(165 days)
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.
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 and pediatrics.
The provided documentation describes the FDA 510(k) clearance for the Edan Instruments Vital Signs monitor, Model: iM3s, iM3As, iM3Bs, iHM3s. However, the document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and software verification/validation, rather than detailing a clinical study with specific acceptance criteria for AI/algorithm performance.
Therefore, many of the requested details regarding acceptance criteria, sample size, expert involvement, and ground truth establishment for a study proving device performance in an AI/algorithm context are not applicable or not provided in this specific FDA clearance document. The device is a vital signs monitor, not explicitly described as incorporating AI for diagnosis or interpretation that would necessitate an MRMC study or detailed ground truth establishment in the context of AI performance.
The document states "Clinical data: Not applicable," further confirming the absence of a clinical study for this clearance.
Here's a breakdown based on the information available in the document:
1. A table of acceptance criteria and the reported device performance:
The document refers to compliance with consensus standards for device performance, where the "acceptance criteria" are implied by adherence to these standards and the "reported device performance" is that the device "meets its accuracy specification and meet relevant consensus standards." Specific numerical acceptance criteria are mentioned for the measurement accuracy of SpO2, PR, and NIBP, and various temperature modules.
| Parameter | Acceptance Criteria (from Predicate Device/Standard) | Reported Device Performance (Implied) |
|---|---|---|
| SpO2 (EDAN Module) | ||
| Measurement Range | 0% to 100% | Complies |
| Accuracy (Adult/Pediatric, 70-100%) | ±2% | Meets specification |
| Accuracy (Adult/Pediatric, 0-69%) | Undefined | Undefined (as per spec) |
| Accuracy (Neonates, 70-100%) | ±3% | Meets specification |
| Accuracy (Neonates, 0-69%) | Undefined | Undefined (as per spec) |
| PR from SpO2 | ||
| Measurement Range | 25 to 300 bpm | Complies |
| Accuracy | ±2 bpm | Meets specification |
| TEMP (Covidien F3000 Quick Temp Module) | ||
| Measuring Range | 30°C~43°C | Complies |
| Prediction Range | 35°C~43°C | Complies |
| TEMP (Exergen TAT-5000S-RS232-QR Temp Module) | ||
| Temperature Range | 61 to 110°F (15.5 to 43°C) | Complies |
| Accuracy | ± 0.2°F or 0.1°C | Meets specification |
| Clinical Accuracy | Per ASTM E1112 | Complies with ASTM E1112 |
| TEMP (HTD8808C Non-contact Infrared Thermometer Temp Module) | ||
| Measurement Range | 34 °C to 43.0 °C (Differs slightly from predicate) | Complies |
| Accuracy (34.0~34.9°C) | ± 0.3°C | Meets specification |
| Accuracy (35.0~42.0°C) | ± 0.2°C | Meets specification |
| Accuracy (42.1~43.0°C) | ± 0.3°C | Meets specification |
| TEMP (T100A Internal Forehead TEMP Module) | ||
| Accuracy (34.0 - 34.9 °C) | ±0.3 °C | Meets specification |
| Accuracy (35.0 - 42.0 °C) | ±0.2 °C | Meets specification |
| Accuracy (42.1 - 43.0 °C) | ±0.3 °C | Meets specification |
| EDAN-NIBP (ICFUS) & EDAN-NIBP (IFAST) | ||
| SYS Measurement Range | Adult: 25-290 mmHg; Pediatric: 25-240 mmHg; Neonatal: 25-140 mmHg | Complies |
| DIA Measurement Range | Adult: 10-250 mmHg; Pediatric: 10-200 mmHg; Neonatal: 10-115 mmHg | Complies |
| MAP Measurement Range | Adult: 15-260 mmHg; Pediatric: 15-215 mmHg; Neonatal: 15-125 mmHg | Complies |
| NIBP PR Measurement Range | 40 bpm to 240 bpm | Complies |
| NIBP PR Accuracy | ± 3 bpm or 3.5%, whichever is greater | Meets specification |
2. Sample size used for the test set and the data provenance:
- The document explicitly states "Clinical data: Not applicable." The "test set" for performance was conducted through "Non-clinical data" including "Electrical safety and electromagnetic compatibility (EMC)" and "Performance testing-Bench."
- No specific sample sizes (e.g., number of patients/measurements) for "bench" testing are provided.
- Data provenance (e.g., country of origin, retrospective/prospective) is not applicable given no clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as no clinical ground truth or expert-adjudicated test set was used. Device performance was assessed against established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring adjudication was used.
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:
- No MRMC study was performed as this device is a vital signs monitor, not an AI-assisted diagnostic device requiring human reader improvement assessment. Clinical data was deemed "Not applicable."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The performance assessment focused on the device's ability to accurately measure vital signs according to specifications and consensus standards (e.g., IEC 80601-2-30 for NIBP, ISO 80601-2-56 for temperature, ISO 80601-2-61 for pulse oximetry). This is essentially a "standalone" performance evaluation of the measurement algorithms within the device against physical standards, but not in the context of an AI-driven diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance testing, the "ground truth" would be the reference measurements from calibrated and traceable sources, as specified by the relevant international standards (e.g., simulated physiological signals/conditions, calibrated temperature sources, etc.).
