The iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

Device Description

iSirona Magellan, is an on-site messaging integration solution which forwards information about patient alarms and other medical-related events obtained from information sources such as patient monitors, ventilators, infusion pumps, etc. to the user. The user receives the information via selective remote devices such as centralized computer stations and mobile communication devices provided by third-party companies. iSirona Magellan utilizes the existing hospital network to process data and relay secondary notifications. It is not to be considered a primary alarming device.

iSirona Magellan connects to the information sources through wired ethernet connections which are part of the customer's infrastructure. The user configures iSirona Magellan to determine which information, including alarm notifications, is delivered to which users, iSirona Magellan then formats the data for wireless delivery to the centralized computer stations and mobile communication devices.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the iSirona Magellan device, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for iSirona Magellan does not specify quantifiable acceptance criteria in the traditional sense of performance metrics (e.g., sensitivity, specificity, accuracy, latency targets). Instead, the performance testing focuses on verifying the software's adherence to its design specifications and relevant regulatory guidelines.

Here's a table summarizing the reported device performance and the general criteria used:

Acceptance Criteria (Implicit/General)	Reported Device Performance
Software Design & Development Compliance: Designed and developed according to a robust software development process and relevant FDA guidance documents (e.g., software contained in medical devices, off-the-shelf software, general principles of software validation, cybersecurity).	"Software was designed and developed according to a robust software development process, and was rigorously verified and validated.""Test results indicate that iSirona Magellan complies with its predetermined specifications, and applicable standards and guidance documents."
Functional Performance Compliance: Meets predetermined specifications for its intended function (forwarding patient alarms and medical events to users via remote devices).	"iSirona Magellan was tested for performance in accordance with internal requirements.""Test results indicate that iSirona Magellan complies with its predetermined specifications and the applicable standards."
Safety and Effectiveness: Demonstrates safety and effectiveness when used as intended.	"Verification and validation activities were conducted to establish the performance and safety characteristics of iSirona Magellan. The results of these activities demonstrate that iSirona Magellan is safe and effective when used in accordance with its intended use and labeling.""Therefore, iSirona Magellan is considered substantially equivalent to the predicate device."

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

The 510(k) summary does not provide any details about the sample size used for a specific "test set" in the context of clinical or diagnostic performance evaluation. The testing described is primarily focused on software verification and validation, and internal performance testing, rather than a clinical study with patient data.

Therefore, information on:

Sample size for the test set: Not provided.
Data provenance (country of origin, retrospective/prospective): Not applicable/not provided for this type of software and performance testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not applicable and not provided. The iSirona Magellan is a communication and notification system; its performance testing described here is focused on the reliability and accuracy of message routing and software functionality, not on diagnostic accuracy requiring expert interpretation of medical images or data. Therefore, there's no "ground truth" in the clinical diagnostic sense established by medical experts for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As there's no mention of a test set requiring expert interpretation or a "ground truth" established by experts, there's no adjudication method described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) summary. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The iSirona Magellan's function as a communication system does not involve human interpretation for diagnostic purposes.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The performance testing described is essentially a "standalone" or algorithm-only evaluation of the software's ability to correctly route and format information based on its predetermined specifications. The device itself is an automated system for message delivery. However, it's important to note that the device's role is to supplement human vigilance; it's explicitly stated that the "primary alarm notification is the device producing the alarm or event" and "this product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices." So while the algorithm operates standalone in its function, its intended use is ancillary to human monitoring, not as a standalone diagnostic or primary alarming device.

7. The Type of Ground Truth Used

The "ground truth" for iSirona Magellan's performance testing is its predetermined specifications and the applicable standards and guidance documents. The tests verified that the software functions as designed, routing the correct information to the correct recipients based on its internal logic and configuration. It is not about clinical ground truth derived from pathology, outcomes, or expert consensus on patient conditions.

8. The Sample Size for the Training Set

This information is not provided. The iSirona Magellan is an integration and communication software solution; it is not described as utilizing machine learning or AI models that require a "training set" in the typical sense for image analysis or predictive algorithms. Its "training" would involve configuring its rules and connections based on a hospital's existing infrastructure and desired notification logic.

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

This information is not applicable/not provided. As mentioned above, the device doesn't appear to use a "training set" in the context of developing a machine learning model for which a ground truth would need to be established by experts or other data sources. Its "ground truth" for operational setup would be the validated configuration settings defined by the hospital and the software's adherence to its design specifications.

