The Matrix Data Management System software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiological signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various disease and or treatment regimens. The Matrix Data Management System software also provides non-diagnostic functions such as patient management, data security, search tools for patient. and/or test records and support for exporting data to Electronic Medical Record systems.

The Matrix Data Management System and associated accessories are intended for use by or on the order of a physician in a hospital or clinic setting. The product is designed for use on both adult and pediatric patients, subject to any specific contraindications identified below.

-- Ambulatory Blood Pressure Monitor Indication For Use-

The Oscar 2, system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses.

Optionally, Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

It is to be used on those patients where information related to ascending aortic blood pressure is desired but the risks of cardiac catheterization procedure or other invasive monitoring may outweigh the benefits (excludes pediatic subjects).

-- Matrix Holter System Indication For Use-

The M12 Matrix Holter System is intended to be used as a Holter ambulatory electrocardiograph system for the purpose of screening for ECG rhythm disturbances over periods up to 48-hours. The Matrix Holter System is intended for use under the supervision of a Physician or those knowledgeable in all aspects of ECG morphology, rhythm and arrhythmia. This procedure is commonly called a Holter procedure which captures ECG rhythm abnormalities which may be infrequent or provoked by activities outside of the physician office.

The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (M12R) and the Matrix Holter System Application (Ml2A).

The Matrix Holter Recorder component of the system will be worn by the patient and is used to record anbulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder

The subject Devices will provide the following diagnostic functions:

Acquiring, viewing, storing and printing ambulatory ECG waveforms using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
Using optional Holter algorithms to generate measurements, data presentations and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
Using optional interpretive algorithms to generate measurements, data presentations, and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

--- Matrix Mini ECG Monitor Indication for Use-

The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tibrillation in general medical and surgical floors. general hospital and professional healthcare facilities. The system is indicated for use in pediatric and adult patients.

Device Description

The Matrix Data Management System is intended for use by clinicians for managing sensor data of pediatric and adult patients in health care facilities.

The current sensors supported by the Matrix Data Management System include Ambulatory blood pressure monitoring with optional sensors for Ambulatory ECG and Patient Monitoring.

The Ambulatory blood pressure monitoring sensor used within DMS is approved as Oscar 2 (K151520).

The Ambulatory ECG Monitoring sensor used within the DMS is approved as Matrix Holter System, Model M12 (K051730).

The Patient Monitoring sensor used within the DMS is approved as Matrix Mini ECG Monitor (K152701)

AI/ML Overview

This document is a 510(k) premarket notification for the Matrix Data Management System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Welch Allyn CardioPerfect Workstation) through technological characteristics and non-clinical testing, rather than presenting clinical study data for device performance against specific acceptance criteria.

Therefore, many of the requested details regarding acceptance criteria for device performance and a study proving the device meets those criteria cannot be extracted from this document, as the submission explicitly states:

"No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data for this device or the predicate device." (Page 7)
"No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Page 7)

The approval is based on non-clinical tests (electrical safety, software lifecycle, risk management) and the similarity to an already approved predicate device.

However, I can provide the information that is available:

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

The document does not provide a table of acceptance criteria for device performance based on clinical outcomes or accuracy, as no clinical studies were conducted for this purpose. The device's performance is gauged through non-clinical verification and validation against established standards.

Acceptance Criteria (Not explicitly stated for clinical performance)	Reported Device Performance
Electrical Safety (AAMI/IEC 60601-1 Ed. 3.1: 2012)	Passed all applicable test requirements.
Risk Management (ISO 14971: 2007)	Assessed against this standard.
Software Life Cycle Processes (IEC 62304: 2006)	Assessed against this standard.
Device Functionality (Acquisition, analysis, formatting, display, printing, and storage of physiological signals)	Verified and validated to ensure expected performance (Non-clinical).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for test set: Not applicable/not stated, as no clinical studies were performed measuring human or patient data. The "test set" here refers to non-clinical verification and validation.
Data provenance: Not applicable, as no clinical patient data was used.

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

This information is not provided as no clinical studies requiring expert ground truth establishment were conducted.

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

This information is not provided as no clinical studies requiring adjudication were conducted.

