Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s
Device Facts
| Record ID | K233038 |
|---|---|
| Device Name | Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s |
| Applicant | Edan Instruments, Inc. |
| Product Code | MWI · Cardiovascular |
| Decision Date | Mar 8, 2024 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 870.2300 |
| Device Class | Class 2 |
| Attributes | Pediatric |
Indications for Use
The device is intended to be used for measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics (including neonates). 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 display real-time values, store data, and generate clinical prompts. Used in hospital environments by trained healthcare professionals for spot-checking or ward rounds. Output provides clinicians with patient vital signs to support clinical decision-making and patient monitoring. Connectivity includes Wi-Fi and E-Link (Bluetooth) for data transmission.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and performance testing per consensus standards: IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters).
Technological Characteristics
Class II monitor. Parameters: NIBP (oscillometric), SpO2, PR, TEMP (various modules: F3000, Exergen, HTD8808C, T100A). Connectivity: Wi-Fi (802.11b/g/n, 2.4/5GHz) and Bluetooth (BR, EDR, BLE). Standards: IEC 60601-1, IEC 60601-1-2, IEC 80601-2-30, ISO 80601-2-56, ISO 80601-2-61.
Indications for Use
Indicated for measuring, storing, and generating prompts for physiological parameters (NIBP, SpO2, PR, TEMP) in adult, pediatric, and neonatal populations. Intended for use by trained healthcare professionals in hospital settings. Contraindicated for MRI environments; F3000 Quick Temp module contraindicated for neonates.
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
- Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s (K202892)
Reference Devices
- VS 9 Vital Signs Monitor (K221267)
- Non-contact Infrared Body Thermometer, Model HTD8808C (K203332)
- FORA IR20B EAR THERMOMETER (K090395)
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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 8, 2024
Edan Instruments, Inc. Tracy Yue Regulatory Affairs Engineer 15 Jinhui Road, Jinsha Community, Kengzi Sub-district Pingshan District, Shenzhen, Shenzhen 518122 China
Re: K233038
Trade/Device Name: Vital Signs monitor, Model: 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 Dated: September 25, 2023 Received: September 25, 2023
Dear Tracy Yue:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
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For comprehensive regulatory information about mediation-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,
# Stephen C. Browning -S
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
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# Indications for Use
510(k) Number (if known) K233038
Device Name
Vital Signs monitor, Model: 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 (including neonates). 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) | |
|-------------------------------------------------|---------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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#### 510(K) Summary
## Prepared in accordance with the content and format regulatory requirements of 21 CFR Part 807.92
| <b>1. Submitter:</b> | Edan Instruments, Inc.<br>#15 Jinhui Road, Jinsha Community,<br>Kengzi Sub-District, Pingshan District,<br>Shenzhen, 518122 P.R.China.<br>Tel: +86(0755) 26858736<br>Fax: +86(0755) 26882223 |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Contact person:</b> | Tracy Yue |
| <b>Preparing date:</b> | September 25, 2023 |
| <b>2. Device name and classification:</b> | Trade Name: Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3s<br>Common/Usual Name: Vital Signs Monitor |
| Classification Name | Product code |
|---------------------------------------------------------------------------------------------|--------------|
| 21 CFR 870.2300<br>Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI |
| Subsequent Product Code | |
|----------------------------------------------------------------------|-----|
| 21 CFR 870.1130<br>System, Measurement, Blood-Pressure, Non-Invasive | DXN |
| 21 CFR 880.2910<br>Thermometer, Electronic, Clinical | FLL |
| 21 CFR 870.2700<br>Oximeter | DQA |
| Regulatory Class: Class II | |
**3. Predicate Device(s):**
1) Edan Instruments, Inc., Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s, K202892 (Primary predicate device)
- 2) Shenzhen Mindray Bio-Meidcal Electronics Co., LTD, VS 9 Vital Signs Monitor, K221267 (Reference device)
- 3) HeTaiDa Technology Co., Ltd, Non-contact Infrared Body Thermometer, Model HTD8808C, K203332 (Reference device)
- 4) TaiDoc Technology Corporation, FORA IR20B EAR
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THERMOMETER , K090395 (Reference device)
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 and pediatrics. 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 (including neonates). 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 device Vital Signs Monitor: iM3s, iM3As, iHM3s (K202892) which is intended to be used for measuring, storing, and reviewing of, and to generate prompts for, multiple physiological parameters of adults and pediatrics in healthcare environments by trained healthcare professionals.
