(122 days)
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.
The iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s are intended to be used for measuring, storing, reviewing of, and generating prompts for multiple physiological parameters of adults, pediatrics and neonates.
Here's an analysis of the provided text regarding the acceptance criteria and study data for the Vital Signs Monitor (iM3s, iM3As, iM3Bs, iHM3s).
Please note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It primarily presents performance specifications and shows that the new device meets those, often by referencing existing standards or previous clearances. It does not typically include detailed experimental setups for clinical or performance studies in the way a research paper would. Therefore, some information requested (like sample size for training sets, specific adjudication methods, MRMC studies, or detailed ground truth establishment for training data) is not present in this type of regulatory document.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are generally implied by the predicate device's specifications and compliance with relevant ISO/IEC standards. The "Reported Device Performance" for the subject device is stated as meeting these same specifications.
| Parameter | Acceptance Criteria (from Predicate/Standards) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Accuracy | Adult/Pediatric: | Adult/Pediatric: |
| 70 to 100%: ±2 % | ±2% (70% to 100% SpO2) | |
| 0-69% unspecified | Undefined (0% to 69% SpO2) | |
| Neonate: | Neonate: | |
| 70 to 100%: ±3% | ±3% (70% to 100% SpO2) | |
| 0-69% unspecified | Undefined (0% to 69% SpO2) | |
| PR from SpO2 Accuracy | ±2 bpm | ±2 bpm |
| TEMP Measurement Range | 30°C~43°C | 30°C~43°C |
| TEMP Prediction Measurement Range | 35°C~43°C | 35°C~43°C |
| NIBP PR Accuracy | (Referenced to NIBP module of X series cleared by K192514, which would presumably have its own stated accuracy. The document states NIBP PR accuracy as) | ±3 bpm or 3.5%, whichever is greater |
| Electrical Safety | Compliance with ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012 | Complies (assessed for conformity) |
| EMC | Compliance with IEC 60601-1-2:2014 (Fourth Edition) | Complies (assessed for conformity) |
| NIBP Performance | Compliance with IEC 80601-2-30:2009+A1:2013 | Meets accuracy specification and relevant consensus standards |
| TEMP Performance | Compliance with ISO 80601-2-56: 2017+A 1:2018 | Meets accuracy specification and relevant consensus standards |
| Pulse Oximeter Performance | Compliance with ISO 80601-2-61: 2017 | Meets accuracy specification and relevant consensus standards |
| Software Verification & Validation | Adherence to FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | Documentation provided and testing conducted |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the document. The performance is validated through "functional and system level testing" and compliance with standards, not a clinical trial with a specified patient sample size for device comparison.
- Data Provenance: The studies are described as "non-clinical data" and "bench testing." No country of origin is mentioned for patient data, as no clinical studies with human subjects are detailed. The nature of the testing implies it's retrospective, based on existing standards and validation procedures, rather than prospective clinical data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- This information is not provided in the document. The "ground truth" for these performance tests would typically be established by highly calibrated reference instruments or simulated physiological signals according to the requirements of the cited ISO/IEC standards, rather than expert human interpretation in a clinical context.
4. Adjudication Method for the Test Set
- This information is not applicable and not provided. As no clinical studies with human subjects or interpretation tasks are described, there is no need for an adjudication method. The assessment is against technical specifications and standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical data: Not applicable." The focus is on the device's standalone performance against engineering and international standards.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, the performance reported is essentially standalone. The "bench testing" and "software verification and validation testing" assess the device's accuracy and functionality in isolation, without an explicit human-in-the-loop component for interpreting outputs in the context of the device's core physiological measurements (NIBP, SpO2, PR, TEMP).
7. The Type of Ground Truth Used
- The ground truth for the performance testing is based on:
- Reference measurements from calibrated equipment: For parameters like SpO2, NIBP, and TEMP, the "ground truth" would be simulated physiological signals or measurements from highly accurate, traceable reference devices as mandated by the respective ISO/IEC standards.
- Compliance with international standards: The device is tested against the specific requirements and accuracy tolerances defined in standards such as IEC 80601-2-30 (NIBP), ISO 80601-2-56 (thermometers), and ISO 80601-2-61 (pulse oximeters).
8. The Sample Size for the Training Set
- This information is not provided and is not applicable in the context of this device and document. This device is a vital signs monitor, not typically an AI/machine learning diagnostic device that relies on "training sets" in the conventional sense of machine learning algorithms. Its parameters are measured directly through hardware and firmware, validated against physical standards.
