Alio

K223073 · Alio, Inc. · DRG · Mar 17, 2023 · Cardiovascular

Device Facts

• Record ID: K223073
• Device Name: Alio
• Applicant: Alio, Inc.
• Product Code: DRG · Cardiovascular
• Decision Date: Mar 17, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2910
• Device Class: Class 2
• Attributes: AI/ML

AI Performance

Output	Acceptance	Observed	Dev DS	Test DS
Hemoglobin (Hgb) Measurement	Not specified	Evaluated within reference range of 7-15 g/dL	Not specified	Multicenter, prospective clinical study with 125 subjects
Hematocrit (Hct) Measurement	Not specified	Evaluated within reference range of 21-45%	Not specified	Multicenter, prospective clinical study with 125 subjects
Abnormal Potassium Level Assessment	Not specified	Accurately assessed abnormal potassium levels	Not specified	Multicenter, prospective clinical study with 125 subjects

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.

Device Story

Alio is a wireless remote monitoring system comprising a flexible, silicone-encased SmartPatch wearable, a Hub, and a Cloud-based Portal. The SmartPatch collects photoplethysmography (PPG) waveforms, skin temperature, and auscultation sounds from patients with ESKD (placed on AV access) or general care patients. Data transmits via Bluetooth to the Hub, then via cellular connection to the Alio Cloud. An AI/ML algorithm analyzes PPG variability to provide a qualitative indicator of abnormal potassium levels. Clinicians access processed data via the Alio Portal for visualization and review. The system serves as a secondary, adjunct monitor to support clinical decision-making; it does not replace standard-of-care monitoring. Benefits include remote physiological tracking and non-invasive assessment of dyskalemia risk.

Clinical Evidence

Multicenter, prospective clinical study (n=125) validated Alio's ability to quantify Hgb, Hct, and assess abnormal potassium levels compared to standard-of-care blood results. Results demonstrated accurate assessment of potassium, Hgb, and Hct when placed on AV access in ESKD patients, and confirmed continued accuracy for heart rate and auscultation sound recording.

Technological Characteristics

Flexible, silicone-encased wearable patch; Bluetooth connectivity to Hub; cellular uplink to Cloud. Sensing includes PPG, temperature, and acoustic sensors. Complies with IEC 60601-1, IEC 60601-1-11, IEC 80601-2-56, IEC 80601-2-61, IEC 62471, IEC 60529, IEC 60086-4, and ISO 10993 biocompatibility standards. Software follows IEC 62304.

Indications for Use

Indicated for general care patients 18+ years old in clinical and non-clinical settings. Provides heart rate, skin temperature, Hgb, Hct, and qualitative abnormal potassium risk assessment. Records/transmits auscultation sounds. For potassium, Hgb, Hct, and heart rate, sensor must be placed on arm-based arteriovenous access in patients with end-stage kidney disease (ESKD).

Regulatory Classification

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.

Predicate Devices

• Alio Medical Remote Monitoring System (K211365)

Reference Devices

• Masimo Rad-67 Pulse CO-Oximeter and Accessories (K182887)
• Masimo MightSat Pulse Oximeter (K181956)
• Pulse oximeter NBM-200 (K142209)
• Masimo Rad-97 Pulse CO-Oximeter and Accessories (K193626)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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) | |
|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Official Contact: Kimberly Snyder, Vice President of Quality

### REPRESENTATIVE/CONSULTANT

Kevin Go, MBA, RAC, CQA Allison Komiyama, Ph.D., RAC RQM+ Telephone: [phone] Email: [e-mail] [e-mail]

### 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<br>Accessories | Reference |
| K181956 | Masimo MightSat Pulse Oximeter | Reference |
| K142209 | Pulse oximeter NBM-200 | Reference |
| K193626 | Masimo Rad-97 Pulse CO-Oximeter and<br>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

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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

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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 ●

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- 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

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| | 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