(168 days)
Yes
The document explicitly states "Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the calculation of the new physiologic parameters".
No
The device is described as a "wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data." It is explicitly stated that "Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. Therapeutic management decisions... should be made based on a complete assessment of the patient's condition and should not be based solely on Alio." This indicates its purpose is diagnostic or monitoring, not therapeutic.
Yes
Explanation: The device collects physiological data (measured hemoglobin, hematocrit, skin temperature, auscultation sound data, heart rate, and qualitative indicator of abnormal potassium levels) for healthcare provider review, and a clinical study was conducted to validate its ability to quantify these measurements and assess abnormal potassium levels compared to standard of care. This activity of collecting and analyzing physiological data to assess a patient's condition falls under the definition of a diagnostic device.
No
The device description clearly outlines hardware components: the Alio SmartPatch (a wearable sensor) and the Alio Hub. While software is a critical part of the system (Alio Cloud, Alio Portal), the system relies on physical hardware to collect and transmit data.
Based on the provided information, the Alio device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Alio system collects physiological data directly from the patient's body via a wearable sensor (SmartPatch) placed on an arteriovenous access site. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The data collected is physiological. The system measures parameters like hemoglobin, hematocrit, skin temperature, auscultation sound data, heart rate, and provides a qualitative indicator of abnormal potassium levels based on waveform analysis. These are all physiological measurements taken from the living body.
- The device description and intended use clearly describe a remote monitoring system. The system is designed to collect and transmit data from the patient to healthcare providers for review, not to perform diagnostic tests on biological samples.
While the device measures parameters that are often assessed through IVD tests (like hemoglobin, hematocrit, and potassium), the method of measurement and the type of data collected classify it as a physiological monitoring device, not an IVD.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / Indications for Use
Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review.
The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.
Alio is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the patient having an abnormal potassium level. The SmartPatch sensor is indicated to record and transmit auscultation sound data. For qualitative assessment of abnormal potassium levels, and quantitative measurement of heart rate, skin temperature, Hgb and Hct, the SmartPatch should be placed on an arm based arteriovenous access on patients with end stage kidney disease (ESKD).
Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. Therapeutic management decisions, including management of dyskalemia, should be made based on a complete assessment of the patient's condition and should not be based solely on Alio.
Product codes
DRG, DOD
Device Description
Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. Alio is intended to be used on general care patients and patients with end stage kidney disease (ESKD), who are 18 years of age or older in clinical and non-clinical settings. Alio includes the following components:
-
Alio SmartPatch
The Alio SmartPatch is a flexible, silicone-encased patch designed to be worn between the cannulation sites of the arteriovenous (AV) fistula or graft for up to seven days. It houses numerous sensor technologies which collect data for the derivation of physiologic parameters including hemoglobin, hematocrit, an assessment of normal or abnormal (hyper or hypokalemic) levels of serum potassium (K+), skin temperature, auscultation sound data, and heart rate. The data from the sensors is transmitted from the SmartPatch to the Alio Hub via a bluetooth connection. The data is then transmitted to the Alio Cloud, via the Alio Hub, where it is analyzed and made available to a clinical care team via the Alio Portal. -
Alio Hub
The Alio Hub is designed for use in clinical and non-clinical use settings. It automatically communicates with the activated Alio SmartPatch via Bluetooth and uploads physiological data to the Alio Cloud via cellular connection. -
Alio Cloud
The Alio Cloud allows clinicians to access patient data collected via the Alio SmartPatch and wirelessly transferred from the Alio Hub to the secure server (the Alio Cloud). -
Alio Portal
The Alio Portal stores data received from the Alio Cloud database that supports storage, analytics, system monitoring and visualization capabilities. This data is encrypted and HIPAA compliant. The Alio Portal also serves as the interface with the HCP who can then visualize and interact with data being generated by the system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the calculation of the new physiologic parameters
Input Imaging Modality
Not Found
Anatomical Site
arm based arteriovenous access
Indicated Patient Age Range
18 years of age or older.
