(324 days)
Unknown
The device description mentions "Alio's proprietary algorithms" for processing and analyzing data in the cloud, but does not explicitly state whether these algorithms utilize AI or ML. The lack of mention of AI, DNN, or ML, and the absence of details about training or test sets, make it impossible to definitively confirm the presence of AI/ML.
No
The device is described as a "remote monitoring system" that "intermittently collect physiological data" and is "not intended to replace existing standard-of-care patient monitoring practices." It collects data like skin temperature, auscultation sound, and heart rate for "HCP's review." This indicates it is for diagnostic or monitoring purposes, not for providing therapy.
Yes
The device intermittently collects physiological data (skin temperature, auscultation sound data, and heart rate) for healthcare professionals to review, and the data is processed and analyzed using Alio's proprietary algorithms, which are typical functions of a diagnostic device used to assess health conditions.
No
The device description explicitly lists hardware components (SmartPatch and Bedside Hub) that are integral to the system's function of collecting and transmitting physiological data.
Based on the provided information, the Alio Medical Remote Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Alio Medical RMS Function: The Alio Medical RMS collects physiological data directly from the body (skin temperature, auscultation sound data, heart rate) using a wearable sensor. It does not analyze samples taken from the body.
- Intended Use: The intended use is for remote monitoring of physiological data in home settings, not for performing diagnostic tests on biological samples.
Therefore, the Alio Medical Remote Monitoring System falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review.
The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated.
The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
Product codes
DRG, DOD
Device Description
Alio Medical Remote Monitoring System, or "Alio Medical RMS", utilizes a wearable device (SmartPatch) on the skin to gather physiological data and then transmits it to a device (Bedside Hub) located in the subject's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed using Alio's proprietary algorithms. Data is accessible to Healthcare Professionals and the Alio clinical team via a web-based Clinician Portal. The SmartPatch and Bedside Hub are intended to be used on general care patients who are 18 years of age or older in a non-clinical environment. The web-based Clinical Portal is to be used by healthcare professionals in an office environment.
The Alio Medical Remote Monitoring System includes the following components:
- SmartPatch
- Bedside Hub
- Alio Medical Cloud (backend only - not user facing)
- Clinician Portal
SmartPatch: A flexible, silicone-encased patch that can be worn where clinically indicated for up to seven days at a time. It houses numerous sensor technologies, which include a microphone, accelerometer, temperature sensors, and a PPG sensors collect physiological data including skin temperature, auscultation sound data, and heart rate. Data is transmitted to the Cloud, via the Hub, where it is analyzed and sent to a Healthcare Professional via the Web Portal.
Bedside Hub: The Bedside Hub has the form and finish of an at-home device. It automatically communicates with the activated SmartPatch and uploads physiological data to the Alio Medical Cloud.
Alio Medical Cloud: The Cloud features a database that supports storage, analytics, system monitoring and visualization capabilities. The Alio Medical Cloud is encrypted and HIPAA compliant. All patient data is fully traceable to device and patient ID via the database.
Clinician Portal: The Clinician Portal is the interface tool between a user (healthcare professional users only) and the system that enables the user to visualize and interact with data being generated by the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
18 years of age or older (Adult - 18+)
Intended User / Care Setting
Healthcare professionals and the Alio clinical team (Clinician Portal).
Home use settings (non-clinical environment).
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
Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Alio Medical RMS was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications.
Key Metrics
Measurement Range, HR: 30-200 bpm
Arms, HR: 5 bpm
Predicate Device(s)
Vital Connect Platform K152139
Reference Device(s)
Eko Core K200776, BB-613 WP K190792
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 24, 2022
Graftworx, Inc. dba Alio Allison Komiyama, PhD, RAC Principal Consultant ROM+ 2251 San Diego Ave. Suite B-257 San Diego, California 92110
Re: K211365
Trade/Device Name: Alio Medical Remote Monitoring System Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, DOD Dated: March 21, 2022 Received: March 23, 2022
Dear Allison Komiyama:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jennifer Shih Kozen Assistant Director External Heart Rhythm and Rate Team Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211365
Device Name Alio Medical Remote Monitoring System
Indications for Use (Describe)
The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review.
The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated.
