(260 days)
Not Found
No
The description mentions "proprietary mathematical algorithms" for calculating HRV, but there is no mention of AI, ML, deep learning, or any related concepts. The performance studies focus on standard medical device testing and usability, not on training or testing AI/ML models.
No.
The device measures heart rate variability, but the measurements "are not intended for any specific clinical diagnosis." It explicitly states that "The ECG is not intended to be used to diagnose or monitor cardiovascular conditions" and "The device does not provide assessments of cardiovascular abnormalities/arrhythmias." These statements indicate it's not a therapeutic device.
No
Explanation: The "Intended Use / Indications for Use" section explicitly states, "These measurements are not intended for any specific clinical diagnosis" and "The ECG is not intended to be used to diagnose or monitor cardiovascular conditions. The device does not provide assessments of cardiovascular abnormalities/arrhythmias." While it acquires ECG information, it is stated to be an "aid by clinicians" and the clinical significance of HRV is to be "determined by the physician", rather than the device providing a diagnosis itself.
No
The device description explicitly states that the system acquires ECG data 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," which are hardware components.
Based on the provided information, the Inmedix® CloudHRV™ System is an IVD (In Vitro Diagnostic).
Here's why:
- It measures a physiological parameter (Heart Rate Variability) from a biological sample (ECG data derived from the body's electrical signals). While ECG data isn't a traditional "sample" like blood or urine, it's a measurement taken from the patient's body to assess a physiological state.
- The intended use is to provide information that aids clinicians in their overall medical assessment. Although it explicitly states it's not for specific clinical diagnosis, the output (HRV measurements) is used by clinicians to inform their understanding of the patient's condition. This aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease.
While the device doesn't analyze traditional biological fluids, the collection and analysis of physiological signals from the body to provide information for clinical assessment falls under the broader scope of IVDs in some regulatory contexts. The fact that it's a medical device intended for use in a healthcare setting and provides data for clinical interpretation further supports its classification as an IVD.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DPS
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients (age 22 or above)
Intended User / Care Setting
clinicians, healthcare facility including a physician office or a hospital outpatient clinic
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, sample size, AUC, MRMC, standalone performance, key results)
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
- . 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
Adherence 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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
3
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.
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/arthythmias.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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
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.
5
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
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/arrhvthmias.
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 medical | |||
| assessment. | |||
| Intended Use | The DyAnsys, Inc. ANSiscope™ ECG Monitoring System and | ||
| accessories, is intended to acquire, | |||
| analyze, display and record | |||
| electrocardiographic information | |||
| and to measure-heart rate | |||
| variability. These and other | |||
| measurements are not intended for | |||
| any specific clinical diagnosis. The | |||
| clinical significance of HRV and | |||
| other parameters must be | |||
| determined by the physician. | 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. | Substantially | ||
| Equivalent | |||
| Indications for Use | The DyAnsys, Inc. ANSiscope™ ECG Monitoring System and | ||
| accessories, is intended to acquire, | |||
| analyze, display and record | |||
| electrocardiographic information | |||
| and to measure-heart rate | |||
| variability. These and other | |||
| measurements are not intended for | |||
| any specific clinical diagnosis. The | |||
| clinical significance of HRV and | |||
| other parameters must be | |||
| determined by the physician. | 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. | Substantially | ||
| Equivalent | |||
| Displayed | |||
| Parameters - ECG | |||
| related | • Real-time ECG waveform | ||
| • Real-time heart rate | |||
| • ECG lead selection | • Real-time ECG waveform during | ||
| assessment | Substantially | ||
| Equivalent | |||
| Aspect | Predicate Device | Subject Device | Comparison |
| Displayed | |||
| Parameters – HRV | |||
| related | • Real-time sympathovagal balANS | ||
| (from -50 to 50) | • Statistical Time-Domain Indices: | ||
| SDNN, SDSD, RMSSD | Substantially | ||
| Equivalent | |||
| • Real-time sympathetic ANSi index | |||
| (from -50 to 50) | • Geometric Time-Domain Indices: | ||
| DRR, AMO, Baevsky Index | |||
| • Real-time parasympathetic ANSi | |||
| index (from -50 to 50) | • Frequency Domain Indices: High | ||
| Frequency, Low Frequency, Total | |||
| power, LF/HF ratio | |||
| • Measurement of Dysfunction: | |||
| Static balANS, Percent of | |||
| dysfunction | |||
| Type of Analysis | Separation of sympathetic and | ||
| parasympathetic components of the | |||
| Autonomic Nervous System (ANS) | |||
| by scale covariance approach | |||
| Sympathetic response is real part of | |||
| complex wave function | |||
| Parasympathetic response is | |||
| imaginary part of complex wave | |||
| function | HRV indices calculated using ~5 | ||
| minutes of RR interval series with | |||
| signal normalized and artifacts | |||
| removed. | Substantially | ||
| Equivalent | |||
| Number of | |||
| Electrodes | Three (3) for HRV | ||
| One (1) for grounding | |||
| Chest lead for ECG functionality | Three (3) for vectors I, II, III | ||
| One (1) for grounding (right leg | |||
| drive) | Substantially | ||
| Equivalent | |||
| Electrode location | Chest lead, torso, right ankle. | Left and right wrists, left and right | |
| ankles | Substantially | ||
| Equivalent | |||
| Measurement | The initial ANSindex reading is | ||
| displayed after 60 R-R intervals | |||
| (approx 1 minute) | |||
| Subsequent readings are taken with | |||
| every heartbeat | |||
| The display is updated with every | |||
| heartbeat | Records five (5) minutes of ECG to | ||
| calculate all indices | Substantially | ||
| Equivalent | |||
| Standard leads | |||
| acquired | I, II, III, aVR, aVL, aVF, V1-6 | I,II,III | Substantially |
| Equivalent | |||
| Aspect | Predicate Device | Subject Device | Comparison |
| Digital sampling | |||
| rate | 200 samples/sec | 500 samples/sec | Substantially |
| Equivalent | |||
| DC offset capability | 300 mV DC | 280 mV DC | Substantially |
| Equivalent | |||
| Sampling | |||
| resolution | 16 bit, bipolar | 16 bit, bipolar | Same |
| Frequency | |||
| response | 0.5 Hz to 40 Hz | 0.5 Hz to 113 Hz | Substantially |
| Equivalent | |||
| Data Storage | |||
| Capability | · USB memory keys (Thumb drives) | ||
| can be used for data | |||
| storage/backup | |||
| · Also supports SCSI compatible | |||
| USB mass storage devices | |||
| · Data can be exported to a PC via | |||
| a USB memory key | Patient Health Information and | ||
| patient indices are stored in the | |||
| secure Inmedix Cloud. Data can be | |||
| made available as a PDF | Substantially | ||
| Equivalent | |||
| Electrical Safety | |||
| Classification | Class II - Type CF device as per | ||
| IEC requirements | Class II - Type CF device as per | ||
| IEC 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 | Substantially |
| Equivalent |
Table 1 - Comparison between subject and predicate device
6
7
8
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
9
- . 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.