The Zynex Monitoring System, Model CM-1600, simultaneously monitors various parameters of a patient's body. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature. A Relative Index value is calculated as a combination of the changes in these parameters and is represented by a single number. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.

AI/ML Overview

The provided text is a 510(k) summary for the Zynex Monitoring System, Model CM-1600. It describes the device, its intended use, a comparison to a predicate device, and performance data provided in support of substantial equivalence.

However, the provided document does not contain information regarding an AI/ML device, expert ground truth establishment, or specific details on studies proving the device meets acceptance criteria related to AI/ML performance metrics (like sensitivity, specificity, or AUC). The device described, the Zynex Monitoring System, Model CM-1600, monitors physiological parameters such as Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature and calculates a "Relative Index" as a combination of changes in these parameters. This appears to be a traditional medical monitoring device, not a device incorporating artificial intelligence or machine learning for diagnostic or interpretive purposes.

Therefore, many of the requested points, such as AI/ML acceptance criteria, sample size for AI/ML test sets, expert adjudication methods, MRMC studies, or ground truth establishment for AI/ML models, cannot be answered from the provided text because the text does not describe an AI/ML device or studies typically associated with its validation.

The available information related to device performance and validation is summarized below:

Device: Zynex Monitoring System, Model CM-1600

Intended Use: Monitoring of Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, and Skin Temperature, and their relative changes in fluid volume in adult patients. It provides numerical values to aid diagnosis by a physician; it is the physician's responsibility to make proper judgments based on these measurements.

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

The document does not specify "acceptance criteria" in terms of numerical performance thresholds (like accuracy percentages or error rates) for the physiological measurements themselves. Instead, it relies on demonstrating compliance with recognized standards and substantial equivalence to a predicate device through various performance tests.

Test Name	Testing Criteria	Reported Device Performance (Pass/Fail)
Biocompatibility	ISO 10993	Pass
Device Safety, Electrical Safety, and Electromagnetic Compatibility (EMC)	IEC 60601-1 and 60601-1-2	Pass
Wireless Coexistence Testing	AAAMI-TIR63	Pass
Performance Testing	V&V/Predicate Testing	Pass

Note: The document states "Animal Testing: No Testing Required" and "Clinical Testing: No Testing Required", indicating these were not part of the performance data submitted for this 510(k) clearance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not detail specific sample sizes for "test sets" in the way one would for an AI/ML algorithm. The performance testing (V&V/Predicate Testing) demonstrates that the device meets applicable requirements and is substantially equivalent to the predicate device. This typically involves engineering and functional validation, not data-driven performance assessments on patient cohorts for diagnostic accuracy. No information is provided regarding data provenance (country of origin, retrospective/prospective). Since clinical testing was not required/conducted, there isn't patient-specific data being referred to in this context.

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

Not applicable. The document does not describe the establishment of a "ground truth" by experts for diagnostic purposes or for validating an AI/ML model. The device provides raw physiological parameters and a "Relative Index," which are direct measurements or calculations, not interpretations requiring expert consensus for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set requiring adjudication in the context of diagnostic or interpretive performance.

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 applicable. This is not an AI-assisted diagnostic device, and no MRMC study was mentioned or conducted.

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

Not applicable. The device provides physiological measurements and a calculated index. There isn't an "algorithm only" component that generates a diagnosis or interpretation independent of human interpretation for which standalone performance would be relevant in the context of AI/ML.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of physiological monitoring device, "ground truth" would relate to the accuracy of its direct measurements (e.g., how accurately it measures bioelectrical impedance or temperature) against a calibrated standard, not against expert consensus on a diagnosis, pathology, or outcomes data, as these are beyond the scope of a monitoring device providing raw or relative change data.

8. The sample size for the training set

Not applicable. The document does not describe the use of a "training set" for an AI/ML model for this device.

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

Not applicable. As no training set for an AI/ML model is mentioned, the method for establishing its ground truth is not discussed.

