI/machine learning algorithm described in this submission.

Summary

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K042656
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Special 510(k): Device Modification Infinity Gamma/GammaXL and Vista with VF5 software

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 Contact person for this submission: Penelope H. Greco Regulatory Submissions Manager Date submission was prepared: September 24, 2004

Trade Name, Common Name and Classification Name:

INFINITY Gamma/GammaXL and Vista with VF5 modifications 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 GammaXL & SC 6802XL with Scio Infinity Gamma

K033600, K040188 K041087

Description of Device Modifications:

Intended Use:

The intended use of this device is to monitor heart rate, respiration rate, invasive pressure, noninvasive pressure*, arthythmia, 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. * not available with the Infinity Vista monitor

Page 1 of 2

COMPANY CONFIDENTIAL

Draeger Medical Systems, Inc.

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

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Assessment of non-clinical performance data for equivalence: Verification and validation testing performed indicates that the modifications implemented with software version VF5 are as safe and effective as previous versions and have not altered the fundamental technology of the device(s).

Assessment of clinical performance data for equivalence: Not applicable

Biocompatability: Not applicable

Sterilization: Not applicable

Standards: IEC 60601-1

COMPANY CONFIDENTIAL

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 U.S. Department of Health & Human Services (HHS). The seal features a stylized eagle with three tail feathers, representing the department's commitment to health, services, and people. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT & - 2004

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

Re: K042656

Trade Name: INFINITY Gamma/GammaXL and Vista Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment measurement and alarm) Regulatory Class: II (two) Product Code: MHX Dated: September 24, 2004 Received: September 28, 2004

Dear Ms. Greco :

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be 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 encreatment date of the Medical Device Amendments, or to commerce prior to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices mat have been recassmed in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The r ou may, mercrore, market the act include requirements for annual registration, listing of general connois provisions of use tice, 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 device is classinod (600 as controls. Existing major regulations affecting your device can may be subject to success to success Regulations, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obecaments 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 r lease oc advised that I Dri b 150 and 10 evice complies with other requirements of the Act that I DA has made a acted regulations administered by other Federal agencies. You must of any I cacal statutes and regarments, including, but not limited to: registration and listing (21 Comply with an the riot 8 requirements, are and manufacturing practice requirements as set CFN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quarty byovisions (Sections 531-542 of the Act); 21 CFR 1000-1050. product taanation come of proved in marketing your device as described in your Section 510(k) I ms icter witi anow you to oegin maine of substantial equivalence of your device to a legally prematicated predicated on . The PDF intentig sification 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 acriously 3 (301) 594-4646. Also, please note the regulation entitled, connact the Office or Cremarket notification" (21CFR Part 807.97) you may obtain. Wher general information on your responsibilities under the Act may be obtained from the Oinci general information on your respectional 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,

Summons for
B. Zukerman, M.D.

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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K042656

510(k) Number (if known): ___

Device Name: INFINITY Gamma/GammaXL and Vista

Indications for Use:

This devices are 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 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.

not available with Infinity Vista

MRI Compatibility Statement:

The devices are not compatible for use in an 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)

B.B.McClenon

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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.