Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s
Device Facts
| Record ID | K202892 |
|---|---|
| Device Name | Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s |
| Applicant | Edan Instruments, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Jan 28, 2021 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Intended Use
The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments. Parameters include: NIBP, SpO2, PR (pulse rate), TEMP. The F3000 Quick TEMP module is not intended for neonates. The device is not intended for MRI environments.
Device Story
Vital signs monitor (iM3s, iM3As, iM3Bs, iHM3s) measures NIBP, SpO2, pulse rate, and temperature. Inputs include physiological signals via NIBP cuffs, SpO2 sensors, and temperature probes. Device processes signals to calculate vital signs; generates prompts for clinicians. Used in hospital environments by trained healthcare professionals. Output displayed on device screen for clinical review; supports spot-checking and ward round monitoring. Benefits include efficient patient data collection and monitoring to assist clinical decision-making. Connectivity includes Wi-Fi (2.4/5GHz) and Bluetooth Low Energy.
Clinical Evidence
No clinical data. Bench testing only. Functional and system-level testing validated performance against consensus standards: IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters). Software verification and validation conducted per FDA guidance.
Technological Characteristics
Vital signs monitor with NIBP (oscillometric), SpO2, PR, and TEMP (F3000 Quick TEMP module) measurement capabilities. Connectivity: Wi-Fi (802.11b/g/n, 2.4/5GHz) and Bluetooth Low Energy 4.0. Complies with ANSI AAMI ES 60601-1 and IEC 60601-1-2. Software-based processing for parameter calculation and prompt generation.
Indications for Use
Indicated for measuring, storing, and generating prompts for physiological parameters (NIBP, SpO2, PR, TEMP) in adult and pediatric patients. Intended for use by trained healthcare professionals in hospital settings. F3000 Quick TEMP module contraindicated for neonates. Not for use in MRI environments.
Regulatory Classification
Identification
A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.
Predicate Devices
- Mindray North America, Accutorr 3 Vital Signs Monitor (K132037)
Reference Devices
- Edan Instruments, Inc, Vital signs monitor Model iM3 (K180380)
- Edan Instruments, Inc, Patient Monitor Model X8,X10,X12 (K192514)
- HeTaiDa Technology Co., Ltd, HTD8808C Non-Contact Infrared Body Thermometers (K171888)
- Capsule Technologie, SAS, SmartLinx Vitals Plus Patient Monitoring System (K171751)
- Exergen TemporalScanner Thermometer TAT5000S (K011291)
Related Devices
- K233038 — Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s · Edan Instruments, Inc. · Mar 8, 2024
- K180380 — vital signs monitor · Edan Instruments, Inc. · Dec 21, 2018
- K051375 — VITAL SIGNS MONITOR · Mediana Co., Ltd. · Jul 28, 2005
- K161909 — IQvitals Zone · Midmark Corporation · Nov 17, 2016
- K093802 — ULTRAVIEW DM3 MONITOR · Zoe Medical, Inc. · Apr 9, 2010
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 28, 2021
Edan Instruments, Inc. Alice Yang Regulatory Engineer #15 Jinhui Road, jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, Guangdong 518122 China
Re: K202892
Trade/Device Name: Vital Signs Monitor:iM3s, iM3As, iHM3s Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, FLL, DQA, DXN Dated: December 25, 2020 Received: December 28, 2020
Dear Alice Yang:
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
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (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,
for LT 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
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# Indications for Use
510(k) Number (if known) K202892
Device Name
Vital Signs Monitor ( iM3s\iM3As\iM3Bs\ iHM3s)
Indications for Use (Describe)
The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments.
Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.
The F3000 Quick TEMP module is not intended for neonates.
