(295 days)
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.).
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.
The provided text describes the Edan Instruments, Inc. Telemetry Transmitter, model iT20, and its substantial equivalence to predicate devices, but it contains limited information regarding a formal acceptance criteria study of the device's performance measures directly. Instead, it focuses on comparing the proposed device's specifications to those of predicate devices and adherence to various safety and performance standards.
The document indicates that "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." This implies that the acceptance criteria are met by complying with these standards.
Here's an attempt to extract the requested information based on the provided text, while noting significant gaps where the information is not present:
Acceptance Criteria and Device Performance Study for Edan Instruments, Inc. Telemetry Transmitter, model iT20
The evaluation of the Edan Instruments, Inc. Telemetry Transmitter, model iT20, primarily relies on demonstrating substantial equivalence to predicate devices and compliance with relevant international standards for safety and performance. No specific stand-alone study "proving" the device meets acceptance criteria as a new AI/algorithmic device with defined accuracy metrics is detailed, rather its performance is compared to established standards and predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the operational parameters and performance accuracy specified in the comparison table with the predicate device (TMS-6016) and compliance with the listed standards.
| Performance Metric (Acceptance Criteria per Standards/Predicate Comparison) | Reported Device Performance (iT20) |
|---|---|
| ECG Function: | |
| HR Calculation Range (Adult) | 15 bpm to 300 bpm (Similar to predicate) |
| HR Calculation Range (Pediatric) | 15 bpm to 350 bpm (Improved range compared to predicate's 15-300 bpm) |
| HR Accuracy | ±1% or 1 bpm, whichever is greater (Same as predicate) |
| HR Resolution | 1 bpm (Same as predicate) |
| ECG Sensitivity | ≥300 µVPP (Improved sensitivity compared to predicate's ≥200 µVPP) |
| ST Numeric Range | -2.0 mV to +2.0 mV (Same as predicate) |
| ECG Bandwidth (Diagnosis) | 0.05Hz to 150Hz (Improved range compared to predicate's 0.1 Hz to 40 Hz) |
| ECG Bandwidth (Monitor) | 0.5Hz to 40Hz (Same as predicate) |
| ECG Bandwidth (Surgery) | 1Hz to 20Hz (Same as predicate) |
| CMRR (Diagnosis) | >95dB (the Notch filter is off) (Similar to predicate's 105dB) |
| CMRR (Monitor/Surgery) | >105dB (the Notch filter is on) (Similar to predicate's 105dB) |
| Pace Pulse Indicator (Amplitude, Width, Ascending Time) | Meets IEC 60601-2-27: 2011, Sect. 201.12.1.101.12 requirements for specific ranges (Improved compared to stricter predicate's minimal amplitude) |
| SpO2 Function: | |
| Measurement Range | 0-100% (Same as predicate) |
| Accuracy (Adult/Pediatric) | ±2 % (70% to 100%), Undefined (0% to 69%) (Similar to predicate, with clarification for 0-69%) |
| Resolution | 1 % (Same as predicate) |
| Pulse Rate Measuring Range | 25 bpm to 300 bpm (Similar to predicate's 18-300 bpm) |
| Pulse Rate Accuracy | ±2bpm when MR: 25 bpm to 300bpm (Improved compared to predicate's varying ±3, ±6, ±9 bpm) |
| Pulse Rate Resolution | 1 bpm (Same as predicate) |
| Environmental Specifications (Operating): | |
| Temperature Range | 0°C to +40°C (Same as predicate) |
| Humidity Range | 15% to 95% (non-condensing) (Same as predicate) |
| Altitude Range | 86kPa to 106kPa (Similar to predicate's 70.0 to 106.0kPa) |
| Compliance Standards: | |
| Electrical Safety | Complies with IEC 60601-1:2005/A1: 2012 |
| EMC | Complies with IEC 60601-1-2:2007 |
| Alarms | Complies with IEC 60601-1-8: 2006 |
| ECG Performance | Complies with IEC 60601-2-27: 2011, ANSI/AAMI EC57: 2012 |
| Multi-parameter Patient Monitoring Equipment | Complies with IEC 60601-2-49: 2011 |
| Pulse Oximeter Equipment | Complies with ISO 80601-2-61: 2011 |
| Biocompatibility | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-5-10 |
| Software | Verified and Validated per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." (Concern Level: "major") |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in terms of patient data or case numbers. The performance data is stated to be derived from "Bench testing" and "non-clinical data" used for substantial equivalence determination and compliance with standards. There is no mention of geographical origin or whether data was retrospective or prospective in the context of device performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The compliance with standards and comparison to predicate device specifications serves as the basis for performance claims, rather than a specific expert-adjudicated ground truth for a test set.