9. How the Ground Truth for the Training Set Was Established
- This information is not provided and is not applicable as there is no "training set" for an AI algorithm described for this device. The device's fundamental operational principles are based on established physiological measurement techniques, not on learning from a dataset.
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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) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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 ArrhythmiaDetection 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):
-
- Mindray North America, Accutorr 3 Vital Signs Monitor, K132037 (Primary)
-
- Edan Instruments, Inc, Vital signs monitor Model iM3, K180380 (Reference)
-
- Edan Instruments, Inc, Patient Monitor Model X8,X10,X12, K192514 (Reference)
-
- HeTaiDa Technology Co., Ltd, HTD8808C Non-Contact Infrared Body
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K202892
Thermometers , K171888 (Reference)
-
- 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.
-
- 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 | EDAN Instrument Inc.iM3 Vital Signs Monitor | EDAN Instrument Inc.iM3s series Vital Signs Monitor | ComparisonResult | |
|---|---|---|---|---|
| Manufacturer/K# | K180380 | Current Submission | -- | |
| Description | The monitor is intended to be used formonitoring, storing, recording, andreviewing of, and to generate alarmsfor, multiple physiological parametersof adults, pediatrics and neonates. Themonitor is intended for use by trainedhealthcare professionals in hospital | The device is intended to be usedfor measuring, storing, andreviewing of, and to generateprompts for, multiple physiologicalparameters of adults and pediatrics.The device is intended for use bytrained healthcare professionals in | Similar | |
| environments.Monitored parameters include: NIBP,SpO2, PR (pulse rate), QuickTEMP/Infrared TEMP.The monitor is not intended for MRIenvironments. | hospital environments.Parameters include: NIBP, SpO2,PR (pulse rate), TEMP.The F3000 Quick TEMP module isnot intended for neonates.The device is not intended for MRIenvironments. | |||
| MeasurementParameters | SpO2, PR, NIBP, TEMP | SpO2, PR, NIBP, TEMP | Same | |
| Operation mode | Monitoring, Spot-checking, WardRound | Spot-checking, Ward round | Different | |
| SpO2 (EDAN Module) | ||||
| Measurement Range | 0% to 100% | 0% to 100% | Same | |
| Accuracy | Adult/pediatric, non-motion conditions70 to 100%: ±2 %0-69% unspecifiedNeonate70 to 100%: ±3%0-69% unspecified | Adult /Pediatric:±2% (70% to100% SpO2)Undefined (0% to 69% SpO2)Neonate:±3% (70% to100% SpO2)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 | |
| Predictionmeasurement 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. TransmitPower(±2 dBm) | 17 dBm for 802.11b DSSS17 dBm for 802.11b CCK15 dBm for 802.11g/n OFDM | 2.4GHz:17dBm (802.11b DSSS)17dBm (802.11b CCK)17dBm (802.11g/n OFDM)5GHz:10dBm (802.11g OFDM)9dBm (802.11n) | Different | |
| e-Link | Bluetooth Low Energy 4.0 | Bluetooth Low Energy 4.0 | Same | |
| NIBP-Edan | ||||
| Principle | Oscillometry | |||
| Measuringparameter | SYS, DIA, MAP, PR | |||
| Measurement Range | Adult Mode:SYS: 25 mmHg to 290 mmHgDIA: 10 mmHg to 250 mmHgMAP: 15 mmHg to 260 mmHgPediatric Mode:SYS: 25 mmHg to 240 mmHgDIA: 10 mmHg to 200 mmHgMAP: 15 mmHg to 215 mmHgNeonatal Mode:SYS: 25 mmHg to 140 mmHgDIA: 10 mmHg to 115 mmHgMAP: 15 mmHg to 125 mmHg | The NIBPmodule issimilar toNIBP moduleof X seriescleared byK192514 | ||
| NIBP PRMeasurement range | 40 bpm to 240 bpm | |||
| NIBP PR Accuracy | ±3 bpm or 3.5%, whichever isgreater | |||
| HTD8808CNon-contact InfraredThermometer | iM3s series is compatible with HTD8808C Non-contact Infrared Thermometer cleared byK171888 | |||
| ExergenTemporalScannerThermometerTAT5000S | iM3s series is compatible with Exergen TemporalScanner Thermometer TAT5000S cleared byK011291 |
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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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).