The device is not intended for MRI environments.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------|--|
| <span> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> | |
| <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | |
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#### K202892
## 510(K) Summary
# Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| 1. Submitter: | Edan Instruments, Inc. | | |
|-------------------------|-----------------------------------------------------------------------------|--------------|--|
| | #15 Jinhui Road, Jinsha Community, | | |
| | Kengzi Sub-District, Pingshan District, | | |
| | Shenzhen, 518122 P.R.China. | | |
| | Tel: +86(0755) 26858736 | | |
| | Fax: +86(0755) 26882223 | | |
| Contact person: | Alice Yang | | |
| Preparing date: | September 25, 2020 | | |
| 2. Device name and | Trade Name: Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3s | | |
| classification: | Common/Usual Name: Vital Signs Monitor | | |
| | Classification Name | Product code | |
| | 21 CFR 870.2300 | MWI | |
| | Monitor, Physiological, Patient (Without Arrhythmia<br>Detection Or Alarms) | | |
| Subsequent Product Code | | | |
| | 21 CFR 870.1130 | DXN | |
| | System, Measurement, Blood-Pressure, Non-Invasive | | |
| | 21 CFR 880.2910 | FLL | |
| | Thermometer, Electronic, Clinical | | |
| | 21 CFR 870.2700 | DQA | |
| | Oximeter | | |
| | | | |
## 3. Predicate Device(s):
- 1) Mindray North America, Accutorr 3 Vital Signs Monitor, K132037 (Primary)
- 2) Edan Instruments, Inc, Vital signs monitor Model iM3, K180380 (Reference)
- 3) Edan Instruments, Inc, Patient Monitor Model X8,X10,X12, K192514 (Reference)
- 4) HeTaiDa Technology Co., Ltd, HTD8808C Non-Contact Infrared Body
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#### K202892
Thermometers , K171888 (Reference)
- 5) Capsule Technologie, SAS, SmartLinx Vitals Plus Patient Monitoring System, K171751(Reference)
- The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are 4. Device Description: intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults, pediatrics and neonates.
- 5. Indication for Use The device is intended to be used for measuring, storing, and reviewing of, and to generate prompts for, multiple physiological parameters of adults and pediatrics. The device is intended for use by trained healthcare professionals in hospital environments.
Parameters include: NIBP, SpO2, PR (pulse rate), TEMP.
The F3000 Quick TEMP module is not intended for neonates.
The device is not intended for MRI environments.
#### 6. Predicate Device Comparison
The intended use of the subject devices iM3s series is the same as the primary predicate Mindray Accutor 3 Vital Signs Monitor which is intended for spot-checking monitoring physiologic parameters, including Pulse Oximetry (SpO2), Pulse Rate (PR), Non Invasive Blood Pressure (NIBP) and Temperature (TEMP), on adult, pediatric, and neonatal patients in healthcare facilities by physicians or appropriate medical staff under the direction of physicians.
The table below compares the indication for use and parameter modules of the subject devices to the reference predicate devices.
| Item | <Predicate Device><br>EDAN Instrument Inc.<br>iM3 Vital Signs Monitor | <Subject Device><br>EDAN Instrument Inc.<br>iM3s series Vital Signs Monitor | Comparison<br>Result | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------|
| Manufacturer/K# | K180380 | Current Submission | -- | |
| Description | The monitor is intended to be used for<br>monitoring, storing, recording, and<br>reviewing of, and to generate alarms<br>for, multiple physiological parameters<br>of adults, pediatrics and neonates. The<br>monitor is intended for use by trained<br>healthcare professionals in hospital | The device is intended to be used<br>for measuring, storing, and<br>reviewing of, and to generate<br>prompts for, multiple physiological<br>parameters of adults and pediatrics.<br>The device is intended for use by<br>trained healthcare professionals in | Similar | |
| | | | | |
| | environments.<br>Monitored parameters include: NIBP,<br>SpO2, PR (pulse rate), Quick<br>TEMP/Infrared TEMP.<br>The monitor is not intended for MRI<br>environments. | hospital environments.<br>Parameters include: NIBP, SpO2,<br>PR (pulse rate), TEMP.<br>The F3000 Quick TEMP module is<br>not intended for neonates.<br>The device is not intended for MRI<br>environments. | | |