8. The sample size for the training set:
- Not applicable. This document describes the clearance of a vital signs monitor, not an AI/machine learning algorithm requiring a separate training set.
9. How the ground truth for the training set was established:
- Not applicable, as no AI training set is described.
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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
| 1. Submitter: | Edan Instruments, Inc.#15 Jinhui Road, Jinsha Community,Kengzi Sub-District, Pingshan District,Shenzhen, 518122 P.R.China.Tel: +86(0755) 26858736Fax: +86(0755) 26882223 |
|---|---|
| Contact person: | Tracy Yue |
| Preparing date: | September 25, 2023 |
| 2. Device name and classification: | Trade Name: Vital Signs Monitor, Model: iM3s, iM3As, iM3Bs, iHM3sCommon/Usual Name: Vital Signs Monitor |
| Classification Name | Product code |
|---|---|
| 21 CFR 870.2300Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI |
| Subsequent Product Code | |
|---|---|
| 21 CFR 870.1130System, Measurement, Blood-Pressure, Non-Invasive | DXN |
| 21 CFR 880.2910Thermometer, Electronic, Clinical | FLL |
| 21 CFR 870.2700Oximeter | DQA |
| Regulatory Class: Class II |
3. Predicate Device(s):
- Edan Instruments, Inc., Vital Signs Monitor:iM3s, iM3As, iM3Bs, iHM3s, K202892 (Primary predicate device)
-
- Shenzhen Mindray Bio-Meidcal Electronics Co., LTD, VS 9 Vital Signs Monitor, K221267 (Reference device)
-
- HeTaiDa Technology Co., Ltd, Non-contact Infrared Body Thermometer, Model HTD8808C, K203332 (Reference device)
-
- 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 | EDAN Instrument Inc.iM3s series Vital Signs Monitor | EDAN Instrument Inc.iM3s series Vital Signs Monitor | ComparisonResult |
|---|---|---|---|
| K# | K202892 | Current Submission | -- |
| Intended Use | |||
| Description | The device is intended to be used formeasuring, storing, and reviewing of,and to generate prompts for, multiplephysiological parameters of adults andpediatrics. The device is intended foruse by trained healthcare professionalsin hospital environments.Parameters include: NIBP, SpO2, PR(pulse rate), TEMP.The F3000 Quick TEMP module is notintended for neonates. | The device is intended to be usedformeasuring, storing, andreviewing of, and to generateprompts for, multiple physiologicalparameters of adults and pediatrics(including neonates). The device isintended for use by trainedhealthcare professionals in hospitalenvironments.Parameters include: NIBP, SpO2,PR (pulse rate), TEMP | Different |
| The device is not intended for MRI | The F3000 Quick TEMP module is | ||
| environments. | not intended for neonates.The device is not intended for MRIenvironments. | ||
| MeasurementParameters | 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 includingneonate): | Adult /Pediatric (not includingneonate): | ||
| 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 | |
| Predictionmeasurement 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 BalanceRangefor BodyTemperature | 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 | Different | |
| TEMP (FORA IR20B EAR THERMOMETER TEMP Module) | |||
| DisplayedTemperature Range | 89.6°F to 109.4°F (32°C to 43°C) | ||
| Accuracy | ±0.4°F (±0.2°C) for the range of96.8°F to 102.2°F (36.0°C to 39.0°C)±0.5°F (±0.3°C) from 89.6°F to96.6°F (32.0°C to 35.9°C) and from102.4°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(±2 dBm) | 2.4GHz:17dBm (802.11b DSSS)17dBm (802.11b CCK)17dBm (802.11g/n OFDM)5GHz:10dBm (802.11g OFDM)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 mmHgDIA: 10 mmHg to 250 mmHgMAP: 15 mmHg to 260 mmHg | SYS: 25 mmHg to 290 mmHgDIA: 10 mmHg to 250 mmHgMAP: 15 mmHg to 260 mmHg | ||
| Pediatric Mode:SYS: 25 mmHg to 240 mmHgDIA: 10 mmHg to 200 mmHgMAP: 15 mmHg to 215 mmHg | Pediatric Mode:SYS: 25 mmHg to 240 mmHgDIA: 10 mmHg to 200 mmHgMAP: 15 mmHg to 215 mmHg | ||
| Neonatal Mode:SYS: 25 mmHg to 140 mmHgDIA: 10 mmHg to 115 mmHgMAP: 15 mmHg to 125 mmHg | Neonatal Mode:SYS: 25 mmHg to 140 mmHgDIA: 10 mmHg to 115 mmHgMAP: 15 mmHg to 125 mmHg | ||
| NIBP PRMeasurement 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:SYS: 25 mmHg to 290 mmHgDIA: 10 mmHg to 250 mmHgMAP: 15 mmHg to 260 mmHg | |||
| Measurement Range | / | Pediatric Mode:SYS: 25 mmHg to 240 mmHgDIA: 10 mmHg to 200 mmHgMAP: 15 mmHg to 215 mmHg | Different |
| iFAST: 15 s (depend on SYS, armcircumference and HR/motiondisturbance) (measured with E8cuff, PR is set as 80 bpm andsystolic pressure within 120/80mmHg) | |||
| Typicalmeasurement 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.
§ 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).