(295 days)
No
The description focuses on standard signal processing and analysis techniques for ECG and SpO2 data, with no mention of AI or ML algorithms. The performance studies also do not indicate the use of AI/ML.
No.
This device is a monitoring device that collects physiological parameters (ECG, SpO2, PR) and transmits them to a central monitoring station for analysis. It does not actively provide therapy or treatment.
Yes
The device monitors physiological parameters (ECG, SpO2, PR) and provides information (like ECG waveform and SpO2 values) that is used by medical professionals to interpret a patient's health status, including whether there are arrhythmias or other altered functions. This data is essential for diagnosing conditions.
No
The device description explicitly states that the iT20 collects physiological parameters using "ECG cables and SPO2 sensors" and that the SpO2 measurement is based on a "finger sensor and SpO2 measuring unit." This indicates the device includes hardware components beyond just software.
Based on the provided information, the iT20 telemetry transmitter is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The iT20 monitors physiological parameters directly from the patient's body (ECG from the skin, SpO2 from a finger sensor). It does not analyze blood, urine, tissue, or other bodily fluids or substances.
- The intended use and device description clearly state it monitors physiological parameters. It collects electrical signals from the heart and light absorption from blood, which are direct measurements from the living patient.
- The device description focuses on the technology used for direct physiological measurement. It describes ECG electrode placement and the principles of pulse oximetry.
Therefore, the iT20 telemetry transmitter is a patient monitoring device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The iT20 telemetry transmitter is intended to monitor physiological parameters including: ECG, oxygen saturation of arterial blood (SpO2) and pulse rate (PR) for adults and pediatric patients. The iT20 requires the EDAN MFM-CMS (Central Monitoring Station) to provide full functionality of the device.
The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).
Product codes
MHX, DSI, MLD, DRT, DOA, BZO, GXY, DPS, DRG
Device Description
iT20 collects physiological parameters by ECG cables and SPO2 sensors, then achieves data analyzing and processing. After that, data will be sent to MFM- CMS via Wi-Fi. The parameters supported are ECG, SPO2 and PR.
The ECG monitor samples small voltages of about 1 mV that appear on the skin as a result of cardiac activity. Three or five electrodes arranged in standard configurations called leads, are placed on the skin to sense these voltages. At least two electrodes are required for an ECG leads; The third electrode is used as a reference to reduce electrical interference. Each lead presents a heart, producing ECG waveform whose P waves, QRS complex, and T waves vary in amplitude and polarity. The signals from the different leads provide the cardiologist with a complete representation of the electrical activity of the heart, including the HR, which is interpreted as the R- to-R Interval. The timing and wave shape of ECG provides information on whether the patient's HR is characterized by arrhythmia or other altered functions requiring treatment. The ECG is also used to monitor the effects of infusing antiarrhythmia or cardiotonic agents.
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.
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
Adults and pediatric patients.
Intended User / Care Setting
Clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).
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
Non-clinical data:
Biocompatibility evaluation: The biocompatibility evaluation for the iT20 Patient Monitor were conducted in accordance with the 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 worst case of the whole system is considered tissue contacting for duration of less than 24 hours.
Electrical safety and electromagnetic compatibility (EMC) / Wireless: Electrical safety and EMC testing were conducted on the iT20 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1:2005/A1: 2012 for safety and the IEC 60601-1-2:2007 standard for EMC. Wireless coexistence testing was also performed.
Bench Testing: Bench testing was conducted on the iT20 Patient Monitor device, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1-8: 2006, IEC 60601-2-27: 2011, IEC 60601-2-49: 2011, ISO 80601-2-61: 2011, ANSI/AAMI EC57: 2012 standards for performance effectiveness.
Software Verification and Validation Testing: Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.