The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image shows the logo for Alio Medical. The word "alio" is stacked on top of the word "MEDICAL". The letters "ali" are gray, and the "o" is purple. The word "MEDICAL" is gray.
510(k) Summary
General Information 1.
| 510(k) Sponsor | Alio, Inc. |
|---|---|
| Address | 544B Bryant St |
| San Francisco, CA 94107 | |
| Correspondence Person | Allison C. Komiyama, Ph.D., R.A.C. |
| RQM+ | |
| Contact Information | Email: akomiyama@rqmplus.com |
| Phone: +1 (412) 816-8253 | |
| Date Prepared | March 24, 2022 |
2. Proposed Device
| Proprietary Name | Alio Medical Remote Monitoring System |
|---|---|
| Common Name | Alio Medical RMS |
| Classification Name | Radiofrequency physiological signal transmitter and receiver |
| Regulation Number | 21 CFR 870.2910 |
| Product Code | DRG, DQD |
| Regulatory Class | II |
3. Predicate Device
| Proprietary Name | Vital Connect Platform |
|---|---|
| Premarket Notification | K152139 |
| Classification Name | Radiofrequency physiological signal transmitter and receiver |
| Regulation Number | 21 CFR 870.2910 |
| Product Code | DRG, DSI, MHX |
| Regulatory Class | II |
4. Reference Device
| Proprietary Name | Eko Core |
|---|---|
| Premarket Notification | K200776 |
| Classification Name | Stethoscope |
| Regulation Number | 21 CFR 870.1875 |
| Product Code | DQD |
| Regulatory Class | II |
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Image /page/4/Picture/0 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in a sans-serif font, with the "a", "l", and "i" in gray and the "o" in purple. The "o" is stylized to resemble a target or a medical symbol. Below the word "alio" is the word "MEDICAL" in a smaller, gray, sans-serif font.
5. Reference Device
| Proprietary Name | BB-613 WP |
|---|---|
| Premarket Notification | K190792 |
| Classification Name | Oximeter, non-invasive blood pressure measurement system |
| Regulation Number | 21 C.F.R. 870.2700 Oximeter, 870.1130 Noninvasive blood pressure |
| measurement system | |
| Product Code | DQA, DXN, DRG |
| Regulatory Class | II |
6. Device Description
Alio Medical Remote Monitoring System, or "Alio Medical RMS", utilizes a wearable device (SmartPatch) on the skin to gather physiological data and then transmits it to a device (Bedside Hub) located in the subject's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed using Alio's proprietary algorithms. Data is accessible to Healthcare Professionals and the Alio clinical team via a web-based Clinician Portal. The SmartPatch and Bedside Hub are intended to be used on general care patients who are 18 years of age or older in a non-clinical environment. The web-based Clinical Portal is to be used by healthcare professionals in an office environment.
The Alio Medical Remote Monitoring System includes the following components:
- SmartPatch
- Bedside Hub
- Alio Medical Cloud (backend only - not user facing)
- Clinician Portal
SmartPatch
A flexible, silicone-encased patch that can be worn where clinically indicated for up to seven days at a time. It houses numerous sensor technologies, which include a microphone, accelerometer, temperature sensors, and a PPG sensors collect physiological data including skin temperature, auscultation sound data, and heart rate. Data is transmitted to the Cloud, via the Hub, where it is analyzed and sent to a Healthcare Professional via the Web Portal.
Bedside Hub
The Bedside Hub has the form and finish of an at-home device. It automatically communicates with the activated SmartPatch and uploads physiological data to the Alio Medical Cloud.
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Image /page/5/Picture/1 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in two different colors. The "al" part of the word is in gray, and the "io" part of the word is in purple and is shaped like a circle. Below the word "alio" is the word "MEDICAL" in gray.
Alio Medical Cloud
The Cloud features a database that supports storage, analytics, system monitoring and visualization capabilities. The Alio Medical Cloud is encrypted and HIPAA compliant. All patient data is fully traceable to device and patient ID via the database.
Clinician Portal
The Clinician Portal is the interface tool between a user (healthcare professional users only) and the system that enables the user to visualize and interact with data being generated by the system.
Note - none of the above components/accessories of the Alio Medical RMS have received prior 510(k) clearance.
