Intel-GE Care Innovations Connect RCM is intended to collect vital sign measurements from physiological measurement devices intended for use in the home. Patients can review the stored vital sign measurement information and receive educational and motivational content from caregivers. Patients can also engage in videoconferences with caregivers and answer the caregivers' questions by participating in surveys.

Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when time-critical care is not required.

Care Innovations Connect RCM is contraindicated for patients requiring direct medical supervision or emergency intervention. It is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.

Care Innovations Connect RCM will be available for over the counter use.

Device Description

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. The software executes on a web server and is accessed via a browser from the patient's COTS personal computing device. A small validated software application known as Device Connector runs on patients' home COTS platforms. Off the Shelf (OTS) software is also used with the internally developed software to provide functionality such as: setting & receiving email and text-based notifications, creating & editing calendar entries, playing Learn More videos, and holding a video conference with a clinician.

Care Innovations™ Connect RCM is a software application for use with measurement devices commercially available for home use. Connect RCM provides the same client capabilities of collecting and transmitting patient data to the clinician database system as the predicate devices, and uses the existing clinician database system in the Intel-GE Care Innovations 10 Guide (K130290). No changes were required to the existing clinician database system to support the new client software.

Patients can also enter measurement data manually entered data is stored in the backend clinician database as well as the Personal Health Data Record. It is flagged as manually entered data.

AI/ML Overview

The provided document, K130821, states that the "Connect RCM does not rely on an assessment of clinical performance data." It asserts that "The device will conform to FDA 's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy." Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on demonstrating substantial equivalence to predicate devices and conformity to recognized consensus standards for safety and efficacy.

Given this, I cannot fill out the requested table or answer most of the follow-up questions because the submission explicitly states that clinical performance data was not used.

Here's what I can provide based on the document:

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

The document does not provide a table of acceptance criteria and reported device performance in the context of clinical studies. The "acceptance criteria" for this device appear to be its conformity to FDA recognized consensus standards and its substantial equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Conformity to AAMI/ANSI/IEC ES 60601-1 (Software Safety Standard)	Device "will conform" to this standard.
Functional equivalence to Intel-GE Care Innovations Guide (K130290)	Device has "the same functionality" as the predicate.
Does not introduce new questions concerning safety or efficacy	Device "introduces no new questions" on safety/efficacy.
Collection of vital sign measurements from home physiological devices	Intended to "collect vital sign measurements."
Review of stored vital sign measurement information by patients	Patients "can review the stored vital sign measurement."
Receive educational and motivational content from caregivers	Patients "receive educational and motivational content."
Engage in videoconferences with caregivers	Patients "can engage in videoconferences."
Respond to caregiver questions via surveys	Patients "answer the caregivers' questions by participating in surveys."

2. Sample size used for the test set and the data provenance

Not applicable. The device does not rely on clinical performance data for its 510(k) submission.

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

Not applicable. No clinical test set described.

4. Adjudication method

Not applicable. No clinical test set described.

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. The device is a remote patient monitoring system, not an AI-assisted diagnostic tool, and no such study was performed or described.

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

Not applicable. The device is software for collecting and displaying patient data, not an algorithm for standalone performance evaluation in a clinical sense.

7. The type of ground truth used

Not applicable. No clinical performance data was used for the 510(k) submission. The "ground truth" for regulatory approval appears to be the documented functionality of the predicate device and the adherence to safety standards.

8. The sample size for the training set

Not applicable. No machine learning model or training set is described in the context of clinical performance for this 510(k).

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

Not applicable. No training set is described.

Summary

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K130821 pg 1 of 4

510(k) Summary As required by 21 CFR §807.92(c)

Submitter

510(k) Owner:	Intel-GE Care Innovations, LLC
Address:	3721 Douglas Blvd, #100, Roseville, CA 95661
Telephone:	916.847.7794
Contact Person:	Maureen Glynn
Date Prepared:	March 20th 2013

Device Information

AUG 09 2013

Trade Name:	Intel-GE Care InnovationsTM Connect RCM
Common Name:	Remote Patient Monitoring System
Classification Name:	Transmitters and Receivers, Physiological Signal,Radiofrequency (21 CFR 870.2910, Product Code DRG)

Substantial Equivalence of intended use is claimed to the following Over the Counter devices:

1. Intel-GE Care Innovations Guide (K130290)
Wellaho Personalized Outpatient Management System (K123671) 2.
1. Vignet Telehealth Manager (K113446)

Device Description

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Patients can also enter measurement data manually entered data is stored in the backend clinician database as well as the Personal Health Data Record. It is flagged as manually entered data.