Clinical data: Not applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a symbol consisting of three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 3, 2017
Edan Instruments, Inc. c/o Mr. Doug Worth Sr. Dir. US RA/QA 1200 Crossman Way, Suite 200 Sunnyvale, California 94089
Re: K161056 Trade/Device Name: Telemetry Transmitter, model iT20 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector And Alarm (Including St-Segment Measurement And Alarm) Regulatory Class: Class II Product Code: MHX, DSI, MLD, DRT, DOA, BZO, GXY, DPS, DRG Dated: December 27, 2016 Received: December 30, 2016
Dear Mr. Doug Worth,
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. 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 801); medical device reporting (reporting of medical device
1
related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Mude Jellman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161056
Device Name Telemetry Transmitter, model iT20
Indications for Use (Describe)
The iT20 telemetry transmitter is intended to monitor physiological parameters including: ECG, oxygen saturation of arterial blood (SpO2) and pulse rate (PR) for adults and pediatric patients. The iT20 requires the EDAN MFM-CMS (Central Monitoring Station) to provide full functionality of the device.
The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).
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) |
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Page 1 of 11
510 (K) Summary
Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. |
|---|---|
| 3/F - B, Nanshan Medical | |
| Equipments Park, Nanhai Rd 1019#, | |
| Shekou, Nanshan Shenzhen, | |
| 518067 P.R. China | |
| Tel: +86(0755) 26858736 | |
| Fax: +1 (408) 418-4059 | |
| Contact person: | Alice Yang |
| Preparing date: | January 23, 2017 |
| 2. Device name and | Device Name: Telemetry Transmitter, model iT20 |
| classification: | Model: iT20 |
| Classification Name/ Product code: | |
| 870.1025 monitor, physiological, patient(with arrhythmia detection or | |
| alarms)/ MHX | |
| 870.1025 Detector and Alarm, Arrhythmia/ DSI | |
| 870.1025 Monitor, ST Segment with Alarm/ MLD |
4
Page 2 of 11
870.2300 Cardiac monitor (including cardiotachometer and rate alarm)/ DRT
870.2700 Oximeter, Pulse/ DQA
882.1320 Cutaneous electrode/GXY
870.2340 Electrocardiograph/DPS
870.2910 Radiofrequency physiological signal transmitter and receiver/ DRG
Regulatory Class: Class II
| 3. Predicate Device(s): | 1) Shenzhen Mindray Bio-Medical Electronics Co., Ltd, TMS-6016 cleared under
K132036.
2) Edan Instruments, Inc. iM70/ K131971 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Reason for
Submission | Introduce a new device iT20. |
| 5. Pre-Submission, IDE | Not applicable, there is no prior submission. |
| 6. Device Description: | iT20 collects physiological parameters by ECG cables and SPO2 sensors, then
achieves data analyzing and processing. After that, data will be sent to MFM-
CMS via Wi-Fi. The parameters supported are ECG, SPO2 and PR.
The ECG monitor samples small voltages of about 1 mV that appear on the
skin as a result of cardiac activity. Three or five electrodes arranged in
standard configurations called leads, are placed on the skin to sense these
voltages. At least two electrodes are required for an ECG leads; The third
electrode is used as a reference to reduce electrical interference. Each lead
presents a heart, producing ECG waveform whose P waves, QRS complex,
and T waves vary in amplitude and polarity. The signals from the different
leads provide the cardiologist with a complete representation of the
electrical activity of the heart, including the HR, which is interpreted as the R-
to-R Interval. The timing and wave shape of ECG provides information on |
5
whether the patient's HR is characterized by arrhythmia or other altered
functions requiring treatment. The ECG is also used to monitor the effects of infusing antiarrhythmia or cardiotonic agents.
SpO2 is based on the absorption of pulse blood oxygen to red and infrared light by means of finger sensor and SpO2 measuring unit. The light-electronic transducer in finger sensor converts the pulse red and infrared light modulated by pulse blood oxygen into electrical signal, the signal is processed by hardware and software of the unit. The PLETH curve and numeral value of SpO2 will be obtained.
7. Intended Use/Indications for Use:
The iT20 telemetry transmitter is intended to monitor physiological parameters including: ECG, oxygen saturation of arterial blood (SpO2) and pulse rate (PR) for adults and pediatric patients. The iT20 requires the EDAN MFM-CMS (Central Monitoring Station) to provide full functionality of the device.
The iT20 telemetry transmitter is intended to be used in clinical divisions of hospital environments, including CCU and general wards (as Cardiology Dept.).