The table below compares the indication for use and parameter modules of the subject devices to the primary predicate devices.
| Manufacturer/Item | <Predicate Device><br>EDAN Instrument Inc.<br>iM3s series Vital Signs Monitor | <Subject Device><br>EDAN Instrument Inc.<br>iM3s series Vital Signs Monitor | Comparison<br>Result |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| K# | K202892 | Current Submission | -- |
| Intended Use | | | |
| Description | The device is intended to be used for<br>measuring, storing, and reviewing of,<br>and to generate prompts for, multiple<br>physiological parameters of adults and<br>pediatrics. The device is intended for<br>use by trained healthcare professionals<br>in hospital environments.<br>Parameters include: NIBP, SpO2, PR<br>(pulse rate), TEMP.<br>The F3000 Quick TEMP module is not<br>intended for neonates. | The device is intended to be used<br>for<br>measuring, storing, and<br>reviewing of, and to generate<br>prompts for, multiple physiological<br>parameters of adults and pediatrics<br>(including neonates). The device is<br>intended for use by trained<br>healthcare professionals in hospital<br>environments.<br>Parameters include: NIBP, SpO2,<br>PR (pulse rate), TEMP | Different |
| | The device is not intended for MRI | The F3000 Quick TEMP module is | |
| | environments. | 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 | Spot-checking, Ward round | Spot-checking, Ward round | |
| SpO2 (EDAN Module) | | | |
| Measurement Range | 0% to 100% | 0% to 100% | |
| | Adult /Pediatric (not including<br>neonate): | Adult /Pediatric (not including<br>neonate): | |
| | 70% to100% : ±2% | 70% to100% : ±2% | |
| Accuracy | 0% to 69%: Undefined | 0% to 69%: Undefined | Same |
| | Neonate: | Neonate: | |
| | 70% to100%: ±3% | 70% to100%: ±3% | |
| | 0% to 69%: Undefined | 0% to 69%: Undefined | |
| PR from SpO2 | | | |
| Measurement range | 25 to 300 bpm | 25 to 300 bpm | |
| Accuracy | ±2 bpm | ±2 bpm | Same |
| | TEMP (Covidien F3000 Quick Temp Module) | | |
| Measuring range | 30°C~43°C | 30°C~43°C | |
| Prediction<br>measurement range | 35°C~43°C | 35°C~43°C | Same |
| Sensor type | Oral /axillary /rectal | Oral /axillary /rectal | |
| Measuring Mode | Direct Mode /Adjusted Mode | Direct Mode /Adjusted Mode | |
| | TEMP (Exergen TAT-5000S-RS232-QR Temp Module) | | |
| Temperature Range | 61 to 110°F (15.5 to 43°C) | 61 to 110°F (15.5 to 43°C) | |
| | ± 0.2°F or 0.1°C | ± 0.2°F or 0.1°C | |
| Clinical Accuracy | Per ASTM E1112 | Per ASTM E1112 | |
| Arterial Heat Balance<br>Range<br>for Body<br>Temperature | 94 to 110°F (34.5 to 43°C) | 94 to 110°F (34.5 to 43°C) | Same |
| | TEMP (HTD8808C Non-contact Infrared Thermometer Temp Module) | | |
| Measurement Range | 34 °C to 42.9 °C | 34 °C to 43.0 °C | |
| | 34.0~34.9°C: ± 0.3°C | 34.0~34.9°C: ± 0.3°C | |
| | (93.2-94.8°F: ± 0.5°F); | (93.2-94.8°F: ± 0.5°F); | |
| | Accuracy | 35.0~42.0°C: ± 0.2°C | 35.0~42.0°C: ± 0.2°C |
| | (95.0-107.6°F: ± 0.4°F); | (95.0-107.6°F: ± 0.4°F); | |
| | 42.1~42.9°C: ± 0.3°C | 42.1~43.0°C: ± 0.3°C | |
