(242 days)
Not Found
No
The summary describes the device as calculating a "Relative Index value" as a "combination of the changes in these parameters," which suggests a deterministic algorithm rather than AI/ML. There are no mentions of AI, ML, DNN, training sets, or test sets.
No
The device is described as a monitoring system and its intended use is for monitoring various physiological parameters, not for providing therapy or treatment.
No
The device description clearly states its purpose is "Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients," and it calculates a "Relative Index value" based on these changes. It does not mention diagnosis or provide a diagnostic output.
No
The device description explicitly states the system is comprised of two subsystems, a Wearable and a Monitor, both of which are hardware components.
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 Zynex Monitoring System, Model CM-1600, monitors physiological parameters directly from the patient's body (Bioelectrical Impedance, ECG Amplitude, PPG Amplitude, Skin Temperature). It does not analyze samples taken from the body.
- Intended Use: The intended use is for "Monitoring of the following parameters and their relative of relative of relative changes in fluid volume in adult patients," which is a form of physiological monitoring, not diagnostic testing of samples.
Therefore, the device falls under the category of a physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes (comma separated list FDA assigned to the subject device)
DSB, DQA, FLL, MWI
Device 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.
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.
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
This device is intended to be used in a professional medical environment (e.g., hospitals, and 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.
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)
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 |
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.
Key results: 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).
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
§ 870.2770 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
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
1
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
2
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 Circle | |
| Englewood, 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 Detection | ||
| Or 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.
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.
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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Image /page/5/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, curved line arches over the word "Zynex", adding a visual element to the logo.
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+AMD1:2012 | |
| 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 14971:2019 | 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 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.