Telemetry Transmitter

K161056 · Edan Instruments, Inc. · MHX · Feb 3, 2017 · Cardiovascular

Device Facts

• Record ID: K161056
• Device Name: Telemetry Transmitter
• Applicant: Edan Instruments, Inc.
• Product Code: MHX · Cardiovascular
• Decision Date: Feb 3, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Pediatric

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.).

Device Story

The iT20 is a telemetry transmitter collecting ECG and SpO2 data; ECG signals are captured via 3 or 5 skin electrodes; SpO2 is measured via finger sensor using light absorption. The device processes these signals to derive HR, PLETH curves, and SpO2 values; data is transmitted via Wi-Fi to the EDAN MFM-CMS (Central Monitoring Station). Used in hospital clinical settings (CCU, general wards) by medical personnel. The CMS provides remote monitoring, storage, and review of patient data. The system supports clinical decision-making by providing real-time physiological monitoring, arrhythmia detection, and alarm management, enabling timely intervention for patients with altered cardiac function or oxygenation status.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), wireless coexistence, and performance effectiveness testing against standards including IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, ISO 80601-2-61, and ANSI/AAMI EC57.

Technological Characteristics

Internally powered telemetry transmitter; 1.46-inch color display (128x128); Wi-Fi connectivity (IEEE 802.11b/g/n, 2.4GHz ISM band). ECG sensing via 3/5-lead configuration; SpO2 via pulse oximetry. Biocompatibility per ISO 10993-1. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-27, IEC 60601-2-49, ISO 80601-2-61, ANSI/AAMI EC57.

Indications for Use

Indicated for monitoring ECG, SpO2, and pulse rate in adult and pediatric patients within hospital clinical environments such as CCU and general wards.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Shenzhen Mindray Bio-Medical Electronics Co., Ltd, TMS-6016 (K132036)
• Edan Instruments, Inc. iM70 (K131971)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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

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## 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)

| <span style="padding-right: 5px;"> <input checked="true" type="checkbox"/> </span> Prescription Use (Part 21 CFR 801 Subpart D) |
|---------------------------------------------------------------------------------------------------------------------------------|
| <span style="padding-right: 5px;"> <input type="checkbox"/> </span> 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: [phone] |
| | Fax: [phone] |
| 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<br>alarms)/ MHX |
| | 870.1025 Detector and Alarm, Arrhythmia/ DSI |
| | 870.1025 Monitor, ST Segment with Alarm/ MLD |

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#### 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<br>K132036.<br>2) Edan Instruments, Inc. iM70/ K131971 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 4. Reason for<br>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<br>achieves data analyzing and processing. After that, data will be sent to MFM-<br>CMS via Wi-Fi. The parameters supported are ECG, SPO2 and PR.<br><br>The ECG monitor samples small voltages of about 1 mV that appear on the<br>skin as a result of cardiac activity. Three or five electrodes arranged in<br>standard configurations called leads, are placed on the skin to sense these<br>voltages. At least two electrodes are required for an ECG leads; The third<br>electrode is used as a reference to reduce electrical interference. Each lead<br>presents a heart, producing ECG waveform whose P waves, QRS complex,<br>and T waves vary in amplitude and polarity. The signals from the different<br>leads provide the cardiologist with a complete representation of the<br>electrical activity of the heart, including the HR, which is interpreted as the R-<br>to-R Interval. The timing and wave shape of ECG provides information on |

