Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature.

The Cardiac Monitor, Model 1500, is intended to be used in a professional medical environment such as hospitals, clinics and research institutions. The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use. Measurements are to be performed under uninterrupted patient surveillance by the operator.

The user of the Cardiac Monitor, Model 1500, shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

AI/ML Overview

The provided text is related to a 510(k) submission for the Zynex Medical Cardiac Monitor, Model 1500. However, it does not contain specific acceptance criteria, reported device performance data, details of clinical studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods that would be required to fully answer the request.

The document primarily focuses on regulatory compliance, outlining the device's indications for use, its comparison to predicate devices, and adherence to general medical device safety standards. It emphasizes that the device provides numerical values and that a physician is responsible for making judgments based on these numbers, explicitly stating: "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers." This indicates that the device itself is not making diagnostic claims that would typically require validation against a clinical ground truth for diagnostic accuracy.

Therefore, many of the requested items cannot be extracted from this document because the information is not present. The device is not an AI/ML device that would typically undergo the kind of detailed performance studies described in the prompt (e.g., MRMC studies, standalone algorithm performance against a clinical ground truth). Instead, it's a monitoring device whose performance is assessed against established safety and electrical standards.

Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what cannot be answered:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics in a clinical study. The document focuses on compliance with general medical device standards.
Reported Device Performance: No specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, or error rates) are reported for the Cardiac Monitor, Model 1500. The document states that the device "met all applicable requirements" of the listed standards and is "substantially equivalent" to its predicates.

Parameter Monitored	Acceptance Criteria (Not explicitly stated as numerical performance targets in this document)	Reported Device Performance (No specific numerical data provided)
Bioelectrical Impedance	Compliance with relevant medical device safety standards (IEC 60601-1, IEC 60601-1-2, ISO 14971, ISO 10993-1) and substantial equivalence to predicate devices (BioZ.com System).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
Heart Rate	Compliance with relevant medical device safety standards and substantial equivalence to predicate devices (BioZ.com System, Wrist Ox2 3150).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
ECG Amplitude	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (BioZ.com System).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
PPG Amplitude	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (Wrist Ox2 3150).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.
Skin Temperature (Continuous)	Compliance with relevant medical device safety standards and substantial equivalence to predicate device (TemporalScanner Thermometer).	Met all applicable requirements and substantially equivalent to predicate devices. Device provides numerical values for physician interpretation.

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

Not Applicable / Not Provided: The document does not describe a clinical performance study with a "test set" in the context of an AI/ML device validating diagnostic accuracy. The evaluation appears to be based on adherence to safety standards and comparison to predicate devices' design and methodology.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: There is no mention of experts establishing ground truth for a test set, as the device is for monitoring and not making diagnostic claims itself.

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

Not Applicable / Not Provided: No adjudication method is mentioned because no clinical test set for diagnostic claims is described.

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: No MRMC study was done, as this is a physiological monitoring device, not an AI-assisted diagnostic tool for human readers.

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

Not Applicable: This is a hardware monitoring device, not an algorithm. Its "performance" is based on the accuracy and reliability of its physiological measurements, which are then interpreted by a qualified operator/physician. The document notes that "Operation is to be performed as uninterrupted patient surveillance by the operator" and "The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers."

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

Not Applicable / Not Provided: Ground truth in the context of diagnostic accuracy is not relevant here. The device's "ground truth" would be the actual physiological parameters measured, validated through calibration and comparison to established measurement techniques, but specific details are not in this document.

8. The sample size for the training set

Not Applicable / Not Provided: This device is not an AI/ML algorithm that requires a "training set."

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

Not Applicable / Not Provided: Not an AI/ML device requiring a training set.

Summary

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February 21, 2020

Zynex Medical, Inc. Thomas Sandgaard CEO 9995 Maroon Circle Englewood, Colorado 80112

Re: K191697

Trade/Device Name: Cardiac Monitor 1500 Regulation Number: 21 CFR 870.2770 Regulation Name: Impedance Plethysmograph Regulatory Class: Class II Product Code: DSB. DOA. FLL Dated: January 21, 2020 Received: January 27, 2020

Dear Thomas Sandgaard:

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.

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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 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 (OS) 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.

for

Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191697

Device Name CM-1500

Indications for Use (Describe)

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

Bioelectrical Impedance
· Heart Rate
· ECG Amplitude
· PPG Amplitude

Type of Use (Select one or both, as applicable)
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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 Medical. The word "Zynex" is in bold, black letters, with a blue arc above the letters "NEX". Below the word "Zynex" is the word "Medical" in light gray letters. The logo is simple and modern, and it is likely used to represent a medical company.

Zynex Medical Inc. 9555 Maroon Circle, Englewood, CO 80112 Main: 800-495-6670 Fax: 800-495-6695

510(k) Summary Cardiac Monitor, Model 1500

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 Medical Inc.9555 Maroon CircleEnglewood, CO 80112 USA
	Phone number: +1-800-495-6670Fax Number: +1-866-870-4089
	Operator Number: 9028838Registration number: 1723686
Contact person:	Thomas SandgaardCEOPhone number: +1-800-495-6670E-mail: tsandgaard@zynex.com

2. Device Information

Trade name: Cardiac Monitor, Model 1500

Common name(s)

Impedance cardiograph (ICG) Electrocardiograph (ECG) Photoplethysmograph (PPG)

Classification name	See Table 1
Device class	II

Table 1, Classification Name

Classification Name	21 CFR Section	Product Code	Product Code Type
Plethysmograph, impedance	870.2770	DSB	Major
Oximeter	870.2700	DQA	Minor
Thermometer, electronic, clinical	880.2910	FLL	Minor

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Image /page/4/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "Zynex" in bold, black letters, with a blue swoosh above the letters "NEX". Below the word "Zynex" is the word "Medical" in smaller, gray letters.