7. Intended Use/ Indications for Use
The Alio Medical Remote Monitoring System is a wireless remote monitoring system intended for use by healthcare professionals to intermittently collect physiological data in home use settings. The data includes skin temperature, auscultation sound data and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the healthcare provider's (HCP) review.
The Alio Medical RMS is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to measure skin temperature and pulse rate where clinically indicated. The SmartPatch sensor is indicated to record and transmit auscultation sound data where clinically indicated.
The device is not intended for use in critical care or other high-acuity environments. The Alio Medical RMS is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices.
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Image /page/6/Picture/0 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in gray, with the "o" in purple and divided into four sections by white lines. Below the word "alio" is the word "MEDICAL" in gray, in a smaller font size.
Substantial Equivalence 8.
| Feature/
Function | Device:
Alio Medical RMS | Predicate Device:
Vital Connect Platform
(K152139) |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The Alio Medical Remote
Monitoring System is a wireless
remote monitoring system
intended for use by healthcare
professionals to intermittently
collect physiological data in home
use settings. The data includes skin
temperature, auscultation sound
data and heart rate. Data is
transmitted wirelessly from the
SmartPatch wearable sensor to a
web-based portal for the
healthcare provider's (HCP) review.
The Alio Medical RMS is intended
for use on general care patients
who are 18 years of age or older.
The SmartPatch sensor is indicated
to measure skin temperature and
pulse rate where clinically
indicated. The SmartPatch sensor is
indicated to record and transmit
auscultation sound data where
clinically indicated.
The device is not intended for use
in critical care or other high-acuity
environments.
The Alio Medical RMS is a
secondary, adjunct patient monitor
and is not intended to replace
existing standard-of-care patient
monitoring practices. | The Vital Connect Platform is a wireless
remote monitoring system intended for
use by healthcare professionals for
continuous collection of physiological
data in home and healthcare settings.
This can include heart rate,
electrocardiography (ECG), heart rate
variability, R-R interval, respiratory rate,
skin temperature, activity (including step
count), and posture (body position
relative to gravity including fall). Data
are transmitted wirelessly from the Vital
Connect Sensor for storage and analysis.
The Vital Connect Platform can include
the ability to notify healthcare
professionals when physiological data
fall outside selected parameters. The
device is intended for use on general
care patients who are 18 years of age or
older as a general patient monitor, to
provide physiological information. The
data from the Vital Connect Platform are
intended for use by healthcare
professionals as an aid to diagnosis and
treatment. The device is not intended
for use on critical care patients. |
| Rx or OTC | Rx | Rx |
| Intended
Users | Adult - 18+ | Adult - 18+ |
| Intended
Environment | Home | Home & healthcare settings |
| Application | Patch - SmartPatch only | Patch |
| Single-use | Yes - SmartPatch only | Yes - patch only |
| | | |
| Data transmitted | Skin temperature
Electronic stethoscope for sound auscultation data
Heart rate | - heart rate
- ECG
- heart rate variability
- R-R interval
- respiratory rate
- skin temperature
- activity (including step count)
- posture (body position relative to gravity including fall) |
| Sensor Type | Thermistor
Microphone
Accelerometer
PPG | - ECG electrodes to detect heart rate - 3-axis MEMS accelerometer to detect motion
- Thermistors to detect body temperature |
| Temperature Data | Skin temperature
15°C - 50°C | Skin temperature
15°C - 50°C |
| Sound Data | - heart - lungs
- bowel
- arteries
- veins | N/A |
| Sound Amplification | Yes | N/A |
| Record and Playback Sound | Yes (Playback via Clinician Portal) | N/A |
| Operating Mode | Intermittent | Continuous |
| Data Transmission | Bluetooth - SmartPatch only
Radio Frequency: 2.4 - 2.5 GHz
(Cellular) - SmartHub only | Bluetooth |
| Energy Source | SmartPatch only - battery (Li-ion)
Hub - 5V Mains DC | Sensor only -
battery (Li-ion) |
| Standards | IEC 60601-1 3rd ed.