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

No MRMC comparative effectiveness study was done, as explicitly stated, "No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data for this device." The device is a data management system, 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

This concept is not directly applicable. The device is a data management system for physiological signals. Its "performance" is related to its ability to acquire, store, process, and display data from other approved sensors (like Oscar 2 for ABPM, Matrix Holter System, and Matrix Mini ECG Monitor). The approval is based on its substantial equivalence to a predicate device and adherence to non-clinical standards for software and electrical safety. There's no "algorithm-only" performance in the diagnostic sense that would be independently evaluated for accuracy against ground truth in this submission.

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

For the non-clinical tests, the "ground truth" would be established specifications and compliance requirements of the standards (e.g., IEC 60601-1 for electrical safety, ISO 14971 for risk management, IEC 62304 for software lifecycle processes). There is no clinical ground truth (expert consensus, pathology, outcomes data) used as no clinical studies were performed for efficacy.

8. The sample size for the training set

Not applicable, as no machine learning/AI model requiring a training set is discussed or evaluated in this submission in the context of diagnostic performance.

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

Not applicable, as no machine learning/AI model requiring a training set is discussed or evaluated.

Summary

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 24, 2017

Global Instrumentation, LLC Jason DeMaso Quality Assurance Manager 8104 Cazenovia Road Manlius, New York 13104

Re: K162463

Trade/Device Name: Matrix Data Management System Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN Dated: April 21, 2017 Received: April 24, 2017

Dear Jason DeMaso:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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

the quality systems (OS) 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.htm for 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 Industry and Consumer Education 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.

M.A. Willehemen

for

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

Enclosure

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

Indications for Use

510(k) Number (if known) K162463

Device Name Matrix Data Management System

Indications for Use (Describe)

-- Ambulatory Blood Pressure Monitor Indication For Use-

-- Matrix Holter System Indication For Use-

The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (M12R) and the Matrix Holter System Application (Ml2A).

The subject Devices will provide the following diagnostic functions:

Acquiring, viewing, storing and printing ambulatory ECG waveforms using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
Using optional Holter algorithms to generate measurements, data presentations and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
Using optional interpretive algorithms to generate measurements, data presentations, and

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

interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

--- Matrix Mini ECG Monitor Indication for Use-

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K162463

510(k) Summary

[As described in 21 CFR 807.92]

Owner's Name:	Global Instrumentation LLC.
Address:	8104 Cazenovia RoadManlius, NY 13104 USA
Contact Person:	Jason DeMasoQuality Assurance ManagerPhone: (315) 682-0272 Ext. 116Fax: (315) 685-0278E-mail: demasoj@gi-med.com
Date Prepared:	August, 15th 2016
Trade Name:	Matrix Data Management System
Common Name:	Matrix Data Management System
Classification Name:	Class II, Noninvasive blood pressure measurement system(21 CFR 870.1130, Product Code - DXN).
Predicate Devices:	CardioPerfect WorkstationWelch Allyn, Inc.510(k) Number K052158

NOTE: The Matrix Data Management System is substantially equivalent in intended use and technology, as well as operation and performance, to Welch Allyn CardioPerfect Workstation (K052158) for is functionality in Ambulatory ECG Monitoring, Patient Monitoring and Ambulatory Blood Pressure Monitoring.

{5}------------------------------------------------

Description of the Device:

The Matrix Data Management System is intended for use by clinicians for managing sensor data of pediatric and adult patients in health care facilities.

The current sensors supported by the Matrix Data Management System include Ambulatory blood pressure monitoring with optional sensors for Ambulatory ECG and Patient Monitoring.

The Ambulatory blood pressure monitoring sensor used within DMS is approved as Oscar 2 (K151520).

The Ambulatory ECG Monitoring sensor used within the DMS is approved as Matrix Holter System, Model M12 (K051730).

The Patient Monitoring sensor used within the DMS is approved as Matrix Mini ECG Monitor (K152701)

(Refer to VOL 014; 002 Device Description for further information)

Indications For Use:

The Matrix Data Management System software and associated accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiological signals, as identified below, for the purpose of assisting the clinician in the diagnosis and monitoring of various disease and/or treatment regimens. The Matrix Data Management System software also provides non-diagnostic functions such as patient management, data security, search tools for patient and/or test records and support for exporting data to Electronic Medical Record systems.

