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 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.

AI/ML Overview

The provided text describes the Alio device, its intended use, and summaries of non-clinical and clinical testing performed for its 510(k) submission (K223073).

Unfortunately, the provided text does not contain the specific acceptance criteria or detailed study results (like sensitivity, specificity, accuracy metrics with confidence intervals for Hgb, Hct, or potassium levels) in a format suitable for a table of acceptance criteria vs. device performance. It broadly states that the device "meets its design requirements and intended use" and "can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct)."

Therefore, I cannot directly provide a table of acceptance criteria and reported device performance as requested. I can, however, extract and summarize the other requested information based on the provided text.

Here's a summary of the available information regarding the Alio device's clinical study:

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

Acceptance Criteria: Not explicitly stated in the provided text. The document indicates that the device "meets its design requirements and intended use" and "can accurately assess abnormal potassium levels and measure hemoglobin (Hgb) and hematocrit (Hct)." However, specific numerical thresholds for accuracy, sensitivity, or specificity as acceptance criteria are not detailed.
Reported Device Performance:
- The study "establish[ed] the accuracy of Alio in the assessment of abnormal potassium levels, and measurement of Hgb and Hct, compared to the standard of care blood results and heart rate."
- "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."
- No specific performance metrics (e.g., mean absolute error, correlation coefficients, sensitivity, specificity, AUC) or their numerical values are provided in this summary document.

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

Sample Size for Test Set: 125 subjects.
Data Provenance:
- Country of Origin: Not explicitly stated, but the study was described as a "multicenter, prospective study." Given the FDA submission, it's highly likely to be U.S.-based, but this is an inference, not a direct statement.
- Retrospective or Prospective: Prospective. The text states: "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."

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

This information is not provided in the text. The ground truth was established by "standard of care blood results" for Hgb and Hct, and for abnormal potassium levels, but the expertise involved in interpreting these and deriving final ground truth labels is not specified.

4. Adjudication method for the test set

This information is not provided in the text.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader, multi-case (MRMC) comparative effectiveness study was not described. The study focused on the accuracy of the device in assessing physiological parameters compared to standard of care, not on human reader performance with or without AI assistance. The device is described as a "secondary, adjunct patient monitor," suggesting it aids, but does not necessarily directly compare, human diagnostic performance.

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

Yes, the described study appears to be a standalone performance evaluation of the Alio device's algorithm. The "AI/ML algorithm used in the calculation of the new physiologic parameters" is specifically mentioned. The study assessed the device's ability to "accurately assess abnormal potassium levels, and measure hemoglobin (Hgb) and hematocrit (Hct)" against "standard of care blood results." This implies the algorithm's output was directly compared to ground truth, which is characteristic of a standalone study.

7. The type of ground truth used

For Hemoglobin (Hgb) and Hematocrit (Hct): "standard of care blood results."
For Abnormal Potassium Levels: "standard of care blood results." The study objective was to establish accuracy compared to "standard of care blood results."
For Heart Rate: "standard of care blood results" (implied as part of the comparison, though usually heart rate ground truth comes from ECG or other direct measurements). The text states "compared to the standard of care blood results and heart rate," which might imply different methods for heart rate ground truth.
The study stated it evaluated patients within "defined Hgb and Hct reference ranges (7-15 g/dL Hgb, 21-45% Hct)." This suggests quantitative comparison with clinical lab values.

8. The sample size for the training set

The sample size for the training set is not provided. The text only mentions the clinical study for validation (test set) with 125 subjects. The AI/ML algorithm's training data is not described.

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

This information is not provided, as the training set details are absent from this summary.

Summary

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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 (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

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Indications for Use

510(k) Number (if known) K223073

Device Name Alio

Indications for Use (Describe)

The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.

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 andAccessories	Reference
K181956	Masimo MightSat Pulse Oximeter	Reference
K142209	Pulse oximeter NBM-200	Reference
K193626	Masimo Rad-97 Pulse CO-Oximeter andAccessories	Reference

DEVICE DESCRIPTION

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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

The data also include a qualitative indicator of abnormal levels of potassium derived from relative variability of photoplethysmography waveforms and medically accepted threshold values.

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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

Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).