3. Predicate Devices

The Cardiac Monitor, Model 1500, is substantially equivalent in design (methodology) and indications for use to the predicate devices shown in Table.

Table 2, Predicate Devices

Device Name	Manufacturer	510(k)
BioZ.com System	CardioDynamics International Corporation	K974725
Wrist Ox2 3150	Nonin Medical, Inc.	K102350
TemporalScanner Thermometer	Exergen Corp.	K011291

4. Description

Cardiac Monitor, Model 1500 and accessories monitor a patient's parameters. These parameters include: Bioelectrical Impedance, Heart Rate, ECG Amplitude, and Skin Temperature.

5. Indications for use

Monitoring of the following parameters and their relative changes, indicative of relative changes in fluid volume in adult patients.

· Bioelectrical Impedance
Heart Rate
ECG Amplitude
· PPG Amplitude

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Image /page/5/Picture/0 description: The image shows the logo for Zynex Medical. The logo features the word "Zynex" in large, bold, black letters. Below "Zynex" is the word "Medical" in smaller, gray letters. A blue arc is above the word "Zynex".

6. Intended Use

Cardiac Monitor, Model 1500 (CM-1500) continuously monitors a patient's physiological parameters. These parameters include: Bioelectrical Impedance, Heart Rate, Electrocardiogram (ECG) Amplitude, Photoplethysmography (PPG) Amplitude, and Skin Temperature.

The CM-1500 is intended to be used in a professional medical environment, i.e. hospitals, clinics and research institutions. The CM-1500 is a standalone device intended for desk-top use. Operation is to be performed as uninterrupted patient surveillance by the operator.

The end-user of the CM-1500 shall be a qualified operator. The operator shall have knowledge of the system and data interpretation, obtained via medical education, system manuals and/or specific courses. The device does not report any diagnosis, but provides numerical values. It is the physician's responsibility to make proper judgments based on these numbers.

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

7. Summary of Technical Comparison with Predicate Devices

The Cardiac Monitor, Model 1500, is a combination of the BioZ.com System, the Wrist Ox2 3150 pulse oximeter, and the TemporalScanner Thermometer sensor predicate devices.

As with the BioZ.com System predicate device, the Cardiac Monitor, Model 1500, is indicated for use as a non-invasive monitor. The Cardiac Monitor, Model 1500, provides real-time and on-line monitoring and trending of parameters, just as the BioZ.com System device.

The BioZ.com System has a similar design, and similar methodology as the Cardiac Monitor, Model 1500, Non-Invasive Monitor. The predicate BioZ.com System, provides a similar noninvasive display and measurement of impedance, electrocardiograph (ECG), and pulse rate monitoring as the Cardiac Monitor, Model 1500.

The impedance cardiography (ICG) and electrocardiography (ECG) sections of Cardiac Monitor, Model 1500, consists of similar architecture as the BioZ.com System.

As with the Wrist Ox2 3150, the Cardiac Monitor, Model 1500, is indicated for use as a noninvasive pulse rate monitor. The Cardiac Monitor, Model 1500, is used to provide real-time and on-line monitoring and trending of pulse rate just as with the Wrist Ox2 3150 device.

For pulse rate monitoring, the Wrist Ox2 3150 has the similar indications for use, has similar design, and similar methodology as the Cardiac Monitor, Model 1500, Non-Invasive Monitor. The predicate Wrist Ox2 3150 provides the same non-invasive display and measurement of pulse rate as the Cardiac Monitor, Model 1500.

The photoplethysmography section of The Cardiac Monitor, Model 1500, consists of a similar device architecture as the Wrist Ox2 3150.

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Image /page/6/Picture/0 description: The image shows the logo for Zynex Medical. The logo consists of the word "Zynex" in large, bold, black letters, with the word "Medical" in smaller, gray letters below. A blue arc is above the word "Zynex", starting from the left side of the "Z" and ending on the right side of the "X".

As with the TemporalScanner Thermometer, the Cardiac Monitor, Model 1500, is indicated for use as a continuous skin temperature monitor. The Cardiac Monitor, Model 1500, is used to provide real-time and on-line monitoring of skin temperature just as the TemporalScanner Thermometer device.

For skin temperature monitoring, the TemporalScanner Thermometer has similar indications for use, has similar design, and similar methodology as the Cardiac Monitor, Model 1500. The predicate TemporalScanner Thermometer provides the same non-invasive monitoring and measurement of skin temperature as the Cardiac Monitor, Model 1500.

The temperature section of the Cardiac Monitor, Model 1500, consists of the same device architecture as the TemporalScanner Thermometer.

8. Non-Clinical Performance Data for Substantial Equivalence Determination

Cardiac Monitor, Model 1500, will be in compliance with the medical device safety standards shown in Table 3.

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 14971:2012	Medical devices - Risk management - Application of riskmanagement to medical devices
ISO 10993-1:2009	Biological evaluation of medical devices - Part 1: Evaluationand testing

Table 3, Medical Device Standards Compliance

The data provided demonstrates that the Cardiac Monitor, Model 1500, met all applicable requirements and that it is substantially equivalent to the combination of its predicates BioZ.com System, Wrist Ox2 3150, and TemporalScanner Thermometer.

9. Conclusion

On basis of the information above, it is concluded that the device is as safe, as effective, and performs as well as or better than the predicate devices.

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.