The Infinity CentralStation (ICS) is intended for use by trained healthcare professionals for the purpose of centralized monitoring of adult, pediatric and neonatal patient data within the hospital or clinical environment. Centralized monitoring involves the display and management of data from networked patient monitors including the annunciation of visual and audible physiologic parameter alarms at a central monitoring workstation.

Infinity CentralStation with Rest ECG is intended for the production of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry and nonambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

Device Description

The Infinity® CentralStation (ICS) Wide (or widescreen) is a Central monitoring station capable of real-time display and storage of multi-parameter physiological patient data and alarm annunciation for networked devices including but not limited to ambulatory and non-ambulatory wireless telemetry monitoring.

The Infinity M300/M300+ is a wireless telemetry, patient-worn device with rechargeable lithiumion battery which monitors ECG and SpO2 physiological data and features a color display, local alarm alerts and keypad interface. ECG functions include heart rate, arrhythmia detection and ST segment analysis and SpO2 functions include pulse plethysmogram and pulse rate. Infinity M300/M300+ with TruST allows for 12-lead ECG monitoring with a reduced set of electrodes by deriving values for missing leads.

AI/ML Overview

The provided text is a 510(k) premarket notification summary for the Draeger Medical Systems Infinity CentralStation Wide, Infinity M300, and Infinity M300+ devices. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, it does not explicitly contain detailed acceptance criteria tables with reported device performance or specific study details regarding sample sizes, ground truth establishment for test sets, expert qualifications, or adjudication methods for this specific submission's changes.

The document states that the changes related to cybersecurity and M300+ swappable battery were evaluated through verification and validation testing. It emphasizes that these modifications do not raise new issues of safety and effectiveness and do not change the fundamental scientific technology of the cleared devices, meaning the previous performance characteristics are considered to remain valid.

The key performance data described pertains to compliance with various standards related to electrical safety, EMC, alarm systems, electrocardiographic monitoring, and pulse oximetry. These standards implicitly contain acceptance criteria.

Based on the provided information, I can extract the following, though some requested details related to individual device performance metrics and specific study designs for this particular 510(k) are not explicitly stated in this summary.

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

The document doesn't provide a table of performance acceptance criteria directly. Instead, it refers to compliance with established international and national standards for medical electrical equipment. The "reported device performance" is implicitly that the device meets these standards.

Acceptance Criteria (Implied by Standards Compliance)	Reported Device Performance (as stated in document)
Electrical Safety: AAMI/ANSI ES60601-1:2005/(R)2012 and amendments (IEC 60601-1 MOD)	Complies with the standard.
Electromagnetic Compatibility (EMC): IEC60601-1-2:2014	Complies with the standard.
Alarm Systems: IEC60601-1-8:2012	Complies with the standard.
Electrocardiographic Monitoring: IEC 60601-2-27:2011	Complies with the standard.
Cardiac Rhythm and ST-Segment Measurement Algorithms: ANSI/AAMI EC57:2012	Complies with the standard.
Pulse Oximetry: ISO 80601-2-61:2017	Complies with the standard.
Cybersecurity (Denial of Service, KRACK, FTP to SFTP, SSH, TLSv1.2):	Risk mitigation measures designed, developed, and tested; validation tests conducted to confirm implementation; results support substantial equivalence.
Biocompatibility: ISO 10993-1 assessment	Materials are biocompatible for intended use; testing results demonstrate compliance.

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 detail specific sample sizes for test sets for the verification and validation of the changes in this submission. The testing done refers to internal company verification and validation efforts rather than clinical studies with patient data for assessing core performance metrics like arrhythmia detection accuracy. Data provenance is not specified.

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):

Not applicable/Not provided. The document summarizes the regulatory submission for changes to existing devices, focusing on technical compliance and safety/effectiveness equivalence, not new clinical performance evaluation requiring external expert ground truth establishment for a diagnostic output. The modifications are for cybersecurity and hardware components (swappable battery).

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

Not applicable/Not provided. Adjudication methods are typically used in clinical studies involving interpretation of medical data, which is not the focus of the performance data section for this specific submission's changes.

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 submission is for modifications (primarily cybersecurity and a new battery component) to existing patient monitoring devices, not for a new AI/CAD system. Therefore, an MRMC study is not relevant to the described changes.

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

The performance data focuses on compliance with technical standards for the device's functions (e.g., ECG monitoring, pulse oximetry, alarm systems) and validation of the cybersecurity and hardware changes. These are "standalone" in the sense that the device's technical functions are tested against defined standards. However, it's not "algorithm only" in the context of a new diagnostic algorithm. The monitoring functions (like arrhythmia detection, ST-segment measurement for 12-lead ECG) are inherent to the device and would have been evaluated in prior clearances against ANSI/AAMI EC57.