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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<br>Result |
|------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| 510(k) Number | Current Submission | K132036 | |
| Indications for Use | | | |
| Intended Use | The iT20 telemetry transmitter is<br>intended to monitor physiological<br>parameters including: ECG, oxygen<br>saturation of arterial blood (SpO2)<br>and pulse rate (PR) for adults and<br>pediatric patients. The iT20<br>requires the EDAN MFM-CMS<br>(Central Monitoring Station) to<br>provide full functionality of the<br>device.<br>The iT20 telemetry transmitter is<br>intended to be used in clinical<br>divisions of hospital environments,<br>including CCU and general wards<br>(as Cardiology Dept.). | The CMS network transfers<br>information between Hypervisor<br>Central Monitoring System and other<br>networked devices, It also allows<br>information transfer between several<br>CMS. Network connections consist<br>of hardwired network cables and/or<br>WLAN connections. CMS can be<br>used for remote monitor<br>management, storing, printing,<br>reviewing or processing of<br>information from networked devices,<br>and it is operated by medical<br>personnel in hospitals or medical<br>institutions.<br>Telemetry Monitoring System is a<br>sub-system of CMS, intended to<br>obtain ECG and SpO2 physiological<br>information from adult and pediatric<br>patients, and send it to CMS via<br>WMTS frequency within a defined<br>coverage area. | Similar |
| ECG Function | | | |
| HR Calculation | | | |
| Range | ADU: 15 bpm to 300 bpm<br>PED: 15 bpm to 350 bpm | ADU: 15 to 300 bpm<br>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 (-<br>3dB) | Diagnosis: 0.05Hz to 150Hz<br>Monitor: 0.5Hz to 40Hz<br>Surgery: 1Hz to 20Hz | Diagnosis: 0.1 Hz to 40 Hz<br>Monitor:0.5 Hz to 40 Hz<br>Surgery: 1 Hz to 20Hz | Similar |
| CMRR<br>(Common<br>Mode<br>Rejection<br>Ratio) | Diagnosis: >95dB (the Notch filter is<br>off)<br>Monitor: >105dB (the Notch filter is<br>on)<br>Surgery: >105dB (the Notch filter is<br>on) | 105dB(50Hz/60Hz) | Similar |
| Pace | | | |
| Pulse Indicator | Pulse is marked if the requirements<br>of IEC 60601-2-27: 2011, Sect.<br>201.12.1.101.12 are met:<br><br>Amplitude: ±2 mV to ±700 mV<br><br>Width: 0.2 ms to 2.0 ms<br><br>Ascending time: 10 µs to 100 µs<br><br>And<br><br>Amplitude: ±3 mV to ±700 mV<br><br>Width: 0.1 ms to 2.0 ms<br><br>Ascending time: 10 µs to 100 µs | Amplitude: ±10 mV to ±700 mV<br><br>Width: 0.1 ms to 2.0 ms<br><br>Ascending time: 10 µs to 100 µs | Similar |
| | Pulse Rejection | Pulse is marked if the requirements<br>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<br>Range | 0-100% | 0 to 100 % | Same |
| Accuracy | Adult /Pediatric :±2 % (70% to 100%)<br>Undefined (0% to 69%) | 70 to 100%,±2%(finger sensor, adult)<br>70 to 100%,±4%(ear sensor)<br><70% not defined(all sensors) | Similar |
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | | | |
| Measuring<br>Range | 25 bpm to 300 bpm | 18 bpm to 300 bpm | Similar |
| Accuracy | ±2bpm when MR: 25 bpm to<br>300bpm | ±3 bpm when MR: 18 bpm to<br>100bpm<br>±6 bpm when MR: 101 bpm to<br>200bpm<br>±9 bpm when MR: 201 bpm to<br>300bpm | Similar |
| Resolution | 1 bpm | 1bpm | Same |
| Electronic Safety | | | |
| Anti-electroshock<br>type | Internally powered equipment | Internally powered equipment | Same |
| Anti-electroshock<br>degree | ECG: CF<br>SpO2: CF | ECG: CF<br>SpO2: BF | Similar |
| Working system | Continuous operation equipment | Continuous operation equipment | Same |
| Environmental Specifications | | | |
| Temperature Range | | | |
| Operating | 0°C to +40°C | 0 to 40°C | Same |
| Storage including<br>transportation | -20°C to +55°C | -20 to 60°C | Similar |
| Humidity Range | | | |
| Operating | 15% to 95% (non-condensing) | 15 % to 95 % Relative Humidity (RH) | Same |
| Storage including<br>transportation | 15% to 95% (non-condensing) | 10 % to 95 % Relative Humidity (RH) | Similar |
| Altitude Range | | | |
| Operating | 86kPa to 106kPa | 70.0 to 106.0kPa | Similar |
| Storage including<br>transportation | 70kPa to 106kPa | 22.0 to 107.4kPa | |
| Physical Characteristics | | | |
| Weight | <140g(excluding the batteries,<br>ECG leads and SpO₂ module) | <140g(excluding the batteries, ECG<br>leads and SpO2 module) | Same |
| Dimensions | 100mm x64mm x26mm | 62mm x 96mm x 26 mm | Similar |
| Display Specification | |…