Summary

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June 16, 2023

Zynex Medical, Inc. Donald Gregg Zynex Monitoring Solutions 9555 Maroon Circle Englewood, Colorado 80112

Re: K223217

Trade/Device Name: Zynex Monitoring System, Model CM-1600 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB, DQA Dated: December 5, 2022 Received: December 6, 2022

Dear Donald Gregg:

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 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

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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,

Robert T. Kazmierski -S

for

LCDR Stephen Browning 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K223217

Device Name

Zynex Monitoring System, Model CM-1600

Indications for Use (Describe)

Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients:

· Bioelectrical Impedance
ECG Amplitude
PPG Amplitude
· Skin Temperature

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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Image /page/3/Picture/1 description: The image shows the logo for Zynex Monitoring Solutions. The logo features the word "Zynex" in a bold, sans-serif font, with the words "Monitoring Solutions" in a smaller font below. A blue swoosh arcs over the word "Zynex", adding a dynamic element to the design. The overall design is clean and professional.

510(k) Summary Zynex Monitoring System, Model CM-1600

This 510(k) summary is being submitted in accordance with the requirements of SMDA and 21CFR § 807.92.

1. Submitter's Information

Submitted by:	Zynex Monitoring Solutions, Inc.
	9555 Maroon CircleEnglewood, CO 80112 USA

Phone number: +1-800-495-6670 Fax Number: +1-866-870-4089

Contact person: Donald Gregg President, Zynex Monitoring Solutions Phone number: +1-800-495-6670 E-mail: dgregg@zynex.com
Date of Summary: 07-October-2022

2. Device Information

Trade name:	Zynex Monitoring System, Model CM-1600
Common name(s):	Impedance cardiograph (ICG)Electrocardiograph (ECG)Photoplethysmograph (PPG)
Classification name:	See Table 1
Device class:	Class II

Table 1. Classification Name

Classification Name	21 CFR Section	Product Code
Plethysmograph, Impedance	870.2770	DSB
Oximeter	870.2700	DQA
Thermometer, Electronic, Clinical	880.2910	FLL
Monitor, Physiological, Patient (Without Arrhythmia DetectionOr Alarms)	870.2300	MWI

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Image /page/4/Picture/1 description: The image shows the logo for Zynex Monitoring Solutions. The word "Zynex" is written in a bold, sans-serif font, with the words "Monitoring Solutions" written in a smaller font below it. A blue arc is above the word "Zynex", adding a design element to the logo. The logo is simple and professional, and it is likely used to represent the company's brand.

3. Predicate Devices

The Zynex Monitoring System, Model CM-1600, is substantially equivalent in design (methodology) and indications for use to the predicate device shown in Table 2.

Table 2. Predicate Device

Device Name	Manufacturer	510(k)
Cardiac Monitor, Model 1500 (CM-1500)	Zynex Medical, Inc.	K191697

4. Description

Patient monitoring with the CM-1600 is intended to provide data to clinicians, doctors, and postoperative care providers. Accurate diagnostic tools and continuous data monitoring systems are valuable additions for anesthesiologists and surgeons through improving post-operative outcomes and provider confidence. The CM-1600 System is comprised of two (2) subsystems, the Wearable and the Monitor. The CM-1600 Wearable is designed and developed by Zynex Monitoring Solutions, and it collects physiological parameters and transmits those parameters to the CM-1600 Monitor via wireless communication. The CM-1600 Monitor is a Zynex-branded, third-party all-in-one medical grade tablet.

5. Indications for use

Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients:

Bioelectrical Impedance
ECG Amplitude
PPG Amplitude
Skin Temperature

6. Intended Use

The Zynex Monitoring System, Model CM-1600 continuously monitors a patient's physiological parameters. These parameters include Bioelectrical Impedance, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature.

This device is intended to be used in a professional medical environment (e.g., hospitals, and

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research institutions). The CM-1600 is a standalone device intended for desktop or mounted use (e.g., mounted to an IV pole), where operation is to be performed as uninterrupted patient monitoring.

The CM-1600 shall only be used by a qualified operator. The operator shall have knowledge of the system and data interpretation obtained via medical education, system documentation, and/or specific training. The device does not report any diagnosis but provides numerical values to aid the diagnosis by a physician; it is the physician's responsibility to make proper judgements based on these measurements.

IMPORTANT: This device must be ordered or prescribed by a licensed physician.