Ambulatory Blood Pressure Monitor Indication For Use

The Oscar 2 system is a non-invasive oscillometric ambulatory blood pressure monitor that is intended to be used with a PC-based computer program for the recording and displaying of up to 250 measurements of systolic and diastolic blood pressure and heart rate. It is intended for use as an aid or adjunct to diagnosis and treatment when it is necessary to measure an adult and pediatric (> 3yrs.) patient's systolic and diastolic blood pressures over an extended period of time. The system is only for measurement, recording, and display. It makes no diagnoses. Optionally, Oscar 2 will provide a derived ascending aortic blood pressure waveform and a range of central arterial indices. These measurements are provided non-invasively through the use of a brachial cuff.

{6}------------------------------------------------

Matrix Holter System Indication For Use

The M12 Matrix Holter System is comprised of the Matrix Holter Recorder (MI2R) and the Matrix Holter System Application (M12A).

The Matrix Holter Recorder component of the system will be worn by the patient and is used to record ambulatory electrocardiograph data from the patient. The Matrix Holter System Application is used to analyze the data recorded by the Matrix Holter Recorder.

The subject Devices will provide the following diagnostic functions:

Acquiring, viewing, storing and printing ambulatory ECG waveforms from patients ● using the Matrix Holter Recorder and associated accessories that provide signal acquisition for up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the body.
Using optional Holter algorithms to generate measurements, data presentations and graphical presentations on an advisory basis for patients. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.
Using optional interpretive algorithms to generate measurements, data presentations, graphical presentations, and interpretive statements on an advisory basis for patients of sixteen (16) years of age and above. These are presented for review and interpretation by the clinician based upon knowledge of the patient, the results of the physical examination, the ambulatory ECG data full disclosure displays, and other clinical findings.

Matrix Mini ECG Monitor Indication for Use

The Matrix Mini ECG Monitor is intended for continuous measurement of heart rate, respiration rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation in general medical and surgical floors, general hospital and professional healthcare facilities. The system is indicated for use in pediatric and adult patients.

Technological Characteristics:

The Matrix Data Management System (DMS) provides functionality to manage data acquired from various physiologic data acquisition sensors. The DMS supports a mechanism to initialize sensors, acquire data from the sensors and provide summaries of the results obtained from the sensors. The predicate device selected is the CardioPerfect Workstation (CPWS) which provides similar functionality. The DMS and CPWS both provide support for multiple types of sensors and both provide support for Ambulatory Blood Pressure Monitoring sensors (ABPM) which has a product code of DXN. The current sensors supported by the Matrix Data

{7}------------------------------------------------

Management System include Ambulatory blood pressure monitoring with optional sensors for Ambulatory ECG and Patient Monitoring.

The Ambulatory blood pressure monitoring sensor used within DMS is approved as Oscar 2 (K151520).

The Ambulatory ECG Monitoring sensor used within the DMS is approved as Matrix Holter System, Model M12 (K051730).

The Patient Monitoring sensor used within the DMS is approved as Matrix Mini ECG Monitor (K152701)

The device was tested in accordance with AAMI/IEC 60601-1 Electrical Safety 60601-1 Ed. 3.1: 2012 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance. The device passed all applicable test requirements and confirmed that the device is substantially equivalent to the predicate device.

There is no device performance based on animal testing required for this device or the predicate device.

No clinical studies were utilized for the purpose of obtaining safety and/or efficacy data for this device or the predicate device.

(Refer to VOL_013; 002_Executive Summary for further information)

Non-Clinical Tests:

Verification and validations were conducted to ensure expected performance of the Matrix Data Management System. (Refer to VOL 022 Test Results)

The Matrix Data Management System was tested to evaluate its safety and effectiveness based on the following standards:

. ISO 14971: 2007 - Medical devices - Application of risk management to medical devices
IEC 62304: 2006 Medical device software Software life cycle processes ●
IEC 60601-1 3rd Edition - Medical Design Standards

Clinical Performance Data:

No clinical studies were utilized for the purpose of obtaining safety or effectiveness data.

Conclusion:

Based on the information presented in this 510(k) premarket notification, the Global Instrumentation LLC Matrix Data Management System is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed device cited in this submission.

Regulation Number and Section

§ 870.1130 Noninvasive blood pressure measurement system.

(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).