(58 days)
No
The summary describes standard physiological monitoring and analysis (ECG, NIBP, SpO2, etc.) with alarm functions. There is no mention of AI, ML, or any advanced analytical techniques that would typically indicate the use of such technology. The analysis mentioned (Arrhythmia and ST segment) is described as being the same as previously cleared devices, suggesting established algorithms rather than novel AI/ML approaches.
No.
This device is described as a monitor that monitors, stores, displays, analyzes, and controls physiological parameters and alarms in case of abnormality, which indicates it is a diagnostic or monitoring device, not a therapeutic one.
Yes
The device monitors, displays, and analyzes multiple physiological parameters (ECG, SpO2, NIBP, etc.), and includes features like arrhythmia detection and ST segment analysis, which are used for diagnosis.
No
The device description explicitly mentions hardware components such as display screens, touch screens, and various parameter modules (SpO2, NIBP, ECG, etc.). It also details hardware testing as part of the quality assurance measures.
Based on the provided information, the iM50 and iM80 Patient Monitors are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The iM50 and iM80 Patient Monitors directly monitor physiological parameters from the patient's body (ECG, SpO2, NIBP, etc.) using sensors and electrodes applied externally or invasively. They do not analyze samples in vitro (outside the body).
- Intended Use: The intended use describes monitoring physiological parameters and providing alarms based on these measurements. This is consistent with a patient monitoring device, not an IVD.
- Device Description: The description details the parameters monitored and how the device displays and analyzes these real-time measurements from the patient.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the iM50 and iM80 Patient Monitors are considered patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
iM80: The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
iM50: The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
Product codes (comma separated list FDA assigned to the subject device)
DRT, DXN, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, DRT, DSI, MLD, MHX
Device Description
iM50 /iM80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
iM50 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP.
iM80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP, C.O. and AG.
The above is the maximum configuration for iM50 and iM80, the user may select different monitoring parameters in according with the requirement.
iM50 is outfitted with a 8.4-inch display screen, iM80 is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses. Besides, iM80 supports software upgrade online and networking.
iM50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, CO2, IBP and Quick Temp.
iM80 could be configured with three different NIBP modules, one is EDAN NIBP module, one is Omron NIBP module, the other is Suntech NIBP module; Omron NIBP module used in iM80 is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003. Suntech NIBP module is cleared by FDA in K032363
CO2 module and Nellcor SpO2 module used in iM50 and iM80 are the same to those used in M3B, which has been cleared by K083821 in May 14, 2009.
Arrhythmia and ST segment Analysis used for ECG diagnoses in iM80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010
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
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
Intended User / Care Setting
Not Found
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)
Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K100939, K102825, K083821, K032363, K032857, K103604
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.
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
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
0
Patient Monitor Traditional 510K Submission
Section 1
510(k) Summary of Safety and Effectiveness
This summary of 510k safety and effectiveness is being submitted in according with 21CFR part 807.92
| Submitter: | Edan Instruments, Inc
3/F - B, Nanshan Medical
Equipments Park, Nanhai Rd 1019#,
shekou, Nanshan Shenzhen,
518067 P.R. China
Tel: 86-755-26882220
Fax:86-755-26882223
Contact person: Randy Jiang |
| ------------ | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
2011-12-02 Date of Preparation:
Patient Monitor (Models iM50 and iM80 ) Proprietary Name:
Classification:
| Description | Classification | Product
code |
|------------------------------------------------------------------------------------|----------------|-----------------|
| 21 CFR 870.2300 Cardiac monitor (including cardiotachoment and rate alarm) | II | DRT |
| 21 CFR 870.1130 Non-Invasive blood pressure measurement System | II | DXN |
| 21 CFR 870.1110 Blood pressure computer | II | DSK |
| 21 CFR 880.2910 Clinical Electronic Thermometers-Temperature Monitor with
Probe | II | FLL |
| 21 CFR 870.2700 Oximeter, Pulse | II | DQA |
| 21 CFR 870.1400 Carbon Dioxide Gas Analyzer | II | CCK |
| 21 CFR 868.1500 Enflurane gas analyzer | II | CBQ |
| 21 CFR 868.1620 Halothane gas analyzer | II | CBS |
| 21 CFR 868.1700 Nitrous Oxide gas analyzer | II | CBR |
| 21 CFR 868.1720 Oxygen gas analyzer | II | CCL |
| 21 CFR 868.2900 cable, transducer and electrode, patient, (including connector) | II | DSA |
| 21 CFR 870.2300 monitor, cardiac (incl. cardiotachometer & rate alarm) | II | DRT |
| 21 CFR 870.1025 Detector and Alarm, Arrhythmia | II | DSI |
| 21 CFR 870.1025 Monitor, ST Segment with Alarm | II | MLD |
Regulatory Class:_ Class II
Page 1 OF 4
1
Legally Marketed Predicate Devices::
| Manufacturer | Predicate Device | 510(k) number | Cleared date |
|---|---|---|---|
| Philips Medical System | MP5 | K100939 | April.1.2010 |
| Edan Instruments, Inc | M3 and M3A | K102825 | Dec.27.2010 |
| Philips Medical System | MP70 | K100939 | April.1.2010 |
| Edan Instruments, Inc | M3B | K083821 | May.14,2009 |
| ZOLL Medical Corporation | ZOLL M series NIBP | ||
| option | K032363 | July 30, 2003 | |
| Colin Medical Instruments Corp | BX-10 | K032857 | April.21,2003 |
| PHASEIN AB | Carbon-dioxide | ||
| analyzer | K103604 | March.28, 2011 |
iM50 /iM80 Patient Monitor provides the following primary features: Device Description:
iM50 /iM80 Patient Monitor can perform long-time continuous monitoring of multiple physiological parameters. Also, it is capable of storing, displaying, analyzing and controlling measurements, and it will indicate alarms in case of abnormity so that doctors and nurses can deal with them in time.