7. Summary of Technical Comparison with Predicate Device(s)

The Zynex Monitoring System, Model CM-1600 is a wireless version of the CM-1500, which monitors the same physiological and is indicated for use as a noninvasive monitor.

The CM-1600 features similar technology and techniques of obtaining physiological data as the CM-1500. The impedance cardiography (ICG) and electrocardiography (ECG) sections of the CM-1600 consist of similar architecture as the Cardiac Monitor, Model 1500. Both devices capture these signals with identical surface electrodes. For skin temperature monitoring, the Zynex Monitoring System, Model CM-1600, has identical indications for use, methodology, and processing as the Cardiac Monitor, Model 1500. For plethysmography amplitude monitoring the Zynex Monitoring System, Model CM-1600, method of measuring plethysmograph signal is reflective photoplethysmography on the bottom of the Wearable, whereas the Cardiac Monitor, Model CM-1500 used transmissive technology. For plethysmography amplitude monitoring, the CM-1600 has identical indications for use and similar processing as that of the predicate.

The basic elements of the UI (e.g., Relative Index™ trend graph, PPG waveform, and parameter pane locations) are identical between the Zynex Monitoring System, Model CM-1600 and the predicate.

8. Performance Data

The following performance data were provided in support of substantial equivalence determination:

Test Name	Testing Criteria	Test Results (Pass/Fail)
Biocompatibility	ISO 10993	Pass
Device Safety, Electrical Safety,and Electromagnetic Compatibility(EMC)	IEC 60601-1 and 60601-1-2	Pass
Wireless Coexistence Testing	AAAMI-TIR63	Pass
Animal Testing	N/A	N/A
Clinical Testing	N/A	N/A
Performance Testing	V&V/Predicate Testing	Pass

Table 3. Performance test names, criteria, and results for the CM-1600.

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Image /page/6/Picture/1 description: The image contains the logo for Zynex Monitoring Solutions. The logo features the word "Zynex" in a bold, sans-serif font, with the words "Monitoring Solutions" in a smaller font below. A blue swoosh arcs over the word "Zynex", adding a dynamic element to the design.

Zynex Monitoring Solutions Inc. 9555 Maroon Circle, Englewood, CO 80112 Main: 800-495-6670

Biocompatibility Testing

The biocompatibility evaluation of the CM-1600 was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing,"" May 1, 1995, and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The battery of testing included the following tests:

Cytotoxicity
Sensitization ●
. Irritation

Device Safety, Electrical safety, and electromagnetic compatibility (EMC)

Mechanical safety, Electrical safety and EMC testing were conducted on the CM-1600, consisting of the Wearable, Monitor, and Charging Station. The system complies with the IEC 60601-1 standard and the IEC 60601-1-2 standard for EMC.

Animal Testing: No Testing Required.

Clinical Testing: No Testing Required.

Standard Number	Standard Name
IEC 60601-1:2005+AMD1:2012CSV	Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirementsfor basic safety and essential performance - CollateralStandard: Electromagnetic disturbances - Requirements andtests
ISO 14971:2019	Medical devices - Risk management - Application of riskmanagement to medical devices
ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluationand testing

Table 4. Medical Device Standards Compliance (full list in Section 9)

The data provided from the performance testing demonstrates that the Zynex Monitoring System, Model CM-1600 meets all applicable requirements and is substantially equivalent to the predicate device, the Zynex Monitoring Solutions Cardiac Monitor, Model 1500 (CM-1500).

9. Conclusion

The CM-1600 device is as safe and as effective as the predicate device, the CM-1500, when considering device indication for use, performance, safety, EMC, biocompatibility, and other data presented above. Therefore, the CM-1600 is substantially equivalent to the predicate device. Any minor differences between the subject and predicate devices do not raise any different safety or effectiveness concerns with the subject device.

Regulation Number and Section

§ 870.2770 Impedance plethysmograph.

(a)
Identification. An impedance plethysmograph is a device used to estimate peripheral blood flow by measuring electrical impedance changes in a region of the body such as the arms and legs.(b)
Classification. Class II (special controls). The device, when it is a body composition analyzer which is not intended to diagnose or treat any medical condition, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.