| Measurement<br>Parameters | SpO2, PR, NIBP, TEMP | SpO2, PR, NIBP, TEMP | Same | |
| Operation mode | Monitoring, Spot-checking, Ward<br>Round | Spot-checking, Ward round | Different | |
| SpO2 (EDAN Module) | | | | |
| Measurement Range | 0% to 100% | 0% to 100% | Same | |
| Accuracy | Adult/pediatric, non-motion conditions<br>70 to 100%: ±2 %<br>0-69% unspecified<br>Neonate<br>70 to 100%: ±3%<br>0-69% unspecified | Adult /Pediatric:<br>±2% (70% to100% SpO2)<br>Undefined (0% to 69% SpO2)<br>Neonate:<br>±3% (70% to100% SpO2)<br>Undefined (0% to 69% SpO2) | Same | |
| | PR from SpO2 | | | |
| | Measurement range | 25 to 300 bpm | 25 to 300 bpm | Same |
| Accuracy | ±2 bpm | ±2 bpm | Same | |
| TEMP (Covidien F3000 Quick Temp Module) | | | | |
| Measuring range | 30°C~43°C | 30°C~43°C | Same | |
| Prediction<br>measurement range | 35°C~43°C | 35°C~43°C | Same | |
| Sensor type | Oral /axillary /rectal | Oral /axillary /rectal | Same | |
| Measuring Mode | Direct Mode /Adjusted Mode | Direct Mode /Adjusted Mode | Same | |
| Wi-Fi | | | | |
| IEEE | 802.11b/g/n | 802.11b/g/n | Same | |
| Frequency Band | 2.4GHz ISM band | 5GHz & 2.4GHz | Different | |
| Max. Transmit<br>Power<br>(±2 dBm) | 17 dBm for 802.11b DSSS<br>17 dBm for 802.11b CCK<br>15 dBm for 802.11g/n OFDM | 2.4GHz:<br>17dBm (802.11b DSSS)<br>17dBm (802.11b CCK)<br>17dBm (802.11g/n OFDM)<br>5GHz:<br>10dBm (802.11g OFDM)<br>9dBm (802.11n) | Different | |
| e-Link | Bluetooth Low Energy 4.0 | Bluetooth Low Energy 4.0 | Same | |
| NIBP-Edan | | | | |
| Principle | | Oscillometry | | |
| Measuring<br>parameter | | SYS, DIA, MAP, PR | | |
| Measurement Range | | Adult Mode:<br>SYS: 25 mmHg to 290 mmHg<br>DIA: 10 mmHg to 250 mmHg<br>MAP: 15 mmHg to 260 mmHg<br><br>Pediatric Mode:<br>SYS: 25 mmHg to 240 mmHg<br>DIA: 10 mmHg to 200 mmHg<br>MAP: 15 mmHg to 215 mmHg<br><br>Neonatal Mode:<br>SYS: 25 mmHg to 140 mmHg<br>DIA: 10 mmHg to 115 mmHg<br>MAP: 15 mmHg to 125 mmHg | The NIBP<br>module is<br>similar to<br>NIBP module<br>of X series<br>cleared by<br>K192514 | |
| | | | | |
| | | | | |
| | | | | |
| NIBP PR<br>Measurement range | | 40 bpm to 240 bpm | | |
| NIBP PR Accuracy | | ±3 bpm or 3.5%, whichever is<br>greater | | |
| HTD8808C<br>Non-contact Infrared<br>Thermometer | iM3s series is compatible with HTD8808C Non-contact Infrared Thermometer cleared by<br>K171888 | | | |
| Exergen<br>TemporalScanner<br>Thermometer<br>TAT5000S | iM3s series is compatible with Exergen TemporalScanner Thermometer TAT5000S cleared by<br>K011291 | | | |
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As seen in the comparison tables, the subject and predicate devices have similar design features and performance specifications. The technological differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
# 7. Performance Data:
# Non-clinical data:
# Electrical safety and electromagnetic compatibility (EMC)
iM3s Series Vital Signs Monitor were assessed for conformity with the relevant requirements of the following standards and found to comply:
- ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 Medical
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#### K202892
electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014 (Fourth Edition) Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: electromagnetic disturbances - Requirements and tests.
### Performance testing-Bench
Edan has conducted functional and system level testing to validate the performance of the results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 80601-2-30:2009+A1:2013 Medical electrical equipment - part 2-30: particular requirements for the basic safety and essential performance of automated non-invasive sphygmomanometers
- ISO 80601-2-56: 2017+A 1:2018 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ISO 80601-2-61: 2017 Medical electrical equipment - part 2-61: particular requirements for basic safety and essential performance of pulse oximeter equipment
### 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".
### Clinical data: Not applicable.
### Summary
The non-clinical performance testing showed that the subject devices are as safe and as effective as the predicate device.
### 8. Conclusion
The bench testing data and software verification and validation demonstrate that iM3s Series Vital Signs Monitor are substantially equivalent to the predicate devices.