4. Adjudication method for the test set
This information is not provided, as no expert-adjudicated test set is detailed.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a telemetry transmitter for physiological parameters, not an AI-assisted diagnostic tool for interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document implies that the device's functional performance (e.g., accuracy of HR and SpO2 measurement) was assessed in a standalone manner during bench testing and compliance evaluations against technical standards. The context is measuring physiological parameters rather than an algorithm producing diagnostic outputs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance metrics listed (e.g., HR accuracy, SpO2 accuracy), the ground truth is implicitly defined by the measurement standards and methodologies used in bench testing to assess compliance with the specified accuracy ranges (e.g., using calibrated simulators for vital signs).
8. The sample size for the training set
This information is not applicable and not provided. The device described is a hardware telemetry transmitter with embedded software for physiological parameter monitoring, not a machine learning or AI model that typically requires a distinct training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as the device is not described as involving machine learning or AI that would require a ground truth for a training set.
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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
{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
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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)
| 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 oralarms)/ 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 underK132036.2) Edan Instruments, Inc. iM70/ K131971 |
|---|---|
| 4. Reason forSubmission | 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, thenachieves 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 theskin as a result of cardiac activity. Three or five electrodes arranged instandard configurations called leads, are placed on the skin to sense thesevoltages. At least two electrodes are required for an ECG leads; The thirdelectrode is used as a reference to reduce electrical interference. Each leadpresents a heart, producing ECG waveform whose P waves, QRS complex,and T waves vary in amplitude and polarity. The signals from the differentleads provide the cardiologist with a complete representation of theelectrical 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 | ComparisonResult |
|---|---|---|---|
| 510(k) Number | Current Submission | K132036 | |
| Indications for Use | |||
| Intended Use | The iT20 telemetry transmitter isintended to monitor physiologicalparameters including: ECG, oxygensaturation of arterial blood (SpO2)and pulse rate (PR) for adults andpediatric patients. The iT20requires the EDAN MFM-CMS(Central Monitoring Station) toprovide full functionality of thedevice.The iT20 telemetry transmitter isintended to be used in clinicaldivisions of hospital environments,including CCU and general wards(as Cardiology Dept.). | The CMS network transfersinformation between HypervisorCentral Monitoring System and othernetworked devices, It also allowsinformation transfer between severalCMS. Network connections consistof hardwired network cables and/orWLAN connections. CMS can beused for remote monitormanagement, storing, printing,reviewing or processing ofinformation from networked devices,and it is operated by medicalpersonnel in hospitals or medicalinstitutions.Telemetry Monitoring System is asub-system of CMS, intended toobtain ECG and SpO2 physiologicalinformation from adult and pediatricpatients, and send it to CMS viaWMTS frequency within a definedcoverage area. | Similar |
| ECG Function | |||
| HR Calculation | |||
| Range | ADU: 15 bpm to 300 bpmPED: 15 bpm to 350 bpm | ADU: 15 to 300 bpmPED: 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 150HzMonitor: 0.5Hz to 40HzSurgery: 1Hz to 20Hz | Diagnosis: 0.1 Hz to 40 HzMonitor:0.5 Hz to 40 HzSurgery: 1 Hz to 20Hz | Similar |
| CMRR(CommonModeRejectionRatio) | Diagnosis: >95dB (the Notch filter isoff)Monitor: >105dB (the Notch filter ison)Surgery: >105dB (the Notch filter ison) | 105dB(50Hz/60Hz) | Similar |
| Pace | |||
| Pulse Indicator | Pulse is marked if the requirementsof IEC 60601-2-27: 2011, Sect.201.12.1.101.12 are met:Amplitude: ±2 mV to ±700 mVWidth: 0.2 ms to 2.0 msAscending time: 10 µs to 100 µsAndAmplitude: ±3 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100 µs | Amplitude: ±10 mV to ±700 mVWidth: 0.1 ms to 2.0 msAscending time: 10 µs to 100 µs | Similar |
| Pulse Rejection | Pulse is marked if the requirementsof 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) | |||
