The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters; the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their caregivers ("Users") to view readings, set reminders to take meter readings and pills, set reading thresholds which will trigger alert messages and set who will get reminder and alert messages. Reading history can be printed or exported. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can set goals and rewards for taking readings and for keeping readings in target ranges. A patient survey tool can be used to gather qualitative health information. The System also has a shared calendar and message board to coordinate among Users. General health information from accredited sources is also available.

The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors.

Device Description

The System consists of:

(1) Ambio Wireless Connectors (Wireless Connectors):
The Wireless Connector is an electronic device that plugs into the USB port of compatible Blood Pressure Monitors and Blood Glucose Monitors to read the log, encrypt the data, and wirelessly transmit the data to the Ambio Gateway. Readings are sent automatically based on a schedule stored in the Wireless Connector or, the User can push the button on the Wireless Connector to initiate reading the Monitor log and transferring the data.

(2) Ambio Scale
The Ambio Scale is a stand on digital weight scale with an embedded Ambio Wireless Connector. When the User takes a weight reading, it is then encrypted by the Ambio Wireless Connector and wirelessly transmitted to the Ambio Gateway.

(3) Ambio Gateway
The Ambio Gateway is an electronic device that connects to the Patient's existing home Internet router using an Ethernet cable. The Ambio Gateway wirelessly receives encrypted data from the Ambio Wireless Connector and transmits it through the user's home broadband internet router to the Ambio Care Portal.

(4) Ambio Care Portal
The Ambio Care Portal is a secure, web based data base and software application that allows Users to review patient data collected from the described health devices using the Ambio Wireless Connector and Ambio Gateway.

The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and achieving readings target. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Ambio Remote Health Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document (K130676) is a 510(k) Summary, which primarily focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific, quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. The "acceptance criteria" presented are related to compliance with electrical safety and electromagnetic compatibility (EMC) standards, and the general functionality of the system components.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Electrical Safety Standards	Compliance with IEC 60601-1 (Ed. 2), Amd. 1-1991, Amd. 2-1995, Corrigendum-1995	Found to be compliant	Based on testing by Intertek Testing Services. This ensures the device is safe from electrical hazards.
Medical Electrical Systems Safety	Compliance with IEC 60601-1-1 (Ed. 2)	Found to be compliant	Ensures safety of medical electrical systems.
Programmable Electrical Medical Systems Safety	Compliance with IEC 60601-1-4 (Ed. 1.1), Ed. 1:1996 Consolidated	Found to be compliant	Addresses safety for software-controlled medical devices.
Electromagnetic Compatibility (EMC)	Compliance with IEC/EN 60601-1-2 (Ed. 2): 2001 +A1: 2004	Found to be compliant	Ensures the device does not interfere with, and is not interfered by, other electronic devices.
Design Control Verification & Validation	Testing of all executable code and functionality; confirmation that all identified risks (including human factors/usability) have been adequately addressed. Verification plans for all Design Specifications. Test plan execution to ensure each user accessory medical device (glucose, blood pressure, scale) works with Ambio Wireless Connector, Gateway, and Care Portal.	Testing performed; ensures requirements and design specifications are met as intended. Risk analysis performed, concluding no significant risks.	This is a general statement about internal quality processes. Specific pass/fail rates or detailed outcomes are not provided in this summary.
Substantial Equivalence	Device is as safe and effective as predicate devices.	Concluded by Arrayent Health LLC.	This is the overarching goal of a 510(k) submission and not a performance metric itself. The FDA reviewed and concurred with this assessment.

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

The document does not specify a sample size for an external "test set" in the context of clinical performance or diagnostic accuracy. The testing described is primarily non-clinical engineering and software verification/validation.

Test Set Sample Size: Not applicable/not provided for clinical performance testing.
Data Provenance: Not applicable for clinical performance testing, as no such data is described. The non-clinical testing was performed by Intertek Testing Services.

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

Not applicable. The described testing is technical (electrical safety, EMC, software functionality) not clinical. Therefore, there is no mention of experts establishing a clinical "ground truth."