| (107.8-109.2°F: ± 0.5°F); | | | |
| TEMP (T100A Internal Forehead TEMP Module) | | | |
| Measurement Range | / | | |
| Accuracy | 34°C~43°C (93.2°F~109.4°F)<br>±0.3 °C: 34.0 °C -34.9 °C;<br>±0.2 °C: 35.0 °C -42.0 °C;<br>±0.3 °C: 42.1°C -43.0 °C; | Different | |
| TEMP (FORA IR20B EAR THERMOMETER TEMP Module) | | | |
| Displayed<br>Temperature Range | 89.6°F to 109.4°F (32°C to 43°C) | | |
| Accuracy | ±0.4°F (±0.2°C) for the range of<br>96.8°F to 102.2°F (36.0°C to 39.0°C)<br>±0.5°F (±0.3°C) from 89.6°F to<br>96.6°F (32.0°C to 35.9°C) and from<br>102.4°F to 109.4°F (39.1°C to 43.0°C) | Different | |
| Wi-Fi | | | |
| IEEE | 802.11b/g/n | Same | |
| Frequency Band | 5GHz & 2.4GHz | | |
| Max. Transmit Power<br>(±2 dBm) | 2.4GHz:<br>17dBm (802.11b DSSS)<br>17dBm (802.11b CCK)<br>17dBm (802.11g/n OFDM)<br><br>5GHz:<br>10dBm (802.11g OFDM)<br>9dBm (802.11n) | | |
| E-Link | | | |
| Radio Technology | BR, EDR, BLE | Same | |
| Frequency Range | 2402 MHz ~ 2480 MHz | | |
| EDAN-NIBP(ICFUS) | | | |
| Principle | Oscillometry | Same | |
| Measuring parameter | SYS, DIA, MAP, PR | | |
| Measurement Range | Adult Mode: | | |
| | | | |
| | SYS: 25 mmHg to 290 mmHg<br>DIA: 10 mmHg to 250 mmHg<br>MAP: 15 mmHg to 260 mmHg | SYS: 25 mmHg to 290 mmHg<br>DIA: 10 mmHg to 250 mmHg<br>MAP: 15 mmHg to 260 mmHg | |
| | Pediatric Mode:<br>SYS: 25 mmHg to 240 mmHg<br>DIA: 10 mmHg to 200 mmHg<br>MAP: 15 mmHg to 215 mmHg | Pediatric Mode:<br>SYS: 25 mmHg to 240 mmHg<br>DIA: 10 mmHg to 200 mmHg<br>MAP: 15 mmHg to 215 mmHg | |
| | Neonatal Mode:<br>SYS: 25 mmHg to 140 mmHg<br>DIA: 10 mmHg to 115 mmHg<br>MAP: 15 mmHg to 125 mmHg | Neonatal Mode:<br>SYS: 25 mmHg to 140 mmHg<br>DIA: 10 mmHg to 115 mmHg<br>MAP: 15 mmHg to 125 mmHg | |
| NIBP PR<br>Measurement range | 40 bpm to 240 bpm | 40 bpm to 240 bpm | |
| NIBP PR Accuracy | $\pm$ 3 bpm or 3.5%, whichever is greater | $\pm$ 3 bpm or 3.5%, whichever is greater | |
| EDAN-NIBP(IFAST) | | | |
| Principle | | Oscillometry | |
| Measuring parameter | | SYS, DIA, MAP | |
| | | Adult Mode:<br>SYS: 25 mmHg to 290 mmHg<br>DIA: 10 mmHg to 250 mmHg<br>MAP: 15 mmHg to 260 mmHg | |
| Measurement Range | / | Pediatric Mode:<br>SYS: 25 mmHg to 240 mmHg<br>DIA: 10 mmHg to 200 mmHg<br>MAP: 15 mmHg to 215 mmHg | Different |
| | | iFAST: 15 s (depend on SYS, arm<br>circumference and HR/motion<br>disturbance) (measured with E8<br>cuff, PR is set as 80 bpm and<br>systolic pressure within 120/80<br>mmHg) | |
| Typical<br>measurement time | | | |
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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:
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#### 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:
- IEC 60601-1: 2005/A1: 2012/A2: 2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance.
- IEC 60601-1-2:2014+A1:2020 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 devices. The results of the bench testing show that the subject device meets its accuracy specification and meet relevant consensus standards.
- IEC 80601-2-30:2018 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.