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

For the specific changes in this submission (cybersecurity, swappable battery), the "ground truth" would be the successful implementation and verification of design requirements and risk mitigations, as tested internally by Dräger. For the underlying physiological monitoring capabilities (ECG, SpO2, arrhythmia, ST-segment), the ground truth for performance evaluation in predicate devices would typically be established through recognized test databases (e.g., MIT-BIH Arrhythmia Database for arrhythmia detection, or similar validated datasets for ST-segment analysis) or expert review against reference standards, as per standards like ANSI/AAMI EC57. The document for this submission does not detail these for the underlying performance.

8. The sample size for the training set:

Not applicable. The described changes and performance data do not relate to machine learning model training.

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

Not applicable. Not a machine learning submission.

Summary

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October 17, 2023

Draeger Medical Systems, Inc. Deborah Herrington Senior Principal Regulatory Affairs Specialist 6 Tech Drive Andover, Massachusetts 01810

Re: K231477

Trade/Device Name: Infinity CentralStation Wide, Infinity M300, Infinity M300+ Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including ST-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX Dated: September 15, 2023 Received: September 18, 2023

Dear Deborah Herrington:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shruti N. Mistry -S

for

Jennifer Kozen Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231477

Device Name

Infinity CentralStation (ICS) Wide with Infinity M300/M300+

Indications for Use (Describe)

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

Contraindications:

The Infinity M300/M300+ is not compatible for use in an MRI magnetic field.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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Indications for Use Statement

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l. Submitter: Draeger Medical Systems, Inc. 6 Tech Drive Andover, MA 01810-2434

Tel: (978) 935-6561

Contact Person: Deborah Herrington Senior Principal RA Specialist

E-mail: mailto:deborah.herrington@draeger.com Date Prepared: May 22, 2023

II. Device

Names / Common Names / Classification Names:

Common Name:	Multi-parameter patient monitor
Trade Name:	Infinity CentralStation and Infinity M300/M300+
Classification Name:	Monitor, Physiological, Patient (with Arrhythmia detection or alarms)
Product Code:	MHX
Regulatory Class:	II
Regulation Number:	21 CFR §870.1025

III. Predicate Device:

Infinity CentralStation (VG2 MS26800) was cleared under K151860 on September 2, 2015 and Infinity M300 was cleared under K200859 on August 28, 2020.

Mindray BeneVision Central Monitoring System with TM80 was cleared under K193391 on May 21, 2020.

IV. Device Description:

Infinity CentralStation device description

Infinity M300/M300+ device description

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Infinity M300 components

The standard Infinity M300 includes the following:

Infinity M300 patient-worn transceiver —
-Infinity M300 Bedside Charger
Infinity M300 CentralCharger |
Infinity M300 programming kit —

Infinity M300+ components

The standard Infinity M300+ includes the following:

Infinity M300+ patient-worn transceiver
-Infinity M300+ swappable battery (2)
| Infinity M300+ remote battery charging station (charging capacity of up to 10 swappable batteries)
Infinity M300+ programming kit —
Infinity M300+ battery retainer (4) —

Infinity M300/M300+ environment of use

The Infinity CentralStation with Infinity M300/M300+ 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.

Infinitv M300/M300+ communications

Infinity M300/M300+ connects to the Infinity network via 802.11 wireless communication with hospital access points (AP). From the AP, data is routed over the Infinity network via wired Ethernet for real-time display and annunciation at the Infinity CentralStation Wide (Widescreen), the Dräger central monitoring workstation. The Infinity CentralStation (ICS) Wide allows for simultaneous central monitoring of up to thirty-two (32) Infinity M300/M300+ devices to support wireless telemetry monitoring.

Infinity M300/M300+ user interfaces and functions

The Infinity M300/M300+ communicates bilaterally with the Infinity CentralStation (ICS) central nursing workstation which serves as the primary display, user interface and alarm annunciator for acquired M300/M300+ physiological patient data. The Infinity M300/M300+ local keypad and display serves as a secondary user interface for clinicians to access local features and functions.

To facilitate patient mobility clinicians can place the Infinity M300/M300+ in a disposable or reusable shower pouch worn by the patient. When a patient is sedentary (in bed or sitting) the clinician can place the Infinity M300 in the Bedside Charger to provide a slow charge for the device. When the Infinity M300 is not in clinical use, it may be stored and recharged at an accelerated rate in the CentralCharger. When an Infinity M300+ swappable battery is exchanged, it can be charged in the M300+ battery charger to be made ready for later use.

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V. Indications for Use / Intended Use:

Infinity CentralStation

Infinity CentralStation with Rest ECG is intended for the production and interpretation of diagnostic electrocardiograms for adult and pediatric patients when connected to a monitor with diagnostic 12-Lead ECG monitoring enabled.

Infinity M300/M300+

The Infinity M300/M300+ is intended for use with the ICS to monitor ECG and pulse oximetry on ambulatory and non-ambulatory adult and pediatric patients using wireless communication over the Infinity patient monitoring network.

The Infinity M300/M300+ with TruST is intended for 12-Lead ECG monitoring with a reduced set of electrodes. Reconstructed leads are intended for real-time assessment of ST segment changes.

Contraindications:

The Infinity M300/M300+ is not compatible for use in an MRI magnetic field.

VI. Comparison of Technological Characteristics with the Predicate Device:

The intended use, performance and technological characteristics are substantially equivalent to the referenced predicate devices. In comparison to the predicate devices, the modified ICS Wide VG4.0 with M300/M300+ VG3.0 has the same intended use, indications for use, packaging materials and shelf life. Proposed modifications do not change the fundamental scientific technology of the cleared devices. The ICS Wide VG4.0 with M300/M300+ VG3.0 differs from the predicate device in regards to proposed significant change modifications and non-significant historical modifications listed below:

Significant Change Modifications introduced in this submission:

Infinity CentralStation VG4 with M300/M300+ VG3

TLSv1.2 secure communications for ICS-M300(+) data-in-transit (Authentication/Authorization, Encryption and Integrity)
-Configurable service and engineering passwords

Infinity M300/M300+ VG3

Denial of Service protections (i.e. packet storm, input validation) —
KRACK fix with wireless module firmware update —
Update FTP to SFTP —
Added SSH for service access
Infinity M300+ swappable battery and battery retainer

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VII. Performance Data

Verification Testing:

Dräger evaluated the substantial equivalence of the devices with proposed modifications through system performance and verification testing. Dräger performed a risk assessment for the devices with proposed modifications and identified the need for risk mitigations to support cybersecurity protections. The risk control measures were designed, developed and tested in accordance with 21 CFR 820.30 design controls. The results of Verification testing confirm that the modified device continues to meet equivalent criteria demonstrating substantial equivalence to the predicate device. The devices with proposed modifications meet the criteria for substantial equivalence to the predicate devices and do not raise new issues of safety and effectiveness.

Validation Testing:

Dräger design controls in compliance with 21 CFR 820.30 (g) govern validation and risk analysis of device modifications. Dräger identified hazardous situations following recommendations in FDA guidance documents "General Principles of Software Validation" issued January 2002 and "Applying Human Factors and Usability Engineering to Medical Devices" issued February 2016. Validation tests were conducted to confirm the implementation of software design input requirements, established risk mitigations and user adoption of the proposed modifications. Validation test results support the claim of substantial equivalence to the predicate devices and do not raise new issues of safety and effectiveness.

Biocompatibility:

Dräger design controls in compliance with 21 CFR 820.30 govern the assessment of materials used in the Infinity M300/M300+. Dräger selected materials appropriate for the use-case of the device per FDA's quidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process." Considering the intended use of the device and the transient nature of skin contact, an assessment was made for compliance to ISO 10993-1 and appropriate methods of testing were conducted on the materials. The results of testing and assessment demonstrate materials are biocompatible for their intended use and support the claim of substantial equivalence with the predicate device.

Sterilization:

ICS Wide and Infinity M300/M300+ do not require sterilization to accomplish their intended use. Reprocessing of the Infinity M300/M300+ follows the criteria for low level cleaning and disinfecting.

Standards / Compliance testing:

ICS Wide with Infinity M300M300+ has been tested and complies with the following standards in support of Electrical Safety, EMC and particular standards requirements:

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Infinity CentralStation with Infinity M300/M300+:

AAMI/ANSIES60601-1FR Recognition# 19-4	2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(R) 2012	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD)
IEC60601-1-2(M300/M300+)and ICSFR Recognition# 19-8	M300/M300+Edition 4.0 2014-02ICSEdition 4.12014	Medical Electrical Equipment - Part 1-2: GeneralRequirements for Basic Safety and EssentialPerformance - Collateral Standard:Electromagnetic Compatibility - Requirements andTests
IEC60601-1-8FR Recognition# 5-76	Edition 2.1 2012-11	Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essentialperformance - Collateral Standard: Generalrequirements, tests and guidance for alarmsystems inmedical electrical equipment and medical electricalsystems
IEC 60601-2-27FR Recognition# 3-126	Edition 3.0 2011-03	Medical electrical equipment - Part 2-27: Particularrequirements for the basic safety and essentialperformance of electrocardiographic monitoringequipment [Including: Corrigendum 1 (2012)]
ANSI/AAMIEC57FR Recognition# 3-118	Edition 2012	Testing and Reporting Performance Results ofCardiac Rhythm and ST-Segment MeasurementAlgorithms
ISO 80601-2-61	Edition 2017	Medical electrical equipment - Part 2-61: Particularrequirements for basic safety and essentialperformance of pulse oximeter equipment

VIII. Conclusion

Substantial Equivalence:

Infinity CentralStation VG4.0 with Infinity M300/M300+ VG3.0 significant change modifications are substantially equivalent to the predicate devices cleared under K151860 on September 2, 2015 and K200859 on August 28, 2020. The intended use of the Infinity CentralStation VG4.0 and Infinity M300/M300+ VG3.0 as described in the product labeling has not changed as a result of the proposed modifications. The results of verification and validation for the proposed modifications support substantial equivalence to the predicate 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.