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. An MRMC comparative effectiveness study was not done or reported. This device is a remote monitoring system, not a diagnostic imaging or interpretation aid where MRMC studies are typically employed to assess human reader performance with and without AI assistance.

6. Standalone Performance Study (i.e., algorithm only without human-in-the-loop performance):

No. This device is a system for data collection and display, not an AI or algorithm with standalone diagnostic performance metrics (e.g., sensitivity, specificity). The "algorithm" here refers to the software for data transfer, storage, and display, which was tested for functionality.

7. Type of Ground Truth Used:

For the non-clinical performance data, the "ground truth" would be established by the specifications of the standards (e.g., IEC 60601-1) and the internal design specifications of the Ambio Health System. For example, for EMC testing, the "ground truth" is whether measured emissions/immunity levels fall within the limits defined by IEC/EN 60601-1-2.

Expert Consensus: Not applicable.
Pathology: Not applicable.
Outcomes Data: Not applicable.
Other: Compliance with established engineering and safety standards, and adherence to internal design specifications.

8. Sample Size for the Training Set:

Not applicable/not provided. This device is not an AI/ML system that would require a "training set" in the typical sense for learning patterns from data to make predictions or classifications. The software is deterministic and performs predefined functions (data transfer, encryption, storage, display, alerts based on thresholds).

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

Not applicable, as there is no "training set."

Summary of the Study:

The "study" described in the 510(k) Summary is a non-clinical evaluation focusing on:

Compliance with Recognized Standards: The primary evidence provided is that the system components (Wireless Connectors, Scale, Gateway, Care Portal) comply with relevant electrical safety (IEC 60601-1 series) and electromagnetic compatibility (IEC/EN 60601-1-2) standards. These tests were performed by Intertek Testing Services.
Internal Design Control Verification and Validation: This involved testing of all executable code and functionality, confirming that identified risks (including human factors for usability) were addressed, and verifying that the system interfaces correctly with various accessory medical devices (glucose meters, blood pressure monitors, scales). This "study" ensures that the product meets its own design specifications and is suitable for its intended use, which is remote monitoring and data display, not diagnostic interpretation.

The conclusion is that based on these non-clinical tests and a comparison of technological characteristics and intended use with predicate devices, the Ambio Remote Health Monitoring System is as safe and effective as the predicates. The FDA concurred with this assessment, leading to the 510(k) clearance.

Summary

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510(k) SUMMARY

510(k) Owner:	Arrayent Health LLC /dba Ambio Health
Contact:	Kevin Jones, CEO
Date Summary Prepared:	March 15, 2012
Device:
Trade Name:	Ambio Remote Health Monitoring System
Common/Classification Name:	Remote Patient Monitoring System
Classification:	Class II
Predicate Devices:	K062377 MedApps 2.0 - Remote Patient Monitoring SystemK111932 Positive ID - iglucose tm Device, Secure Database, Diabetes Management PortalK080798 Intel Health Guide PHS6000
Intended Use:	The Ambio Remote Health Monitoring System ("System") consists of Ambio Wireless Connectors to send readings from off-the-shelf blood pressure and blood glucose meters, the Ambio Scale with built in wireless connectivity to send readings through the Ambio Gateway to the Ambio Care Portal. The Care Portal is used by patients and their authorized caregivers ("Users") to view readings, set reminders, set personalized thresholds which will trigger alert messages. Reading history can be printed or exported. Users can set goals and rewards for taking readings per their schedule and for achieving reading targets. Users can maintain an exercise log, food log and records of doctor visits and lab tests. Users can create patient surveys to gather qualitative information. Users can coordinate using a shared calendar and message board. Health information from accredited sources can also be displayed.
	The Ambio Remote Health Monitoring System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when time-critical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The System does not alter the indicated use of the described blood pressure or blood glucose monitors.

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The System consists of:

System Description:

(1) Ambio Wireless Connectors (Wireless Connectors):

The Wireless Connector is an electronic device that plugs into the USB port of compatible Blood Pressure Monitors and Blood Glucose Monitors to read the log, encrypt the data, and wirelessly transmit the data to the Ambio Gateway. Readings are sent automatically based on a schedule stored in the Wireless Connector or, the User can push the button on the Wireless Connector to initiate reading the Monitor log and transferring the data.

(2) Ambio Scale
The Ambio Scale is a stand on digital weight scale with an embedded Ambio Wireless Connector. When the User takes a weight reading, it is then encrypted by the Ambio Wireless Connector and wirelessly transmitted to the Ambio Gateway.
(3) Ambio Gateway
The Ambio Gateway is an electronic device that connects to the Patient's existing home Internet router using an Ethernet cable. The Ambio Gateway wirelessly receives encrypted data from the Ambio Wireless Connector and transmits it through the user's home broadband internet router to the Ambio Care Portal.

(4) Ambio Care Portal

The Ambio Care Portal is a secure, web based data base and software application that allows Users to review patient data collected from the described health devices using the Ambio Wireless Connector and Ambio Gateway.

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K130676 pg. 3 of 6

Technological Characteristics:

The operation of the System is the same as the predicate devices in all respects other than the wireless protocol and frequency used to communicate readings from the health meter / Wireless Connector to the Gateway. Predicate devices use Bluetooth (2.402 to 2.48 GHz) or GSM Cellular (850 / 900 / 1800 / 1950 MHz) as the wireless technology and the subject device uses the 900MHz (902 - 928MHz) band approved by the FCC for unlicensed communication equipment.

Attribute	MedAppsRemotePatientMonitoringDevice	IDEAL LIFEPod	Positive IDIglucoseSystem	SubjectDevice(AmbioHealthRemoteHealthMonitoringSystem)
	K112559	K080538	K111932
Indicationsof Use	Enableshealthcareproviders tomonitor andmanagechronicconditions ofpatientsremotelyFlag readingsbased onspecificthresholdsbeingexceeded.Maintaincomplianceto schedules.Graphictrending.	Enablespeople athome andhealthcareproviders toreview andevaluatehistoricalbloodglucose,weight andbloodpressure testresults	Enablespeople athome andhealthcareproviders toreview andevaluatebloodglucose dataas an aid insupportingdiabetesmanagement.Graphictrending.	Enablespeople athome andhealthcareproviders tomonitor andmanagechronicconditionsof patientsremotelyFlagreadingsbased onspecificthresholdsbeingexceeded.Maintaincompliancetoschedules.Graphictrending.
Intended use	TelemedicineSystem	Same	Same	Same
IntendedUsers	Home usersandHealthcareProviders	Same	Same	Same
Site of Use	Home, Clinic	Same	Same	Same
DataCollectionSoftwareFunctionality	Transmitdata fromsensordevices toCentralDatabase	Same	Same	Same
Communication method ofhub withCentralServer	Cellular	Internet orTelephoneline	Cellular	Internet
Types ofsensorswhich can beinterfaced(wired orwirelessly) toreceiver hub	MedicalDevicesdesigned forHome Use:GlucoseScaleBloodPressurePulseOx	MedicalDevicesdesigned forHome Use:GlucoseScaleBloodPressure	MedicalDevicedesign forHome Use:Glucose	MedicalDevicesdesignedfor HomeUse:GlucoseScaleBloodPressure
SensorSoftware	SensorSoftwareunchanged	Same	Same	Same
Implementa-tion Methodof collectingdata fromsensors	Wireless(Bluetooth)and Wired(tethered)cables	Wireless	Data cable	Data cable(one end ofWirelessConnector)
Connectivity	Wireless(Bluetooth)and Wired(tethered)cables	Wireless(Bluetooth)and WiredSmartCable	Data cable	Wireless(900 MHz -other end ofWirelessConnector)
Communica-tion methodof hub withdevices	Wireless(Bluetooth)and Wired(tethered)cables	Wireless(Bluetooth)and Wired(tethered)cables	Cellular	Wireless(900MHz)
Communica-tion Protocol	Wireless(Bluetooth)and Wired(tethered)cables	Wireless(Bluetooth)and Wired(tethered)cables	Cellular	Wireless(900MHz)
Communica-tionFrequency	Bluetooth2.402 to2.480 GHzGSM: 850 /900 / 1800 /1950 MHz	Bluetooth2.402 to 2.48GHz	GSM: 850 /900 / 1800 /1950 MHz	900MHz(902-928MHz)
PowerSource	Wall powerplug (120VAC/50-60)RechargeableBatteries inHealthPAL	Wall powerplug (120VAC/50-60)	Wall powerplug (120VAC/50-60)andrechargeablebattery iniGlucose	Wall powerplug (120VAC/50-60) andcoin cellbattery inWirelessConnector
VisualFeedback /Display	LED Lightindicators	Same	Same	Same
Communica-tion withPatients	Audio/visualreadingfeedbackfrom LEDlightindicators &audio tones;InteractiveVoiceResponse(IVR) systemfor patientcontact	Data isviewed in aweb-basedapplication;sent viaemail, SMStext and fax.	Data isviewed in aweb-basedapplication;sent viaemail, SMStext and fax.	Data isviewed in aweb-basedapplication;sent viaemail, SMStext andIVR.

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K130676

Pg. 4 of 6

K150076
pg. 4 of 6

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K130676 pg. 5 of 6

Performance Data:

Non-clinical Testing

The submitted system was found to be compliant to the following standards based on testing performed by Intertek Testing Services:

1. IEC 60601-1 Issue1988/12/01 Ed:2 Medical Electrical Equipment Part 1: General Requirements for Safety; (Amd. 1-1991) (CENELEC EN 60601-1: 1990) (Amd. 2-1995) (Corrigendum-1995)
1. IEC 60601-1-1 Issued:2000/12/01 Ed:2 Medical Electrical Equipment -Part 1-1: General Requirements for Safety - Collateral Standard: Safety K130676 P 6/6
1. Requirements for Medical Electrical Systems

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K130676 pg. 6 of 6

1. IEC 60601-1-4 Issue:2000/04/01 Ed:1.1 Medical Electrical Equipment -Part 1-4: General Requirements for Safety - Collateral Standard: Programmable Electrical Medical Systems; Edition 1:1996 Consolidated
1. IEC/EN 60601-1-2 (Ed. 2): 2001 +A1: 2004 Medical electrical equipment, Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests. with Amendment ! : 1999

The submitted system has undergone Ambio Health's design control verification and validation testing. Ambio Health validation testing includes testing of all executable code and functionality and confirmation that all identified risks have been adequately addressed by software functionality, the user interface, documentation or the User Guide.

Ambio Health System verification and validation activities as part of the design control process include testing of all Design Specifications based on risk analysis and verification plans. Ambio Health System test plan execution ensures each type of user accessory medical device (glucose, blood pressure, scale) works with the Ambio Wireless Connector and Gateway components and the Ambio Care Portal software. The output of these design control verification analysis documents Ambio Remote Health Monitoring System shall meet its requirements and design specifications as intended.

Arrayent Health used its Risk Management Plan to perform risk analysis regarding human factors for usability to determine that there are no significant risks.

The performance data discussed in this 510(k) application demonstrate that the Conclusions: Ambio Health - Remote Patient Monitoring System is as safe and effective, as the predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the symbol. The logo is black and white.

T OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 8, 2013

Arrayent Health LLC d/b/a Ambio Health c/o Mr. Kevin Jones CEO 1266 E Main Street Stamford, CT 06902

Re: K130676

Trade/Device Name: Ambio Remote Health Monitoring System Regulatory Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: II (two) Product Code: 74 DRG Dated: May 13, 2013 Received: May 14, 2013

Dear Mr. Jones:

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. Ilsting 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

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Page 2 - Mr. Kevin Jones

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/ucm 1 15809.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.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 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/Resourcesfor You/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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K130676

Indications for Use

510(k) Number Not assigned. (if known):

Device Name: Ambio Remote Health Monitoring System

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Owen
2013.
-04'0

Owen P. Faris -S 2013.07.08 16:15:20 -04'00'

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).