Intended User / Care Setting
healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings.
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: multicenter, prospective study
Sample size: 125 subjects
Key results: The results of the study demonstrate that Alio can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct) when placed on an arteriovenous access site in patients with ESKD. The results further confirm that Alio can still accurately measure heart rate and record auscultation sound data at the new location.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
K182887, K181956, K142209, K193626
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).
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2023
Alio, Inc. % Kevin Go, MBA, RAC, CQA Regulatory Consultant ROM+ 2790 Mosside Boulevard, Suite 800 Monroeville, Pennsylvania 15146
Re: K223073
Trade/Device Name: Alio Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency physiological signal transmitter and receiver Regulatory Class: II Product Code: DRG, DOD Dated: February 15, 2023 Received: February 15, 2023
Dear Kevin Go:
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,
Gema Gonzalez -S
Gema Gonzalez, MS Acting Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223073
Device Name Alio
Indications for Use (Describe)
Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review.
The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.
Alio is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the patient having an abnormal potassium level. The SmartPatch sensor is indicated to record and transmit auscultation sound data. For qualitative assessment of abnormal potassium levels, and quantitative measurement of heart rate, skin temperature, Hgb and Hct, the SmartPatch should be placed on an arm based arteriovenous access on patients with end stage kidney disease (ESKD).
Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-of-care patient monitoring practices. Therapeutic management decisions, including management of dyskalemia, should be made based on a complete assessment of the patient's condition and should not be based solely on Alio.
| 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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K223073 Page 1/5
Alio
510(k) Summary
DATE PREPARED
March 17, 2022
MANUFACTURER AND 510(k) OWNER
Alio, Inc. 10901 W. 120th Ave., Suite 380 Broomfield, CO 80021 USA Telephone: 855-979-1600 Official Contact: Kimberly Snyder, Vice President of Quality
REPRESENTATIVE/CONSULTANT
Kevin Go, MBA, RAC, CQA Allison Komiyama, Ph.D., RAC RQM+ Telephone: 630-272-1282 Email: KGo@rqmplus.com AKomiyama@rqmplus.com
DEVICE INFORMATION
| Proprietary Name/Trade Name: | Alio |
|---|---|
| Common Name: | Alio |
| Regulation Number: | 21 CFR 870.2910 |
| Class: | Class II |
| Product Code: | DRG, DQD |
PREDICATE DEVICE IDENTIFICATION
Alio is substantially equivalent to the following predicates:
| 510(k) Number | Predicate Device Name / Manufacturer | Predicate/Reference |
|---|---|---|
| K211365 | Alio Medical Remote Monitoring System | Predicate |
| K182887 | Masimo Rad-67 Pulse CO-Oximeter and | |
| Accessories | Reference | |
| K181956 | Masimo MightSat Pulse Oximeter | Reference |
| K142209 | Pulse oximeter NBM-200 | Reference |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and | |
| Accessories | Reference |
DEVICE DESCRIPTION
Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. Alio is intended to be used on general care patients and patients with end stage kidney disease (ESKD), who are 18 years of age
4
or older in clinical and non-clinical settings. Alio includes the following components:
● Alio SmartPatch
The Alio SmartPatch is a flexible, silicone-encased patch designed to be worn between the cannulation sites of the arteriovenous (AV) fistula or graft for up to seven days. It houses numerous sensor technologies which collect data for the derivation of physiologic parameters including hemoglobin, hematocrit, an assessment of normal or abnormal (hyper or hypokalemic) levels of serum potassium (K+), skin temperature, auscultation sound data, and heart rate. The data from the sensors is transmitted from the SmartPatch to the Alio Hub via a bluetooth connection. The data is then transmitted to the Alio Cloud, via the Alio Hub, where it is analyzed and made available to a clinical care team via the Alio Portal.
