(241 days)
Not Found
No
The summary describes a device that monitors physiological parameters and provides numerical values for interpretation by a qualified operator. There is no mention of AI, ML, or any algorithms that perform complex data analysis or pattern recognition beyond basic parameter measurement. The performance studies focus on compliance with safety standards and substantial equivalence to predicate devices that are not described as using AI/ML.
No
The device is a monitor that provides numerical values for parameters like bioelectrical impedance and heart rate, which are used by a physician to make judgments, rather than directly providing therapy.
No
The device monitors physiological parameters and provides numerical values, but it explicitly states, "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 it's a monitoring device, not a diagnostic one.
No
The device description explicitly states "The Cardiac Monitor, Model 1500, is a standalone device intended for desktop use" and mentions "accessories," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the device monitors physiological parameters directly from the patient's body (Bioelectrical Impedance, Heart Rate, ECG Amplitude, PPG Amplitude, Skin Temperature). It does not analyze samples taken from the body.
- Intended Use: The intended use is monitoring parameters indicative of fluid volume changes in adult patients, not diagnosing a condition based on laboratory analysis of samples.
- Device Description: The device is described as a "Cardiac Monitor," which is a type of medical device that measures physiological signals directly from the patient.
Therefore, this device falls under the category of a non-IVD medical device that monitors physiological parameters.
N/A
Intended Use / Indications for Use
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
Product codes
DSB, DOA, FLL
Device Description
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.
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.
Intended User / Care Setting
professional medical environment such as hospitals, clinics and research institutions. The user of the Cardiac Monitor, Model 1500, shall be a qualified operator.
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)
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.
- IEC 60601-1:2005+AMD1:2012 CSV: Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014: Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- ISO 14971:2012: Medical devices - Risk management - Application of risk management to medical devices
- ISO 10993-1:2009: Biological evaluation of medical devices - Part 1: Evaluation and testing
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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) |
|---|
| ------------------------------------------------- |
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."
3
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 Circle
Englewood, CO 80112 USA |
|-----------------|------------------------------------------------------------------------------------------|
| | Phone number: +1-800-495-6670
Fax Number: +1-866-870-4089 |
| | Operator Number: 9028838
Registration number: 1723686 |
| Contact person: | Thomas Sandgaard
CEO
Phone number: +1-800-495-6670
E-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 |
4
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.
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.
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
5
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.
6
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+AMD1:2012 | |
| CSV | Medical electrical equipment - Part 1: General requirements for |
| basic safety and essential performance | |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements |
| for basic safety and essential performance - Collateral | |
| Standard: Electromagnetic disturbances - Requirements and | |
| tests | |
| ISO 14971:2012 | Medical devices - Risk management - Application of risk |
| management to medical devices | |
| ISO 10993-1:2009 | Biological evaluation of medical devices - Part 1: Evaluation |
| and 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.