| MeasurementRange | 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)<70% not defined(all sensors) | Similar |
| Resolution | 1 % | 1 % | Same |
| Pulse Rate | |||
| MeasuringRange | 25 bpm to 300 bpm | 18 bpm to 300 bpm | Similar |
| Accuracy | ±2bpm when MR: 25 bpm to300bpm | ±3 bpm when MR: 18 bpm to100bpm±6 bpm when MR: 101 bpm to200bpm±9 bpm when MR: 201 bpm to300bpm | Similar |
| Resolution | 1 bpm | 1bpm | Same |
| Electronic Safety | |||
| Anti-electroshocktype | Internally powered equipment | Internally powered equipment | Same |
| Anti-electroshockdegree | ECG: CFSpO2: CF | ECG: CFSpO2: 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 includingtransportation | -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 includingtransportation | 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 includingtransportation | 70kPa to 106kPa | 22.0 to 107.4kPa | |
| Physical Characteristics | |||
| Weight | <140g(excluding the batteries,ECG leads and SpO₂ module) | <140g(excluding the batteries, ECGleads and SpO2 module) | Same |
| Dimensions | 100mm x64mm x26mm | 62mm x 96mm x 26 mm | Similar |
| Display Specification | |||
| Description | 1.46-inch color screen | Not available | Similar |
| Resolution | 128x128 | Not available | |
| CMS Specification | |||
| NETwork interface | Protocol:IEEE802.3;Speed:10M/100M(self-adaptive)Connector:RJ45 | Protocol:IEEE802.3;Speed:10M/100M(self-adaptive)Connector:RJ45 | Same |
| SoftwarePerformance | Trend:240-hour for each patientAlarm, event:720 events for each patient | Trend:240-hour for each patientAlarm, event:720 events for each patient | Same |
| Power Supply | |||
| Power type | Two AA size,1.5V alkalinebatteries | Two AA size,1.5V alkaline batteries | Same |
| Battery voltagerange | 2V to 3.4VDC | 2 to 3.4VDC | |
| Standard Compliance | |||
| Generalrequirement | IEC 60601-1:2005 | IEC 60601-1 | Similar |
| IEC 60601-2-27: 2011 | No mention | ||
| Specialrequirement | EC13:1991/2002. | EC13:1991/2002 | |
| ISO 80601-2-61: 2011 | No mention | ||
| IEC 60601-2-49: 2011 | No mention | ||
| EMC | IEC 60601-1-2:2007 | IEC 60601-1-2:2001 + A1:2004. | |
| Alarm | IEC 60601-1-8:2006 | No mention | |
| Biocompatibility | Compliance with ISO10993-1 ISO10993-5,ISO 10993-5-10 | Compliance with ISO10993-1 ISO10993-5,ISO 10993-5-10 | |
| Alarm System | |||
| Physiological alarms | Physiological alarms | ||
| Alarm Categories | Technical alarms | Technical alarms | Same |
| Prompt information | Prompt information | ||
| High level alarms | High level alarms | ||
| Alarm Levels | Medium level alarms | Medium level alarms | Same |
| Low level alarms | Low level alarms | ||
| Alarm Modes | Visual alarms | Visual alarms | Same |
| Audible alarms | Audible alarms | ||
| Alarm messages | Alarm messages | ||
| Parameter flashes | Parameter flashes | ||
| Reminder Tones | Reminder Tones |
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Comparison to Reference Device iM70
| Item | Proposed device, iT20 | Predicate device, iM70 | Comparison |
|---|---|---|---|
| K# | Current Submission | K131971 | Result |
| Wi-Fi | |||
| IEEE | 802.11b/g/n | 802.11b/g/n | Same |
| Frequency Band | 2.4GHz ISM band | 2.4GHz ISM band | Same |
| Modulation | OFDM with BPSK, QPSK, 16-QAM,and 64-QAM 802.11b with CCKand DSSS | OFDM with BPSK, QPSK, 16-QAM,and 64-QAM802.11b with CCK and DSSS | Same |
| Typical TransmitPower | 13 dBm for 802.11b DSSS13 dBm for 802.11b CCK13 dBm for 802.11g/n OFDM | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | Similar |
As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The main technological differences between the subject and predicate devices are minor differences, and do not raise different questions of safety or effectiveness. As demonstrated in the non-clinical testing, the different technological characteristics do not affect the safety and effectiveness of the Edan iT20 system.
9. Performance Data:
Non-clinical data:
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Page 10 of 11
The following performance data were provided in support of the substantial equivalence determination.
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.
Summary
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Page 11 of 11
Based on the non-clinical and clinical performance as documented in the system development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
10. Conclusion
The non-clinical data support the safety of the device and the hardware and software verification and validation demonstrate that the iT20 Patient Monitor device should perform as intended in the specified use conditions. The clinical data demonstrate that the subject devices perform comparably to the predicate device that is currently marketed for the same intended use. In other words, the subject the iT20 Patient Monitor devices are substantially equivalent to the predicate devices.
§ 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.