(137 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on data collection, storage, and communication, without mentioning any analytical or interpretive functions that would typically involve AI/ML.
No
The device is described as "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." This explicitly states it does not provide therapeutic intervention.
No
The "Intended Use / Indications for Use" section explicitly states, "Care Innovations Connect RCM is not interpretive, nor is it intended for diagnosis or as a substitute for medical care".
Yes
The device is described as a "software application" that runs on a web server and is accessed via a browser on a patient's personal computing device. While it interacts with physiological measurement devices, the device itself is the software application for collecting and transmitting data, not the measurement devices themselves.
Based on the provided information, the Intel-GE Care Innovations Connect RCM is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for collecting vital sign measurements from physiological measurement devices used in the home. It is for patients to review this information, receive educational content, and communicate with caregivers. It explicitly states it is not interpretive, not intended for diagnosis, and not a substitute for medical care.
- Device Description: The device is described as a software application that collects and transmits data from commercially available home-use measurement devices. It does not perform any tests on biological samples.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the Connect RCM does not involve any such activities.
The device is a remote patient monitoring system that facilitates the collection and communication of physiological data, but it does not perform diagnostic testing on biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DRG
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
will be available for over the counter use.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K982481, K081703, K062347, K062058, K043197, K053529, K043359, K081285
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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:
-
- Intel-GE Care Innovations Guide (K130290)
- Wellaho Personalized Outpatient Management System (K123671) 2.
-
- Vignet Telehealth Manager (K113446)
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.
1
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
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.
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
| Physiological
Parameter | Vignet Telehealth
Manager
(K113446) | Intel-GE Care
Innovations Guide
(K103290) | Intel-GE Care
Innovations Connect
RCM
(K130821) |
|----------------------------|-------------------------------------------|-------------------------------------------------|----------------------------------------------------------|
| Blood
Pressure | A&D UA-767-
PBT
A&D UA-851- | A&D UA-767PC
(K982481) | A&D UA-767PC
(K982481) |
2
| PBT | |||
|---|---|---|---|
| Weight | A&D UC- | ||
| 321PBT | A&D UC-321PBT | ||
| (exempt) | A&D UC-321PBT | ||
| (exempt) | |||
| Omron Weight | |||
| Scale TD-3250C | A&D UC-321PL | ||
| (exempt) | A&D UC-321PL | ||
| (exempt) | |||
| Blood | |||
| Glucose | |||
| Level | Entra Health | ||
| Systems MGH- | |||
| BT1 (K081703) | Bayer Diagnostics | ||
| Ascensia Breeze2 | |||
| (K062347) | Bayer Diagnostics | ||
| Ascensia Breeze2 | |||
| (K062347) | |||
| Fora Care, Inc. | |||
| Taidoc | |||
| Technology TD- | |||
| 3250C | Bayer Diagnostics | ||
| Ascensia Contour | |||
| Blood Glucose | |||
| Monitoring System | |||
| (K062058) | Bayer Diagnostics | ||
| Ascensia Contour | |||
| Blood Glucose | |||
| Monitoring System | |||
| (K062058) | |||
| LifeScan OneTouch | |||
| Ultra Family of Blood | |||
| Glucose Monitoring | |||
| Systems (K043197) | LifeScan OneTouch | ||
| Ultra Family of Blood | |||
| Glucose Monitoring | |||
| Systems (K043197) | |||
| LifeScan OneTouch | |||
| Ultra 2 of Blood | |||
| Glucose Monitoring | |||
| Systems (K053529) | LifeScan OneTouch | ||
| Ultra 2 of Blood | |||
| Glucose Monitoring | |||
| Systems (K053529) | |||
| Oxygen | |||
| Saturation | Nonin 4100 Pulse | ||
| Oximeter (K043359) | Nonin 4100 Pulse | ||
| Oximeter (K043359) | |||
| Onyx® II 9560 | |||
| (K081285) | Onyx® II 9560 | ||
| (K081285) |
。
3
| 510(k) Notification Submission - Abbreviated
Intel-GE Care Innovations™ Connect RCM | K130821
pg 4 of 4 |
| ---------------------------------------------------------------------------------------- | ---------------------- |
|---|
| Parameter | Intel-GE Care
Innovations™ Health
Guide (K130290) | Connect RCM
(K130821) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Software Safety Standard | AAMI/ANSI/IEC ES 60601-
1 Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance | AAMI/ANSI/IEC ES 60601-
1 Medical electrical
equipment - Part 1: General
requirements for basic safety
and essential performance |
| Hardware Safety Standard | UL 60950-1:2007
Information Technology
Equipment - 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.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its body and wings.
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.
5
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
6
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:
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.
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'