(122 days)
No
The summary does not mention AI, ML, deep learning, or any related terms, and the device description focuses on standard physiological parameter measurement.
No
The device is intended for measuring, storing, and generating prompts for physiological parameters, not for treating or diagnosing medical conditions.
No
The device is described as a vital signs monitor that measures, stores, and generates prompts for physiological parameters. It does not mention any diagnostic capabilities or the ability to interpret data to identify diseases or conditions.
No
The device description explicitly states "iM3s series vital signs monitors including iM3s\iM3As\iM3Bs\ iHM3s", indicating a hardware device. The performance studies also mention electrical safety, EMC, and bench testing, which are typical for hardware devices.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living organism (in vitro).
- Device Function: The description clearly states the device is used for "measuring, storing, and to generate prompts for, multiple physiological parameters of adults and pediatrics." These parameters (NIBP, SpO2, PR, TEMP) are measured directly from the patient's body using non-invasive methods (like a blood pressure cuff, pulse oximeter, and thermometer).
- No Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient.
Therefore, because the device measures physiological parameters directly from the patient rather than analyzing samples in vitro, it falls under the category of a patient monitor or vital signs monitor, not an In Vitro Diagnostic.
N/A
Intended Use / 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. 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.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DXN, FLL, DQA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults and pediatrics. The F3000 Quick TEMP module is not intended for neonates.
Intended User / Care Setting
Trained healthcare professionals in hospital environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data:
- Electrical safety and electromagnetic compatibility (EMC) assessed for conformity with ANSI AAMI ES 60601-1:2005/(R) 2012 and A1:2012, C1:2009(R) 2012 and A2:2010/(R) 2012, and IEC 60601-1-2:2014 (Fourth Edition).
- Performance testing-Bench: Functional and system level testing conducted. Results show the subject device meets its accuracy specification and relevant consensus standards (IEC 80601-2-30:2009+A1:2013, ISO 80601-2-56: 2017+A 1:2018, ISO 80601-2-61: 2017).
- Software Verification and Validation Testing: Conducted and documentation provided as recommended by FDA's Guidance for Industry and FDA Staff.
- 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. The bench testing data and software verification and validation demonstrate that iM3s Series Vital Signs Monitor are substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
SpO2 EDAN Module Accuracy:
Adult /Pediatric: ±2% (70% to100% SpO2), Undefined (0% to 69% SpO2)
Neonate: ±3% (70% to100% SpO2), Undefined (0% to 69% SpO2)
PR from SpO2 Accuracy: ±2 bpm
NIBP PR Accuracy: ±3 bpm or 3.5%, whichever is greater
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K180380, K192514, K171888, K171751, K011291
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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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3
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 | |||
| 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):
-
- 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
4
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 | Comparison
Result | |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------|------|
| Manufacturer/K# | K180380 | Current Submission | -- | |
| Description | The monitor is intended to be used for
monitoring, storing, recording, and
reviewing of, and to generate alarms
for, multiple physiological parameters
of adults, pediatrics and neonates. The
monitor is intended for use by trained
healthcare professionals in hospital | 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 | Similar | |
| | | | | |
| | environments.
Monitored parameters include: NIBP,
SpO2, PR (pulse rate), Quick
TEMP/Infrared TEMP.
The monitor is not intended for MRI
environments. | 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. | | |
| Measurement
Parameters | SpO2, PR, NIBP, TEMP | SpO2, PR, NIBP, TEMP | Same | |
| Operation mode | Monitoring, Spot-checking, Ward
Round | Spot-checking, Ward round | Different | |
| SpO2 (EDAN Module) | | | | |
| Measurement Range | 0% to 100% | 0% to 100% | Same | |
| Accuracy | Adult/pediatric, non-motion conditions
70 to 100%: ±2 %
0-69% unspecified
Neonate
70 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°C43°C | 30°C43°C | Same | |
| Prediction
measurement range | 35°C43°C | 35°C43°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
Power
(±2 dBm) | 17 dBm for 802.11b DSSS
17 dBm for 802.11b CCK
15 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 | | |
| Measuring
parameter | | SYS, DIA, MAP, PR | | |
| Measurement Range | | Adult Mode:
SYS: 25 mmHg to 290 mmHg
DIA: 10 mmHg to 250 mmHg
MAP: 15 mmHg to 260 mmHg
Pediatric Mode:
SYS: 25 mmHg to 240 mmHg
DIA: 10 mmHg to 200 mmHg
MAP: 15 mmHg to 215 mmHg
Neonatal Mode:
SYS: 25 mmHg to 140 mmHg
DIA: 10 mmHg to 115 mmHg
MAP: 15 mmHg to 125 mmHg | The NIBP
module is
similar to
NIBP module
of X series
cleared by
K192514 | |
| | | | | |
| | | | | |
| | | | | |
| NIBP PR
Measurement range | | 40 bpm to 240 bpm | | |
| NIBP PR Accuracy | | ±3 bpm or 3.5%, whichever is
greater | | |
| HTD8808C
Non-contact Infrared
Thermometer | iM3s series is compatible with HTD8808C Non-contact Infrared Thermometer cleared by
K171888 | | | |
| Exergen
TemporalScanner
Thermometer
TAT5000S | iM3s series is compatible with Exergen TemporalScanner Thermometer TAT5000S cleared by
K011291 | | | |
5
6
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
7
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.