iM50 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP.
iM80 Patient Monitor can monitor parameters including SpO2, NIBP, ECG, RESP, TEMP, CO2, IBP, C.O. and AG.
The above is the maximum configuration for iM50 and iM80, the user may select different monitoring parameters in according with the requirement.
iM50 is outfitted with a 8.4-inch display screen, iM80 is 15-inch, as well as an equal large touch screen, which enables the operation by touching the screen, thus offering convenience for doctors and nurses. Besides, iM80 supports software upgrade online and networking.
iM50 Patient Monitor has parameter modules including SpO2 (pulse oxygen saturation, pulse rate and SpO2 plethysmogram) with EDAN SpO2 module or Nellcor SPO2 module, NIBP (systolic pressure, diastolic pressure, mean pressure and pulse rate), TEMP, ECG, RESP, CO2, IBP and Quick Temp.
iM80 could be configured with three different NIBP modules, one is EDAN NIBP module, one is Omron NIBP module, the other is Suntech NIBP module; Omron NIBP module used in iM80 is the same to that used in BX-10, which has been cleared by K032857 in April.21.2003. Suntech NIBP module is cleared by FDA in K032363
CO2 module and Nellcor SpO2 module used in iM50 and iM80 are the same to those used in M3B, which has been cleared by K083821 in
PAGE 2 OF 4
2
May 14, 2009.
Arrhythmia and ST segment Analysis used for ECG diagnoses in iM80 is the same to that in PC ECG which has been cleared by FDA under K102854 and K092010
Comparison with predicate device
The iM50 and iM80 Patient Monitors have the following similarities to that which previously received 510(k) concurrence:
- · have the same indications for use,
- · use the similar operating principle,
- · have the same or similar performance specifications
In summary, the iM50 and iM80 Patient Monitor described in this submission is, in our opinion, substantially equivalent to the predicate device
Intended Use:
iM80 :
The monitor monitors parameters such as ECG (3-lead, 5-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
iM50 :
The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature
( Quick TEMP. The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
Contraindications:
It is not intended for use in patient's home or residence, or when it has not been ordered by a physician.
Test Summary:
The following quality assurance measures were applied to the development of the Patient Monitor
- · Software testing
- · Hardware testing
PAGE 3 OF 4
3
- Safety testing
- Environment test
- Risk analysis
- Final validation
Conclusion:
Verification and validation testing was done on the Patient Monitor. This premarket notification submission demonstrates that Patient Monitor is substantially equivalent to the predicate device.
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
FEB - 1 2012
Edan Instruments, Inc. c/o Mr. Randy Jiang Certification Engineer 3/F-B, Nanshan Medical Equipment Park, Nanhai Rd., 1019 No. Shenzhen CHINA 518067
Re: K113623
Trade/Device Name: Patient Monitor, Models iM50 and iM80 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection or alarms) Regulatory Class: Class II (two) Product Codes: MHX, DXN, DRT, DSK, FLL, DQA, CCK, CBQ, CBS, CBR, CCL, DSA, DRT, DSI and MLD Dated: November 2, 2011
Received: December 3, 2011
Déar Mr. Jiang:
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. 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.
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.
5
Page 2 - Mr. Randy Jiang
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indication for Use
510(k) Number (if known):
Device Name: Patient Monitor Models iM50 and iM80
iM80 :
The monitor monitors parameters such as ECG (3-lead, 12-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (2/4 channels IBP NIBP), Cardiac Output (CO), Temperature (dual-TEMP), Expired CO2 and Anesthetic gas (AG). The monitor is equipped with alarms that indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
iM50 :
The monitor monitors parameters such as ECG (3-lead, 5-lead selectable), Respiration (RESP), Functional arterial oxygen saturation (SpO2), Invasive or noninvasive blood pressure (dual-IBP, NIBP), Temperature (dual-TEMP), Expired CO2 and Quick Temperature indicate system faults (such as loose or defective electrodes), physiologic parameters that have exceeded the limits set by the operator, or both.
The arrhythmia detection and ST Segment analysis are not intended for neonatal patients.
× Prescription Use (21 CFR Part 801 Subpart D) And/Or Over the Counter Use (21 CFR Part 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
sion of Cardiovascular Devices
510(k) Number K113623