8. Predicate Device Comparison
The subject devices share the same characteristics in all items with the predicate device, concluding from using the same technology and principle. All the technological differences existed between the subject and predicate devices are only some performance parameters improvement, detailed substantial equivalence discussion is included in the following tables.
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Page 4 of 11
Comparison to Primary Predicate Device TMS-6016
| Item | Proposed device: iT20 | Predicate device: TMS-6016 | Comparison
Result |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Current Submission | K132036 | |
| Indications for Use | | | |
| Intended Use | The iT20 telemetry transmitter is
intended to monitor physiological
parameters including: ECG, oxygen
saturation of arterial blood (SpO2)
and pulse rate (PR) for adults and
pediatric patients. The iT20
requires the EDAN MFM-CMS
(Central Monitoring Station) to
provide full functionality of the
device.
The iT20 telemetry transmitter is
intended to be used in clinical
divisions of hospital environments,
including CCU and general wards
(as Cardiology Dept.). | The CMS network transfers
information between Hypervisor
Central Monitoring System and other
networked devices, It also allows
information transfer between several
CMS. Network connections consist
of hardwired network cables and/or
WLAN connections. CMS can be
used for remote monitor
management, storing, printing,
reviewing or processing of
information from networked devices,
and it is operated by medical
personnel in hospitals or medical
institutions.
Telemetry Monitoring System is a
sub-system of CMS, intended to
obtain ECG and SpO2 physiological
information from adult and pediatric
patients, and send it to CMS via
WMTS frequency within a defined
coverage area. | Similar |
| ECG Function | | | |
| HR Calculation | | | |
| Range | ADU: 15 bpm to 300 bpm
PED: 15 bpm to 350 bpm | ADU: 15 to 300 bpm
PED: 15 to 300 bpm | Similar |
| Accuracy | ±1% or 1 bpm, whichever is greater | ±1% or 1 bpm, whichever is greater | Same |
| Resolution | 1 bpm | 1bpm | Same |
| Sensitivity | ≥300 µVPP | ≥200µVPP | Similar |
| ST Numeric | | | |
| Range | -2.0 mV to +2.0 mV | -2.0 mV to +2.0 mV | Same |
| Range of Sinus and SV Rhythm | | | |
| Bandwidth (-
3dB) | Diagnosis: 0.05Hz to 150Hz
Monitor: 0.5Hz to 40Hz
Surgery: 1Hz to 20Hz | Diagnosis: 0.1 Hz to 40 Hz
Monitor:0.5 Hz to 40 Hz
Surgery: 1 Hz to 20Hz | Similar |
| CMRR
(Common
Mode
Rejection
Ratio) | Diagnosis: >95dB (the Notch filter is
off)
Monitor: >105dB (the Notch filter is
on)
Surgery: >105dB (the Notch filter is
on) | 105dB(50Hz/60Hz) | Similar |
| Pace | | | |
| Pulse Indicator | Pulse is marked if the requirements
of IEC 60601-2-27: 2011, Sect.
201.12.1.101.12 are met:
Amplitude: ±2 mV to ±700 mV
Width: 0.2 ms to 2.0 ms
Ascending time: 10 µs to 100 µs
And
Amplitude: ±3 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 µs to 100 µs | Amplitude: ±10 mV to ±700 mV
Width: 0.1 ms to 2.0 ms
Ascending time: 10 µs to 100 µs | Similar |
| | Pulse Rejection | Pulse is marked if the requirements
of IEC 60601-2-27: 2011, Sect. | Amplitude: ±10 mV to ±700 mV |
| | 201.12.1.101.12 are met: | Width: 0.1 ms to 2.0 ms | |
| | Amplitude: ±2 mV to ±700 mV | Ascending time: 10 µs to 100 µs | |
| | Width: 0.1 ms to 2.0 ms | | |
| | Ascending time: 10 µs to 100 µs | | |
| SpO2 Function (EDAN) | | | |
| Measurement
Range | 0-100% | 0 to 100 % | Same |
| Accuracy | Adult /Pediatric :±2 % (70% to 100%)
Undefined (0% to 69%) | 70 to 100%,±2%(finger sensor, adult)
70 to 100%,±4%(ear sensor)