IEC 60601-1-11:2010
IEC 80601-2-56:2017
IEC 80601-2-61:2017
IEC 62471:2008
IEC 60529:2013
IEC 60086-4:2019
IEC 60601-1-2:2007/2014
IEC 62304:2006/A1:2016
IEC 62366-1:2007/2015
FCC CRF47
Part 15 Subpart B
ISO 10993-5:2009 | ISO 10993-1:2009
IEC 60601-1
IEC 60601-1-11
IEC 60601-1-6
IEC 60601-2-25
IEC 60601-2-47
IEC 60601-1-2
IEC/TS 62657-2
FCC CRF47
Part 15 Subpart C |
| Feature/
Function | Device:
Alio Medical RMS | Reference Device:
BioBeat BB-613P
(K190792) |
| Application | Skin - SmartPatch only | Wrist area and skin |
| Monitoring | Intermittent | Spot Check/Intermittent |
| Principle of
Operation | Pulse reflectance technology.
Light source is comprised of 6
LEDs (2x green, 2x red, 2x IR),
reflected light is detected by 4
photodiodes. An accelerometer
provides additional heart rate
data. | Pulse reflectance technology, Four LED (red
- IR) and photo diode absorbs reflected
light. Tracking changes of blood pressure is
done by pulse wave transit time (PWTT)
which is obtained utilizing pulse
measurements from the integrated skin
attached SpO2 sensor |
| Emitted light peak
wavelength | 530 nm (Green), 650 nm (Red),
940 nm (IR) | 880nm (IR), 650nm (Red) |
| Measurement
Range, HR | 30-200 bpm | 40-250bpm |
| Arms, HR | 5 bpm | ±3% |
| Application Method | Biocompatible adhesive patch | Biocompatible adhesive patch |
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Image /page/7/Picture/1 description: The image shows the logo for Alio Medical. The logo consists of the word "alio" in gray, with the "o" replaced by a purple circle with a white cross inside. Below the word "alio" is the word "MEDICAL" in gray, in a smaller font size. The logo is simple and modern, and the use of purple and gray gives it a professional look.
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Image /page/8/Picture/0 description: The image shows the logo for Alio Medical. The word "alio" is in gray, with the "o" being a purple circle with a white plus sign in the center. Below the word "alio" is the word "MEDICAL" in gray, with the letters being smaller than the letters in "alio."
Technological Characteristic Comparison with Reference Devices
| Feature/
Function | Device:
Alio Medical RMS | Reference Device:
EKO Device
(K200776) |
|--------------------------------|-----------------------------|----------------------------------------------|
| | | |
| Auscultation Data | | |
| Measurement
Frequency Range | 55 - 2000 Hz | unknown |
| Sound Amplification | Yes | Yes |
| Connectivity | Bluetooth | Bluetooth |
| Record and Save | Yes | Yes |
9. Performance Data
Nonclinical verification and validation test results established that the device meets its design requirements and intended use, that it is as safe, as effective, and performs as well as the predicate devices, and that no new issues of safety and effectiveness were raised. The Alio
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Image /page/9/Picture/1 description: The image shows the logo for Alio Medical. The word "alio" is in gray, with the "o" being a purple circle made of smaller circles. Below the word "alio" is the word "MEDICAL" in gray.
Medical RMS was designed, verified, and validated according to the company's Design Control process and has been subjected to extensive safety and performance testing as shown in the test results provided in this submission. Verification and Validation testing data demonstrate that the device meets all of its specifications including compliance with the following standards:
Safety
- IEC 60601-1 3rd Ed. ●
- IEC 60601-1-11:2010
- IEC 80601-2-56:2017 ●
- IEC 80601-2-61:2017 ●
- IEC 62471:2008 ●
- IEC 60529:2013
- IEC 60086-4:2019 ●
EMC
- . IEC 60601-1-2:2007/2014
- FCC Part 15 Radio Frequency Devices, Subpart B - Unintentional Radiators
Software
- . IEC 62304:2006/A1:2016
- FDA Guidance document, "Guidance for the Content of Premarket Submissions for . Software Contained in Medical Devices" and "Content of Premarket Submission for Management of Cybersecurity in Medical Devices."
Usability
- . IEC 62366-1:2007/2015
- . FDA Guidance document, "Applying Human Factors and Usability Engineering to Medical Devices"
Biocompatibility
- . ISO 10993-5:2009
- ISO 10993-10:2010 ●
10. Conclusion
Based on the information submitted in this premarket notification, and based on the indications for use, technological characteristics and performance testing, Alio Medical Remote Monitoring System raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance.