The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician.

Assessment is indicated for patients in a healthcare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport.

Normal sinus rhythm is determined by the physician. The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias.

Device Description

The Inmedix® CloudHRV™ System acquires approximately 5 minutes of 3-lead electrocardioaraphic (ECG) data from a patient lying supine and at rest to measure heart rate variability (HRV). The raw cardiac electrical signals are detected using four standard ECG electrodes applied to the wrists and ankles of the patient and a custom 4-lead wire (one reference) ECG cable assembly.

The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV. The CloudHRV™ System outputs are used as an aid by clinicians who are accustomed to evaluating HRV as a part of their overall medical assessment.

AI/ML Overview

The provided text does not contain detailed acceptance criteria and the results of a specific study to prove the device meets these criteria. Instead, it lists the standards and guidance documents used for design verification and validation, along with a high-level statement that testing demonstrates the device's safety and effectiveness compared to the predicate.

Therefore, many of the requested details cannot be extracted from the given information.

However, I can provide what is available, noting the limitations.

Missing Information:

Specific quantitative acceptance criteria for device performance.
The results of a specific study that quantitatively demonstrates the device meets acceptance criteria.
Sample size used for a dedicated test set for performance evaluation (only general mention of "validation testing").
Data provenance for any test set.
Number and qualifications of experts for ground truth establishment.
Adjudication method for any test set.
Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
Information on a standalone algorithm performance study.
The type of ground truth used for performance assessment.
Sample size for the training set.
How ground truth for the training set was established.

Information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria and their corresponding reported performance values are not detailed in the document for HRV measurement accuracy or related metrics, this table cannot be populated as requested. The document primarily focuses on regulatory compliance through adherence to standards and safety/EMC testing, and a functional comparison to a predicate device.

Acceptance Criteria	Reported Device Performance
Not specified in the document	Not specified in the document
(e.g., HRV measurement accuracy to within X bpm, etc.)	(e.g., Achieved Y bpm accuracy, etc.)
Compliance with IEC 60601-1 (Basic safety and essential performance)	Testing was conducted and demonstrates compliance.
Compliance with IEC 60601-1-2 (Electromagnetic disturbances)	Testing was conducted and demonstrates compliance.
Compliance with IEC 60601-2-25 (Electrocardiographs specific requirements)	Testing was conducted and demonstrates compliance.
Compliance with IEC 60601-1-6 (Usability)	Testing was conducted and demonstrates compliance.
Compliance with IEC 62366-1 (Usability engineering)	Testing was conducted and demonstrates compliance.
Compliance with ANSI/AAMI EC57 (Cardiac rhythm and ST-segment measurement algorithms)	Testing was conducted and demonstrates compliance.
Compliance with ANSI/AAMI EC53 (ECG trunk cables and patient leadwires)	Testing was conducted and demonstrates compliance.
Compliance with ASTM D4169-22 (Performance testing of shipping containers)	Testing was conducted and demonstrates compliance.
Compliance with IEC 62304 (Medical device software life-cycle processes)	Testing was conducted and demonstrates compliance.
Compliance with FDA Guidance: Content of Premarket Submissions for Device Software Functions	Adhered to the guidance.
Compliance with FDA Guidance: Cybersecurity in Medical Devices	Adhered to the guidance.
Design Validation against Product Requirements	Design Validation by Design Review was performed and successful.
Human Factors and Usability Engineering	Human Factors and Usability Engineering Report was generated and successful.

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

Sample Size: Not specified for any performance-specific test set. The document refers generally to "Design validation testing" and "Design verification testing" but does not give sample sizes for subjects or data records.
Data Provenance: Not specified.

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

Not specified.

4. Adjudication method for the test set

Not specified.

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

Not specified. The CloudHRV™ System calculates HRV indices and displays results, which are "used as an aid by clinicians." It does not appear to be an AI-assisted diagnostic or interpretation tool in the context of human reader improvement.

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

The document implies standalone algorithm performance for HRV calculation: "The raw cardiac electrical signals are detected...The ECG data collected from the patient are transmitted to a cloud-based service hosted by Inmedix. where proprietary mathematical algorithms calculate HRV." However, no specific performance metrics (e.g., accuracy, precision) are provided for just the algorithm, nor is a dedicated study described.

7. The type of ground truth used

Not specified for the performance of the HRV calculation itself. The compliance testing for standards likely uses reference devices or simulated signals as ground truth for ECG parameters.

8. The sample size for the training set

Not specified.

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

Not specified.

Summary

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January 16, 2025

Inmedix. Inc. % Michael Daniel Consultant Daniel & Daniel Consulting, LLC P.O. Box 129 Minden, Nevada 89423

Re: K241217

Trade/Device Name: CloudHRVTM System (100-01-001) Regulation Number: 21 CFR 870.2340 Regulation Name: Electrocardiograph Regulatory Class: Class II Product Code: DPS Dated: December 20, 2024 Received: December 20, 2024

Dear Michael Daniel:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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assistance/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 W. Shih -S

Jennifer Kozen Assistant Director 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

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Indications for Use

510(k) Number (if known) K241217

Device Name CloudHRVTM System

Indications for Use (Describe)

The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV) in adult patients (age 22 or above) with normal sinus rhythm and resting heart rate within 40 - 110 bpm. These measurements are not intended for any specific clinical significance of HRV must be determined by the physician.

Assessment is indicated for patients in a healtheare facility including a physician office or a hospital outpatient clinic where the patient is able to remain supine and still. The CloudHRV™ System is not indicated for use in a surgical suite or during transport.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: K241217

Applicant Information:

Date Prepared:	April 29, 2024
Name:	Andrew Holman MD
Address:	Inmedix, Inc.17837 First Avenue South, #6,Normandy Park, WA 98148, USA

Contact Person:	Michael A. Daniel
-----------------	-------------------

Email: madaniel@clinregconsult.com

Device Information:

Device Trade Name: CloudHRV™ System
Common Name:	CloudHRV™ System
Classification Name(s):	Electrocardiograph
Product Code/ Regulation:	DPS / 870.2340

Classification: 2

Predicate Device:

ANSiscope™ ECG Monitoring System (K071168)

Subject Device Description

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Subject Device Intended Use

The Inmedix® CloudHRV™ System is intended to acquire, display, and record electrocardiographic (ECG) information to measure heart rate variability (HRV). These measurements are not intended for any specific clinical diagnosis. The clinical significance of HRV must be determined by the physician.

Subject Device Indications for Use

Predicate Device and Subject Device Comparison

The table below compares the CloudHRV to the predicate device.

Aspect	Predicate Device	Subject Device	Comparison
Device Name	ANSiscope™ ECG Monitoring System	CloudHRV™ System	N/A
510(k) Number	K071168	K241217	N/A
Manufacturer	DyAnsys, Inc.	Inmedix, Inc.	N/A
Product Code / Regulation	DPS / 870.2340	DPS / 870.2340	Same
Brief Description	The Portable ANSiscope™ is a device used for measuring heart rate variability (HRV). The device is designed to process raw ECG signals acquired from the patient in order to produce Heart Rate and other ancillary indices. The Portable ANSiscope™ includes an ECG Acquisition System that can digitize raw ECG signals, perform proprietary calculations from the HRV and then display the results utilizing a display unit.	The CloudHRV™ System is a device used for measuring heart rate variability (HRV). The device acquires ~5 minutes of 3-lead ECG data from a patient lying supine and at rest. ECG data is transmitted to a cloud-based service hosted by Inmedix, where proprietary mathematical algorithms calculate HRV and then display the results on the Tablet. The results are used as an aid by clinicians who are accustomed to evaluating HRV as a	Substantially Equivalent
Aspect	Predicate Device	Subject Device	Comparison
		part of their overall medicalassessment.
Intended Use	The DyAnsys, Inc. ANSiscope™ ECG Monitoring System andaccessories, is intended to acquire,analyze, display and recordelectrocardiographic informationand to measure-heart ratevariability. These and othermeasurements are not intended forany specific clinical diagnosis. Theclinical significance of HRV andother parameters must bedetermined by the physician.	The Inmedix® CloudHRV™ Systemis intended to acquire, display, andrecord electrocardiographic (ECG)information to measure heart ratevariability (HRV). Thesemeasurements are not intended forany specific clinical diagnosis. Theclinical significance of HRV must bedetermined by the physician.	SubstantiallyEquivalent
Indications for Use	The DyAnsys, Inc. ANSiscope™ ECG Monitoring System andaccessories, is intended to acquire,analyze, display and recordelectrocardiographic informationand to measure-heart ratevariability. These and othermeasurements are not intended forany specific clinical diagnosis. Theclinical significance of HRV andother parameters must bedetermined by the physician.	The Inmedix® CloudHRV™ Systemis intended to acquire, display, andrecord electrocardiographic (ECG)information to measure heart ratevariability (HRV) in adult patients(age 22 or above) with normal sinusrhythm and resting heart rate within40 - 110 bpm. Thesemeasurements are not intended forany specific clinical diagnosis. Theclinical significance of HRV must bedetermined by the physician.Assessment is indicated for patientsin a healthcare facility including aphysician office or a hospitaloutpatient clinic where the patient isable to remain supine and still. TheCloudHRV™ System is notindicated for use in a surgical suiteor during transport.Normal sinus rhythm is determinedby the physician. The ECG is notintended to be used to diagnose ormonitor cardiovascular conditions.The device does not provideassessments of cardiovascularabnormalities/arrhythmias.	SubstantiallyEquivalent
DisplayedParameters - ECGrelated	• Real-time ECG waveform• Real-time heart rate• ECG lead selection	• Real-time ECG waveform duringassessment	SubstantiallyEquivalent
Aspect	Predicate Device	Subject Device	Comparison
DisplayedParameters – HRVrelated	• Real-time sympathovagal balANS(from -50 to 50)	• Statistical Time-Domain Indices:SDNN, SDSD, RMSSD	SubstantiallyEquivalent
	• Real-time sympathetic ANSi index(from -50 to 50)	• Geometric Time-Domain Indices:DRR, AMO, Baevsky Index
	• Real-time parasympathetic ANSiindex (from -50 to 50)	• Frequency Domain Indices: HighFrequency, Low Frequency, Totalpower, LF/HF ratio
	• Measurement of Dysfunction:Static balANS, Percent ofdysfunction
Type of Analysis	Separation of sympathetic andparasympathetic components of theAutonomic Nervous System (ANS)by scale covariance approachSympathetic response is real part ofcomplex wave functionParasympathetic response isimaginary part of complex wavefunction	HRV indices calculated using ~5minutes of RR interval series withsignal normalized and artifactsremoved.	SubstantiallyEquivalent
Number ofElectrodes	Three (3) for HRVOne (1) for groundingChest lead for ECG functionality	Three (3) for vectors I, II, IIIOne (1) for grounding (right legdrive)	SubstantiallyEquivalent
Electrode location	Chest lead, torso, right ankle.	Left and right wrists, left and rightankles	SubstantiallyEquivalent
Measurement	The initial ANSindex reading isdisplayed after 60 R-R intervals(approx 1 minute)Subsequent readings are taken withevery heartbeatThe display is updated with everyheartbeat	Records five (5) minutes of ECG tocalculate all indices	SubstantiallyEquivalent
Standard leadsacquired	I, II, III, aVR, aVL, aVF, V1-6	I,II,III	SubstantiallyEquivalent
Aspect	Predicate Device	Subject Device	Comparison
Digital samplingrate	200 samples/sec	500 samples/sec	SubstantiallyEquivalent
DC offset capability	300 mV DC	280 mV DC	SubstantiallyEquivalent
Samplingresolution	16 bit, bipolar	16 bit, bipolar	Same
Frequencyresponse	0.5 Hz to 40 Hz	0.5 Hz to 113 Hz	SubstantiallyEquivalent
Data StorageCapability	· USB memory keys (Thumb drives)can be used for datastorage/backup· Also supports SCSI compatibleUSB mass storage devices· Data can be exported to a PC viaa USB memory key	Patient Health Information andpatient indices are stored in thesecure Inmedix Cloud. Data can bemade available as a PDF	SubstantiallyEquivalent
Electrical SafetyClassification	Class II - Type CF device as perIEC requirements	Class II - Type CF device as perIEC requirements	Same
AC adapter input	100-240 VAC, 50-60 Hz	100-240 VAC, 50-60 Hz	Same
AC adapter output	12 VDC, 2 Amps max	12 VDC, 2 Amps max	Same
Battery pack type	NiMH rechargeable battery	Lithium-ion	SubstantiallyEquivalent

Table 1 - Comparison between subject and predicate device

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Testing Completed

Design verification testing included use of the following standards:

IEC 60601-1: 2005+A1:2012+A2:2020 Medical equipment Part 1: General . requirements for basic safety and essential performance
. IEC 60601-1-2:2014+A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-2-25:2011/(R2016) Medical electrical equipment Part 2-25: Particular requirements . for the basic safety and essential performance of electrocardiographs
IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 Medical Electrical Equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral standard: Usability

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. IEC 62366-1:2015, AMD1:2020 Medical devices -- Part 1: Application of usability engineering to medical devices
. ANSI/AAMI EC57:2012 Testing and reporting performance results of cardiac rhythm and STsegment measurement algorithms.
ANSI/AAMI EC53:2013/(R2020) ECG trunk cables and patient leadwires ●
ASTM D4169-22 - Standard practice for performance testing of shipping containers and systems.
. IEC 62304:2006 +AMD1:2015 Medical device software - Software life-cycle processes

Adherance to the following FDA Guidance Documents:

. FDA Guidance - Content of Premarket Submissions for Device Software Functions. Issued June 14. 2023.
FDA Guidance - Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions. Issued September 27, 2023.

Design validation testing included the following:

. Design Validation by Design Review against the Product Requirements (User and Stakeholder Requirements)
. Human Factors and Usability Engineering Report

The testing described in this 510(k) demonstrates that the design input requirements have been verified and all user requirements were validated.

Conclusion

Verification and validation activities were conducted to establish the performance and safety characteristics of the Inmedix CloudHRV™ System. The results of these activities demonstrate that the CloudHRV™ System is as safe and effective as compared to the predicate when used in accordance with its intended use, indications for use and labeling. The CloudHRV™ System has similar intended use and technical characteristics to the predicate device. Therefore, it is substantially equivalent to the predicate device and does not raise any new questions regarding safety or effectiveness as compared to the predicate.

Regulation Number and Section

§ 870.2340 Electrocardiograph.

(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).