-
. Alio Hub
The Alio Hub is designed for use in clinical and non-clinical use settings. It automatically communicates with the activated Alio SmartPatch via Bluetooth and uploads physiological data to the Alio Cloud via cellular connection. -
Alio Cloud
The Alio Cloud allows clinicians to access patient data collected via the Alio SmartPatch and wirelessly transferred from the Alio Hub to the secure server (the Alio Cloud). -
. Alio Portal
The Alio Portal stores data received from the Alio Cloud database that supports storage, analytics, system monitoring and visualization capabilities. This data is encrypted and HIPAA compliant. The Alio Portal also serves as the interface with the HCP who can then visualize and interact with data being generated by the system.
INDICATIONS FOR USE
Alio is a wireless remote monitoring system intended for use by healthcare providers (HCP) to collect physiological data in clinical and non-clinical settings. The data includes measured hemoglobin (Hgb) and hematocrit (Hct), skin temperature, auscultation sound data, and heart rate. Data is transmitted wirelessly from the SmartPatch wearable sensor to a web-based portal for the HCP's review.
The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.
Alio is intended for use on general care patients who are 18 years of age or older. The SmartPatch sensor is indicated to provide measurement of heart rate, skin temperature, Hgb, Hct and a qualitative risk assessment of the patient having an abnormal potassium level. The SmartPatch sensor is indicated to record and transmit auscultation sound data. For qualitative assessment of abnormal potassium levels, and quantitative measurement of heart rate, skin temperature, Hgb and
5
Hct, the SmartPatch should be placed on an arm based arteriovenous access on patients with end stage kidney disease (ESKD).
Alio is a secondary, adjunct patient monitor and is not intended to replace existing standard-ofcare patient monitoring practices. Therapeutic management decisions, including management of dyskalemia, should be made based on a complete assessment of the patient's condition and should not be based solely on Alio.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
Alio, Inc. believes that Alio is substantially equivalent to the predicate devices based on the information summarized here:
Alio received previous clearance as the Alio Remote Monitoring System in K211365. This submission introduces several changes to the previously cleared device including:
- Expanding the indications for use to include measurements of hemoglobin (Hgb) and hematocrit (Hct) and a qualitative indicator of abnormal potassium levels. Additionally, the device is being indicated for both clinical and non-clinical settings.
- Addition of an artificial intelligence/machine learning (AI/ML) algorithm used in the ● calculation of the new physiologic parameters
- Modification of the adhesive used to secure the device to the patient
- Minor cosmetic dimensional changes to the Alio SmartPatch ●
Alio and Alio Medical Remote Monitoring Svstem (K211365) have the same intended use and similar indications, technological characteristics and principles of operation. The differences described above do not present any new issues of safety or effectiveness and have undergone nonclinical and clinical testing to ensure the device is as safe and effective as the predicates.
SUMMARY OF NON-CLINICAL TESTING
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. Alio 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 ●
6
- 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/A1:2015
- 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 ●
- ISO 10093-23:2021 ●
SUMMARY OF CLINICAL TESTING
An IRB-approved clinical study has been conducted to validate the ability of Alio to quantify the new measurements and support the proposed expanded indications. Alio was studied in a multicenter, prospective study with 125 subjects. The purpose of this investigational study is to establish the accuracy of Alio in the assessment of abnormal potassium levels, and measurement of Hzb and Hct, compared to the standard of care blood results and heart rate.
The clinical validation study evaluated patients within the defined Hgb and Hct reference ranges (7-15 g/dL Hgb, 21-45% Hct) with only a single value recorded outside the ranges. The results of the study demonstrate that Alio can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct) when placed on an arteriovenous access site in patients with ESKD. The results further confirm that Alio can still accurately measure heart rate and record auscultation sound data at the new location. In conclusion, the results of this IRB study support the safety and efficacy of the device for the clinical intended use.
CONCLUSION
Based on the information submitted in this premarket notification, and based on the indications
7
| K223073 | ||
|---|---|---|
| Traditional 510(k) Premarket Notification | Page 5/5 | Alio |
for use, technological characteristics and performance testing, Alio raises no new questions of safety and effectiveness and is substantially equivalent to the predicate devices in terms of safety, efficacy, and performance