Indications for Use

Care Innovations Connect RCM will be available for over the counter use.

Technological Characteristics

Connect RCM is substantially equivalent to the technology predicate device, the Intel-GE Care Innovations Guide (K130290), in terms of data collection software functionality. communication method of patient's COTS platform with backend server, types of third-party physiological measurement devices which can be interfaced to the patient's COTS platform. implementation method of collecting data from third-party devices, third party device driver software, connectivity, communication protocol, and display method.

Table 1: Peripherals Comparison between the intended use predicate devices and Connect RCM

PhysiologicalParameter	Vignet TelehealthManager(K113446)	Intel-GE CareInnovations Guide(K103290)	Intel-GE CareInnovations ConnectRCM(K130821)
BloodPressure	A&D UA-767-PBTA&D UA-851-	A&D UA-767PC(K982481)	A&D UA-767PC(K982481)

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	PBT
Weight	A&D UC-321PBT	A&D UC-321PBT(exempt)	A&D UC-321PBT(exempt)
	Omron WeightScale TD-3250C	A&D UC-321PL(exempt)	A&D UC-321PL(exempt)
BloodGlucoseLevel	Entra HealthSystems MGH-BT1 (K081703)	Bayer DiagnosticsAscensia Breeze2(K062347)	Bayer DiagnosticsAscensia Breeze2(K062347)
	Fora Care, Inc.TaidocTechnology TD-3250C	Bayer DiagnosticsAscensia ContourBlood GlucoseMonitoring System(K062058)	Bayer DiagnosticsAscensia ContourBlood GlucoseMonitoring System(K062058)
		LifeScan OneTouchUltra Family of BloodGlucose MonitoringSystems (K043197)	LifeScan OneTouchUltra Family of BloodGlucose MonitoringSystems (K043197)
		LifeScan OneTouchUltra 2 of BloodGlucose MonitoringSystems (K053529)	LifeScan OneTouchUltra 2 of BloodGlucose MonitoringSystems (K053529)
OxygenSaturation		Nonin 4100 PulseOximeter (K043359)	Nonin 4100 PulseOximeter (K043359)
		Onyx® II 9560(K081285)	Onyx® II 9560(K081285)

。

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510(k) Notification Submission - AbbreviatedIntel-GE Care Innovations™ Connect RCM	K130821pg 4 of 4
----------------------------------------------------------------------------------------	----------------------

Parameter	Intel-GE CareInnovations™ HealthGuide (K130290)	Connect RCM(K130821)
Software Safety Standard	AAMI/ANSI/IEC ES 60601-1 Medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance	AAMI/ANSI/IEC ES 60601-1 Medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance
Hardware Safety Standard	UL 60950-1:2007Information TechnologyEquipment - Safety - Part 1:General Requirements	N/A

Table 2: Main difference between Connect RCM meeting minimum specifications and the technology predicate device

Safety and Efficacy

Connect RCM does not rely on an assessment of clinical performance data. The device will conform to FDA 's recognized consensus standards and relies on its conformity to demonstrate the safety and efficacy. The device has the same functionality as the predicate device, the Intel-GE Care Innovations Guide (K130290), and introduces no new questions concerning the safety or efficacy and is, therefore, substantially equivalent to the predicate device.

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

August 9, 2013

Intel-GE Care Innovations, LLC c/o Ms. Maureen Glynn 3721 Douglas Blvd. #100 Roseville, CA 95661

Re: K130821

Trade/Device Name: Intel-GE Care Innovations Connect RCM Regulation Number: 21 CFR 870.2910 Regulation Name: Transmitters and Receivers, Physiological Signal, Radiofrequency Regulatory Class: Class II (two) Product Code: DRG Dated: July 8, 2013 Received: July 11, 2013

Dear Ms. Glynn:

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 - Ms. Maureen Glynn

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 (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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Owen P. Faris -S

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

Enclosure

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510(k) Notification Submission - Abbreviated Intel-GE Care Innovations TM LLC Intel-GE Care Innovations Connect RCM

K130821 pg 1 of 1

Indications for Use:

510(k) Number:

Device Name:

Intel-GE Care Innovations™ Connect RCM

Indications for Use:

Care Innovations Connect RCM will be available for over the counter use.

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)

Page 1 of 1

Digitally signed by
Owen P. Faris -S

Date: 2013.08.09
16:14:50-04'00'

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).