Summary

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510(k) Summary

Submission Date:	30 September 2013
Submitter:	iSirona, LLC430 West 5th Street, Suite 800Panama City, FL 32401 USA
Submitter Contact:	Mr. Rabi NurPhone: +1 (850) 250-3966Email: Rabi.Nur@isirona.com	NOV 2 0 2013
ApplicationCorrespondent:	Mr. Thomas KroenkePrincipal ConsultantSpeed To Market, Inc.PO Box 3018Nederland, CO 80466 USAtkroenke@speedtomarket.net303 956 4232
Manufacturing Site:	iSirona, LLC430 West 5th Street, Suite 800Panama City, FL 32401 USA
Trade Name:	iSirona Magellan
Common Name:	System, Network And Communication, Physiological Monitors
Classification Name:	System, Network And Communication, Physiological Monitors
ClassificationRegulation:	21 CFR §870.2300
Product Code:	MSX
SubstantiallyEquivalent Devices:	New iSirona Model	Predicate510(k) Number	PredicateManufacturer / Model
	iSirona Magellan	K102974	Philips Medical Systems /Philips Emergin EventManagement System

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510(k) Summary

Device Description:

Intended Use: The iSirona Magellan software solution provides healthcare professionals with supplemental information about patient alarms and other medical-related events. The product can route all or subsets of this information to selective remote devices such as centralized computer stations and mobile communication devices. Receipt of alarm messages or events by the centralized computer stations and/or mobile communication devices is not confirmed and delivery to the end device is not guaranteed. The primary alarm notification is the device producing the alarm or event. This product is not intended to provide real-time information, nor is it a source of patient alarms, nor is it a replacement for alarming devices.

Technology Comparison:

iSirona Magellan employs the same technological characteristics as the predicate device.

Characteristic	Predicate Device	Proposed Device
Serves as secondary means ofunnunciating patient events	Yes	Same
Relays information from primarymedical device to display device	Yes	Same
Transmission of any aların from amedical device	Yes	Same
Waveform data	Yes, static waveformdata.	Same
Supported medical device inputs	Various manufacturers	I II.7 compatible devices
Fixed display devices	Unknown	Yes, agnostic gateway
Mobile display devices	Pagers	Android devices runningversion 4.0.3 or greater

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510(k) Summary

ﺮ

Summary of Performance Testing:

Software Testing	Software was designed and developed according to a robust software development process, and was rigorously verified and validated.Software information is provided in accordance with internal requirements and the following standards and guidance documents:FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 January 2005. Test results indicate that iSirona Magellan complies with its predetermined specifications, and applicable standards and guidance documents.
Performance Testing	iSirona Magellan was tested for performance in accordance with internal requirements.Test results indicate that iSirona Magellan complies with its predetermined specifications and the applicable standards.
Conclusion	Verification and validation activities were conducted to establish the performance and safety characteristics of iSirona Magellan. The results of these activities demonstrate that iSirona Magellan is safe and effective when used in accordance with its intended use and labeling.Therefore, iSirona Magellan is considered substantially equivalent to the predicate device.

Software Testing

Software was designed and developed according to a robust software development process, and was rigorously verified and validated.Software information is provided in accordance with internal requirements and the following standards and guidance documents:FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05; FDA guidance: Off-the-shelf software use in medical devices, 09 Sep 99; FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, 11 Jan 02; and FDA guidance: Cybersecurity for networked medical devices containing off-the-shelf (OTS) software, 14 January 2005. Test results indicate that iSirona Magellan complies with its predetermined specifications, and applicable standards and guidance documents.

Performance Testing

iSirona Magellan was tested for performance in accordance with internal requirements.Test results indicate that iSirona Magellan complies with its predetermined specifications and the applicable standards.

Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of iSirona Magellan. The results of these activities demonstrate that iSirona Magellan is safe and effective when used in accordance with its intended use and labeling.Therefore, iSirona Magellan is considered substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 20, 2013

iSirona, LLC c/o Thomas Kroenke Principal Consultant Speed to Market, Inc. PO Box 3018 Nederland, CO 80466

K130707 Re:

Trade/Device Name: iSirona magellan Regulation Number: 21 CFR 870.2300 Regulation Name: System, Network and Communication, Physiological Monitors Regulatory Class: Class II (two) Product Code: MSX Dated: October 10, 2013 Received: October 11, 2013

Dear Thomas Kroenke:

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 (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. 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.

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Page 2 - Thomas Kroenke

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, Misbranding by reference to premarket notification (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htmfor the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

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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K130707 Page 1 of 1

Indications for Use

iSirona Magellan

5 10(k) Number (if known):

Device Name:

Indications for Use:

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Digitally signed by Owen P. Farls
Date: 2011.11.20 10:29:54 -05'00'

Page 1 of 1

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).